SCIENCE VERSUS LAW IN WTO JURISPRUDENCE - THE (MIS) INTERPRETATION OF THE SCIENTIFIC Evidence in EC Biotech PDF

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New York University Journal of International Law & Politics

Winter 2009
Articles
*341 SCIENCE VERSUS LAW IN WTO JURISPRUDENCE: THE (MIS)INTERPRETATION OF THE SCIENTIFIC
PROCESS AND THE (IN)SUFFICIENCY OF SCIENTIFIC EVIDENCE IN EC-BIOTECH
Antonia Eliason [FNa1]
Copyright (c) 2009 New York University Journal of International Law and Politics; Antonia Eliason
I.
Introduction
342
II.
Overview
347
A. EC-Biotech Background
347
B. Legal Speak vs. Science Speak
352
C. The Science Behind GMOs
354
D. GMOs and Risk Assessment
357
E. Hazards of GMOs
363
F. European and U.S. Views of the

Precautionary Principle
III.
Science and the WTO
365
372
A. Risk Assessment and the SPS

Agreement--Articles 5.1 and 5.7
372
B. The Panel's Use of Expert Testimony
381
C. Scientific Evidence and the Panel's Interpretation in the Cases of T-25,

Bt-176, and MON810
386
2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
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1. T-25, Bt-176, and MON810

Maize: Background
2. Article 5.1 Analysis
V.
389
a. Article 5.1 Analysis of T-25

Maize
389
b. Article 5.1 Analysis of Bt-176

Maize
392
c. Article 5.1 Analysis of MON810

Maize
395
IV.
387
397
a. Article 5.7 Analysis of T-25

Maize
397
b. Article 5.7 Analysis of Bt-176

Maize
398
c. Article 5.7 Analysis of MON810

Maize
400
Towards a Solution to the Legal/

Scientific Divide
400
Conclusion
404
*342 The clashing point of two subjects, two disciplines, two cultures--of two galaxies, so far as that goes-ought to produce creative chances. In the history of mental activity that has been where some of the breakthroughs came. The chances are there now. But they are there, as it were, in a vacuum, because those in the two
cultures can't talk to each other.
--C.P. Snow, The Two Cultures (1959)
I. Introduction
The World Trade Organization (WTO) today reflects the shifting of the trade law paradigm from a focus on reducing
tariffs as seen in its predecessor, the 1947 General Agreement on Trade and Tariffs (GATT), to a more multifaceted ap-
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proach emphasizing non-tariff barriers as the major hurdles to trade liberalization. The agreements that now make up the
WTO encompass a broad array of trade issues, ranging from subsidies to financial services to agriculture to health-related measures. While the GATT remains at the heart of the WTO, the other, more narrowly tailored multilateral agreements permit sector-specific measures to be implemented and provide frameworks for exceptions to the GATT regime,
addressing the non-tariff barriers that today form the biggest obstacles to furthering free trade.
The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) is representative of the
post-tariff-oriented trade regime. It attempts to resolve trade issues arising from measures designed to protect human,
animal, or plant life or health, applying to all sanitary and *343 phytosanitary measures which may, directly or indirectly, affect international trade. [FN1] The Agreement encourages harmonization, suggesting that Members base their
measures on international standards whenever possible. [FN2] Most importantly for the purposes of WTO jurisprudence,
the SPS Agreement requires that Members base their measures on risk assessments, except in cases where relevant scientific evidence is insufficient, in which case Members may provisionally adopt sanitary and phytosanitary measures on
the basis of available pertinent information. [FN3]
The obligations contained in the SPS Agreement are supplemental to the GATT, meaning that an SPS measure is not
presumed to be GATT legal. In reviewing such a measure it would first be evaluated under the more specific SPS Agreement and thereafter under the GATT. So, for example, a protectionist SPS measure would still be scrutinized under the
national treatment obligation of Article III:4 of the GATT. [FN4] The SPS Agreement provides both a means for Members to implement necessary measures that might otherwise be in violation of the GATT's most-favored nation (MFN) or
national treatment obligations, as well as a way to ensure that such measures are not unduly discriminatory by requiring
that they be based on scientific principles and not maintained without sufficient scientific evidence, with the exception of where sufficient scientific evidence does not exist. [FN5]
*344 The WTO Dispute Settlement Understanding (DSU) provides a means of resolving disputes that arise between
Members under the WTO agreements. If no mutually satisfactory solution is reached, a request for the establishment of a
panel is submitted by the complaining party. [FN6] Panels generally have three panelists, who are nominated by the Secretariat and agreed upon by the parties, and who are well-qualified governmental and/or non-governmental individuals.
[FN7] There is no requirement that the panelists possess expertise specific to the case, although the list of qualified potential panelists kept by the Secretariat indicates areas of expertise to allow for the selection of panelists particularly
qualified for the case in question. [FN8]
Following the hearings and submissions by the parties to the dispute, the parties to the dispute have an opportunity to
object and notify the Dispute Settlement Body (DSB) of their intention to appeal the panel report. [FN9] In reviewing
panel decisions, the Appellate Body (AB) is limited to issues of law covered in the panel report and legal interpretations
developed by the panel and cannot review facts. [FN10]
Each step of the dispute settlement process is supposed to occur according to a strict time-frame, although in practice,
disputes, particularly ones requiring expert testimony and an evaluation of scientific evidence, tend to run considerably
over the mandated time-frame.
WTO case law dealing with the SPS Agreement has made clear that in order to pass judgment on the compatibility of
particular measures with this agreement, it is necessary for panels and the AB to delve into the realm of science in order
to clarify the legal meaning of the SPS Agreement's text. This process, as will be discussed throughout this Article, is
fraught with difficulties, since the persons tasked with adjudicatory functions are not themselves scientists and find themselves applying legal logic to questions of scientific evidence.
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*345 In a world where technology and science are intertwined with daily life, we are all becoming amateur scientists.
Bombarded by information regarding new science-based products, and inundated by articles popularizing-- and often incorrectly characterizing--recent scientific discoveries, it is not surprising that we are turning the language of science into
a rhetoric of political and commercial use. The infiltration by non-scientists into the scientific domain extends beyond
popular media into the realm of law, where the discipline's specialized focus on the literal meaning of words poses a particular difficulty for understanding scientific research processes and concepts. Nevertheless, as novel scientific techniques increasingly become a part of daily life, it is imperative that legal and regulatory bodies address the pressing concerns arising from these discoveries, particularly the potential health and environmental safety issues they raise. What is
required, not only in the context of WTO disputes but more generally in the international legal arena, is a better dialogue
between the disciplines of law and science and an elucidation of goals designed to facilitate cross-field communications.
The gap in the legal understanding of science affects not only the validity of the panels' interpretations of science, but
also the logic underlying their legal rationale in applying the SPS Agreement. [FN11]
How panels understand the process of scientific experimentation and how they view the empirical weight of experimental data affects their application of the relevant legal rules *346 and the consequent outcomes of their rulings in disputes involving the SPS Agreement. Furthermore, how scientific experts perceive questions concerning science posed by
legal experts affects how their responses are shaped, and panels' use of expert testimony is indicative of the difficulties in
breaching the lawyer-scientist communication gap. As a growing number of products based on cutting edge scientific
technology reach the market, the need for consistent interpretation of scientific evidence with regards to risk assessment
will continue to increase. As it stands, however, the approach used by WTO panels to interpret scientific evidence will
exacerbate disputes, reflecting as it does a flawed understanding of the principles of scientific research. The WTO methodology of interpretation of scientific evidence is, therefore, of great importance for future disputes, not just regarding
the SPS Agreement, but more broadly, regarding all products based on novel scientific technologies.
This Article examines the issue of interpretation of scientific evidence by panels primarily within the framework of
the European Communities (EC)-Biotech decision, but also looks to the recent US-Hormones Suspension and CanadaHormones Suspension panel decisions (US/Canada-Hormones Suspension). [FN12] Part II lays out the basic framework for this discussion, beginning with a brief overview of the EC-Biotech decision, followed by a discussion of the
difference between the semantic understanding of legal experts and that of scientific experts, and the general role of risk
assessment and the precautionary principle in the international legal order. This Part also provides a background for nonscientists on the science underlying the creation of genetically modified (GM) products.
Part III examines the relevant portions of the SPS Agreement (Articles 5.1 and 5.7) from the context of the panel's
*347 evaluation in EC-Biotech. While the issue of how to interpret scientific evidence has already been brought to light
in previous SPS-related cases, [FN13] EC-Biotech gives clear shape to the problem. A brief look at the use of expert
testimony in by the panels in EC-Biotech and US/Canada-Hormones Suspension is followed by an examination of the
panel's analysis of the compatibility of safeguard measures pertaining to three GM products (T-25 maize, Bt-176 maize,
and MON810 maize) with Articles 5.1 and 5.7 of the SPS Agreement.
In Part IV, the Article highlights some of the problems raised by the EC-Biotech panel's approach to scientific processes and offers some suggestions on how to convey the scientific community's understanding of scientific evidence to
non-scientist legal professionals who will increasingly be forced to face legal issues that are indelibly intertwined with
science, both in the WTO and in a variety of other international judicial settings.
II. Overview
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A. EC-Biotech Background
The analytical approach taken by WTO panels in recent decisions, most notably EC-Biotech and US/
Canada-Hormones Suspension, is illustrative of the problem posed by the law/science divide. EC-Biotech is particularly
crucial to this discussion because it embodies an attempt by the panel to synthesize and comprehend thousands of pages
of scientific evidence and expert testimony. EC-Biotech addresses safeguard measures imposed by European Union
(EU) Member States banning various genetically modified organisms (GMOs), and raises a number of controversial
questions concerning specifically the safety of GMOs and, more generally, the role of the precautionary principle in
WTO jurisprudence. These matters will be discussed in much greater detail later in this Article. [FN14]
*348 Since the case deals with SPS measures, it is important to clarify what an SPS measure is, as the intertwining of
science and law stems from the nature of these measures. As defined in Annex A(1) of the SPS Agreement, an SPS measure is one which is 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;
(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. [FN15]
In other words, SPS measures are designed to protect human, animal, and plant life or health from risks associated
with diseases, pests, and contaminants. Additionally, SPS measures can be used to protect against environmental
risks. At the heart of SPS measures is the notion of protection against risk, and the terms of the SPS Agreement are
broad enough to include a wide variety of possible risks as acceptable justifications for the imposition of an SPS measure.
More so even than in EC-Hormones [FN16] which concerned an EC measure banning the administration of certain
hormones to cattle due to concerns regarding human health, scientific *349 principles have a fundamental effect on the
EC-Biotech panel's analysis of safeguard measures under Articles 5.1 and 5.7 of the SPS Agreement, [FN17] which is
shaped by the panel's interpretation of scientific evidence. That this interpretive process is flawed can be seen from the
decreasingly logical analyses of scientific evidence by various decisional panels, exemplified by the sequence of decisions from EC-Hormones to EC-Biotech to US/Canada-Hormones Suspension. While the conclusions of the panels
may not themselves be incorrect, a flawed interpretive process will reduce legal certainty and undermine the precedential
value of the corresponding decisions, at the same time diminishing the public legitimacy of the WTO. As Robert Howse
suggests, [d]espite formal democratic legitimacy, the social legitimacy of the [WTO] rules themselves could easily be
undermined by interpretations of those rules that do not themselves command legitimacy. [FN18]
The EC-Biotech dispute arises out of the different approaches taken by the United States and the European Communities (EC) [FN19] regarding the regulation of new agricultural biotechnologies. [FN20] As Winickoff and others
have argued, the United States has chosen to adopt the products approach to GMOs, which assumes that no untoward
risk occurs merely from applying this technology to agricultural production, while the European Union (EU) and its
member states have tended to adopt the more precautionary process approach. [FN21] In June 1999, EU member state
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policy on GMOs became more *350 restrictive, and after 1998, EU member states ceased granting new approvals of
GMOs. [FN22] The United States, Canada, and Argentina challenged the EU's restrictions on GMOs, calling for consultation with the EC on May 14, 2003. [FN23]
On September 29, 2006, the panel issued its decision regarding measures to bar the entry of certain biotechnology
products, namely various genetically modified crops, into the EU. This decision, coming more than three years after the
request for the establishment of the panel, was not only the longest in the history of WTO decisions, but was also one of
the most complex, incorporating a wealth of scientific evidence in an effort to determine whether the EU's measures were
in compliance with the SPS Agreement and based either on acceptable risk assessments (Article 5.1 of SPS) or on the absence of sufficient scientific evidence to perform risk assessments (Article 5.7 of SPS). The case concerned (1) the operation and application by the European Communities of its regime for approval of biotech products; and (2) certain
measures adopted and maintained by EC member States prohibiting or restricting the marketing of biotech products.
[FN24] Adding to the complexity of the decision, several of the GMOs in question had been found to be safe by the EU's
approval regime but barred from entry into specific member states by member state measures, reflecting the EU's internal
struggles to achieve harmonization of biotech approval policies. [FN25] It is on these safeguard measures that this Article focuses, since it is in the analysis of these measures that the EC-Biotech panel errs in interpreting the risk assessment process and the consequent application of Articles 5.7 and 5.1 of the SPS Agreement. It is noteworthy that the
measures in question in EC-Biotech are to *351 a large extent no longer in force, and the decision does not address the
new EU-level regulatory framework now in place.
The EU regime in place at the time of the complaint consisted of a directive concerning the deliberate release into
the environment of genetically modified organisms (Directive 2001/18) and a regulation concerning novel foods and
food ingredients (Regulation 258/97). [FN26] Directive 2001/18 addresses the precautionary principle in its preamble:
The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account
when implementing it. The precautionary principle, which will be discussed in more detail below, [FN27] has been
defined by the EC as applying where scientific evidence is insufficient, inconclusive or uncertain and there are indications through preliminary objective scientific evaluation 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 chosen level of protection chosen by the EU. [FN28] Its invocation by the EU in the context of GMOs sets the tone for the mechanisms available to member states under the Directive and the Regulation, particularly the availability of safeguard measures to
Member States in respect of biotech products approved at the EU-level. [FN29] Once imposed, a safeguard*352 measure
must be relayed to the European Commission as well as to other Member States, and a decision on the measure must subsequently be made at the Community level within a period specified in the Directive. [FN30]
In its decision in EC-Biotech, the panel found in favor of the complainants, the United States, Canada, and Argentina,
holding that none of the challenged EC Member State safeguard measures were based on risk assessments under Article
5.1 of the SPS Agreement, nor were they compliant with Article 5.7 of the SPS agreement. [FN31] The rationale behind
the panel's conclusion will be further examined in Part II.
B. Legal Speak vs. Science Speak
As the debate over GMOs has intensified in the legal and regulatory communities, the use of scientific evidence by
non-scientists has correspondingly increased. While it would be impossible to conduct thorough discussions of GMOs in
the absence of scientific information, the legal community has approached scientific articles and statements by scientific
experts from a legal rather than a scientific perspective They consequently ignore fundamental differences between what
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I term science speak and legal speak, or rather the meaning carried by words used by scientists as compared to their
corresponding meaning to legal authorities. What, then, is this difference, and why is it so important?
From a legal standpoint, words carry enormous weight and must be interpreted as literally as possible given the surrounding legal and regulatory environment so as to prevent interpretive ambiguity. This does not mean adopting a strict
textualist approach that ignores the richer contextual matrix to the detriment of the resulting legal decision, as discussed by Joseph Weiler and Henrik Horn in their excellent critique of the AB's failings in this respect in the ECSardines case. [FN32] Instead,*353 the point concerns the methodological differences between legal reasoning and scientific reasoning. To put it in a different way, as Crawford-Brown and colleagues state: An important aspect of science
is that it is by nature progressive, with methods designed to approach a better understanding over time. Judicial decisionmaking, in contrast, requires a quick and definitive response to a controversy thought desirable to settle then and there,
once and for all. [FN33] In such a context, an expert's testimony that she cannot conclusively state anything concerning
the possible risks inherent in a product due to the lack of evidence could logically be interpreted as stating that there is
insufficient evidence to reach a conclusion (i.e. to complete a risk assessment).
On the other hand, for a scientist, the same comment is merely a statement of fact. Science is rarely conclusive, and
a good scientist will almost never make emphatic statements of conclusive fact, but will rather qualify every declaration
to reflect the uncertainties inherent in scientific research. As Stephen Breyer writes, scientists will often hesitate to
state conclusions, publicly and on the record, that reach beyond scientifically acceptable evidence. They may say no
more than there is some evidence that. . . or there is no acceptable evidence that. . ., although they also know that how
they phrase their statement will inevitably affect the regulator's ultimate decision. [FN34] The difference between legal
speak and science speak may seem at first glance to be slight. In practice, however, a scientist's unwillingness to make
unqualified statements may result in a dialogue between the scientist and the lawyer where each speaks at the other with
seeming mutual comprehension while in fact neither party is fully aware of the semantic differences that result in different meanings being given to the same phrases in a scientific versus a legal context.
Although the panels in EC-Hormones and EC-Biotech appear to clearly separate risk assessment from political risk
management, it is impossible to fully differentiate the two when addressing the potential environmental hazards of
GMOs. The importance accorded to protecting the environment, even in the face of great scientific uncertainty concerning the level of risk, is both a political and a scientific issue, and cannot*354 ignore national preferences. To suggest that
these preferences cannot exist is effectively to claim that a uniform level of risk acceptability must be imposed on a global scale; a claim not that different from arguing that if euthanasia is accepted as a fundamental right in one state then, irrespective of national preferences, all states must permit euthanasia.
Underlying the discussion of legal versus scientific reasoning is the difficulty of reconciling two vastly different
standards that must operate concurrently in assessing environmental risk--the subjective standard based on risk acceptability and the objective scientific processes used to determine potential risks. Even though the EC-Biotech panel attempts
to squeeze the entire analytic process into an objective and narrow rule, without concrete minimum and maximum
threshold values globally applicable to the determination of whether sufficient risk exists to apply safeguard measures,
the objective scientific processes themselves become subjective once viewed through the lens of national regulatory
policies. Science in its purest form may be objective, but once used to make any sort of qualified assessment, it takes on
guises of subjectivity. With this blurring of the subjective/objective divide, the words chosen by scientists in their scholarship and expert testimony lose objectivity when interpreted by panelists whose expertise is legal rather than scientific.
C. The Science Behind GMOs
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Genetically modified organisms, as understood in the context of international trade issues, can be of several varieties. In particular, GMOs can be for planting or for consumption. Within the category of consumption, there is food for
human and for animal consumption. The acceptable level of risk varies with each of these categories, although the underlying science remains the same.
GMOs are produced by inserting foreign genes into the recipient organism's cells. [FN35] There are three major techniques commonly used to insert foreign DNA into a plant genome, all *355 of which rely on recombinant vectors to
carry the foreign DNA. [FN36] The most common technique uses bacteria to transfer a piece of the bacteria's own DNA
into the host plant cells. [FN37] The second technique involves the use of microinjection, electroporation, or chemical
treatment whereby the DNA is inserted into the plant protoplast (a plant cell without a cell wall). The third technique is
mechanical, relying on high velocity ballistic delivery or microprojectile bombardment to convey the DNA into the plant
cells.
The EC emphasized in its first written submission that on a molecular level none of these methods are actually able
to precisely control where the foreign gene will insert into the recipient cell's genome, or whether the insertion will be
stable. [FN38] Without context, however, this statement is somewhat misleading as it suggests a greater degree of uncertainty in the end product than these methods actually generate. While the exact insertion point cannot be precisely determined at the moment of insertion, subsequent screening and testing will demonstrate where the gene is located.
[FN39] Once the desired gene is transmitted into the plant cell, the process of testing to see whether it has been properly
inserted begins. A key method for screening involves the use of antibiotic resistant markers inserted into the plasmid vectors along with the desired gene. In the initial screening, if antibiotics are administered, only those cells with the antibiotic resistance gene (and consequently the desired gene) will grow. [FN40]
The step of inserting the foreign gene occurs at the very beginning of the process of creating a GM plant, and is followed by extensive experiments, characterization, and in-lab breeding and evaluation before release for commercial consideration. [FN41] The result of this process is that the GM plant is *356 almost as unlikely to experience sudden genetic
variation due to the inserted gene as a non-GM plant. The real potential hazard with GMOs, if there is one, lies not in
some improbable inherent instability, but in their potential long-term environmental effects. The insertion of foreign
genes may, as discussed later, result in changes in molecular pathways, either intentional or unintentional, that could affect how the plant interacts with the soil and organisms around it, giving rise to potentially deleterious environmental effects. [FN42]
The state of scientific knowledge does not automatically impart validity on any claims of risk raised against
GMOs. It is easy for a country with a protectionist bent to state that in the absence of conclusive proof of a product's
safety, the product must be banned due to its inherent risks, even where evidence of such risks is not just non-conclusive
(as would most often be the case in evaluating scientific risk) but non-existent. This does not mean that all scientifically
unjustifiable measures are protectionist--unless discriminating against other countries, measures that succumb to popular
hysteria rather than risk-based precaution will not be found to be protectionist under WTO law. Furthermore, the SPS
Agreement has provisions such as Articles 5.5 and 5.6 in place to identify and eliminate protectionist measures. [FN43]
Nevertheless, the lacunae in scientific knowledge are not in themselves justifications for protectionist or overly precautionary measures.
*357 Protectionism was the underlying charge raised against the EC by the United States and others in ECHormones and EC-Biotech, as well as an undercurrent in the conclusion of the panel in US/Canada-Hormones Suspension. [FN44] However, not all of the concerns about GMOs expressed by the EC in EC-Biotech are merely a protectionist excuse for restricting trade, but reflect as-of-yet unresolved scientific questions and concerns. Equally, not all of the
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claims made in EC-Biotech are of much scientific validity and instead reflect more protectionist goals. Adding to the
problem of determining which measures in question in EC-Biotech are based on sound science and which are not is the
fragmented nature of EU GMO policy, where despite directives aiming to harmonize GMO adoption EU-wide, individual
member state concerns have frequently overridden these policies to implement their own, nationally oriented interpretations of the precautionary principle.
At stake in this discussion is not an evaluation of whether GMOs are safe or not, but whether the ability of WTO
members to impose safeguard measures is being undermined by the legal reasoning used in the panel report on ECBiotech. This analysis requires placing the scientific debate concerning GMOs within the regulatory framework as interpreted by the panel in order to understand how, irrespective of the conclusion, the reasoning used by these legal experts
is flawed.
D. GMOs and Risk Assessment
In order to properly evaluate the panel's interpretation of science in EC-Biotech, understanding the nature of risk assessment concerning novel scientific products and GMOs in particular is crucial. It is also important to consider the sliding-scale nature of risk assessment as well as the differences in views, legitimate or not, of risk assessment between the
United States and the EU. Furthermore, an examination should be made of how risk assessment and management in the
political and legal arenas are perceived when shaping policy regarding matters of scientific complexity. Any endeavor
will necessarily *358 have certain risks, both internal and external. The question is how those risks are evaluated, and
what, if anything, is done to address them. These complexities must be kept in mind when analyzing how the panel in
EC-Biotech navigated the provisions of the SPS Agreement, since the approach is influenced by the panel's understanding of risk assessment in the context of GMOs.
The basic paradigm of safety assessment includes hazard identification and characterization, exposure assessments,
and subsequent risk characterization. [FN45] The aim of such a safety assessment is to show that the GM food is as safe
as its traditional counterpart and that it does not introduce new risks. [FN46]
The leading principle for food safety assessment of GMOs is the principle of substantial equivalence, which was predominantly formulated by the Organisation for Economic Co-operation and Development (OECD). [FN47] This principle is based on the assumption that the history of safe use of conventional plants can establish a baseline for the safety
assessment of new GM plant varieties derived from established plant lines. [FN48] The application of the principle requires thorough compositional analysis of the varieties under scrutiny (the GM line and its traditional counterpart).
[FN49] As Cellini and others explain, three possible scenarios exist when applying the principle of substantial equivalence: (1) the novel food is equivalent to an acceptable traditional food, requiring no further testing; (2) the novel food is
equivalent to its traditional counterpart except for some well defined differences requiring targeted safety assessments;
or (3) the novel food differs from its traditional counterpart in many ways or there is no traditional counterpart, requiring
an extensive safety assessment. [FN50]
In 1986, the OECD adopted a basic framework for risk assessment of transgenic plants, which offered scientific principles that could be used in formulating risk management approaches*359 for dealing with GMOs. [FN51] Other relevant
OECD documents include the 1993 Safety Evaluation of Food Derived by Modern Biotechnology, which specifically addresses the substantial equivalence principle, stating in its forward that it elaborates scientific principles to be considered in making such evaluations, based on a comparison with traditional foods that have a safe history of use. [FN52]
The OECD is also a strong driver of the movement to harmonize biotechnology regulations. [FN53]
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Despite the widespread use of the principle of substantial equivalence in evaluating food safety for GMOs, it is not a
perfect test. Among the obstacles to thoroughly comparing GMOs to their traditional equivalents is fragmentary knowledge of key factors such as levels and toxicity of anti-nutritional factors in less economically important crop plants,
varying environmental conditions, and the potential difficulty in finding an appropriate comparator to the GM line.
[FN54] The last point is particularly important, since the direct parent line from which the GMO is derived is molecularly the proper comparator, but may no longer be available, if for instance it is in the possession of another breeding
company. [FN55]
A similar approach has been taken regarding ecological risks, although their evaluation requires a larger-scale multifactor analysis. As defined by the United States Environmental Protection Agency (EPA), ecological risk assessment is
a process for evaluating the likelihood that adverse ecological effects may occur or are occurring as a result of exposure
to one *360 or more stressors. [FN56] In performing ecological risk assessments, both the GMO and the environment
into which the GMO may be introduced must be evaluated. This evaluation combines an assessment of the stability of the
GMO with the ecological characteristics of the environment in question and the potential unintended effects caused by
the insertion of the new gene both on the GMO and on the environment. [FN57] Since GM crops often address pressing
food supply needs, the relevant ecological risks should be evaluated in light not only of the ecological and agricultural
environment, but also in terms of the socio-economic and cultural environment. [FN58] As such, the weight given to the
scientific element of the risk assessment process may be counterbalanced by socio-economic needs depending on the relative value of factors such as biodiversity compared to factors like insect resistance or increased crop yield.
Ecological risk assessment procedures are less uniformly defined and accepted than human health-related risk assessment processes in part due to the multiplicity of factors involved and the difficulty of performing comprehensive ecological testing without exposing the environment in question to the risks being tested for. [FN59] From a scientific perspective, as Romeis and others explain, [e]cological risk assessment for regulatory purposes is commonly organized in a
step-wise (tiered) approach, where the assessment increases in complexity and realism based on the knowledge gained
during previous tests. [FN60] While encompassing similar elements, the varying *361 procedures outlined by governmental agencies and NGOs are sufficiently different to make a legal analysis of ecological risk assessments more difficult, since there is no uniform international standard to apply.
According to EU guidelines, the same four step process is followed in an ecological risk assessment as in a health
risk assessment: (1) the identification of the hazard, (2) an effects assessment to identify the hazard based on its properties and intended use, (3) an exposure assessment in which the predicted environmental concentration is determined, and
(4) characterization of the risk. [FN61] The U.S. EPA has also published guidelines on performing ecological risk assessment. [FN62] These guidelines, similar to those issued by the EU, divide the process into two major elements
(characterization of effects and characterization of exposure), which provide the focus for the three phases of risk assessment: problem formulation, analysis and risk characterization. [FN63]
Of particular importance to the GMO debate in the WTO context are the standards issued by the Codex Alimentarius
Commission and the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Cartagena Protocol). Established by the UN Food and Agriculture Organization and the World Health Organization, the Codex Alimentarius Commission is explicitly recognized in the preamble to the SPS Agreement and has issued a number of standards concerning foods produced using recombinant DNA technology. [FN64] Measures that conform to these standards
are presumed to be *362 compliant with both the SPS Agreement and the GATT, giving them considerable legal weight.
[FN65] According to the Codex Alimentarius Commission's Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology, risk assessment includes a safety assessment, which is characterized by an assessment of a
whole food or a component thereof relative to the appropriate conventional counterpart:
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A) taking into account both intended and unintended effects;

