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EU Bows to White House Pressure to Force Gene-Altered Foods on Europe’s Consumers

The European Communities (EC) elected today not to appeal a World Trade Organization (WTO) dispute panel decision on regulating genetically engineered (GE) crops brought by the U.S., Canada, and Argentina.

Many of us thought the European Union was the
central large force fighting unregulating genetically altered crops and food, but we have some very bad news for you.
With six years of Bush Cheney business firstiness, something is apparently giving, and here is the story from

EU Bows to White House Pressure to Force Gene-Altered Foods on Europe’s Consumers
EC Drops the Ball on WTO Biotech Ruling
Decision Not to Appeal Lets Stand WTO Ruling to Override UN Treaty
IATP, 11/22/06
Straight to the Source
MINNEAPOLIS / GENEVA – November 22 – The European Communities (EC) elected today not to appeal a World Trade Organization (WTO) dispute panel decision on regulating genetically engineered (GE) crops brought by the U.S., Canada, and Argentina. The decision NOT to appeal leaves intact a controversial ruling that a United Nations environmental treaty did not apply in regulating GE crops, according to the Institute for Agriculture and Trade Policy (IATP).

ìThe EUís unfortunate decision could be used to undercut international environmental treaties across the board,î said Steve Suppan, an IATP senior policy analyst and author of a backgrounder in the case. ìThe decision says that WTO members cannot keep their commitments to multilateral environmental agreements [MEAs] if measures to do so are challenged under WTO rules. The ruling sets a terrible legal precedent that will be used to attack regulations that comply with MEA commitments.î

In the WTO dispute, the EC defended its regulatory system before the WTO by referring to the UNís Cartagena Protocol on Biosafety, a ratified treaty that authorizes signatories to take a precautionary approach to regulating GE crops when there is scientific uncertainty or insufficient data about a product. Over 130 countries around the world have signed onto the Biosafety Protocol, but the U.S. is not one of them. The WTO panel ruled that because the U.S., Argentina and Canada have not ratified the Protocol, the EC could not use a Protocol based defense.

ìOnly a diplomatic conference could reconcile commitments to divergent international treaties,î said Suppan. ìBy declining to appeal, the EC has allowed a very bad precedent to become a foundation for ruling on disputes about trade vs. MEA conflicts, for example, disputes about the regulation of synthetic biology or agri-nanotechnology products.î

Europe utilizes the ìprecautionary principleî to regulate not only GE crops, but also toxic chemicals as part of their recently approved REACH system. The WTO panel ruled that the precautionary principle is too controversial and unsettled in international public law to serve as a basis for panel rulings.

The U.S., Argentina and Canada brought the case against the ECís regulatory system for ìundue delayî in approving new GE crops. The EC has since modified its regulatory system and approved GE crops. EC officials argue these modifications already make the EC compliant with the Biotech Products ruling. U.S. officials dispute that conclusion and may launch another dispute to challenge EC rules that require labeling and traceability of GE crops and foods. European consumers are overwhelmingly opposed to GE crops. IATP supports labeling of approved GE foods and moratoria against commercialization of GE crops such as wheat that have been rejected by farmers, food processors and consumers.

IATP has written a backgrounder and analysis of the case, available at:


Here is the text from the pdf version of the “backgrounder”:

U.S. vs. EC
Biotech Products Case
WTO Dispute Backgrounder
a publication of
the institute for agriculture and trade policy
trade and global governance program

about IATP:
The Institute for Agriculture and Trade Policy promotes resilient family farms, rural communities and ecosystems around the world through research and education, science and technology, and advocacy.
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Tel.: (612) 870-0453
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Mark Ritchie, President
© 2005 iatp. All rights reserved.
about this publication
Backgrounder on WTO Dispute:
U.S. vs. EC BioTech Products Case
Written by Steve Suppan
Published September 2005

U.S. vs. EC Biotech Products Case 1
By the end of October 2005, the World Trade Organization dispute panel hearing the ìEuropean Communities
Measure Affecting the Approval and Marketing of Biotech Productsî (EC Biotech Products)
case is scheduled to issue its ruling, first to the parties to the dispute, followed by publication of the ruling
about a month later. The date of the rulingís issue has been postponed twice due to ìseveral import new issues
raised by the partiesî and by ìa vast amount of materialî that requires review as a result of consultation
with experts.1 An interim ruling could come out as early as September with a final ruling handed down in
October.2 The panel and ruling combine the cases of the United States (DS 291/17), Canada (DS 292/17)
and Argentina (DS 293/17) against the European Communities. This short analysis reviews the main
issues drawn from available U.S. and EC submissions plus related documents.
Whatís at stake?
The stakes in the outcome of this rulingóall but certain to be appealedóare very high. If the panel rules
against the EC and the appellate body upholds the ruling, the plaintiffs will be able to seek at least two
forms of redress. First, they are eligible to seek monetary reward in the form of tariffs imposed on EC
exports in the amount of negotiated damages due to EC regulations on genetically modified organisms
(GMOs). Already as of 2002, the U.S. State Department had claimed at least $300 million in lost sales of
genetically modified corn and soy products.3 A no doubt larger claimed amount of damages would likely
be negotiated downward in the compliance phase of a ruling favorable to the plaintiffs.
Secondly, the victorious plaintiffs will be able to seek changes to the EC regulatory regime that would
presumably make that regime more like the U.S. regime, which the EC has characterized as ìlaissez-faire,î
or a deregulatory regime.4 Any changes to the EC regulatory regime would come at a politically difficult
moment when the European Commission is struggling to enforce its legislation on GMOs in the face of
six EC member state bans on GMOs.5 The commission is seeking to overturn EC member state marketing
and import bans both through the European Court of Justice and through fostering greater cooperation
between member state scientific bodies and the European Food Safety Agency. Recent votes on regulatory
committees to lift marketing or import bans on GMOs have been defeated by narrow margins, in a process
in which each EC member state receives votes based on its population size.6 However, on June 24, 22 of
25 EU member states voted against eight commission proposals to end GMO bans in the member states.
As a result, the commission may introduce a totally new law to end the bans, rather than submit further
proposals through the existing regulatory system.7
Finally, and most importantly, the ruling will very likely be treated as a precedent by future WTO panels
ruling on food safety, public health and environmental health measures applied to international traded
goods and services. Developing countries, many of which have yet to establish regulatory regimes for
GMO crops, will be particularly affected by the ruling. Also, the ruling could impact the regulation of
other industries. For example, aspects of the ruling could be cited if the U.S. decides to launch a WTO case
against draft EC rules to test certain industrial chemicals for their public health consequences. The Bush
administration charges that the rules would cost the United States $20 billion annually in lost chemical
trade to Europe. The administration and the State Department have joined the U.S. chemical industry in
an extensive campaign to weaken those rules.8
The WTO case against the EC regulatory regime comes at a highly charged political moment when the constitutional viability of the EC is in question only months after the expansion of the EC from 10 to 25 members. The panel decision will come in the midst of U.S. charges that new EC GM testing requirements,
as a result of recent illegal U.S. GM corn exports to Europe, will result in the loss of hundreds of millions of dollars of sales of U.S. corn gluten feed.9 In addition, the European press has widely covered the recent discovery of internal studies by Monsanto that a variety of GM corn, Mon 863, under consideration to be commercialized in the EC, when fed to rats, caused changes in the blood composition and reduced kidney size.10 While such revelations fall outside the period of EC regulatory review against which the U.S. has brought charges, the ECís ability to implement the WTO ruling will certainly be affected by the ongoing ìsurprisesî about GMOs not revealed in the U.S. approval process for biotech products.

