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  ANNEX F 
 
REPLIES BY THE PARTIES TO QU ESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
AND COMMENTS BY THE PARTIES ON THE OTHER PARTIES' REPLIES 
 
 
Contents Page 
Annex F-1 Replies by the United States to questions posed by the Panel in the 
context of the second substan tive meeting (7 March 2005) F-2 
Annex F-2 Replies by the United States to additional questions posed by the 
Panel in the context of the second substantive meeting 
(11 March 2005) F-26 
Annex F-3 Comments by the United States on the replies of the European 
Communities to questions posed by the Panel in the context of the second substantive meeting (18 March 2005) F-44 
Annex F-4 Replies by Canada to questions  posed by the Panel in the context of 
the second substantive meeting (7 March 2005) F-56 
Annex F-5 Replies by Canada to additiona l questions posed by the Panel in the 
context of the second substan tive meeting (11 March 2005) F-72 
Annex F-6 Comments by Canada on the re plies of other parties to questions 
posed by the Panel in the context of the second substantive meeting (18 March 2005) F-93 
Annex F-7 Replies by Argentina to questions posed by the Panel in the context 
of the second substantive meeting (7 March 2005) F-110 
Annex F-8 Replies by Argentina to add itional questions posed by the Panel in 
the context of the second substantive meeting (11 March 2005) F-117 
Annex F-9 Replies by the European Communities to questions posed by the 
Panel in the context of the second substantive meeting (7 March 2005) F-123 
Annex F-10 Replies by the European Co mmunities to additional questions posed 
by the Panel in the context of the second substantive meeting 
(11 March 2005) F-154 
Annex F-11 Comments by the European Communities on the replies by the 
complainants to questions posed by  the Panel in the context of the 
second substantive meeting (18 March 2005) F-174 
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  ANNEX F-1 
 
REPLIES BY THE UNITED STATES TO QUESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
7 MARCH 2005 
 
 
For all parties
: 
119. With reference to exhibit US-123 (reproduced  at para. 9 of attachment II of the US 
rebuttal), do the references in ISPM 11 to "indirectly  affect plants ... by other processes such as 
competition" (page 34) and "significant reduction , displacement, or elimination of other plant 
species" (page 19) support the view that the term "injurious" in the IPPC definition of "pest" ("any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants or plant 
products") should be given a broad interpretation?    
1. The cited language makes clear that the definiti on is to be interpreted to include all reasonably 
foreseeable injuries that an organism might cause to plant life or health.  Also relevant in this regard is 
the discussion in Annex 1 of ISPM 11, which explicitly provides that the scope of the IPPC also extends to those injuries caused by organisms that indirectly affect  plant species or health, through 
effects on other organisms in the ecosystem.  The di scussion in Annex I thus directly contradicts many 
of the artificial distinctions the EC has previously suggested.  
 
120. With reference to Annex A(1)(d) of th e SPS Agreement, please an swer the following 
questions: 
 
 (a) What is the meaning of the term "other damage"?     (b) Does the term "other" imply that A nnex A(1)(a) through (c) are also about 
"damage"?  If so, does the term "other damage" cover damage sustained by plants, animals or humans other than damage to their "life or health"?  Please 
provide examples. 
  (c) Is "other damage" limited to damage sustained by plants, animals or humans?  If 
not, please provide examples. 
 
2. Subpart (a): The meaning of the term "other damage" in Annex A(1)(d) is indicated by its 
context:  in particular, the meaning of this term is i ndicated by the fact that the term "other damage" is 
used at the end of a list in Annex A(1) of different types of risks of damage "arising from the entry, establishment, or spread of pests."  Paragra ph A(1)(a) specifies that the SPS Agreement addresses 
damage to "animal or plant life or health" arising from the "entry, establishment or spread of pests," 
and Paragraph A(1)(c) specifies that the SPS Agreem ent addresses damage to "human life or health" 
arising from the "entry, establishment or spread of p ests."  Thus, in context, the term "other damage" 
must mean damage other than damage to "animal or  plant life or health" or "human life or health." 
 3. Subpart (b) and (c):  As discussed in the answer to subpart (a) above, the use of the term 
"other" in Annex A(1)(d) does imply that Annex A( 1)(a) through (c) are also about "damage," and the 
term "other damage" should be construed to address da mage other than damage to the life and health of 
plants, animals or humans.  The damage could, but  would not necessarily, be to plants, animals or 
humans, and could include, for example, property damage from pests.  Nothing in the phrase "other  WT/DS291/R/Add.4 
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  damage" limits that term to property damage, and nothing in this phrase excludes  non-life or non-
health damage to plants, animals or humans caused by pests.  
4. With regard to examples, during the ne gotiation of the SPS Agreement an oft-discussed 
example was damage to property arising from the entry, establishment or spread of termites.  
121. With reference to Article 5.1 of the SPS Agreement, what were  the relevant risk 
assessment techniques developed by the relevant in ternational organizations that the European 
Communities had to take into account in th e relevant period (October 1998 - August 2003)?  
 