B) identifying new or altered hazards;
C) identifying changes, relevant to human health, in key nutrients. [FN66]
This application of the principle of substantial equivalence continues by requiring that risk assessments take into account all available scientific data and information derived from different testing procedures, provided that the procedures are scientifically sound and the parameters being measured are comparable. [FN67]
The Codex Alimentarius Commission's Principles takes its definition of modern biotechnology from the Cartagena
Protocol. [FN68] While not of equivalent legal weight in the WTO context to the Codex Alimentarius Commission's
guidelines, the Cartagena Protocol is particularly applicable to the GMO debate since it addresses not only food safety issues but also those pertaining to environmental concerns. [FN69] Adopted in 2000, the Cartagena Protocol currently has
147 ratifiers but has yet to be recognized as an international standard by the WTO. It embraces the precautionary approach as elaborated in Principle 15 of the Rio Declaration on Environment and Development *363 both in its preamble
and in Article 1 of the Protocol, which sets out its objectives. [FN70] Apart from this endorsement of the precautionary
principle, the approach to risk assessment set out by the Cartagena Protocol is quite similar to that of the SPS Agreement.
E. Hazards of GMOs
As suggested by the discussion above, the major potential hazards posed by GMOs fall within two categories: hazards to human health and hazards to the environment. [FN71] The more problematic hazards from a perspective of availability of scientific evidence, and the ones fundamentally at issue in the EC-Biotech case, are environmental. Environmental hazards largely overlap with the hazards found to human health, including toxicity, antibiotic resistance, and gene
transfer, as well as particularly non-target effects like invasiveness and development of resistance. They also are concerned with the unintended effects arising through GMO-related management practices and micro-environmental issues,
such as loss of biodiversity. [FN72] These hazards most clearly reflect the novelty of GMOs and raise the most contentious questions concerning levels of acceptable risk, since at stake are not just individual human and animal lives, but potentially entire ecosystems. The overlap of the political, legal, and scientific dimensions of GMOs in domestic regulations can be better understood by outlining the potential hazards of GMOs. In the context of EC-Biotech, understanding
these hazards provides guidance in differentiating protectionist from legitimate measures. At the same time, an overview
of the hazards of GMOs emphasizes the inherent uncertainties in characterizing and isolating these hazards.
*364 The three major categories of environmental hazards are: (1) non-target and biodiversity risks, (2) risks associated with gene flow and recombination, and (3) risks associated with the evolution of resistance in the target organisms.
Most relevant to the discussion in EC-Biotech are non-target and biodiversity risks, which include effects on nontarget species, ecosystem functions, and soil content. [FN73] Non-target species include beneficial species, non-target
herbivores, soil organisms, endangered species, and species contributing to local biodiversity. [FN74] Among the possible effects on such non-target species is toxicity, where a particular product designed to be specifically toxic to target
organisms is less specific than anticipated and negatively affects the non-target species through its toxicity.
The classic example, discussed in greater detail in Part III of this paper, is the negative effect of the Cry1Ab toxin
(found in Bt corn) on certain butterfly larvae. [FN75] The evolutionary process of scientific research in the area of
GMOs is highlighted by studies conducted on butterfly larvae, since earlier studies found insignificant risks, while more
recent studies have revealed a much higher toxicity of Bt pollen and anthers than found in previous studies. [FN76]
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This shift in perception may be due to the change in research focus from commercial corn fields to dispersal of pollen
and growth of GM crops in non-intended areas. [FN77] Recent studies have also demonstrated that the Cry1Ab toxin
may have effects on the soil, where the toxin can persist for months, potentially hurting soil biodiversity. [FN78] Such
risks are of concern to areas with fragile ecosystems and endangered non-target species, and underline the possibility that
future risk assessments may result in considerably different outcomes as the focus of the assessments and techniques
used are modified.
Gene flow, which is the incorporation of genes into the gene pool of one population from one or more other populations,*365 [FN79] is among the most frequently highlighted potential risks of GM crops. Relatively easy to understand
from a lay perspective, gene transfer in the context of GMOs occurs when a GM plant's seeds become dispersed and
cross with a non-GM plant. Since GM plants are often intentionally hardier than their non-GM cousins, this can potentially lead to a loss of biodiversity and an upsetting of delicate ecological balances, particularly in micro-environments
with localized indigenous species. [FN80]
Of the major categories of environmental risks, risks associated with organisms evolving new resistances are of the
greatest immediate concern: about 99% of all transgenic crops worldwide are Bt or herbicide-tolerant crops. [FN81] In
the event of resistance passing to the organisms targeted by the pesticide or herbicide, the effects on food sources and
crop yields could be striking as commonly used herbicides and pesticides would become ineffective in controlling weed
or insect populations. Herbicide and pesticide resistance has already occurred in a multitude of species through natural
evolution. Resistance-management techniques have been used in controlling Bt crops, which to date have not led to any
resistance failure. [FN82] As with the aforementioned risks, risks related to evolving resistance are not unique to GMOs
but may be heightened by the increased hardiness of GM crops.
F. European and U.S. Views of the Precautionary Principle
Having provided a brief overview of the major potential risks with GMOs, I now sketch out the major differences
between European and U.S. views of the precautionary principle, particularly concerning GMOs. The precautionary
principle espouses a goal of preventing rather than reacting to environmental harm, [FN83] and understanding where
the EU and the United States differ in their approach is important to comprehend how difficult it is for any legal body to
evaluate the merits*366 of each party's arguments. It is not just a question of clear-cut scientific procedure, but also a
matter of differing standards of risk acceptability.
European and U.S. views of the precautionary principle reflect the two main schools of thought on the subject. The
EU and its member states have agreed that the precautionary principle plays an important role in addressing GMO-related questions, but disagree as to its application. At the European Community treaty level, only Article 174 (on environment) makes explicit reference to the principle. [FN84] The Commission has held, however, that this does not limit the
application of the precautionary principle to environmental issues. [FN85] When faced with potential risks involving
novel scientific or technological products that could harm human or environmental health, the EU has vacillated in
choosing the appropriate strength of the precautionary principle, with the European Court of First Instance (ECFI) taking
a stronger position, and the European Court of Justice (ECJ) suggesting a weaker interpretation of the precautionary principle. [FN86] Under the rationale of the precautionary principle, individual member states are entitled to implement their
own national legislation affording their own desired levels of protection as long as such legislation is not based on a
purely hypothetical approach to risk. [FN87] Despite the ECFI's adoption of a relatively strong version*367 of the precautionary principle, Joanne Scott has highlighted how the ECFI's language concerning its approach to the precautionary
principle was clearly influenced by the jurisprudence of the WTO. [FN88] A desire to harmonize regulations concern-
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ing GMOs has contributed to the moderation of the precautionary principle in the related jurisprudence of the ECJ. Member states, however, remain hesitant to accept any such limitations of the principle, and have consequently applied a
stronger version of the precautionary principle in many of their decisions concerning novel scientific products, as seen in
the EC-Biotech challenge. This disagreement between member states and EU institutions on the acceptable scope of the
precautionary principle within the EU is indicative of the range of differing risk acceptability levels at issue in complex
cases like EC-Biotech. Disagreement as to the application of the precautionary principle exists not only between parties
with widely differing interpretations of the precautionary principle, such as the US and Europe, but also within the EU itself, reflecting the lack of a unified interpretation of what the precautionary principle is.
Recent ECJ case law has addressed both member state refusal to acquiesce to marketing of GMOs approved by the
Commission and the applicability of the precautionary principle. In Monsanto v. Italy, the fast-track approval procedure
established in Regulation 258/97 was challenged by Italy on the basis that the GMOs in question required a full review
under the normal procedure. [FN89] The ECJ's ruling attempted to assuage both member state concerns and EU concerns
by finding that while the mere presence in novel foods of residues of transgenic protein at certain levels does not preclude those foods from being considered substantially equivalent to existing foods, fast track does not apply if there is
scientific knowledge at the time of the assessment of a risk of potentially dangerous effects on human health. [FN90]
*368 In the recent case of Italy v. Codacons, the GMO issue in question was one of labeling under Regulation
1139/98. [FN91] While the Regulation only requires that accidental presence of GMOs over a threshold of 1% of the final product be indicated on food labels, Codacons, contrary to the Italian health ministry's view, argued that the threshold
should not apply to baby food on the basis of the precautionary principle. [FN92] The ECJ held that since all of the
GMOs covered by the Regulation had undergone thorough risk assessment before authorization, further precautionary
measures were not justified. The Court also reasoned that while the precautionary principle, where relevant, is part of
such a decision-making process, [FN93] the precautionary principle, presupposes that there is uncertainty as to the existence or extent of risks to human health. [FN94] While the ECJ's assessment of the scope of the precautionary principle in Codacons seems on its surface to be narrower than its view of the precautionary principle in Monsanto, the factual circumstances of Codacons are much more limited than Monsanto. In Codacons, the Italian health ministry itself did
not see the applicability of the precautionary principle, so in making its ruling, the ECJ was not ruling against member
state policy.
Member states are wary of the EU's movement towards harmonization of regulations concerning GMOs. The biggest
fear of member states is that harmonization will result in the abandonment of member state interests. As Rafael LealArcas argues, [a]lthough the EC increasingly wants to become an international actor and somehow assert its international personality and identity, it also has to accept that member states and third parties have legitimated interests. [FN95]
This results in the use of the precautionary principle by member states as a catch-all exception to permit them to circumvent EU-wide legislative measures. At issue in EC-Biotech, for instance, were member state safeguard measures applied
on the basis of the precautionary principle to counteract Commission approval of EU-wide marketing of specific GMOs.
*369 While the EU has a broad capacity to enact policies that will further the complete integration of the market,
[FN96] member state concerns regarding the possible loss of national control over key issues such as approval of GMOs
and environmental safety have hindered the harmonization process and highlighted the importance of the precautionary
principle at a national level. The precautionary principle is perhaps applied most strongly by France, where in February
2005 an amendment was added to the French constitution explicitly recognizing the precautionary principle. [FN97] The
supremacy of EU law established in Costa, even at times over national constitutions, is most likely to be challenged in
France, where the constitutionally enshrined precautionary principle will almost inevitably come up against EU legislation. [FN98] In the seminal 1998 French case Sarran, the Conseil d'tat held that the supremacy conferred on internation-
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al agreements does not apply in the internal legal order to provisions of a constitutional nature. [FN99] The implication
of this decision when taken in conjunction with the newly adopted constitutional protection of the precautionary principle
is significant--not only for France, but also for the EU. In effect, since the precautionary principle is now a constitutional
provision, Sarran provides France with a backdoor mechanism to block all EU efforts at harmonizing GMO legislation.
The EU's approach to the application of the precautionary principle vis--vis GMOs is limited by the ability of member states to implement their own interpretation of the principle. The broad version of the precautionary principle commonly attributed to the EU is not entirely a result of the adoption of such a viewpoint at the EU-level, but is also a result
of pressure from member states. This has led to some confusion in the *370 GMO approval process, where member
states and the EU often have conflicting interests. While the panel in EC-Biotech addressed the EU GMO regime as a
supranational legal regime due to the EC's role as voice of all EU member states in the WTO, this conflict of interest
between the EU and its constituent states in the application of the precautionary principle should be kept in mind.
The United States has taken a much more narrow approach to the precautionary principle, particularly in the context
of GMOs. In the 1980 case, Industrial Union Dept., AFL-CIO v. API, the U.S. Supreme Court held that OSHA had to
demonstrate significant risk before imposing regulations. [FN100] This ruling narrowed the scope of the precautionary
principle in the United States and led to the use of scientific risk assessment in risk regulation. [FN101] Whereas the EU
focuses on scientific uncertainty in its application of the precautionary principle, the United States requires the existence
of risk, a more stringent standard. While the United States does not accept the precautionary principle as espoused by the
EU, it is wrong to say that Europeans are more precautionary than Americans; instead, as Cass Sunstein argues,
Europeans and Americans are averse to different types of risk. [FN102] Jonathan Wiener makes a similar point, emphasizing that [t]he United States and Europe do not diverge as much as is claimed on the general use of precaution in regulation, but they often do diverge on the particular question of which risks to worry about and regulate most. [FN103]
Wiener lists a range of issues on which the United States has been more precautionary than Europe, including air pollution, mad cow disease, and terrorism. [FN104]
In the United States, the Food and Drug Administration (FDA) regulates the introduction of GM foods while the EPA
regulates GM crops modified to produce plant pesticides such *371 as Bt toxins. [FN105] The fundamental difference
between the European and the American regulatory approaches lies in the characterization of the GM product--in the
United States, GM foods are not considered different from foods produced through other techniques. The U.S. focus is
instead on actual differences between products rather than differences in production methods. [FN106] Only in the cases
of plant pesticides, where the EPA determines a threshold level of tolerance for pesticide residue allowable in raw agricultural commodities under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), and food additives, under
which category introduced foreign gene products may be included, are there lines drawn differentiating between GM
products and their non-GM counterparts. [FN107] This difference in approaches towards GMOs is also manifested in the
different time-frames for product approval, with the United States not surprisingly taking much less time to approve
GMOs than the EU. With regards to GMOs, therefore, the United States clearly applies a less precautionary standard
than the EU. Furthermore, unlike the EU, the United States has not faced conflicting interpretations of the precautionary
principle at the state level.
The different approaches employed by the United States and the EU towards the precautionary principle and risk
management explains some of the complications in evaluating the scientific evidence presented in the EC-Biotech
case. Without an accepted legal definition of the precautionary principle, panels and the AB have struggled to clarify the
principle's role with regards to the SPS Agreement and has followed a somewhat murky approach that balances between
the United States' narrow interpretation of the precautionary principle and the EU's broader, more inclusive understanding of the same. The AB in EC-Hormones simultaneously recognized the presence of the precautionary principle in Art-
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icles 5.7 and 5.3 and in the sixth paragraph of the preamble of the SPS Agreement, agreeing with the EC that the principle was not limited to Article 5.7, while at the same time underlining the notion that by itself the precautionary principle is insufficient to override*372 SPS Articles 5.1 and 5.2. [FN108] This approach, rather than clarifying the contours
of the precautionary principle as applicable to the SPS Agreement, has instead increased confusion as to the WTOcompatibility of measures based on a strong version of the precautionary principle.
III. Science and the WTO
A. Risk Assessment and the SPS Agreement--Articles 5.1 and 5.7