U.S. vs. EC Biotech Products Case 3
Four central questions in the case

1. Will the EC and other WTO members be able to develop and maintain a regulatory system for GMOs that allows for the use of precautionary measures (see ìThe precautionary
principle,î below) to protect consumer, animal and/or plant health when there is insufficient scientific evidence to assess the risks of a biotech product presented to governments for commercialization approval? If the panel rules that the EC regulatory system violates provisions in the WTO Agreement on the Application of Sanitary and Phytosanitary
Measures (the SPS Agreement), the U.S. may demand changes to the EC regulatory review system to make it more like the U.S. system, which the EC has characterized as laissez-faire or deregulatory. An adverse ruling will be weaken the ECís ability to use a precautionary approach in regulating to meet public health, safety and environmental objectives.

2. Will the panel agree with the EC that some of its regulatory objectives for GMOs fall outside of the competence of WTO agreements and are covered by other international agreements (e.g. the objective to preserve biodiversity against plant species invasion by GM varieties)? The EC argues that measures to preserve biodiversity are the competence of the Cartagena Protocol on Biosafety, to which the U.S. is not a party. The WTO does not recognize the protocol as containing presumptively authoritative standards. Indeed, WTO members have not allowed the secretariat of the Convention on Biological Diversity, to which the protocol is appended, to be an observer at the WTO Committee on Trade and Environment.
If the panel disagrees with the EC argument that part of the U.S. complaint concerns measures outside the WTOís competence and that of the standard setting organizations referenced in its agreements, then an international public law controversy will arise about the scope of the application of WTO rules. However, if the panel invokes the first WTO appellate body ruling that the General Agreement on Tariffs and Trade (GATT) ìis not to be read in clinical isolation from international public law,î then the panel may rule that the Protocol is a lex specialis useful for interpreting more general WTO rules.11

3. How will the panel document its use of expert opinion in determining the factual matters
that pertain to the main legal issues of the dispute? Determining whether the EC has violated the provision against ìundue delayî in its regulatory review procedures will depend on how the panel interprets the ìvast amount of materialsî about GMOs submitted by the experts. Determination of violation will also depend on how the panel interprets the answers from experts to questions put to them and to the disputing parties by the panel. Panelists are not required to use expert opinion to make their ruling and the U.S. argued unsuccessfully that no expert opinion was needed to decide the dispute. However, since the panel has requested expert opinion, it is vital to the credibility of the ruling that the expertsí opinions, the documentary basis for the opinion and questions put to the experts be appended to the ruling.

4. How will the panel use previous WTO dispute panel and appellate body rulings on ìscientific uncertaintyî to justify its ruling? The disputants interpret past WTO rulings differently to support their arguments. Particularly important is how the panelists rule on the relation of ìinsufficient scientific informationî to ìscientific uncertaintyî as that relation was ruled in the case of a dispute over SPS measures that Japan took to prevent fire blight in apples. If the panel rules against the EC that there is no basis in the SPS agreement for ìscientific uncertaintyî resulting from ìinsufficient scientific information,î then the EC likely will not be able to defend itself against the U.S. charge of ìundue delayî in its regulatory review procedures.
The precautionary principle
Since the EC has taken a number of steps to revise its regulatory system to commercialize GMOs, the U.S. objectives in bringing the dispute are not entirely clear. One underlying objective is to get a dispute panel and/or appellate body ruling that there is no basis in the WTO agreements to support ECís argument ìthat states have the right to adopt a precautionary approach when dealing with GMOs.î12 In support of this argument, the EC cites articles 10(6) and 11(8) of the Cartagena Protocol on Biosafety, an international public law agreement to which none of the plaintiffs are parties.
The ìprecautionary approachî derives from German air pollution legislation in 1968 as a result of suggestive but not conclusive evidence that industrial air pollution was damaging the environment. In addition to justifying the governmentís authority to take preventative action against environmental damage, the legislation required that the regulatory actions be ìproportionalî to the potential for harm and that there be an assessment of the costs and benefits of action and inaction.13 Subsequent formulations of the precautionary principle, including
those applied to the risk analysis of GMOs, have specified the relation between scientific evidence and a typology of scientific uncertainty, and the need to shift the burden of proof to the technology developer to demonstrate the safety of a new technology (ìharmful until proven safeî).14
An EC Communication describes precaution as a risk management tool which is part of a risk analysis framework
rather than the overall guide to its (i.e., the frameworkís) implementation. According to this argument, precautionary action should only be taken after experts prepare an ìobjectiveî quantitative risk assessment. Precaution is seen as a temporary measure pending further risk assessment.î15 The commissionís interpretation
of the precautionary principle is clearly an attempt to make its application conform with the provisions of the SPS agreement. A great deal of the commissionís work has been to analyze the application of precautionary
approaches to government regulation over a wide range of products and over a time frame much longer than the decade since the commercialization of the first GM crops.16
U.S. corporations have taken a strong stand against a precautionary approach to the regulation of new goods and services.17 Additionally, the current head of the U.S. Office of Information and Regulatory Affairs in the presidentís Office of Management Budget has sought to pervert the precautionary principle by assuming that new products are safe until proven otherwise and putting a prohibitive cost-benefit analysis against most regulation. Given the antipathy of the White House and major U.S. corporations to the precautionary approach, most regulatory applications of precautionary approaches have occurred at the sub-federal level.