5. As indicated in Annex A(3) of the SPS Agre ement, the Codex is a relevant international 
organization with respect to food safety, and the International Plant Protection Convention (IPPC) is a 
relevant international organizati on with respect to plant health.  The following Codex and IPPC 
documents set out the relevant risk assessmen t techniques for the period in question:   
 
 Codex standards:    (1) Working Principles for Risk Analysis for Application in the Framework of the Codex 
Alimentarius, Section III, Codex Procedural Manual, 14th edition. 
 
 (2) CAC/GL 44 2003 Principles for the Risk Analysis of Foods Derived from Modern 
Biotechnology  
  (3) CAC/GL 45 2003 Guideline for the Conduct of Food Safety Assessment of Foods 
Derived from Recombinant-DNA Plants  
 
 IPPC Standards:   (4) ISPM # 02: 1996: Guidelines for pest risk analysis    (5) ISPM # 06: 1997: Guidelines for surveillance  
 
 (6) ISPM # 11 Rev. 1 (2003):  Pest Risk Analysis for quarantine pests including analysis 
of environmental risks. 
 
122. Please explain your views as to the relationship between a Member's appropriate level of 
protection and the requirement in Article 5.1 to en sure a measure is based on a risk assessment, 
as appropriate to the circumstances.  Is the a ppropriate level of protection relevant to the 
conduct of the risk assessment? 
 
6. The SPS Agreement indicates that the "appropriate  level of protection" and "risk assessment" 
are distinct concepts.  Annex A defines a "risk assessme nt" as an "evaluation" of  particular risks.  Once 
conducted, the risk assessment – that  is, the evaluation of certain risks – is then used to decide whether 
to impose a measure because otherwise the risk w ould be greater than th e appropriate level of 
protection.    7. The distinction between the "appropriate le vel of protection" and "risk assessment" are 
reinforced by Articles 5.2 and 5.3 of the SPS Agreemen t.  These articles specify at length the factors to 
be taken into account in conducting a risk assessment:  WT/DS291/R/Add.4 
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  "5.2. In the assessment of ri sks, Members shall take into  account available scientific 
evidence;  relevant processes and production methods;  relevant inspection, sampling 
and testing methods;  prevalence of specific diseases or pests; existence of pest- or 
disease-free areas; relevant ecological and environmental conditions; and quarantine or 
other treatment." 
"5.3. In assessing the risk to animal or plant life or health and determining the 
measure to be applied for achieving the appr opriate level of sanitary or phytosanitary 
protection from such risk, Members shall take into account as relevant economic 
factors:  the potential damage in terms of lo ss of production or sales in the event of the 
entry, establishment or spread of a pest or  disease;  the costs of control or eradication 
in the territory of the importing Member ;  and the relative cost-effectiveness of 
alternative approaches to limiting risks." 
Notably, neither of these articles provides that the "appr opriate level of protection" is one such factor to 
be taken into account in conducting a risk assessmen t.  Rather, as indicated in Article 5.3, the 
"appropriate level of protection" is distinct from risk assessment, and that level is used to "determin[e] 
the measure to be applied for achieving the appropria te level of sanitary or phytosanitary protection 
from such risk.  
123. Please assume for the sake of argument that Article 5.7 of the SPS Agreement provides 
for an exception in the nature of an affirmative defence: 
  (a) Could the Panel assess the merits of an y such defence without having previously 
found an inconsistency with Article 2.2 of the SPS Agreement?  
 
 (b) If not, in a case such as this one where a claim of inconsistency with Article 2.2 of 
the SPS Agreement is based on a claim of inconsistency with Article 5.1 of the SPS Agreement, would it be correct for the Panel to begin its analysis with the 
Article 5.1 claim, then move to the consequential Article 2.2 claim and finally turn to the Article 5.7 defence? 
 
8. Subpart (a) . As a general matter, it is possible  to examine the validity of an affirmative 
defense under the WTO Agreement without first findi ng a substantive violation of a WTO obligation.  
If the EC is willing to simply concede that its meas ure is not based on a risk assessment and would be 
inconsistent with Article 2.2 excep t for Article 5.7, then the Panel could find a breach of Articles 2.2 
and 5.1 and proceed directly to an examinati on under Article 5.7.  However, unless the EC so 
concedes, it would not be practical to address Article  5.7 without first addressing the inconsistency of 
the EC's measures with Articles 2.2 and 5.1 of the SP S Agreement.  Furthermore, Articles 2.2, 5.1, and 
5.7 are closely interrelated, so an analysis under Article 5.7 would necessarily involve an examination 
of many of the same underlying issues as an analysis under Articles 2.2 and 5.1.  Specifically, since Article 5.7 only applies where there is insuffici ent evidence to conduct a ri sk assessment, and where 
the Member has sought to obtain additional inform ation necessary for a risk  assessment within a 
reasonable period of time, the Panel would in any event have to analyze the sufficiency of any 
purported risk assessment or steps to complete one  (which would seem to require an analysis under 
Article 5.1) before being able to  make a finding under Article 5.7.  In addition, in prior disputes 
involving Article 5.7 of the SPS Agreement, panels and the Appellate Body have examined Articles 
2.2 and 5.1 before turning to Article 5.7.
1 
                                                      