Given the different approaches to risk assessment and the varying interpretations of the precautionary principle discussed above, it is not surprising that the panel in EC-Biotech struggled in its evaluation and interpretation of scientific
evidence in the context of making determinations regarding the sufficiency of evidence and what a risk assessment is
meant to entail. The EC-Biotech panel not only misconstrued the nature of scientific experiments required to evaluate
environmental risk, but also misinterpreted Articles 5.1 and 5.7 of the SPS Agreement and the standard of insufficiency
of scientific evidence required to provisionally adopt an SPS measure under Article 5.7.
The SPS Agreement is the WTO's effort to allow member states to protect human, animal, or plant life or health on
the grounds of scientific evidence, thereby differentiating trade issues requiring scientific studies from general trade issues. Article 2.2 of the SPS Agreement states that Members shall ensure that any sanitary or phytosanitary measure is
applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and
is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5. [FN109]
While not explicitly stated in the agreement, the precautionary principle is embodied in Article 5.7, allowing WTO members to implement SPS measures even in the absence of sufficient scientific evidence. [FN110] In order to harmonize
SPS measures as widely as possible, Article 3.1 instructs members to base their measures on international standards,
guidelines, or recommendations, *373 where they exist. [FN111] Article 3.3 allows a higher level of sanitary or
phytosanitary protection to be imposed if there is a scientific justification, or if the member deems it appropriate in accordance with Article 5. [FN112] As with all other WTO agreements, the SPS Agreement prohibits members from using
SPS measures to arbitrarily or unjustifiably discriminate between members where similar conditions prevail. [FN113]
Most importantly, the SPS Agreement in Article 5.1 requires members to base their SPS measures on a risk assessment.
[FN114] The relevant definitions are contained within Annex A of the SPS Agreement. [FN115]
Annex A(4) of the Sanitary and Phytosanitary (SPS) Agreement defines risk assessment as:
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. [FN116]
Article 5.1 of the SPS Agreement states that:
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.
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The AB in Australia-Salmon found that within the context of Article 5.1, a risk assessment has to:
1)identify the diseases [or pests] whose entry, establishment or spread a Member wants to prevent on its territory, as well as the potential biological and economic*374 consequences associated with the entry, establishment or
spread of these diseases;
2) evaluate the likelihood of entry, establishment or spread of these diseases [or pests], as well as the associated potential biological and economic consequences; and
3) evaluate the likelihood of entry, establishment or spread of these diseases [or pests] according to the SPS measures
which might be applied. [FN117]
The interpretation of this approach to risk assessment in recent WTO cases highlights a key problem with the evaluation of scientific evidence by WTO panels. The EC-Biotech panel proceeded on an assumption that proper risk assessment will entail evaluations of likelihood of risk that can often only be performed through potentially dangerous field trials. [FN118] Evaluating scientific likelihood is a delicate process, since extrapolation from existing laboratory data can
often result in unreliable projections when not coupled with further field testing. But further testing may be impossible
without exposing the environment to the very risk being tested for, particularly if a likelihood of risk emerges in the
laboratory tests. [FN119] Furthermore, field tests are more difficult to control than laboratory tests, since it is impossible
to limit testing in the field to the single or several variables found in well-designed*375 laboratory experiments. Field trials should only be performed if the laboratory results indicate a low likelihood of risk, and even then, small scale field
trials should be initiated before attempting larger scale trials. Improperly conducted field trials would result not only in
possible environmental risks, but in unreliable projections that would undermine the value of risk assessments based on
such evidence.
Article 5.7 of the SPS Agreement provides for Members to provisionally adopt SPS measures on the basis of
available pertinent information where relevant scientific evidence is insufficient:
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. [FN120]
In Japan-Agricultural Products, the AB found that there were four cumulative requirements in Article 5.7 that must
be met in order for a provisional SPS measure to be adopted and maintained:
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 assessment of risk; and
*376 (2) review[s] the . . . measure accordingly within a reasonable period of time . [FN121]
While these criteria seem fairly explicit, they leave room for considerable interpretation. In particular, what consti-
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tutes insufficient scientific information? It is here where the EC-Biotech panel's interpretation of scientific evidence
and testing procedures results in a critical logical error. To the panel, approaching the issue from a legal standpoint, scientific evidence is rarely insufficient for the provisional adoption of an SPS measure if a risk assessment has previously
been performed in accordance with the panel's understanding. In many cases, however, evaluating the likelihood of entry
and establishment of diseases and pests and evaluating the potential for adverse effects on human and animal life may be
difficult without exposing large areas to possible contamination. To a scientist, insufficiency of scientific evidence for
the purposes of a risk assessment will be viewed as a determination subject to change. If there is a risk that a product will
cause serious ecological harm, field trials on a scale necessary to demonstrate the safety or risk of the product should not
be performed without further laboratory testing. Moreover, as molecular and genetic techniques continue to develop,
more potential risks may come to light that were not known about at the time of the initial risk assessment. As this Article argues, the results of a risk assessment are not equivalent to sufficient scientific evidence, and interpreting Article
5.7 in such a light appears to effectively make the provision inapplicable in all but the most obvious cases. Article 5.7
should operate as an exception to the requirement of a risk assessment not only where none has been performed, but also
where new scientific knowledge raises the possibility of risks and results in the existing scientific information becoming
insufficient to properly perform a risk assessment.
In the case of GMOs and other novel technologies, as compared to more traditional applications of science, the uncertainty of scientific knowledge conflicts with the EC-Biotech panel and the AB's understanding of what constitutes
either an appropriate risk assessment or an insufficiency of scientific *377 evidence. As the EC emphasized in its first
written submission in EC-Biotech, the issue in that case was very different than that in Japan-Apples, for instance, where
the safeguard measures were imposed to guard against a blight that had been known about for centuries and that had a
relatively narrow spectrum of possible consequences (compared to GMOs generally). [FN122]
The EC-Biotech panel characterized Article 5.7 of the SPS Agreement as a right and not an exception from a general obligation under Article 2.2, meaning that Article 2.2 excludes from its scope of application the kinds of situations
covered by Article 5.7. [FN123] The four cumulative requirements set forth in Japan-Agricultural Products II and discussed above, however, must still be met for a measure to be consistent with Article 5.7. This means that the right embodied in Article 5.7 is a qualified rather than an absolute right. [FN124] Thus, if all four requirements are met, the obligations of sufficient scientific evidence under Article 2.2 are not applicable; but if any of the four requirements are not
met, an evaluation of the sufficiency of scientific evidence is required as per Article 2.2. [FN125] The burden of proof
for establishing inconsistency with both Article 5.7 and Article 2.2, according to the panel, lies with the complaining
party. [FN126]
Having found that Article 5.7 is a right and not an exception, the EC-Biotech panel proceeded to evaluate the general
relationship between 5.7 and 5.1. Citing the AB in Japan-Agricultural Products II, the panel stated that relevant scientific evidence will be insufficient within the meaning of Article 5.7 if the body of available scientific evidence does
not *378 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. [FN127] The panel concluded by finding that Article 5.7
operates as a qualified exemption from the obligation under Article 5.1 to base SPS measures on a risk assessment.
[FN128]
Referring to the AB in EC-Hormones, the panel emphasized that Article 5.1 does not require a Member to conduct
its own risk assessment, and that risk assessment used as a basis for a measure can be one carried out by another Member or an international organization. [FN129] Furthermore, the SPS Agreement does not require that risk assessments be
of a quantitative nature in order to satisfy the definition in Annex A(4). [FN130] As to the important question of when a
risk assessment must be undertaken in order to be valid, the panel held that both a risk assessment carried out before the
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adoption of a particular safeguard measure and a risk assessment carried out after its adoption could sufficiently warrant, or reasonably support, the maintenance of that measure. [FN131] This flexibility in timing is, however, apparently limited to risk assessments carried out prior to the establishment of a panel. The panel continued to state that while
it is of no particular importance whether a specific risk assessment which is claimed to serve as a basis for a safeguard
measure was performed before or after the adoption of that safeguard measures; what matters is that the relevant risk
assessment was appropriate to the circumstances existing at the time this Panel was established. [FN132]
In highlighting that relevant circumstances may change over time, and that at any given time, SPS measures must
be based on an assessment of risks which is appropriate to the circumstances existing at that time, the panel appears to
have adopted a broad view of what constitutes an assessment appropriate to the circumstances, as defined in Article
5.1. [FN133] This seemingly moderate approach, while not in fact applied *379 in the instant case, offers some possibility for interpretive flexibility in future decisions concerning risk assessment and the SPS Agreement. In particular, this
approach would lend itself to addressing questions of insufficiency of scientific evidence that develop as the state of scientific knowledge evolves. Indeed, in the most recent AB ruling on the subject, the AB in US-Hormones Suspension
found that WTO Members should be permitted to take a provisional measure where new evidence from a qualified and
respected source puts into question the relationship between the pre-existing body of scientific evidence and the conclusions regarding the risk. [FN134] Such flexibility is compatible with an understanding of the process of scientific analysis and offers a means for future panels to better address questions of scientific insufficiency. It remains to be seen, of
course, how this flexibility is interpreted in practice.
It is worth quoting the EC-Biotech panel's view on the interrelationship between Articles 5.1 and 5.7 of the SPS
Agreement and risk assessment at length, since the panel's interpretation fails to take into account that a pre-existing risk
assessment does not necessarily mean that scientific evidence is sufficient to base the SPS measure on the risk assessment in question:
We note in this regard that if relevant scientific evidence were insufficient to perform a risk assessment as
defined in Annex A(1) [sic] of the SPS Agreement and as required by Article 5.1 of the SPS Agreement, pursuant
to Article 5.7 of the SPS Agreement, a Member may provisionally adopt an SPS measure on the basis of available
pertinent information. Contrariwise, in situations where relevant scientific evidence is sufficient to perform a risk
assessment, a Member must base its SPS measure on a risk assessment. Of course, the mere fact that relevant scientific evidence is sufficient to perform a risk assessment does not mean that the result and conclusion of the risk
assessment are free from uncertainties (e.g., uncertainties linked to certain assumptions made in the course of the
performance of a risk assessment). Indeed, we *380 consider that such uncertainties may be legitimately taken into account by a Member when determining the SPS measure, if any, to be taken. In view of these uncertainties, a
given risk assessment may well support a range of possible measures. Within this range, a Member is at liberty to
choose the one which provides the best protection of human health and/or the environment, taking account of its
appropriate level of protection, provided that the measure chosen is reasonably supported by the risk assessment
and not inconsistent with other applicable provisions of the SPS Agreement, such as Article 5.6. [FN135]
The approach articulated by the panel is striking when taken together with its later finding that any risk assessment
which might be required by the first sentence of Article 5.7 would not need to meet the definition of a risk assessment
contained in Annex A(4). [FN136] The panel goes on to state that if the right conferred by the first sentence of Article
5.7 only arises in cases where the scientific evidence is insufficient for an adequate risk assessment as required by Article
5.1 and as defined in Annex A(4), then the kind of risk assessment which the first sentence might require by definition
could not meet the standard set out in Annex A(4). [FN137] This view presents a logical fallacy. There is no reason why
a risk assessment performed by another WTO Member or by the Member imposing the SPS measure under Article 5.7
cannot meet the standard set out in Annex A(4), since advances in scientific processes may undermine the evidentiary
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sufficiency of the risk assessment, despite the risk assessment's sufficiency at the time it was performed.
The panel's emphasis is on what exactly constitutes sufficient scientific evidence to perform a risk assessment. This
approach appears to simultaneously preclude the use of Article 5.7 in the event that a previous risk assessment was performed, despite possible subsequent findings of insufficiency in the previously existing scientific evidence, while allowing for quasi-safeguard measures to be taken in the event that uncertainty exists in the risk assessment as undertaken under Article *381 5.1. Unfortunately, the disputes to date do not shed light on this interpretation and on the precise interlinkage between Article 5.1 and 5.7. A further analysis of this matter will be undertaken later in this Part addressing the
panel's interpretation of specific safeguard measures. [FN138]
B. The Panel's Use of Expert Testimony
The process of asking experts questions is the clearest manifestation in WTO proceedings of the gap between legal
and science speak, since it is the only point at which panelists and scientists directly engage in dialogue. Despite the
clear necessity of using experts to obtain information concerning matters relating to scientific procedures, panels' subsequent interpretation of the responses emphasizes the lack of understanding on the legal side of how scientific processes
operate. The scientific uncertainty involved in evaluating the risks posed by GMOs is apparent not only in the substantive findings of the panel, but also in the expert testimony presented to the panel. The answers provided by the scientific
experts to questions posed by the panel demonstrate both the disagreement found within the scientific community on the
matter of GMOs as well as systemic problems with the process of using experts in the WTO, particularly in addressing
matters open to scientific debate. In many cases, a limited number of experts may offer answers to specific questions, reducing the value of having multiple experts on a given subject. In other cases, panels' decisions to address experts individually rather than as a group have affected the reliability of the responses.
As of the end of 2008, eight WTO decisions had used expert testimony to clarify matters of scientific evidence.
[FN139] Each such decision has addressed the experts individually, rather *382 than as a group, although Article 13 of
the Dispute Settlement Understanding (DSU) allows for expert review groups to be established. A review of the process
and outcomes in all of these decisions is beyond the scope of this Article. Instead, I will focus on a few aspects of the
testimony provided in EC-Biotech and US/Canada-Hormones Suspension to highlight some of the key issues regarding
the use of scientific expert testimony by WTO panels. [FN140]
The answers given by the science experts in response to the EC-Biotech panel's questions reflect the uncertainty surrounding GMOs. As one of the experts, Dr. Geoff Squire of the Scottish Crop Research Institute in Dundee, Scotland,
indicated, one of the problems in addressing scientific issues is the absence of agreed criteria on issues such as the information necessary to perform a risk assessment and the manner in which to interpret the relevant data. [FN141]
Moreover, many of the panel's questions were admittedly outside the expertise of the scientists providing answers. For
instance, in addressing whether antibiotic resistance marker genes (ARMG) could pass from GMOs to bacteria, thus conferring antibiotic resistance, Dr. Marilia Nutti, Director of the National Research Center for Food Technology at the
Brazilian Agricultural Research Corporation in Rio de Janeiro, Brazil, stated that she did not have the required expertise
to address the question relating to environmental safety. [FN142] Even when experts are knowledgeable, keeping up with
current research in the broad range of fields addressed in the panel's questions is nearly impossible. In response to the
question on antibiotic resistance with regards to food and feed, Dr. Nutti stated that to date there were no reports of
marker genes in plant DNA transferring to microbial and mammalian cells. [FN143] The EC disputed *383 this statement, citing a study from 2004 that demonstrated such gene transfer. [FN144]
Another problem with expert testimony submitted to panels is the number of experts addressing each ques-
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tion. Despite the appointment of four general experts (and two specialized ones to address more limited issues), [FN145]
only Dr. Nutti addressed the EC-Biotech panel's question on ARMGs. [FN146] An isolated response defeats the purpose
of consulting multiple scientific experts whose views presumably would be meant to offer either different perspectives or
a unified voice on the issues in question. A single opinion is insufficient to provide a panel with legitimate guidance, particularly regarding issues as controversial and disputed as those surrounding GMOs. Furthermore, individual scientists
cannot be expected to have a flawless knowledge of all experimental results, as discussed above, resulting in a greater
chance that an individual opinion might inaccurately reflect the current state of science. As such, although expert testimony gathered by the panel provides a necessary clarification of scientific issues, its usefulness is limited by the inherent
scientific uncertainties surrounding novel technologies such as GMOs, the limited expertise of the individuals, the number of responses to each question, and the nature of the questions posed to the experts.
This problem of insufficient scientific input was inadvertently highlighted by the panel of the recent US/
Canada-Hormones Suspension decision, in its statement that [b]ecause all questions were ultimately answered by at
least one of the selected experts, the panel did not find a need to consult additional experts. [FN147] As previously discussed, this appears to undermine the value of the responses offered by the experts, particularly in the context of elucidating matters subject to varying scientific opinions.
The value of expert scientific testimony is further mitigated by the recurring preference of panels to address individual experts rather than groups of experts; in no case to date has a panel chosen the latter option. Carruth and Goldstein, in
their critique of the use of scientific experts in EC-Asbestos, *384 emphasize the problems with this individual-based
rather than consensus-based approach. These problems include the variance in the responses of the individual experts, the
unavailability of a proper opportunity for cross-examination, and the lack of an opportunity to search for consensus
among the experts. [FN148] In their insightful discussion of the flaws stemming from using an individual-based approach, Carruth and Goldstein argue that a consensus approach is most likely to produce the closest approximation to
current scientific understanding and to provide the most useful answers to a specific charge from the panel. [FN149]
Furthermore, [s]cientists are accustomed to participating in consensus committees or other groups that are multidisciplinary in nature. They are able to understand each other, to evaluate the contributions from the various disciplines, and to
synthesize those contributions far better than a lay panel can. [FN150]
Joost Pauwelyn, while explaining the practical reasons why the WTO panels have chosen to address experts individually (less time consuming, does not require the production of a report by the experts), is also skeptical of this approach. He warns that it runs the risk of panels having to decide, or seek a minimum common ground, as between competing scientific experts, which as he points out, panels (mostly lawyers or economists) are not qualified to do.
[FN151] Most importantly, Pauwelyn notes that for panels to nonetheless intervene in, or even decide, substantive scientific debates would exceed their competence and stain the legitimacy that is traditionally linked to science-based outcomes. [FN152] His critique is apt, and as WTO panels have continued to prefer the individual-based approach to eliciting responses from experts in a growing number of science-based cases, it appears that their involvement in deciding the
weight of scientific evidence has indeed blurred the line between law and science to the detriment of the legitimacy of
the decisions in question.
*385 The panel in US-Hormones Suspension appears to have explicitly shifted towards a more proactive position in
evaluating scientific evidence:
We note that we have a duty to consider the evidence presented to us and to make factual findings on the basis
of that evidence. It is also generally within our discretion to decide which evidence we choose to utilise in making
findings. Likewise, a panel is not expected to refer to all statements made by the experts advising it and should be
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allowed a substantial margin of discretion as to which statements are useful to refer to explicitly as long as we do
not deliberately disregard or distort evidence. [FN153]
This rather startling comment raises serious questions for future decisions requiring consideration of scientific evidence. The issue of legitimacy raised by Pauwelyn will clearly be of increased concern, since such an approach delegitimizes the value of the information provided by experts, even if substantively, it is clear that not every statement offered by
experts can or should be considered and referred to in the actual decisions, if only in the interest of brevity.
In his analysis of risk regulation in the WTO, Howse highlights one of the often overlooked dimensions of the use of
expert testimony that relates at its core to the disparity between legal speak and science speak: The scientists called
upon in Salmon were placed in a virtually impossible position: they were asked to make a purely technical/scientific
judgment about the adequacy of risk assessment as a regulatory tool. [FN154] Combined with the divergent opinions espoused by scientists and the frequently limited range of responses to questions posed by the panels, Howse's insight suggests that the value of expert testimony may be mitigated by its interpretation and use in the adjudicatory process, despite
the unquestionable qualifications of the individual experts whose testimony is solicited.
*386 C. Scientific Evidence and the Panel's Interpretation in the Cases of T-25, Bt-176, and MON810
Among the various challenged issues in EC-Biotech were nine safeguard measures imposed by six member states, all
but one of which were taken pursuant to Article 16 of Directive 90/220. [FN155] In its decision, the panel held that member states of the EU cannot reject a risk assessment which meets the definition of Annex A(4) as not appropriate to its
circumstances on the basis that this risk assessment indicates constraint or uncertainties, and that this would not enable
the Member concerned to determine with a sufficient degree of precision whether a particular type of measure would in
fact achieve its appropriate level of protection. [FN156]
As the preceding overview of GMOs and their surrounding scientific uncertainty demonstrates, the interpretation of
scientific evidence is at the heart of the EC-Biotech decision and will continue to be at the heart of any cases involving
novel products. In order to illustrate more specifically how the panel interprets scientific evidence, three of the safeguard
measures concerning GM products at issue in EC-Biotech will be examined: those concerning T-25 maize, Bt-176
maize, and MON810 maize. [FN157] For all three of these products, a brief *387 background on the scientific process
required to create them will be given, followed by an evaluation of the panel's findings regarding Article 5.1 and Article
5.7 compatibility of the product-specific safeguard measures imposed by EC member countries.
1. T-25, Bt-176, and MON810 Maize: Background
Manufactured by Bayer CropScience, T-25 maize is designed to protect against the herbicide glufosinate ammonium.
[FN158] A gene encoding PAT, an enzyme that detoxifies the glufosinate ammonium rendering it harmless, was inserted
into the maize protoplasts through a chemically mediated direct DNA introduction method. [FN159] Despite studies indicating a low possibility of risk, Austria and Italy imposed temporary safeguard measures prohibiting sale of T-25
maize. [FN160] The main reasons for these measures included the possible harmful effects due to horizontal gene transfer; antibiotic resistance; effects on non-target organisms; persistence and invasiveness in agricultural habitats; development of resistance; out-crossing; undesirable effects on management practices; biodiversity; monitoring; labeling; coexistence; and eventually human and animal health; etc. [FN161] Clearly, these risks are not equivalent--this is a laundry list of all the possible risks designed to maximize the possibility of the safeguard measures being accepted.
The panel also analyzed safeguard measures imposed on Bt-176 maize. Bt-176 maize is designed to protect against
the herbicide glufosinate ammonium, like T-25, as well as against the European corn borer (ECB), a highly destructive
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insect. [FN162] All insect-pest resistant genes expressed in GM plants come from the common soil bacterium Bacillus
thuringiensis (Bt), *388 which produces an insecticidal protein, Cry1Ab. [FN163] The cry1Ab gene is introduced into a
strain of maize by particle acceleration transformation. [FN164]
The Cry1Ab protein is only lethal when eaten by moth and butterfly larvae, due to specific binding sites found on the
target insects. [FN165] Since there are no similar binding sites on mammalian intestinal cells, the protein cannot directly
affect livestock animals and humans. [FN166] Nevertheless, at the U.S. FIFRA Scientific Advisory Panel Meeting on Bt
Cotton, panelists agreed that while scientific literature indicated that lepidopterans were the only group capable of being
affected by Bt toxins, there were no publications regarding attempts to detect Bt receptors on non-mammal non-target organisms (such as other insects) and that such studies would be desirable. [FN167] Austria, Germany and Luxembourg
imposed safeguard measures on Bt-176 maize, citing concerns about gene transfer (in particular the development of antibiotic resistance) and the development of resistance to the Bt toxin. [FN168]
The third product looked at is MON810 maize, which was developed by the Monsanto Company, and like Bt-176
protects against the European corn borer through the production of the insecticidal protein, Cry1Ab. [FN169] Austria imposed safeguard measures against MON810, citing concerns about potential undesired effects on non-target organisms
and the development of resistance to Bt toxin in insects. [FN170]
*389 The scarcity of additional studies submitted by Austria in support of its position concerning T-25 maize suggests that the safeguard measures imposed on T-25 maize were seemingly more protectionist than precautionary. Nevertheless, the similarity of analysis between this safeguard measure and other, possibly more genuinely precautionary ones
involved in this same dispute indicates that the panel was faced by different situations but chose to apply the same logic
in each scenario.
As will be seen in the subsequent sections, the analysis provided by the panel is almost identical from measure to
measure, even down to the choice of wording. This may be a case of the boy who cried wolf, whereby the volume of the
material presented by all of the EC member states to the panel was such that valid claims for safeguard measures were
subsumed by less valid ones, or it may be an indication that the panel's logic reflects a fundamental misunderstanding of
scientific evidence that unintentionally undermines the goals of the SPS Agreement. Most likely, it is a combination of
the two. Since the EC speaks with a single voice in the WTO, it is difficult for the panel to separate out individual member state measures and evaluate them with equal thoroughness, particularly since it is not the role of the panel to determine which EU member state has complied with the SPS Agreement, but rather to determine whether overall the EC was in
violation of the SPS Agreement in its overarching approval and implementation architecture concerning GMOs. Had the
EC been able to select those member state measures with the most valid precautionary positions to present to the panel,
one could speculate that the outcome would have been different. At the same time, the copy-and-paste style of the panel's findings suggests that having applied a certain logical approach to its analysis of the measures in question under Article 5.1 and 5.7 of the SPS, the panel improperly equated legal logic with scientific logic, and proceeded as though legal
logic was sufficient to sustain identical analyses concerning different products and measures with different scientific underpinnings.
a. Article 5.1 Analysis of T-25 maize
In its Article 5.1 analysis of the safeguard measures in Austria, the EC-Biotech panel focused on whether the documents *390 relied upon by Austria regarding T-25 maize constituted a risk assessment as interpreted by the AB in Australia-Salmon. [FN171] Although the AB in EC-Hormones noted that a risk assessment could set out both the prevailing
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view representing the mainstream of scientific opinion, as well as the opinions of scientists taking a divergent view,
[FN172] in the case of T-25 maize, the panel did not find that the original risk assessment contained any divergent views.
The documentation presented by Austria was limited to several indirectly related studies and Austria's Reasons Document, since the other documents cited came from a January 2004 document, which was after the August 29, 2003 establishment of the panel and thus deemed inadmissible. [FN173] The panel correctly determined that documents compiling
opinions of potentially biased professionals that merely argue a point of view do not constitute risk assessments. [FN174]
Particularly for science-based measures involving contentious issues such as GMOs, opposing sides are likely to submit
documents prepared by industry experts on the one hand, or scientists adamantly opposed to the novel science (or in the
employ of the objecting governments) on the other. This increases the possibility of ideological bias permeating what
should be a scientifically based assessment. Furthermore, risk assessments should be based on experimental data and scientific studies and not just statements of opinion unsupported by relevant data, since that undermines the supposed objectivity of science-based risk assessment. The panel was also correct in stating that unless a risk assessment sets out a
divergent opinion, it cannot be used as the basis of an SPS measure based on a divergent opinion. [FN175] The panel
concluded that Austria had failed to provide a risk assessment for the SPS measure to be based on and that therefore Austria's safeguard measure was inconsistent with the requirements of Article 5.1. [FN176]
*391 A potential logistical problem regarding the availability of new scientific evidence is presented in the panel's
Article 5.1 analysis. Limiting a party's ability to produce additional documentation retroactively supporting its safeguard
measures, like the panel did here, is arguably necessary to protect judicial fairness, since otherwise protectionist actions
could be subsequently justified by newly produced risk assessments. Nevertheless, a risk assessment is a process, not a
mere document, and since the panel previously stated that risk assessments used in support of SPS measures can be performed after the regulation is implemented, the selection of the date of establishment of a panel as the end-date for the
admissibility of evidence seems somewhat arbitrary. In the case of molecular genetics in particular, the rapid pace of research and innovation means that there will undoubtedly be instances where at the time the safeguard measure was taken,
there was insufficient scientific evidence to allow for a risk assessment, or where a pre-existing risk assessment undermined the justifications used for imposing a safeguard measure, but where subsequent scientific evidence might support
the hypothesis on the basis of which the safeguard measure was originally taken and allow for a new risk assessment to
be performed subsequent to the establishment of a WTO panel.
The actual time-frame of WTO dispute settlement proceedings, particularly those requiring a review of science, is
sufficiently long so as to allow for new scientific breakthroughs to occur as the process is unfolding. As the process
stands, there is no mechanism to cope with this sort of situation, and realistically most solutions would lend themselves
towards protectionist abuse of the system, or at least confusion on the part of both panelists and parties if new evidence
was introduced on an ongoing basis during panel proceedings. However, it is possible to envision a situation in which a
safeguard measure imposed under Article 5.7 of the SPS Agreement in the absence of a risk assessment would be in the
process of being evaluated in a panel dispute when a new risk assessment became available, undermining the Article 5.7
justification for the measure. In such a situation, preventing the admission of the risk assessment subsequent to the commencement of litigation would not benefit the complainant and would in fact encourage protectionist abuse since it
would allow an unfounded *392 claim of an absence of risk assessment to be sustained despite the factual inaccuracy of
the claim.
b. Article 5.1 Analysis of Bt-176 Maize
Here, unlike in the case of T-25, Austria provided to the panel substantial additional documentation to support its
case, [FN177] including two studies which it submitted to the Commission in May 1997 in support of its safeguard meas-
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ure, and recent scientific findings in its January 2004 document concerning risks related to allergenicity and toxicity, the
potential environmental impact of Bt toxin, including effects on non-target organisms, as well as antibiotic resistance
marker genes. [FN178] Applying the same rationale it did for T25 maize, the panel held that only the study published
prior to its establishment could be examined, thus precluding the examination of any new scientific evidence. [FN179]
Again, since the panel had previously found that risk assessments could be performed post-imposition of a measure, it is
unclear why the panel decided to arbitrarily cut off the eligibility of a risk assessment at the time of the establishment of
the panel.
Germany cited several additional studies predating August 2003 and the establishment of the panel in support of its
safeguard measure, but the panel reached the same conclusion as it did for Austria, demonstrating an adherence to its formulaic logic not based on consideration of the nature of the scientific evidence presented. [FN180] The panel's misunderstanding of scientific evidence is highlighted by looking closely at two of these studies, both of which briefly summarize
experiments dealing with monarch butterflies: Losey's Transgenic Pollen Harms Monarch Larvae and Saxena and colleagues' Insecticidal Toxin in Root Exudates from Bt Corn. [FN181] It is important to note that monarch butterflies are
not found in Europe, since they are a North American species, but that these studies shed *393 light on the possible effect of the Bt toxin on lepidopterans and non-target insects more generally. [FN182]
The Losey study focused on the potential effect of Bt maize on non-target organisms, namely monarch butterflies.
[FN183] Explaining that most hybrids express the Bt toxin in pollen, and that corn pollen is widely dispersed by the
wind, the study examined the risk to monarch butterfly larvae of corn pollen being deposited on milkweed plants (the
sole source of nourishment for monarch butterfly larvae). [FN184] The experiments were performed in the laboratory,
and involved the dusting of milkweed plants with corn pollen. The study found that larvae fed on leaves with Bt pollen
had slower growth rates than larvae fed on control leaves due to a twofold decrease in consumption rate on leaves with
Bt pollen. [FN185] This indicates a potential risk of Bt maize affecting non-target organisms and potentially upsetting
delicate ecosystems, although questions arise concerning the concentration of pollen in the laboratory as compared to the
concentration that would be found in the wild. While the authors explicitly qualified their results by stating that [t]hese
results have potentially profound implications for the conservation of monarch butterflies, [emphasis added] this is
merely good scientific practice--a laboratory study such as this indicates potential for more widespread risk, but no conclusive observations can be made beyond the limited scope of the specific experiments performed. [FN186] This potential for risk, however, logically precludes the possibility of conducting large-scale field tests that would provide a higher
level of certainty about the risk, since such tests could negatively impact non-target organisms if the risk was in fact serious.
The Saxena study similarly addresses the issue of the Bt toxin and monarch butterfly larvae, this time focusing on Bt
toxin released into the soil in root exudates from Bt corn. [FN187] The study found that larvae placed on medium containing Bt corn exudates stopped feeding and eventually began to die, *394 while there was no such mortality with exudates from non-Bt corn. [FN188] The authors were careful to note that they had no indication of how soil communities
might be affected by Bt toxin in root exudates in the field, but that there may be a risk to non-target insects and organisms in higher levels of the soil. [FN189]
Both studies exposed the possibility of risk to non-target organisms due to the insecticidal nature of Bt maize. If
presented with laboratory experiments indicating a similar possibility of risk as seen in these studies, it would not be unreasonable for a country to impose safeguard measures before further confirmatory field tests were performed. After the
implementation of such measures, however, it would be imperative to conduct further studies to determine more accurately whether the risk is significant or not. The panel's interpretation of science does not permit such a process, however,
either under Article 5.1 or Article 5.7, even though it previously indicated that such a path would be justified. Here, after
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examining the various studies and Germany's Reasons document, the panel concluded that the Reasons document was not
a risk assessment. [FN190] The panel stated that the document includes references to possibilities of risks, but does not
evaluate the potential or likelihood of such risks occurring, citing as an example the document's statement that it cannot be excluded that unacceptable adverse effects on other Lepidoptera species and on some other insects would occur.
[FN191] Since the panel also previously emphasized that risk assessments need not be quantitative, it appears that for a
qualitative risk assessment to be acceptable, it might require more emphatic statements or more positive rather than negative phrasing.
The panel found that under the criteria established by the AB in Australia-Salmon, none of the documents submitted
by Germany constituted a risk assessment, and that the scientific studies cited failed to evaluate the potential or likelihood of the occurrence of the adverse effect identified in the Reasons document. [FN192] Despite the indication by the
studies of potential*395 risks, the preliminary nature of those studies means that scientifically, an evaluation of the likelihood of the occurrence would have been premature without further testing. The panel failed to identify here or elsewhere in EC-Biotech what level of evaluation of potential or likelihood of the occurrence of the adverse effect would be
sufficient for a risk assessment. Future cases would benefit from clearer guidelines for what the sufficient level is in the
eyes of the panel and AB. In this case, while the mere existence of the possibility of a risk means that under scientific
testing procedures, large-scale field tests would be discouraged, further limited field testing was explicitly encouraged at
the conclusion of each of the studies, opening an avenue for an Article 5.7 argument of insufficiency of scientific evidence in support of the temporary safeguard measure. However, the panel viewed the evidence differently.
c. Article 5.1 Analysis of MON810 Maize
The panel's evaluation of safeguard measures imposed by Austria with regards to MON810 maize focused on many
of the same studies cited by Germany in its case for the safeguard measures on Bt-176 maize. [FN193] In discussing the
Losey study on Monarch butterfly larvae, the panel argued not only that it indicated nothing about MON810 maize specifically, but that it also failed to evaluate any of the potential implications of its results. Instead, the panel noted that
the experimental results point to possible environmental outcomes. [FN194] While the panel is correct in asserting that
MON810 was not mentioned anywhere in the study, both the Bt maize strains and MON810 produce the same insecticidal protein from the same gene isolated from the same soil bacteria. [FN195] This suggests that studies indicating potential risks in Bt corn plants would by definition be indicating the same potential risks in MON810 and such risks should
be thoroughly investigated. In addition, in noting that the experimental results only pointed to possible environmental
outcomes, without evaluating the implications of the results, the panel again demonstrated its misperception of the process of scientific experimentation. The Losey study was a preliminary study indicating a potential for risk in a limited
*396 circumstance--any evaluation of larger-scale implications by the authors would have been bad scientific practice,
going beyond the scope of the study and into the realm of pure speculation. Of course, further studies by EU member
states would be required to justify the imposition of safeguard measures under Article 5.7.
The panel also examined several other studies, including one 1998 study by Hilbeck and others titled Effects of
Transgenic Bacillus thuringiensis Corn-Fed Prey on Mortality and Development Time of Immature Chrysoperla carnea
(Neuroptera: Chrysopidae). [FN196] In determining that the Hilbeck study also failed to constitute a risk assessment,
the panel made one of its clearest statements regarding its interpretation of scientific evidence:
While this study concludes that, in this experiment, differences in mortality exist for insect predators fed prey
raised on Bt versus non-Bt maize, the study notes that [n]o conclusions can be drawn at this point as to how results from [. . .] laboratory trials might translate in the field. This statement, in our view, implies that this study per
se cannot be said to evaluate the alleged risks identified by Austria in its Reasons document. In addition, given the
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lack of conclusions concerning how the laboratory trials might translate in the field noted above, we do not consider that the second Hilbeck study provides an evaluation of the potential for adverse effects on insect health from
the presence of Bt toxin in food or feedstuffs. [FN197]
The panel's misunderstanding of experimental procedures could not be more evident. Since there were differences in
mortality for insect predators fed on Bt versus non-Bt maize in the lab, proper scientific procedure would preclude following the study with field tests before further laboratory tests were concluded to determine the extent of the risk in the
field. Laboratory experiments cannot be used to effectively extrapolate to what might occur in the field, since the ability
to control all but one variable in the laboratory is lost in field testing. The Hilbeck study, or any other similar laboratory
*397 study, does not provide a scientifically sound basis to make predictions about the impact of the risk in the field. It
would also be dangerous for field testing to occur given the experimental evidence suggesting the existence of a risk.
More at issue with this study is whether any equivalent studies specific to European species were performed, since monarch butterflies are a primarily North American species; if that is what the panel was attempting to express, its choice of
wording is in this case unfortunate.
a. Article 5.7 Analysis of T-25 Maize
Turning to the panel's Article 5.7 analysis with respect to T-25 maize, the misinterpretation of scientific evidence by
the panel seen in its Article 5.1 analysis of the same product becomes clearer. The panel agreed with the complaining
parties' argument that the review and original assessments of T-25 maize by the Scientific Committee on Plants (SCP)
demonstrated that at the time the Austrians adopted their safeguard measure, the body of available scientific evidence
permitted the performance of a risk assessment as required under Article 5.1. [FN198] As a result, the panel held that
the safeguard measure was imposed in respect of a situation where relevant scientific evidence was not insufficient,
thus failing to qualify under Article 5.7. [FN199]
A logical problem is posed by the panel's Article 5.7 analysis, which reflects the essence of why the analysis is
flawed. If scientific studies on a subject are not at the point where a new risk assessment can be performed yet, but there
is a chance of danger with the product as demonstrated in the lab, safeguard measures under Article 5.7 can never be imposed if there has already been a previous risk assessment, particularly where the previous risk assessment contained no
divergent opinions. As even the panel noted in its general evaluation of risk assessments under Article 5.1 and 5.7, risk
assessments are subject to change as more scientific evidence comes to light, but a new full risk assessment may be impossible to perform at the point the potential for risk is uncovered due to the lack of experimental*398 evidence. This
analysis leads to the weakening of a party's rights under Article 5.7, allowing for the imposition of safeguard measures
only in the case that there has never been a previous risk assessment finding in favor of the product in question.
To this end, the panel held that an SPS measure could be based on a divergent scientific viewpoint found in a risk assessment; that the absence of divergent scientific viewpoints does not preclude their existence; that a risk assessment is
not the sum total of all scientific knowledge on the subject of the assessment; and that the end-product referred to by the
panel will by nature inherently reflect political, and not just scientific, goals. As Ilona Cheyne has aptly stated, a risk
assessment cannot command absolute authority because the assessment of whether a risk exists, and its probability and
magnitude, is in practice likely to involve subjective decisions about how to weigh evidence, interpret evidential lacunae
and evaluate competing opinions. [FN200] While in this instance the panel made a good decision given the scant nature
of the additional evidence, in other situations the logic leads to an incorrect determination of whether or not a safeguard
measure is acceptable.
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The panel ended its discussion of Article 5.7 vis--vis T-25 maize with its evaluation of the first element of the AB's
four element test for SPS compatibility under Article 5.7. Having found that there was sufficient scientific evidence for a
risk assessment, it chose not to continue with the analysis. The panel repeated this same analysis for each of the subsequent product safeguard measures it addressed, indicating that it was confident in each case of the logic it was applying. While it would have been interesting to see the analysis of the other three elements of the test to see how the panel
addressed the issue of available pertinent information, the panel was not obliged to continue with its analysis after
finding the safeguard measure incompatible with either Article 5.1 or Article 5.7.
b. Article 5.7 Analysis of Bt-176 Maize
In addressing the safeguard measures under Article 5.7 of the SPS Agreement, the panel merely reiterated its analysis
from T-25 maize that the parties imposing the safeguard measures*399 failed to demonstrate that there was an insufficiency of scientific evidence justifying the safeguard measures. [FN201] In the context of the studies cited here,
however, an argument could be made that the safeguard measures fell under Article 5.7 of the SPS Agreement due to the
lack of sufficient scientific evidence at the time the safeguard measure was imposed. While there were potential risks
identified, available scientific evidence could not provide a proper evaluation of the likelihood of the occurrences. That
these risks were not considered significant in the original risk assessment does not mitigate their potential destructiveness, since more risks are uncovered and clarified as scientific research on the subject continues.
Scientific studies are not produced on a whim, and generally reflect, at least in part, what is of interest to the scientific community. The process of scientific experimentation being one of trial and error, however, no studies will be published until the results of the experiments are largely conclusive, which may require a considerable investment of time
and resources, including repeated performance of experiments to verify consistency in results. As new risks come to
light, resources can be diverted to address the most pressing concerns and scientific knowledge can be furthered while
providing the WTO with justifications for safeguard measures under Article 5.7. As long as the parties imposing the
safeguard measures are actively seeking scientific evidence to resolve a genuine scientific issue and are not merely using
the measures as a protectionist tool, it seems that under the language of the SPS Agreement and the AB's interpretation of
Article 5.7, such measures would be temporarily acceptable. The issue with this broadening of the applicability of the
precautionary principle in WTO dispute settlement proceedings would of course be finding a reasonable method to distinguish protectionist from precautionary measures. In the case of the EU, it may be argued that some of the EU member
states appeared unwilling to perform further experiments, which would indicate that the safeguard measures were being
imposed more as protectionist measures than as genuine matters of ongoing scientific concern.
*400 c. Article 5.7 Analysis of MON810 Maize
The panel's Article 5.7 analysis of MON810 maize was identical to its analysis for previous products at issue and
offered no independent evaluation of whether there was insufficient scientific evidence, relying instead on the previous
risk assessment and its review by the SCP to determine that there were in fact risk assessments conducted that indicated
sufficient scientific evidence for Austria to base its measure on. [FN202]
IV. Towards a Solution to the Legal/Scientific Divide
The implications of the panel's findings in EC-Biotech extend beyond its interpretation of Articles 5.1 and 5.7 of the
SPS Agreement and go to the heart of the differences between legal speak and science speak, raising questions concerning the approach of panels to disputes requiring an analysis of scientific evidence. Many of the possible solutions to the
logical conundrum posed by the EC-Biotech panel's interpretation of scientific evidence and the SPS Agreement would
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open up further possibility of abuse of the system by countries with protectionist goals. Although Howse correctly argues that an alternative to harmonization may well be to enhance confidence in the ability to distinguish legitimate domestic regulations from protectionist cheating, the question is whether this is at all possible given the way in which scientific evidence is interpreted by the panel and the AB. [FN203] In no case to date has the AB held the risk assessment in
question to be sufficient to uphold the more stringent regulatory measures imposed by member countries, and in only one
case (Australia-Salmon) did a panel find in favor of these measures. Furthermore, a determination of legitimacy requires
an objective analysis of what should be a subjective process, and given the tendency of panels to selectively invoke expert testimony and to themselves consider the weight of the scientific evidence, the effectiveness of mechanisms to verify
the validity of such measures at the WTO level is called into question.
A solution of some sort must be found to the problem of the interpretation of scientific evidence. EC-Hormones, ECBiotech, and US/Canada-Hormones Suspension are only the *401 beginning of what will be an increasingly complex
string of cases requiring in-depth evaluations of cutting-edge scientific technologies. The SPS Agreement was designed
to permit WTO members to impose safeguard measures to protect human, animal and plant life and health. Within the
framework of traditional science, it operated quite effectively. With novel scientific procedures and techniques, however,
the AB and panels' interpretation of the SPS Agreement logically precludes allowing such measures to be imposed in all
but the most obvious cases. Science will continue to play an ever-growing role in the international trade arena, and panels and the AB will find themselves more often having to play the dual role of legal expert and synthesizer of scientific
evidence. With each new breakthrough scientific process, further uncertainties may come to light that must be evaluated
on a case-by-case basis.
In the twenty-first century, the growing number of biotech and other science-based products introduced on the market
means that science can no longer be viewed as separate from regulatory policy. In order for the international trade system to properly evaluate the merits of regulatory policies, the science must also be understood. What we need are legal
experts who are knowledgeable enough about science to recognize the uncertainty and hypothetical qualities that make
up the very essence of scientific research. These legal experts should not judge the scientific evidence, but rather should
apply their scientific knowledge to avoid misunderstandings of scientific procedures when applying legal standards. Otherwise, scientific information of actual merit may be subsumed by the strictures of procedure slavishly adhered
to by panels and by the AB, resulting in judgments that fail to reflect the real risks applicable in the field. The relative
weight of particular criteria for individual parties must also be taken into account, requiring a complex balancing of environmental concerns with food supply and other issues that panels may not be equipped to perform. Furthermore, although WTO jurisprudence allows for the use of risk assessments performed by other states or international bodies, the
value of such risk assessments in addressing specific environmental concerns will necessarily be limited by the ecological similarities between the country whose risk assessment is being used and the country using that risk assessment.
*402 Part of the problem lies in the way scientific evidence is presented. Even where the parties cite to reports of scientific committees and panels, the reports and opinions in question are themselves often summaries of the original scientific studies. Information is presented to parties by other parties whose own self-interests might influence how the material is presented. Howse and Mavroidis point out that one problem is that much of the relevant information and technical expertise resides with the industrial interests that have a stake in marketing GMOs, or with scientists and researchers with strong industry affiliations. [FN204] Some of the studies cited are indeed affiliated with the GMO industry,
casting doubt on the impartiality of the evidence used to conduct risk assessments. Other studies are produced by experts
working for governments, offering the opposite problem of over-precaution in order to support a government's negative
position on products such as GMOs.
A further problem is that the volume of evidence submitted by the parties in EC-Biotech was almost too great to
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properly evaluate. The mass of evidence in this case resulted from the individual EC member states imposing their own
safeguard measures despite approval of the GM products in question at the EC level. This breakdown in attempts at harmonization reflects different levels of acceptable risk and the application of the precautionary principle in different EC
member states and poses internal difficulties that must be resolved if the EC is to act competently as a representative of
its constituent states in the WTO. Generally, the inability of panels to adhere to the dispute settlement time-frame established in the DSU, particularly in SPS cases, indicates that a solution to the volume of evidence submitted may be required if efficiency of the dispute settlement system is to be achieved.
One possible solution to adjudicatory problems at the panel level in decisions requiring an evaluation of scientific
processes would be to employ panelists with dual qualifications in both science and trade law. This specificity in knowledge among trade lawyers is a rarity, however, particularly among lawyers trained in systems where law is an undergraduate degree. It is also unlikely that such significant changes in WTO dispute settlement procedures would be acceptable to members,*403 particularly since the selection of panelists is a somewhat politically-driven process. While panelists may have expertise in a given area of WTO law, such expertise is not required, even in SPS cases. The list of potential panelists kept by the Secretariat is limited, as is the availability of panelists, making it problematic even to require
expertise in the SPS Agreement from the panelists, let alone dual qualifications in science and law.
Similarly, a change in the use of experts from an individual to a group system, which would reduce a panel's ability
to extend its reach and to pick and choose scientific evidence and responses from experts in its deliberations, although
permitted within the DSU, seems unlikely given that to date no disputes have opted to address experts as a
group. Nevertheless, a streamlining and clarification of the role of experts in such disputes could go far in facilitating the
difficult dialogue between science experts and legal experts, particularly if both panelists and scientific experts were
provided with more explicit guidelines focusing on the differences between scientific and regulatory goals.
The greatest difficulty in modifying WTO procedures is the nature of the WTO as both a dispute settlement body and
a diplomatic entity, subject to the desires of its Members. The DSU cannot be added to by decisions of panels or the AB,
and modifications to dispute settlement procedures require negotiations among Members which are prone to long delays
and political disagreements. Where the DSU is silent, as it is for example in regard to panelist qualifications, there may
be room for the Secretariat to modify criteria (although this is subject to objection from Members). The possibility of using expert groups, therefore, while limited in scope and effectiveness, is in the short-term the easiest solution to implement, since it is already provided for in the DSU. In complex cases involving a wide range of scientific issues, agreement among the experts may be difficult to come by; however there is nothing in the DSU that precludes a report from an
expert group from taking into account diverging opinions. Such expert group reports would simplify the panel's job by
limiting the interpretation of scientific evidence required from panelists and giving experts the opportunity to consult
with the other experts regarding scientific matters in question without providing unnecessarily confusing information to
the panel.
*404 In the medium to long term, however, a more substantial solution that addresses the systemic problems at the
panel level is desirable. Since panelists are the interpreters of WTO law, how they comprehend scientific evidence before
them will affect their decisions, whether or not the evidence is presented as a unified report or as a multitude of individual responses. Consequently, the processing of the scientific information submitted in SPS cases is a key hurdle to the
panel's proper interpretation of the legal issues. Since the WTO dispute settlement system only occasionally deals with
questions of science, usually through SPS cases, the establishment of a permanent body to evaluate and synthesize the
volume of scientific information submitted in such cases may not be necessary. An ad hoc committee of independent science and legal experts, called upon only when such cases are brought before the WTO dispute settlement system may
provide a possible means of handling factual scientific information, allowing panels to focus on the legal questions while
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still retaining the expert system to provide further elucidation of unclear aspects. Any such solution would require a renegotiation of the DSU, however, and would raise financial and procedural complications requiring a more extensive overhaul of the system than would be desirable either to Members or to the Secretariat.
V. Conclusion
EC-Biotech is not a catastrophic decision, since the conclusions reached by the panel largely appear to be supported
both by scientific evidence and, most importantly, by the EU itself. The difficulties facing the panel in attempting to address EU member state measures that themselves contradicted EU policy should not be underestimated, and it is clear
from the volume of evidence submitted that not all of the measures and not all of the member states followed a reasoning
based on sound scientific process. Where the decision fails, however, is in its precedential value (albeit non-binding) regarding the applicability of Article 5.7 in the presence of a pre-existing risk assessment. The issues present in ECBiotech are further highlighted in US/Canada-Hormones Suspension and while the AB's most recent decision in US/
Canada-Hormones Suspension sheds light on how the WTO intends to interpret the SPS provisions in question going forward, how the ruling will be applied in *405 practice remains to be seen. In the interim, it is unclear how WTO members
can sustain safeguard measures under Article 5.7 if a risk assessment has already been performed, and it appears that,
contrary to the explicit statements of the panel in EC-Biotech and the AB in EC-Hormones, Article 5.7's applicability has
been narrowed, resulting in a Tuna/Dolphin-like situation whereby environmental concerns are subsumed by the desire
for trade liberalization. [FN205]
To the EC-Biotech panel, scientific evidence is insufficient if a risk assessment has previously been performed that
met the criteria of Article 5.1. Therefore, in cases of GMOs with existing risk assessments, a member's safeguard measure could never be approved under Article 5.7 if it failed to meet the criteria of Article 5.1. This relegates the use of Article 5.7 to the limited circumstances in which no previous risk assessment was possible, an unlikely scenario where novel
scientific products requiring extensive characterization and testing prior to commercial release are involved. Moreover,
the panel's expectation that field tests be conducted if laboratory tests determine potential risks contradicts customary scientific procedure. In scientific research, field tests are performed only if all laboratory tests indicate that the product in
question is safe, or if the risks highlighted in the lab can easily be mitigated in a controlled field study. Field testing potentially risky products brings with it the possibility of dangerous results if the risk is significant. While experimental
capabilities continue to evolve at a rapid pace in the relatively new area of recombinant DNA, without a way to ensure
that field trials will not contaminate the environment, it would be a dangerous exercise to conduct risky large-scale field
trials in order to determine whether there is or is not a risk to the environment.
*406 Although the precautionary principle carries with it the specter of unfairly protectionist domestic regulations,
this is in part due to the misinterpretation of the role of scientific evidence in analyzing the validity of such measures.
Under the language of the SPS Agreement itself, precautionary measures, even when based on non-mainstream scientific
opinions, are ostensibly permitted. However, according to the panel's findings, where an original risk assessment exists,
only those measures based on divergent opinions found in the original risk assessment would be sustainable, while measures based on less-divergent but more recent scientific information would be unacceptable under Articles 5.1 and 5.7 of
the SPS Agreement. Divergent opinions may be omitted from risk assessments where they represent a minority viewpoint, and if those divergent views cannot be subsequently considered in a later evaluation (not compliant with an Article
5.1 risk assessment), the applicability of Article 5.7 in all but the most limited circumstances is called into question.
While much attention has been paid by international trade law scholars as to how disputes are resolved in a legal
framework, the scientific reasoning that underlies the determination of whether risk assessments are suitable has been in-
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sufficiently studied. By assuming that the process whereby the panel is informed of the relevant scientific studies is effective, fundamental inconsistencies between scientific reality and panel interpretation are ignored. The flaw in the panel's analysis of risk assessment procedures under the SPS agreement is not due purely to the panel's faulty legal reasoning, nor due to any willful negligence on the part of the panel, but rather it is due to the lack of scientific expertise on the
panels and the AB. While procedures have been laid out for the risk assessment mechanism, these procedures are not
clear enough to cope with the types of scientific trials required in cases such as EC-Biotech. The adjudicatory and scientific processes are separated by a chasm in semantic and logical understanding that significantly hinders the development of jurisprudence that can adequately address scientific issues in a legal context.
[FNa1]. Antonia Eliason received her B.Sc. in Cell and Molecular Biology and Computer Science from the University of
Michigan in 2003, M.A. from George Washington University in 2004, and J.D. from the University of Michigan Law
School in 2007. I am deeply indebted to Rob Howse for providing the inspiration for this Article through discussions inside and outside of the classroom, as well as for his amazing support and invaluable comments throughout the creative
process. I also would like to particularly thank Vanessa Abballe, Sadeq Bigdeli, and Noam Wiener for their extremely
helpful suggestions in the final revision stages, and would like to acknowledge my father, Dr. James Eliason, for his assistance with the scientific portions of the Article.
[FN1]. Agreement on the Application of Sanitary and Phytosanitary Measures art. 1.1, Apr. 15, 1994, 1867 U.N.T.S. 493
[hereinafter SPS Agreement].
[FN2]. Id. art. 3.1.
[FN3]. Id. arts. 5.1, 5.7.
[FN4]. The national treatment obligation of Article III.4 of the General Agreement on Tariffs and Trade, Oct. 30, 1947,
61 Stat. A-11, 55 U.N.T.S. 194 [hereinafter GATT], states:
The products of the territory of any contracting party imported into the territory of any other contracting party
shall be accorded treatment no less favorable than that accorded to like products of national origin in respect of all laws,
regulations and requirements affecting their internal sale, offering for sale, purchase, transportation or use.
See also Michael J. Trebilcock & Robert Howse, The Regulation of International Trade 207 (3d ed. 2005).
[FN5]. SPS Agreement, supra note 1, arts. 2.2, 5.7.
[FN6]. See Understanding on Rules and Procedures Governing the Settlement of Disputes, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, art. 6.1, Apr. 15, 1994, 1869 U.N.T.S. 401, 33 I.L.M. 1226 [hereinafter
DSU].
[FN7]. Id. art. 8.
[FN8]. Id. art. 8.4.
[FN9]. Id. arts. 15-16.
[FN10]. Id. art. 17.6.
[FN11]. The debate over the science-humanities divide is not new. C.P. Snow, in his seminal 1959 lecture, The Two Cul-
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tures, addressed the communications gap between scientists and literary people, emphasizing their fundamental differences in approaches to matters ranging from the arts to policy concerns to science. See C. P. Snow, The Two Cultures
and the Scientific Revolution (1959). This discussion has continued, albeit without any significant progress in narrowing
the gap, while the importance of science in everyday life, as discussed above, has continued to grow. See, e.g., Stephen
Breyer, Breaking the Vicious Circle: Toward Effective Risk Regulation (1993) (highlighting this element of scientific
uncertainty in the regulatory arena). Even in the specialized field of WTO law, legal scholars such as Crawford-Brown,
Pauwelyn, and Smith have addressed this very issue. See, e.g., Douglas Crawford-Brown et al., Environmental Risk, Precaution, and Scientific Rationality in the Context of WTO/NAFTA Trade Rules, 24 Risk Analysis 461, 462 (2004);
Christian Joerges, Law, Science and the Management of Risks to Health at the National, European and International
Level - Stories on Baby Dummies, Mad Cows and Hormones in Beef, 7 Colum. J. Eur. L. 1 (2001).
[FN12]. Panel Report, European Communities-Measures Affecting the Approval and Marketing of Biotech Products,
WT/DS291/R (Sept. 29, 2006) [hereinafter Panel Report, EC-Biotech]. Given the substantial similarity of the panel's pronouncements in United States-Continued Suspension of Obligations in the EC-Hormones Dispute, WT/DS320/R (Mar.
31, 2008) [hereinafter Panel Report, US-Hormones Suspension], and Canada-Continued Suspension of Obligations in the
EC-Hormones Dispute, WT/DS321/R, (Mar. 31, 2008), they are frequently referred to collectively in the text of this Article as US/Canada-Hormones Suspension. For simplicity, however, all citations will be to the panel's report in USHormones Suspension.
[FN13]. See Appellate Body Report, European Communities-Measures Concerning Meat and Meat Products
(Hormones), WT/DS48/AB/R, WT/DS26/AB/R (Jan. 16, 1998) [hereinafter Appellate Body Report, EC-Hormones]; Appellate Body Report, Australia-Measures Affecting Importation of Salmon, WT/DS18/AB/R (Oct. 20, 1998) [hereinafter
Appellate Body Report, Australia-Salmon].
[FN14]. See infra Part II.D-F.
[FN15]. SPS Agreement, supra note 1, Annex A(1)(a)-(d).
[FN16]. See Appellate Body Report, EC-Hormones, supra note 13. The AB found that a government could impose a
measure based on an evaluation of risk stemming from a non-mainstream scientific opinion. The AB also found that a
minimum level of risk was not necessary, but that the risk in question must be identifiable, and reversed the Panel's finding that a risk assessment must be in place at the time the measure is taken. Since the EC had not proffered any evidence
of a risk assessment, however, the AB found that its measure was not compliant with the SPS Agreement. In order to determine whether the measure was SPS compliant, the panel in EC-Hormones had to examine the underlying science, requiring extensive consultations with experts.
[FN17]. See infra Part III.A for a discussion of Articles 5.1 and 5.7.
[FN18]. Robert Howse, The Legitimacy of the World Trade Organization, in The Legitimacy of International Organizations 355, 375 (Jean-Marc Coicaud & Veijo Heiskanen eds., 2001). Howse also aptly states that [a]s the implications for
the ability of governments to respond to citizens' needs become evident over time, there is a greater possibility of a gap
between ex ante formal democratic legitimacy and ex post social legitimacy. Id. at 363.
[FN19]. For the purposes of this Article, the term EC will be used in WTO dispute-specific contexts, while EU will
be used generally in discussion. The European Union joined the WTO as the EC, pursuant to Opinion 1/94. Subsequently, it became known as the EU, but as a formal entity with legal personality in the WTO, it is the EC.
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[FN20]. David Winickoff et al., Adjudicating the GM Food Wars: Science, Risk, and Democracy in World Trade Law,
30 Yale J. Int'l L. 81, 86-87 (2005).
[FN21]. Id. at 87.
[FN22]. Id. at 88.
[FN23]. Id. at 89.
[FN24]. Panel Report, EC-Biotech, supra note 12, P 2.1.
[FN25]. For a general overview of the difficulties faced by the EU in presenting a harmonized front in its dealings with
the WTO, see Rafael Leal-Arcas, United We Stand, Divided We Fall - The European Community and its Member States
in the WTO Forum: Towards Greater Cooperation on Issues of Shared Competence?, 1 Eur. Pol. Econ. Rev. 65, 69
(2003), available at http:// www.ugbs.org/weru/eper/vol1/no1/leal.pdf; see also Giacinto della Cananea, Mixed Administration: The European Union's Mixed Administrative Proceedings, 68 Law & Contemp. Probs. 197 (2004) (offering an
administrative law perspective on the EU's approach to dealing with the various areas where Member State and EC interests may collide).
[FN26]. Council Directive 90/220, 1990 O.J. (L 117) 15 (EC), repealed by Council Directive 2001/18, 2001 O.J. (L106)
1 [hereinafter Directive 2001/18]; Commission Regulation 258/97, 1997 O.J. (L 043) 1 (EC). For an overview of the implementation of the international standards in the Cartagena Protocol on Biosafety (CPB), see generally Aaron A. Ostrovsky, The European Commission's Regulations for Genetically Modified Organisms and the Current WTO Dispute Human Health or Environmental Measures?: Why the Deliberate Release Directive is More Appropriately Adjudicated in
the WTO Under the TBT Agreement, 15 Colo. J. Int'l Envtl. L. & Pol'y 209 (2004).
[FN27]. See infra Part II.F.
[FN28]. Communication from the Commission on the Precautionary Principle, at 10, COM (2000) 1 final (Feb. 2, 2000)
[hereinafter Communication from the Commission].
[FN29]. In relevant part, Council Directive 2001/18, art. 23, 2001 O.J. (L 106) 13 (EC) provides that:
[w]here a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly
notified and has received written consent under this Directive constitutes a risk to human health or the environment, that
Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.
[FN30]. See id.
[FN31]. Panel Report, EC-Biotech, supra note 12, PP 8.22-8.30.
[FN32]. Henrik Horn & Joseph H. H. Weiler, European Communities - Trade Description of Sardines: Textualism and its
Discontent, in The WTO Case Law of 2002 248, 255 (Henrik Horn & Petros C. Mavroidis eds., 2004).
[FN33]. Crawford-Brown et al., supra note 11, at 462.
[FN34]. Breyer, supra note 11, at 48.
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[FN35]. First Written Submission of the European Communities, European Communities - Measures Affecting the Approval and Marketing of Biotech Products, P 18, WT/DS/291, DS/292, DS/293 (May 17, 2004), available at http://
trade.ec.europa.eu/doclib/docs/2004/june/tradoc_117687.pdf [hereinafter EC First Written Submission].
[FN36]. Id. P 21-24.
[FN37]. Id. P 22; Robert F. Weaver, Molecular Biology 85 (2d ed. 2002).
[FN38]. Id. P 26.
[FN39]. F. Cellini et al., Unintended Effects and Their Detection in Genetically Modified Crops, 42 Food & Chem. Toxicology 1089, 1093 (2004). Additionally, transgene chromosomal location and structure can be detected by methods such
as FISH (fluorescence in situ hybridization) and GISH (genomic in situ hybridization), both of which are sophisticated
cytological techniques. Id.
[FN40]. EC First Written Submission, supra note 35, P 48.
[FN41]. See, e.g., Esther J. Kok & Harry A. Kuiper, Comparative Safety Assessment for Biotech Crops, 21 Trends in Biotech. 439, 441 fig.6 (2003).
[FN42]. See generally D.A. Andow & Claudia Zwahlen, Assessing Environmental Risks of Transgenic Plants, 9 Ecology
Letters 196 (2006) (disusing the current environmental risk assessment techniques and possible risk of transgenic organisms).
[FN43]. Article 5.5 of the SPS Agreement, supra note 1, provides that:
[w]ith the objective of achieving consistency in the application of the concept of appropriate level of sanitary or
phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall
avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade.
Article 5.6 of the SPS Agreement, id., further states that:
[w]hen establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to
achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility.
[FN44]. See, e.g., Executive Summary of the First Written Submission of the United States, Measures Affecting the Approval and Marketing of Biotech Products, P 34, WT/DS291, DS/292, DS/293 (Apr. 30, 2004) (The general moratorium, thus, is effectively an import ban that affects any and all foreign biotech products and, thus, the international trade
in those products.).
[FN45]. Cellini et al., supra note 39, at 1090.
[FN46]. Id.
[FN47]. See OECD, Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles 11 (1993),
available at http:// dbtbiosafety.nic.in/guideline/OACD/Concepts_and_Principles_1993.pdf; see also Kok & Kuiper,
supra note 41, at 440.
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[FN48]. Kok & Kuiper, supra note 41, at 440.