U.S. vs. EC Biotech Products Case 5
On May 13, 2003, the United States informed the European Commission that it would seek WTO consultations
to end an alleged EC moratorium on the approval for commercialization of agricultural biotechnology products. The United States claimed that the alleged moratorium violated provisions of the WTO agricultural,
technical barriers to trade (TBT) and sanitary/phytosanitary (SPS) agreements, as well as the General Agreement on Trade and Tariffs (GATT). To its complaint the U.S. appended a list of biotech product applications
for commercialization that had been submitted to EC member states from April 1996 through July 2001, all of which either were pending approval or which had been withdrawn. The majority of the plaintiffsí claims of EC violations of WTO rules concern the SPS agreement, which is the focus of this analysis. However,
the panel will almost certainly rule on the violations charged under other agreements. The U.S. further justified its complaint by contending that biotech products were necessary to feed developing countries.18
The EC characterized the filing of the complaint as ìlegally unwarranted, economically unfounded and politically unhelpful [with regard to EC efforts to develop a regulatory system for GMOs].î19 Two weeks later, President George Bush brought the trade dispute to wider public attention by charging that the alleged
moratorium on GMO approvals was hindering efforts to reduce hunger in Africa.20
Because the EC consultations with the U.S., Canada and Argentina did not result in the ending of the alleged moratorium, in August 2003 the WTO Dispute Settlement Body (DSB) announced the formation of a single panel to rule on the case. In March 2004, the three panelists were named and in April, the first submissions of evidence began. In addition to the three plaintiff WTO members, Australia, Brazil, Chile, Colombia, India, Mexico, New Zealand and Peru requested consultations with the European Communities and reserved their rights as third parties to benefit from the ruling.21
Since at least as early as July 1999, an interagency task force of U.S. officials had been debating under which provisions of which WTO agreements the U.S. should charge that the EC regulatory review process violated
WTO rules. In June 1999, five EC member states had declared that they would not approve biotech products for commercialization until new EC legislation (Directive 2001/18) concerning the labeling and traceability (ability to document and verify each step in food and animal feed production from the farm to the consumer) of GMOs had been adopted by member states. That declaration triggered U.S. charges of a general moratorium on GMO approvals. Because the EC had not rejected, but only classified as pending, an individual application for commercialization of a biotech product, U.S. officials decided that the most likely provision under which the U.S. could win a WTO dispute would be under article 8 and annex C of the SPS agreement. These provisions seek to ensure that approval and control procedures for products entailing SPS measures be undertaken ìwithout undue delay.î At the time of the filing in 2003, the EU had not approved a new GMO crop since 1996. Even then, one industry official thought it would be difficult for the U.S. to win on that basis, noting that it took the U.S. 50 years to approve imports of avocadoes.22
In general, the U.S. has argued that there are no scientific issues relevant for assisting the dispute panel: ìno dispositive issue in this dispute [U.S. underlining] turns on these abstract scientific questions. In particular, regardless of the answer to abstract questions regarding the purported risks of biotech products, the EC is obligated to complete its approval procedures without ëundue delay.íî23 The EC countered, ìThe independent
expertise is needed to determine whether the time actually used in the specific cases [of alleged ëundue delayí] to address the actual issues which arose was ëundue.íî24
In spite of U.S. objections, in August 2004, the dispute panel decided that it would seek expert advice and began the process of selecting experts and drafting questions for them. The panel is not required by the WTO dispute settlement understanding to take into account expert advice in issuing their ruling, nor does the panel have to append to the ruling questions put to experts, their answers and bibliographical references
to document their answers. Nevertheless, the panel has opened the door to allow experts to comment on scientific issues that the EC regards as relevant and the U.S. regards as irrelevant to determining the outcome of the case.25
U.S. vs. EC Biotech Products Case 7
The main issues
The status of ìfactsî
The first U.S. submission to the dispute panel largely comprises a ìstatement of facts,î followed by a legal discussion that focuses on the SPS agreement. It is not clear what, if any, evidentiary weight the dispute panel will give to U.S. assertions as ìfacts.î In some instances, the U.S. represents as facts claims that are controversial within the scientific community. Consider the claim, documented by an un-cited, presumably commercialization-applicant study, alleging a 21 metric ton reduction in U.S. pesticide use in 2001 due to use of genetically engineered seeds.26 How will the panelists weigh such an undocumented claim as evidence, if it is contrasted to the first detailed analysis of U.S. Department of Agriculture data documenting an increase in U.S. pesticide use on GM crops since 1999?27 In general, how will the panel judge blanket assertions about the environmental safety of GMOs when the U.S. National Research Council concludes, ìclaims concerning
the lack of effects from the tens of millions of hectares of transgenic crops that have been planted in the United States during the last three years are nonscientific. There has been no environmental monitoring of these transgenic crops, so any effects that might have occurred could not have been detectedî?28
Will the panelists give greater evidentiary weight to an EC Research Directorate press release, cited by the U.S., declaring the safety of biotech products29 than it would to a U.S. commercialization approval letter for GMOs? Will the panelists consider the U.S. approval process, which is offered as a WTO conforming, science-based regulatory system? The U.S. does not verify the safety of any biotech product, but approves products based on the ìsafety and nutritional assessmentî submitted by biotech companies and based on the companyís conclusion that its findings ìdo not raise issues that would require pre-market approval.î30 (See ìSample U.S. Food and Drug Administration biotech product commercialization approval,î page 8.) How will panelists be able to compare WTO member compliance with the SPS agreement provisions on approval and control procedures if the U.S. allows biotech companies to de facto self-approve, while the EC requires independent verification by a competent authority of the companyís claims for its products?31
Legal issues
The structure of the U.S. legal argument is in three parts: ì1) General Moratorium Violates the SPS Agreement;
2) Product-Specific Moratoria Violate the SPS Agreement: and 3) EC Member State Marketing or Import Bans Violate the SPS Agreement.î With slight variations, the U.S. claims the same violations of the SPS Agreement in each of the three parts. The United States claims:
1. The existence of alleged moratorium is a violation of the SPS rules against ìundue delayî in SPS agreement approval procedures.
2. Failure to notify the moratorium as an SPS measure is a violation of SPS agreement rules on transparency of rule-making and notification of domestic SPS measures to the WTO SPS committee.
3. The EC and EC member states failed to publish risk assessments on the likelihood of harm resulting from biotech products, as required by article 5.1.
Sample U.S. Food and Drug Administration biotech product commercialization approval
U.S. vs. EC Biotech Products Case 9
4. The alleged moratoria are maintained without ìsufficient scientific evidenceî in violation of article 2.2.
5. By regulating biotech products, such as genetically engineered seeds, more strictly than biotech processing agents, such as enzymes used in food manufacturing, the EC violates article 5.5, which seeks to ensure that WTO members apply SPS measures indiscriminately to domestic and imported products ìin comparable situations.î