[FN49]. Id.
[FN50]. Cellini et al., supra note 39, at 1090.
[FN51]. Org. for Eco. Coop'n & Dev. (OECD), Recombinant DNA Safety Considerations 13 (1986), available at http://
dbtbiosafety.nic.in/guideline/OACD/Recombinant_DNA_safety_considerations.pdf.
[FN52]. OECD, Safety Evaluation of Foods Derived by Modern Biotechnology 3 (1993), available at http://dbtbiosafety.nic.in/guideline/OACD/Concepts_and_ Principles_1993.pdf.
[FN53]. See, e.g., OECD, An Introduction to the Biosafety Consensus Documents of OECD's Working Group for Harmonisation in Biotechnology 7 (2005), available at http://appli1.oecd.org/olis/2005doc.nsf/linkto/env-jm-mono(2005)5
(The benefits of harmonisation are clear. It increases mutual understanding among member countries, which avoids duplication, saves on scarce resources and increases the efficiency of the risk/safety assessment process. This in turn improves safety, while reducing unnecessary barriers to trade.).
[FN54]. See Kok & Kuiper, supra note 41, at 441.
[FN55]. Id.
[FN56]. U.S. Envtl. Prot. Agency (US EPA), Generic Ecological Assessment Endpoints (GEAEs) for Ecological Risk
Assessment 5 (2003), available at http:// cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=55131.
[FN57]. World Health Org., 20 Questions on Genetically Modified (GM) Foods 3, available at http://
www.who.int/foodsafety/publications/biotech/en/20questions_en.pdf.
[FN58]. See generally Genetically Modified Organisms Envtl. Risk Assessment Project, International Project on GMO
Environmental
Risk
Assessment
Methodologies
(2005),
available
at
http://
www.gmoera.umn.edu/public/publications/download/bookletnov05en.pdf.
[FN59]. See Robyn Fairman et al., Environmental Risk Assessment: Approaches, Experiences and Information Sources
67 (1998), available at http:// reports.eea.europa.eu/GH-07-97-595-EN-C2/en/part1-section2.pdf (comparing ecological
risk assessment to health risk assessment).
[FN60]. Jrg Romeis et al., Transgenic Crops Expressing Bacillus thuringiensis Toxins and Biological Control, 24
Nature Biotech. 63, 63 (2006).
[FN61]. Fairman et al., supra note 59, at 67-68.
[FN62]. U.S. EPA, Guidelines for Ecological Risk Assessment (1998).
[FN63]. Id. at 2.
[FN64]. For a more in depth discussion of the Codex Alimentarius Commission and the biotech dispute see generally
Aaron A. Ostrovsky, Note, The New Codex Alimentarius Commission Standards for Food Created with Modern Biotechnology: Implications for the EC GMO Framework's Compliance with the SPS Agreement, 25 Mich. J. Int'l L. 813 (2004).
The relevant Codex documents include Principles for the Risk Analysis of Foods Derived from Modern Biotechnology,
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Codex Doc. CAC/GL 44-2003 (2003) [hereinafter Codex, Risk Analysis Principles]; Guideline for the Conduct of Food
Safety Assessment of Foods Derived from Recombinant-DNA Plants, Codex Doc. CAC/GL 45-2003 (2003); Guideline
for the Conduct of Food Safety Assessment of Foods Produced using Recombinant-DNA Microorganisms, Codex Doc.
CAC/GL 46-2003 (2003); and most recently in 2008, Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals, Codex Doc. CAC/GL 68-2008 (2008).
[FN65]. See SPS Agreement, supra note 1, art. 3.2 (Sanitary or phytosanitary measures which conform to international
standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or
health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.). Codex
guidelines and recommendations are listed in the definition section of the SPS Agreement as international standards for
food safety. Id. Annex A(1)(3).
[FN66]. Codex, Risk Analysis Principles, supra note 64, P 11.
[FN67]. Id. P 15.
[FN68]. Id. P 8.
[FN69]. In EC-Biotech, supra note 12, PP 7.73-7.75, the Panel dismissed the EC's arguments concerning the relevance of
the Cartagena Protocol vis--vis its application of the precautionary principle .
[FN70]. Cartagena Protocol on Biosafety to the Convention on Biological Diversity art. 1, Jan. 29, 2000, 39 I.L.M. 1027;
Principle 15 of the Rio Declaration on Environment and Development, June 14, 1992, 31 I.L.M. 874, provides that
[i]n 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.
[FN72]. Id. PP 51-63.
[FN73]. The overview of environmental risks presented here draws heavily from Andow & Zwahlen, supra note 42, at
197.
[FN74]. Id. at 198.
[FN75]. Id.
[FN76]. Id. at 199.
[FN77]. Id.
[FN78]. Id.
[FN79]. Id. at 200 (quoting Douglas J. Futuyma, Evolutionary Biology 767 (3rd ed. 1998)).
[FN80]. Id. at 200.
[FN81]. Id. at 197.
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[FN82]. Id. at 203.