In its first submission to the dispute panel, the EC deployed various defenses against the U.S., et al., complaint
of ìundue delay.î First, the EC states that ìthe alleged delay in completing the approval procedures for certain applications does not, itself, constitute a sanitary or phytosanitary measure, and thus, these provisions [of the SPS agreement that the U.S. charges the EC violates] do not apply.î32 But even if delays in regulatory review of applications of the commercialization of GMOs were considered to be measures, the EC argues that they are not ìundueî but that the delays are due to legitimate requests for information from applicants and due to the implementation process for Directive 2001/18.
In its first and second submissions, the EC outlines reasons for the delays in final approvals to commercialization
applications to member states. Most of the delays, the EC contends, resulted from lack of applicant response or incomplete response to member-state regulator questions about GMOs. For example, regarding an application to commercialize genetically modified oilseed rape (canola), the EC points to delays in receiving information requested of the applicant, including information related to ìthe impact of herbicide regimes associated with the cultivation of GM herbicide tolerant oilseed rape, on farmland biodiversity, and population dynamics and life cycles in the farming ecosystem (risk issues which obviously go beyond the scope of risk assessment under the SPS agreement).î33 According to the U.S., the scope of the application of SPS measures in the SPS agreement, annex A, paragraph 1, covers all the issues raised by the EC and its members states and, hence, no EC directive nor member-state legislation or regulation is exempt from the claim of violating the ìundue delayî provision.34 For the EC, the delay cannot be ìundueî if it pertains to an issue for risk assessment not covered in the SPS agreement.
The relevance of international SPS standards
versus the Biosafety Protocol
More generally, the EC submits, ìThe SPS Agreement was not intended to address the prevention of risks to the environment.î The common and ordinary meaning of ìenvironmentî is broad and includes the protection of biodiversity. It extends beyond the narrow definitions to be found in annex A of the SPS agreement.35 The EC claims that some of those aspects of the EC regulation of GMOs not covered by the SPS agreement are contained in the Cartagena Protocol on Biosafety.36 The United States not only dismisses the relevance of the protocol to the panelís decision, 37 but asserts that the panelís determination of environmental risks covered by the SPS agreement need not be ìcontrolledî by the definitions of such risks, adduced by the EC, from the Codex Alimentarius Commission and the International Plant Protection
Convention (IPPC).38
Since the Convention on Biological Diversity, to which the protocol belongs, is not even allowed to be an international observer at the meetings of the WTO Trade and Environment Committee, much less mentioned in the SPS agreement, the panel may dismiss or at least not rule on the relevance of the protocol
to the case. However, with notable exceptions, the SPS agreement requires WTO members to base their SPS measures on international standards (article 3.1). Codex and the IPPC are designated as international standard-setting organizations in which WTO members are to participate (article 3.4). Therefore, it is unlikely that the panel will ignore the normative weight of Codex and IPPC definitions employed in the EC argument. Nor can the panel ignore that the SPS agreement calls on members to take into account ìavailable scientific evidenceî in assessing risks, including ìrelevant ecological and environmental conditionsî
(article 5.2).
ìUndue delayî and EC officialsí calls to ìlift the moratoriumî
Perhaps most counterintuitively, the EC argues, ìNo evidence on the existence of a ëmoratoriumí [on the approval of GMOs] has been identified.î39 The EC dismisses the evidentiary validity of statements by EC officials, such as Commissioners David Byrne and Margaret Wallstrˆm, adduced by the United States, about the existence of a ìde facto moratoriumî by EU member states on approvals of GMOs.40 According
to the EC argument, evidence of a moratorium would be an official EC communication declaring a moratorium, and no such communication was issued.41
The U.S. contends that what the EC calls ìalleged delayî is in fact a ìgeneral moratorium [that] is one component of the ECís biotech regime … [which] is unquestionably an SPS measureî42 subject to the disciplines
of the SPS agreement. According to the U.S., ìThe statements of European Commission officials acknowledge not only the existence of the moratorium but also that it is maintained without scientific or legal justification.î43 Whether or not the dispute panelists decide that statements by EC officials in favor of GMOs44 and in support of lifting the alleged moratorium have the force of law, and therefore have evidentiary relevance, is difficult to predict.
ìUndue delayî and ìrisk assessmentî
Panelists will decide the validity of the U.S. argument that the alleged moratorium in its entirety must be justified by a risk assessment, per article 5.1 of the SPS agreement. The EC charges ìthe Complainantsí strategy is to avoid dealing with individual applications or looking at the scientific and risk assessment related reasons that has arisen in each case. Instead they apply a superficial attempt to reduce the whole case to a generalized and indiscriminate moratorium.î45 The EC further points out that the Codex principles
for the risks analysis of ìFoods Derived from Modern Biotechnologyî (CAC/GL 44-2003, points 13-14) advises that all risk analysis should be performed on a case by case and not on the basis of a general regulatory framework.46 However, the status of Codex texts, like all expert opinion as evidence, is only advisory, so, according to the dispute settlement understanding, the panels are not required to take them into account in issuing their ruling. 47
The U.S. argues that a general moratorium requires a risk assessment, based its interpretation of an appellate
body ruling concerning a U.S. case against EU restrictions on the import of meat from animals raised with growth hormones.48 The panel is likely to rule on this argument because it concerns an interpretation of WTO case law that will bear on the future interpretation of the SPS agreement.
Just as importantly, the panel may decide to set a precedent by ruling on the U.S. argument that the entire
U.S. vs. EC Biotech Products Case 11
regulatory risk analysis framework (since the U.S. claims that the alleged moratorium is an SPS measure), and not just specific biotech products, must be justified by a risk assessment.49 If the panel rules in favor of the U.S. on this argument, general regulatory frameworks, such as the U.S. ìsubstantial equivalenceî measure that assumes GMOs to be ìsubstantially equivalentî to their ìconventional counter-partsî unless proven otherwise, could be challenged as having lacked a risk assessment. The regulatory approval of a transgenic event shown not to be ìsubstantially equivalentî50 could be challenged as illegal for having lacked a risk assessment.
The most compelling U.S. argument against the EC is that ìundue delayî occurs when EC member states issue marketing or imports bans to a biotech product despite having received a positive risk assessment from an EC scientific committee. Article 5.1 of the SPS agreement requires that SPS measures are ìbased onî a risk assessment, as defined in the SPS agreement. According to the U.S., ìBecause the member States failed either to put forth their own risk assessment or to provide sufficient information to overturn the European Communitiesí earlier positive assessments, the member States have violated Article 5.1.î51 If the panelists decide that an import or marketing ban is an SPS measure covered under the SPS agreement, then they will have to decide whether a positive risk assessment must lead to a final approval for commercialization of a biotech product.
The EC rebuts the U.S. argument that a positive risk assessment requires the EC or an EU member state to give final approval for commercialization of a biotech product. The EC states that EC scientific opinions are not legally binding on member states, as the U.S. believes they are, and that ìscientific opinions are limited in scope, and, therefore, often do not conclude the risk assessment process, even in the narrow sense.î52 Furthermore, the EC argues that article 5 of the SPS agreement refers to risk management and risk communication elements of risk analysis. The article makes ìit clear that in making an assessment of risks Members are entitled, and indeed obliged (ëMembers shallí), to take into account not only scientific but also economic and regulatory considerations.î53 When scientific knowledge is insufficient to assess a risk, a precautionary approach to risk analysis entitles governments to apply risk management options, such as a traceability scheme ìto detect and identify any negative impact that was unforeseen or unidentified in the initial process of risk assessment.î54
For the EC to defend its regulatory regime against the charge of violating article 5.1, the panel must agree with the EC that the rendering of a positive risk assessment by an EC scientific commitment is not in and of itself sufficient as to require a final approval of a biotech product for commercialization. The U.S. and its allies have successfully blocked Codex work that would advise governments on risk analysis,55 so the panelists
have no international standard to which to refer in judging the EC argument about the components of risk analysis.
The interpretation of provisional measures in SPS article 5.7
in relation to the rest of the agreement
Much of the EC defense of its regulatory regime for GMOs depends on how article 5.7 is interpreted in relation to several other articles that the U.S. charges the EC violates. The EC appears to concede that the member state import and marketing bans are SPS measures, but characterizes them as provisional measures whose consistency or lack of consistency should be judged not under article 5.1, but under article 5.7 on provisional measures applied while sufficient information is gathered to perform ìa more objective
assessment of risk.î56 If the panelists agree with the EC that the complaints against the EC regulatory regime should be judged under article 5.7, then the likelihood that EC can defend that regime improves considerably.
The U.S. does not charge the EC with violating article 5.7, but argues that the EC cannot defend its alleged
moratoria as provisional measures resulting from insufficient scientific evidence.57 The U.S. reads the relation of article 5.7 as subordinate to the article 2.2 requirement to base an SPS measure on ìsufficient scientific evidenceî and the article 5.1 requirement to base an SPS measure on a risk assessment as defined by the SPS agreement.
The EC reads article 5.7 as exclusionary from the article 2.2 and 5.1 requirements. For the EC, article 5.7 allows WTO members to establish a provisional SPS measure without a risk assessment precisely because of the insufficiency of scientific evidence and uncertainty about risks that makes it impossible to carry out a full risk assessment.58 Regulatory review delays resulting from requests by regulators to obtain sufficient relevant scientific evidence to perform a risk assessment, to design risk management measures, such as traceability system and risk communication measures, such as labeling of GMOs, should therefore not be characterized as ìundue delaysî in violation of the SPS agreement.59 The EC notes as an example of the delay required by thorough regulatory review the three-year delay in Canada to approve Monsantoís application to commercialize genetically engineered wheat.60
However, ìthe United States does not agree that the ësufficiency of relevant scientific evidenceí depends on the level of protection [sought by a government for its consumers, plants or animals] or nature of the risks.î The U.S. bases this statement on its reading of an appellate body passage in the Japan-Apples ruling concerning SPS measures to combat apple blight (WT/DS245/AB/R, paragraph 179).61 The EC states that the EC-Biotech Products case is ìvery different from the circumstances of the Japan-Apples case.î The EC notes that the appellate body ruling on the lack of justification for a provisional measure was because the nature of the risks of fire blight for apples, the sufficiency of relevant scientific evidence and the SPS measures to combat it had been known for about 200 years. In contrast, ìGMO technology is still at or close to the frontiers of science and its future consequences (compared to a case like fire blight) are highly uncertainóand potentially much more far reaching.î62
If the dispute panel determines that a judgment about the sufficiency of relevant scientific evidence on which to base an SPS measure can be made regardless of the nature and severity of the risks of a product and regardless of the level of protection that a government seeks for its consumers, plants and animals, then the panel likely will rule in favor of the U.S. If the dispute panel agrees that the material facts of EC-Biotech Products (i.e., the risks of the technology and the SPS measures used to prevent harm to human, plant and animal health) are different from the material facts, the risks and measures for fire blight in Japan-Apples, then the EC might prevail.
Risk assessment, ìsufficiency of evidenceî and scientific uncertainty
The U.S. believes that WTO case law is clearly on its side in the dispute over the relevancy and interpretation of Article 5.7. The U.S. maintains, ìThe ECís general discussion of themes such as ëuncertainty,í however, does not help the EC in the development of any argument under Article 5.7.î63 The U.S. then adduces as support for its argument, this passage from the appellate body ruling on the Japan-Apples case:64
U.S. vs. EC Biotech Products Case 13
The application of Article 5.7 is triggered not by the existence of scientific uncertainty, but rather by the insufficiency of scientific evidence. The text of Article 5.7 is clear: it refers to ìcases where relevant scientific evidence is insufficient,î not to ìscientific uncertainty.î The two concepts are not interchangeable. Therefore,
we are unable to endorse Japanís approach of interpreting Article 5.7 through the prism of ìscientific uncertainty.î
The U.S. then remarks, ìThe Panel should do the same here with respect to the EC suggestion.î 65 If the panel does as the U.S. recommends, and does not endorse the EC interpretation of article 5.7, it will do so not just to uphold the Japan-Apples ìprecedentî ruling on article 5.7. To accept the Japan-Apples ruling on ìscientific uncertainty,î the panel would need to find that there was no more ìscientific uncertaintyî in determining the risks of biotech products and applying SPS measures to control than there is in determining
the risks of and measures to control fire blight.
Regulatory consistency in the application of SPS measures
Article 5.5 aims to ensure regulatory consistency in the application of SPS measures to achieve the appropriate
level of protection (ALOP) that WTO members set. The article is sufficiently controversial so that the SPS committee took five years of negotiations to work out voluntary guidelines for implementation of this article.66 These guidelines not withstanding, implementation of 5.5 presents difficulties in interpreting what are ìcomparable situationsî in the application of SPS measures to meet a designated ALOP. For the U.S., the EC violates article 5.5 when it allows commercialization of biotech food processing agents but maintains a moratorium against other biotech products, such as genetically modified seeds.67 According to the U.S., ìIn contrast to new biotech processing aids, which are not regulated, the EC has imposed a general moratorium on other new biotech products, resulting in an appropriate level of protection of zero risk.î68 The U.S. maintains that this contrast results in ìarbitrary or unjustifiableî differences in the appropriate
level of protection, a violation of article 5.5.
The EC defense against this claim of violation is not a factual one concerning the differences between processing aids and the biotech products submitted for commercialization approval, largely GM seeds and crops. Rather, the EC defense relies, again, on the argument that article 5.5 does not apply to the case because it concerns final SPS measures, and not the delays or interim SPS measures under article 5.7. The EC argues, ìWTO members must necessarily enjoy more flexibility in cases where they lack elements to assess the nature or extent of the risk.î69