[FN83]. John S. Applegate, The Precautionary Preference: An American Perspective on the Precautionary Principle, 6
Hum. & Ecological Risk Assessment 413, 414 (2000).
[FN84]. Communication from the Commission, supra note 28. The relevant portion of Article 174 states:
Community policy on the environment shall aim at a high level of protection taking into account the diversity of
situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles
that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the
polluter should pay.
Treaty of Amsterdam Amending the Treaty on European Union, the Treaties Establishing the European Communities and Certain Related Acts, art. 174, Oct. 2, 1997, 1997 O.J. (C 340) 1.
[FN85]. Communication from the Commission, supra note 28, at 9.
[FN86]. See Jonathan B. Wiener, Whose Precaution After All?: A Comment on the Comparison and Evolution of Risk
Regulatory Systems, 13 Duke J. Comp. & Int'l L. 207, 216-17 (2003); see also Cass R. Sunstein, Beyond the Precautionary Principle, 151 U. Pa. L. Rev. 1003, 1011-15 (2003) (discussing the differences between the strong and weak versions
of the precautionary principle).
[FN87]. Joanne Scott, European Regulation of GMOs and the WTO, 9 Colum. J. Eur. L. 213, 221 (2003) (referring to
Case T-13/99, Pfizer Animal Health v. Council, 2002 E.C.R II-3305).
[FN88]. Id. at 228.
[FN89]. Case C-236/01, Monsanto Agricoltura Italia SpA v. Presidenza del Consiglio dei Ministri, 2003 E.C.R. I-8105, P
22. For a more detailed analysis of the case, see generally Jesse Male, Note, The State of Genetically Engineered Crops
in the European Union Following Monsanto v. Italy and the Adoption of a New Regulatory Framework for Genetically
Modified Food and Feed, 9 Drake J. Agric. L. 439 (2004).
[FN90]. Monsanto, 2003 E.C.R. I-8105, P 84.
[FN91]. C-132/03, Ministero della Salute v. Coordinamento delle associazoni per la difesa dell'ambiente e dei diritti degli utenti e del consumatori (Codacons), 2005 E.C.R. I-04167, P 13.
[FN92]. Id. P 43.
[FN93]. Id. P 63.
[FN94]. Id. P 61.
[FN95]. Leal-Arcas, supra note 25, at 69.
[FN96]. See, e.g., Trebilcock & Howse, supra note 4, at 48 (outlining a number of harmonization measures undertaken
by the EU).
[FN97]. Earthjustice Presents 2005 Environmental Rights Report to UN; Human Right to a Healthy Environment Becoming Int'l Standard, U.S. Newswire, Apr. 8, 2005.
41 NYUJILP 341
41 N.Y.U. J. Int'l L. & Pol. 341
Page 38
[FN98]. See Case 6/64, Costa v. Ente Nazionale Energia Elettrica (ENEL), 1964 E.C.R. 585, 594.
[FN99]. [L]a suprmatie ainsi confre aux engagements internationaux ne s'applique pas, dans l'ordre interne, aux dispositions de nature constitutionnelle. Sarran et Levacher, Conseil d'tat, Ass., 30 Oct. 1998, Lebon 1998, 368.
[FN100]. Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 642 (1980); see Jonathan B. Wiener &
Michael D. Rogers, Comparing Precaution in the United States and Europe, 5 J. Risk Research 317, 318 (2002)
(discussing of the role of the case in determining U.S. risk regulation processes).
[FN101]. See Wiener & Rogers, supra note 100, at 318.
[FN102]. Sunstein, supra note 86, at 1028.
[FN103]. Wiener, supra note 86, at 209.
[FN104]. Id.
[FN105]. See Gijs A. Kleter et al., Regulation and Exploitation of Genetically Modified Crops, 19 Nature Biotech. 1105,
1105-06 (2001).
[FN106]. See id. at 1106.
[FN107]. See id. at 1108.
[FN108]. Appellate Body Report, EC-Hormones, supra note 13, PP 124-25.
[FN109]. SPS Agreement, supra note 1, art. 2.2.
[FN110]. Robert Howse & Petros Mavroidis, Europe's Evolving Regulatory Strategy for GMOs - The Issue of Consistency with WTO Law: Of Kine and Brine, 24 Fordham Int'l L.J. 317, 342 (2000).
[FN112]. Id. art. 3.3.
[FN113]. Id. art. 2.3.
[FN114]. Id. art. 5.1.
[FN115]. Id. Annex A.
[FN116]. Id. Annex A(4).
[FN117]. Appellate Body Report, Australia-Salmon, supra note 13, P 121 (emphasis added).
[FN118]. Determining the likelihood of the spread of negative consequences of GMOs (the risks described in the related
section above) requires tracking their effects in the ecosystems in question. This cannot be determined in a lab. However,
lab tests may indicate a possible risk without being conclusive enough to allow a proper evaluation of likelihood.
[FN119]. According to the Scientists' Working Group on Biosafety, Manual for Assessing Ecological and Human Health
41 NYUJILP 341
41 N.Y.U. J. Int'l L. & Pol. 341
Page 39
Effects of Genetically Engineered Organisms 14 (2001), available at http://www.edmonds-institute.org/fullmanualpr.pdf,