An NGO brief on scientific uncertainty

An NGO amicus brief concedes the appellate bodyís distinction between ìinsufficient evidenceî and ìscientific
uncertaintyî but then notes that ìWTO jurisprudence is not clear as to the influence of uncertainty
in determining whether the scientific evidence is insufficient in a given situation.î70 The brief then goes on
to outline different kinds of scientific uncertainty about GMOs and how such uncertainties influence the
determination about when scientific information is insufficient. For example, the amicus brief characterizes
the uncertainty arising from ìunintended effects of genetic modification arising from the random nature of
rDNA techniques.î71 The brief states, ìRandom and unpredictable genetic modification techniques thus
lack a cardinal feature of both scientific method and reliable commercial technologiesórepeatability.î72
The brief also outlines the problem of determining the sufficiency of evidence to verify the safety of GMOs
when a large portion of the studies asserting safety are applicant studies that are not peer-reviewed in
scientific journals, but are classified often as confidential business information available to nobody outside
the firm but government regulators.73 Finally, the NGOs argue ìUncertainty may not allow, in qualitative
terms, the performance of an adequate risk assessment, thus making scientific evidence ëinsufficientí within
the meaning of Article 5.7.î74 Therefore, concludes the brief, ìthe first condition under Article 5.7, the
ëinsufficiencyí of relevant scientific evidence is met by the EC measures challenged in the present case.î75
The NGO amicus brief offers to the panel the means to refine the appellate body ruling on Japan-Apples
regarding article 5.7. If the panel takes into account the NGO brief, the EC defense of the reasons for its
delays and interim SPS measures stands a better chance of withstanding the U.S. challenge.

U.S. vs. EC Biotech Products Case 15
Significance of EC-Biotech Products
Whether or not the United States wins the EC-Biotech Products case, it is likely that the U.S. will file another case against the Directive 2001/18 on labeling and traceability of GMOs. As one industry official put it, ìremoval of the moratorium is ëutterly uselessí if it is replaced by labeling and traceability rules.î76 However, the likelihood that the United States, et al., will file another case against the EC on its GMO regulations in no way diminishes the impact of this case. The U.S. is seeking a ruling, rather than a negotiated settlement, in EC-Biotech Products to establish a legal precedent, particularly to make it extremely difficult to use article 5.7 to defend domestic SPS measures.77 While the ruling cannot reverse European consumer distaste for GMOs and growing preference for organic products, the ruling can lead to enforcing commission support for planting GM crops and thereby reducing the availability of non-GM products from which to choose.
Furthermore, if the panel rules against the ECís invocation of the precautionary principle, either in the EC context or in the Cartagena Protocol on Biosafety,78 the viability of successfully using a precautionary principle-based defense (e.g., against a threatened U.S. WTO case concerning the new EC chemicals assessment regime79) is reduced. For the EC, ìArticle 5.7 of the SPS Agreement is of course one expression of the precautionary principle. … This is another reason why Article 5.7 is an autonomous right that is also recognized in the Biosafety Protocol.î80 However, the panel well may dismiss the relevance of or evidentiary status of the precautionary principle in its ruling on the article 5.7 defense. A repudiation of the precautionary principle alone may justify to the U.S. the negative civil society reaction that is very likely to follow an EC-Biotech Products ruling in favor of the plaintiffs.
The fact that the commission is working very hard to promote the technology,81 as well as to defend their regulatory system, in the face of considerable public opposition to agricultural biotechnology, does not diminish the importance of the case.82 Former EC Trade Commissioner and incoming WTO Director General Pascal Lamy believes victory for the plaintiffs to lift the moratorium would only result in the status quo, in view of the restarting of approvals for GM products in Europe. However, such a victory could have far more serious precedential consequences for WTO members attempting to justify measures to protect public and environmental health in the context of international agreements for which the highest public policy criterion is the promotion of trade, allowing protective measures only insofar as they can be demonstrated to be ìleast trade restrictive.î

Bibliographical note
To read:
U.S. dispute documents, go to:

EC dispute documents and NGO amicus briefs are at and at

The EC chose not to publish its submissions, despite a legal filing by Friends of the Earth Europe to force it to make public its second submission. [!!!!!]