field trials:
should be done only after laboratory investigations suggest that the GEO may be efficacious, genetically stable,
and ecologically benign. Careful containment and monitoring remain important to prevent accidental release. Suitable
experimental protocols are required, using well-understood designs, appropriate sample sizes, controls, and statistical
analyses.... If efficacy cannot be demonstrated by this stage, there is no justification for proceeding with larger trials. If
genetic exchange or instability appear likely at this point, the consequences of these effects will require additional exploration.
[FN121]. Appellate Body Report, Japan-Measures Affecting Agricultural Products, P 89, WT/DS76/AB/R, (Feb. 2,
1999) [hereinafter Appellate Body Report, Japan-Agricultural Products].
[FN122]. EC First Written Submission, supra note 35, P 608. Unlike EC-Biotech, supra note 12, Japan-Measures Affecting the Importation of Apples, WT/DS245/AB/R (Nov. 26, 2003) [hereinafter Appellate Body Report, Japan-Apples]
concerned traditional applications of science, wherein Japan argued that SPS Article 5.7 was applicable since despite accumulated scientific evidence, unresolved, as opposed to new, scientific uncertainty still existed. The AB held, however,
that scientific uncertainty is insufficient to trigger Article 5.7, which instead requires insufficiency of scientific evidence,
and that uncertainty and insufficiency are not interchangeable concepts. Id. P 184.
[FN123]. Panel Report, EC-Biotech, supra note 12, P 7.2969 (applying the test set forth by the AB in European Communities-Conditions for the Granting of Tariff Preferences to Developing Countries, WT/DS246/AB/R (Apr. 7, 2004)).
[FN125]. Id. P 7.2974.
[FN126]. Id. P 7.2979.
[FN127]. Id. P 7.2990 (quoting Appellate Body Report, Japan-Agricultural Products, supra note 121, P 92).
[FN128]. Id. P 7.2997.
[FN129]. Id. P 7.3024.
[FN130]. Id. P 7.3027.
[FN131]. Id. P 7.3028.
[FN132]. Id. P 7.3034 (emphasis added).
[FN133]. Id. P 7.3031.
[FN134]. Appellate Body Report, United States-Continued Suspension of Obligations in the EC-Hormones Dispute, P
703, WT/DS320/AB/R (Oct. 16, 2008).
41 NYUJILP 341
41 N.Y.U. J. Int'l L. & Pol. 341
Page 40
[FN136]. Id. P 7.2992.