1. ìCommunication from the Chairman of the Panel: European Communities – Measures Affecting The Approval and Marketing of Biotech Products,î WORLD TRADE ORGANIZATION (November 2, 2004) and (June 15, 2005) at
2. ìEU Member States Clash With Commission Over GMOs, Could Signal Changes,î INSIDE U.S. TRADE, July 8, 2005.
3. ìEuropean Commission Opts Not To Push For End of GMO Moratorium,î INSIDE U.S. TRADE, January 25, 2002.
4. EC Biotech Products: ìFirst Written Submission by the European Communitiesî (May 17, 2004), paragraph 75.
5. ìEuropean Union Deadlocked on Votes To Lift Member Statesí GMO Bans,î INSIDE U.S. TRADE, December 3, 2004.
6. Jeremy Smith, ìEU Experts Fail to Agree GMO Maize Approval, Again,î REUTERS, April 28, 2005.
7. Sara Lewis, ìîEuropean Commission considers options after rebuff on biotech bans,î FOOD CHEMICAL NEWS, July 4, 2005.
8. Elizabeth Becker, ìWhite House Undermined Chemical Tests, Report Says,î THE NEW YORK TIMES, April 2, 2004, and Tobias Buck, ìUS diplomats to lobby EU on chemicals rules,î THE FINANCIAL TIMES, May 29, 2004.
9. Joe Kirwin, ìEU Commission Takes 11 States to Court For Failing to Implement GMO Legislation,î INTERNATIONAL ENVIRONMENT REPORTER, July 16, 2003; John Thornhill and Ian Bickerton, ìDutch and French set to vote No at polls, FINANCIAL TIMES, May 23, 2005; ìEU Decides To Uphold Existing GMO Policy, Challenge Member Bans,î INSIDE U.S. TRADE, March 25, 2005; ìEU Presses U.S. To Take Action Against Illegal GMO Exports,î INSIDE U.S. TRADE, April 8, 2005; ìEU GMO Testing Requirements Seen As Threatening U.S. Corn Exports,î INSIDE U.S. TRADE, April 15, 2005.
10. Geoffrey Lean, ìRevealed: health fears over secret study into GM food,î THE INDEPENDENT, May 22, 2005.
11. Simonetta Zarrilli, ìInternational Trade in GMOs and GM Products: National and Multilateral Legal Frameworks,î UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT, Policy Issues in International Trade and Commodities Study Series No. 29 (2005), 37-38.
12. ìOral Statement by the European Communities at the First Meeting of the Panel.î (June 2, 2004), paragraph 28.
13. Andrew Jordan and Timothy OíRiordan, ìThe Precautionary Principle in Contemporary Environmental Policy and Politicsî in Protecting Public Health and the Environment: Implementing the Precautionary Principle, ed. Carolyn Raffensperger and Joel Tickner (Washington, DC: Island Press, 1999), 19-23.
14. Andy Stirling and Sue Mayer, ìPrecautionary Approaches to the Appraisal of Risk: A Case Study of a Genetically Modified Cropî, INTERNATIONAL JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH, Vol. 6, No. 4 (October/December 2000) and Katherine Barret, ìApplying the Precautionary Principle to Agricultural Biotechnology,î SCIENCE AND ENVIRONMENTAL HEALTH NETWORK (March 2000) at
15. ìNicolas de Sadeleer, ìTwo Approaches to Precaution: A Comparative Review of EU and US Theory and Practice of the Precautionary Principle and an Overview of EU and US NGO Positions,î TRANSATLANTIC ENVIRONMENT DIALOGUE, a Heinrich Boell Foundation workshop (May 12, 2000).
16. ìLate lesions from early warnings: the precautionary principle 1896-2000î EUROPEAN ENVIRONMENT AGENCY, Environmental issue report No. 22, EUROPEAN COMMUNITIES (Copenhagen, 2001).
17. E.g. Lawrence Kogan, ìEU Regulation, Standardization and the Precautionary Principle: The Art of Crafting a Three-Dimensional Trade Strategy That Ignores Sound Science,î THE NATIONAL FOREIGN TRADE COUNCIL INC. (August 2003).
18. ìU.S. and Cooperating Countries File WTO Case Against EU Moratorium on Biotech Foods and Crops: EUís Illegal, Non-Science Based Moratorium Harmful to Agriculture and the Developing World,î Office of the U.S. Trade Representative press release, and U.S. letter from Ambassador Linnet Deily to EC Ambassador Carlos Trojan, May 13, 2003 at
19. ìEuropean Commission Regrets U.S. Decision to File WTO Case on GMOs as Misguided and Unnecessary,î EUROPEAN COMMISSION, May 13, 2003.
20. Gary G. Yerkey, ìPresident Bushís High-Profile Criticism of EU Over GMOs Seen Exacerbating Trade Dispute,î INTERNATIONAL TRADE DAILY, May 27, 2003.
21. ìConstitution of the Panel Established at the Requests of the United States, Canada and Argentina,î WORLD TRADE ORGANIZATION, March 5, 2004 at http:/
22. ìU.S. Explores SPS Case on EU GMO Approvals, Comes Up Short So Far,î INSIDE U.S. TRADE, July 23, 1999, EC Biotech Products, ìFirst Submission of the United Statesî (April 21, 2004); paragraphs 34-36; ìCommission improves rules on labeling and tracing of GMOs in Europe to enable freedom of choice and ensure environmental
U.S. vs. EC Biotech Products Case 17
safety,î EUROPEAN COMMISSION, IP/01/1095, June 25, 2001.
23. ìComments of the United States on the ECís Final Position on Whether to Seek Advice from Scientific Experts,î (July 27, 2004), paragraph 12.
24. ìSecond Written Submission by the European Communities,î (July 19, 2004), paragraph 244.
25. ìWTO Panel On EU GMO System To Consult Experts Over U.S. Objections,î INSIDE U.S. TRADE, August 13, 2004.
26. ìFirst Submission of the United States,î (April 21, 2004), paragraph 23.
27. Charles M. Benbrook, ìGenetically Engineered Crops and Pesticide Use in the United States: The First Nine Years,î BioTech InfoNet, Technical Paper No. 7 (October 2004) at
28. Environmental Effects of Transgenic Plants, NATIONAL RESEARCH COUNCIL (2002), cited in EC Biotech Products, ìAmicus Curiae Brief,î CENTER FOR INTERNATIONAL ENVIRONMENTAL LAW et al. (June 1, 2004), paragraph 10.
29. ìFirst Submission of the United States,î paragraph 27.
30. Quoted passages from the letter approving AgrEvoís StarLink corn variety for commercialization, U.S. Food and Drug Administration, May 29,1998, cited in Steve Suppan, ìThe U.S. Request for a WTO Panel on the EC Biotech Moratorium: Why Now and With What Result,î INSTITUTE FOR AGRICULTURE AND TRADE POLICY (September 2003) at
31. For the origins of the U.S. deregulatory approach to agricultural biotechnology, see Mary Ellen Jones, Politically Corrected Science: The Early Negotiation of U.S. Agricultural Biotechnology Policy, Ph.D. Dissertation (Virginia Polytechnic Institute and State University, 1999) at
32. EC Biotech Products: ìFirst Written Submission by the European Communities.î (May 17, 2004), paragraph 469.
33. ìSecond Written Submission by the European Communities.î paragraph 172.
34. ìFirst Submission of the United States,î paragraphs 71-80.
35. ìFirst Written Submission by the European Communities,î paragraphs 416-417.
36. Ibid., paragraph 112.
37. ìComments of the United States on the ECís Responses to the Questions Posed by the Panel after the Second Substantive Meeting,î (March 18, 2005), paragraph 13.
38. Ibid., paragraph 7.
39. ìFirst Written Submission by the European Communities,î paragraph 541.
40. Ibid., paragraph 553.
41. Ibid., paragraphs 557-563.
42. ìExecutive Summary of the First Submission of the United States,î (April 30, 2004), paragraph 26.
43. Ibid., paragraph 18.
44. E.g. Franz Fischler, ìBiotech and Agriculture,î Conference on life sciences and biotechnology, EUROPEAN COMMISSION, Speech 01/421 (September 28, 2001), Brussels.
45. ìSecond Written Submission by the European Communities,î paragraph 241.
46. ìOral Statement by the European Communities at the First Meeting of the Panel,î (June 2, 2004), paragraph 28.
47. ìUnderstanding on Rules and Procedures Government the Settlement of Disputesî, The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations, WORLD TRADE ORGANIZATION, (Geneva 2002), Appendix 4.6.
48. ìFirst Submission of the United States,î paragraphs 107-108.
49. Ibid., paragraphs 100-108.
50. Michael Hansen, ìGenetic Engineering Is Not An Extension of Conventional Plant Breeding,î CONSUMER PLICY INSTITUTE/ COSNUMERS UNION (January 2000) at http:://biotech-info-net/wide_crosses.html and Barry Commoner, ìUnravelling the DNA Myth,î HARPERíS MAGAZINE (February 2002), 39-47.
51. ìFirst Submission of the United States,î paragraph 170.
52. ìSecond Written Submission of the European Communities,î paragraphs 30-31.
53. Ibid., paragraph 23.
54. Ibid., paragraph 26.
55. ìReport of the Twenty-Second Session of the Codex Committee on General Principles,î ALINORM 05/28/33A, paragraphs 31-54, at
56. ìFirst Written Submission of the European Communities,î paragraphs 600ó603.
57. ìU.S. Answers to Questions Posed in the Context of the First Panel Meeting,î (June 16, 2004), paragraphs 87-89.
58. ìSecond Written Submission by the European Communities,î paragraphs 80-103.
59. Ibid., paragraphs 281-282.
60. ìFirst Written Submission by the European Communitiesî, paragraphs 486-489
61. ìU.S. Answers to Questions Posed in the Context of the First Panel Meeting,î (June 16, 2004), paragraph 88.
62. ìFirst Written Submission by the European Communities,î paragraph 608.
63. ìExecutive Summary of U.S. Opening Statement on Expert Issues at the Second Substantive Meeting,î (March 23, 2005), paragraph 14.
64. Ibid. citing ìJapan ñ Measures Affecting Imports of Apples (Japan-Apples),î WTO Docs. WT/DS245/AB/R.
65. Ibid., paragraph 14.
66. ìGuidelines to Further the Practical Implementation of Article 5.5î, Committee on Sanitary and Phytosanitary Measures,î WORLD TRADE ORGANIZATION, G/SPS/15 (July 18, 2000).
67. ìFirst Submission of the United States,î paragraphs 114-127.
68. Ibid., paragraph 119.
69. ìSecond Written Submission by the European Communities,î paragraph 107.
71. Ibid., paragraph 18.
72. Ibid., paragraph 19.
73. Ibid., paragraphs 12-15.
74. Ibid., paragraph 36.
75. Ibid., paragraph 40.
76. ìU.S. Looking At Special DSB Session For First Biotech Panel Request,î INSIDE U.S. TRADE, August 1, 2003.
77. Marc L. Busch and Robert Howse, ìA (Genetically Modified) Food Fight: Canadaís WTO Challenge to Europeís Ban on GM Products,î C.D.. HOWE INSTITUTE COMMENTARY (September 2003), 7.
78. ìFirst Written Submission by the European Commission,î paragraphs 105-108;
79. ìBriefing Paper and Resolution on REACH,î TRANSATLANTIC CONSUMER DIALOGUE (June 2004) at
80. ìOral Statement by the European Communities at the First Meeting of the Panelî, paragraph 58.
81. ìCommunication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions: life sciences and biotechnology — A Strategy for Europe,î COM (2002) 27, January 27, 2002.
82. Alan Osborn, ìEU Commission pushed ahead on GM despite widespread oppositionî, Febraury 22, 2005 at
83. ìComplaint about Maladministration to the European Ombudsman,î FRIENDS OF THE EARTH EUROPE (February 16, 2005) at

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