[FN137]. Id.
[FN138]. See infra Part III.C.2-3.
[FN139]. The relevant cases are EC-Biotech, supra note 13; EC-Hormones, supra note 13; US/Canada-Hormones Suspension, supra note 12; Panel Report, United States-Import Prohibition of Certain Shrimp and Shrimp Products, WT/
DS58/R (May 15, 1998); Australia-Salmon, supra note 12 (involving two sets of experts: one appointed for each of the
original and implementation panels); Japan-Agricultural Products, supra note 121; Appellate Body Report, European
Communities-Measures Affecting the Prohibition of Asbestos and Asbestos Products, WT/DS135/AB/T (Mar. 12, 2001).
For an overview of the use of experts in this context, see generally Joost Pauwelyn, The Use of Experts in WTO Dispute
Settlement, 51 Int'l & Comp. L.Q. 325 (2002).
[FN140]. In no way should the references to specific scientists' testimonies be regarded as commenting on their scientific
abilities--they are merely provided for illustrative purposes to demonstrate the flaws in the process of eliciting such testimony.
[FN141]. Comments by the European Communities on the Scientific and Technical Advice to the Panel, European Communities - Measures Affecting the Approval and Marketing of Biotech Products, P 37, WT/DS291, WT/DS292, WT/
DS293 (Jan. 28, 2005) [hereinafter Comments by the EC].
[FN142]. Id. P 68.
[FN143]. Id. P 78.
[FN144]. Id. P 78, n.24.
[FN145]. Panel Report, EC-Biotech, supra note 12, PP 7.25-27.
[FN146]. Comments by the EC, supra note 141, P 68.
[FN147]. Panel Report, US-Hormones Suspension, supra note 12, P 7.93.
[FN148]. Russellyn S. Carruth & Bernard D. Goldstein, The Asbestos Case: A Comment on the Appointment and Use of
Nonpartisan Experts in World Trade Organization Dispute Resolution Involving Health Risk, 24 Risk Analysis 471,
475-76 (2004).
[FN149]. Id. at 476.
[FN150]. Id. at 478.
[FN151]. Pauwelyn, supra note 139, at 329.
[FN152]. Id. at 329.
[FN153]. Panel Report, US-Hormones Suspension, supra note 12, P 7.416.
[FN154]. Robert Howse, Democracy, Science and Free Trade: Risk Regulation on Trial at the World Trade Organization,
41 NYUJILP 341
41 N.Y.U. J. Int'l L. & Pol. 341
Page 41
98 Mich. L. Rev. 2329, 2347 (2000) [hereinafter Howse, Democracy, Science and Free Trade].
[FN155]. Panel Report, EC-Biotech, supra note 12, P 7.2534-35. Council Directive 90/220, art. 16, 1990 O.J. (L 117) 15
(EC) provides:
1. Where a Member State has justifiable reasons to consider that a product which has been properly notified and
has received written consent under this Directive constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. It shall immediately inform the Commission
and the other Member States of such action and give reasons for its decision. 2. A decision shall be taken on the matter
within three months in accordance with the procedure laid down in Article 21.
[FN157]. The author's choice of these three maize products was made with the goal of showing the different processes
involved in creating GM crops from the same basic plant species, as well as having been chosen in part for the ease of
comparing scientific studies for substantially related and well-researched products. It is interesting to note, however, that
maize is not a crop indigenous to Europe, arguably making measures directed at protection of biodiversity potentially
more tenuous in this basis. Cultivation of maize in Europe for the past several centuries, however, has placed it in the position of a domestic crop, and concern regarding biodiversity is more related to the particular resilience of GM versus
non-GM crops and the possible cross-contamination of non-GM crops with GMOs so as to prevent their labeling as nonGM.
[FN158].
AGBIOS,
GM
Database
(T24,
T25),
tion=ShowProd&data=T14%2C+T25 (last visited Aug. 27, 2008).
http://www.agbios.com/dbase.php?
ac-
[FN159]. Id.
[FN160]. EC First Written Submission, supra note 35, PP 354-55.
[FN161]. Id. P 356.
[FN162]. AGBIOS, GM Database (176), http://www.agbios.com/dbase.php? action=ShowProd&data=176 (last visited
Aug. 27, 2008) [hereinafter ABGIOS (176)].
[FN164]. AGBIOS (176), supra note 162.
[FN165]. Id.
[FN166]. Id.
[FN167]. Memorandum from the FIFRA Scientific Advisory Panel Conveying the Minutes of the FIFRA Scientific Advisory Panel Meeting on Product Characterization, Human Health Risk, Ecological Risk and Insect Resistance Management for Bacillus thuringiensis (Bt) Cotton Products held June 8-10, 2004 (Aug. 19, 2004), available at http://
www.epa.gov/scipoly/sap/meetings/2004/june/final1a.pdf. FIFRA stands for the Federal Insecticide, Fungicide, and Rodenticide Act--a U.S. act designed to provide federal control of pesticide distribution, sale and use.
41 NYUJILP 341
41 N.Y.U. J. Int'l L. & Pol. 341
Page 42
[FN169]. AGBIOS, GM Database (MON810), http://www.agbios.com/dbase.php? action=Submit&evidx=9 (last visited

Sept. 3, 2008) [hereinafter AGBIOS (MON810)].
[FN170]. Panel Report, EC-Biotech, supra note 12 P 7.3090.
[FN171]. Id. PP 7.3035-37.
[FN172]. Appellate Body Report, EC-Hormones, supra note 13, P 194.
[FN173]. Panel Report, EC-Biotech, supra note 12, P 7.3036. The studies cited include a study by Josef Hopplicher, Concepts of GMO-Free Environmentally Sensitive Areas (Federal Institute for Less-Favoured and Mountainous Areas,
1999), which was commissioned by the Austrian government.
[FN175]. Id. P 7.3060.
[FN176]. Id. P 7.3066.
[FN177]. Id. PP 7.3074-75.
[FN178]. Id.
[FN179]. Id. P 7.3075.
[FN180]. Id. PP 7.3142, 7.3159.
[FN181]. John E. Losey et al., Transgenic Pollen Harms Monarch Larvae, 399 Nature 214 (1999); Deepak Saxena et al.,
Insecticidal Toxin in Root Exudates from Bt Corn, 402 Nature 480 (1999).
[FN182]. Losey, supra note 181, at 214.
[FN183]. Id.
[FN184]. Id.
[FN185]. Id.
[FN186]. Id.
[FN187]. Saxena, supra note 181, at 480. Root exudates are materials that have passed from the inside of the root to the
outside soil.
[FN188]. Id.
[FN189]. Id.
[FN191]. Id. P 7.3145.
41 NYUJILP 341
41 N.Y.U. J. Int'l L. & Pol. 341
Page 43
[FN192]. Id. PP 7.3146-47.

[FN193]. Id. PP 7.3090, 7.3142.
[FN194]. Id. P 7.3097.
[FN195]. AGBIOS (MON810), supra note 169.
[FN197]. Id. P 7.3099.
[FN198]. Id. P 7.3260.
[FN199]. Id. PP 7.3260-61.
[FN200]. Ilona Cheyne, Risk and Precaution in World Trade Organization Law, 40 J. World Trade 837, 842 (2006).
[FN201]. Panel Report, EC-Biotech, supra note 12, PP 7.3274 (Austria), 7.3328 (Germany), 7.3370 (Luxembourg).
[FN202]. Id. P 7.3286.
[FN203]. Howse, Democracy, Science and Free Trade, supra note 154, at 2357.
[FN204]. Howse & Mavroidis, supra note 110, at 351.
[FN205]. In its ruling in United States Restrictions on Imports of Tuna, DS21/R (Sept. 3, 1991), GATT B.I.S.D. (39th
Supp.) at 155 (1993), the GATT panel opted for a restrictive reading of Article XX of the GATT and found that the U.S.
embargo on non-dolphin-friendly tuna was illegal. As Robert Howse has stated, [i]gnoring the text of the GATT treaty,
the panel based its decision on an intuition that trade measures to protect the environment might somehow open the door
to green protectionism, thereby threatening the market access negotiated in the GATT framework. Robert Howse, The
Appellate Body Rulings in the Shrimp/Turtle Case: A New Legal Baseline for the Trade and Environment Debate, 27
Colum. J. Env. L. 491, 493 (2002).
41 N.Y.U. J. Int'l L. & Pol. 341
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41 NYUJILP 341

41 N.Y.U. J. Int'l L. & Pol. 341

New York University Journal of International Law & Politics

B. Legal Speak vs. Science Speak

C. The Science Behind GMOs

D. GMOs and Risk Assessment

F. European and U.S. Views of the

Science and the WTO

A. Risk Assessment and the SPS

B. The Panel's Use of Expert Testimony

C. Scientific Evidence and the Panel's Interpretation in the Cases of T-25,

2014 Thomson Reuters. No Claim to Orig. US Gov. Works.

1. T-25, Bt-176, and MON810

a. Article 5.1 Analysis of T-25

b. Article 5.1 Analysis of Bt-176

c. Article 5.1 Analysis of MON810

3. Article 5.7 Analysis

a. Article 5.7 Analysis of T-25

b. Article 5.7 Analysis of Bt-176

c. Article 5.7 Analysis of MON810

Towards a Solution to the Legal/

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A) taking into account both intended and unintended effects;

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A. Risk Assessment and the SPS Agreement--Articles 5.1 and 5.7

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[FN48]. Kok & Kuiper, supra note 41, at 440.

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[FN82]. Id. at 203.

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