1 See Japan – Apples , AB-2003-4, Part V, and Japan-Agricultural Products , AB-1998-8, Parts VII and 
VIII.   WT/DS291/R/Add.4 
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9. Subpart (b) . For the above reasons, the United States agrees that the most efficient way to 
organize an analysis of the EC measures vis a vis a possible Article 5.7 defense would be to begin the 
analysis with the Article 5.1 claim, then move to th e consequential Article 2.2 claim and finally turn to 
the Article 5.7 defence.   
For all complaining parties
: 
 124. With reference to para. 19 of the European  Communities supplementary rebuttal, do the 
complaining parties agree that the Panel "is not asked to determine whether a prudent 
government, in the abstract, should have behaved or  not in a certain manner thus causing delay.  
It merely needs to find whether, in the concrete case and in light of the factual information and 
the legal arguments before the relevant authorities, that behaviour which in the end caused a delay could justifiably have been adopted"? 
 
10. The United States does not agree with the EC's formulation of the pertinent question before the 
Panel with regard to findings relate d to the issue of "undue delay" under Annex C.  In particular, the 
above-cited language from the EC supplem entary rebuttal is addressed to the standard of review to be 
adopted by the Panel in examining whether certain delays were "undue," and the EC appears to be 
arguing that such standard must involve some sort of  special deference or that  the Panel needs to put 
itself into the position of the "relevant authorities" and second-guess the courses action available at a 
given point in time.   11. With respect to deference, in the EC-Hormones  dispute, the Appellate Body addressed the 
standard of review to be used in examining meas ures under the SPS Agreement.  In that case, like in 
the present case, the EC was arguing that a special st andard of review had to be adopted for purposes 
of applying the SPS Agreement.  The Appellate Bo dy rejected the EC argument, and set out the 
following standard of review:    
So far as fact-finding by panels is concerned, their activities are always constrained by the mandate of Article 11 of the DSU:  th e applicable standard is neither de novo 
review as such, nor "total deference", but rath er the "objective assessment of the facts".  
Many panels have in the past refused to  undertake de novo review, wisely, since under 
current practice and systems, they are in any case poorly suited to engage in such a 
review.  On the other hand, "total deference to the findings of the national authorities", it has been well said, "could not ensure an ' objective assessment' as foreseen by Article 
11 of the DSU".
2 
12. The United States submits that in applying the disciplines of the SPS Agreement, the Panel 
should cite to and employ the above  standard of review applied by the Appellate Body.  The EC has 
not provided any basis for the Panel to adopt any di fferent standard of review for the purposes of this 
case.    
13. With respect to "second-guessing," the question is  whether there was any "delay" and if so was 
it "undue."  It is not a question of having to recons truct what relevant authorities "could" have been 
thinking at any particular point in time.  
                                                     
 
2 EC – Hormones, para. 117.   WT/DS291/R/Add.4 
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  125. The European Communities' opening statemen t at the Panel's meeting with the experts 
includes the following statements:    
"The European Communities' approach is to seek more evidence to establish 
whether or not there is a risk  …  in order to make a definitive decision on the 
basis of full information - even if that  takes a little more time". (para. 19) 
"The European Communities reacts  to uncertainty as to the appropriate risk 
management strategies by saying 'let's take our time and reduce the uncertainty". 
(para. 17) 
Do the complaining parties consider that it would be consistent with Annex C(1)(a) of the SPS 
Agreement to delay making a definitive deci sion based on the approach outlined by the 
European Communities?  In answering this questio n, please take into account the provisions of 
Article 2.2 of the SPS Agreement  and Article 5. 7 of the SPS Agreement (adoption of provisional 
measures based on available pertinent information).  
 
14. The above statements by the EC are so vague  and general that is not possible to analyze 
precisely how those statements might apply to the facts of this case or to the relevant disciplines set out 
in the SPS Agreement.  However, the United Stat es disagrees with the tenor of the EC comments on 
several levels.   
 15. First, the above statements by the EC imply th at this dispute simply involves decisions by the 
EC to "take a little more time."  But that character ization fundamentally misstates the key issue in this 
case : namely, that the EC adopted an across-the-board moratorium  on all biotech products for a 
period of five years, and applied that moratorium regardless of the particular facts and circumstances of 
particular product applications.    16. Second, as the United States highlighted in its oral statement at the second panel meeting, the 
Panel must reject the EC's suggestion that all an alyses under the SPS Agreement must be seen in the 
light of "uncertainty."  In fact, the responding party in the  Apples case similarly relied on a general 
theme of uncertainty, and the Appellate Body firmly rejected it:    
The application of Article 5.7 is triggered not by the existence of scientific uncertainty, 
but rather by the insufficiency of scientific ev idence.  The text of Article 5.7 is clear:  
it refers to "cases where relevant scientific evidence is insufficient", not to "scientific 
uncertainty".  The two concepts are not inte rchangeable.  Therefore, we are unable to 
endorse Japan's approach of interpreting Artic le 5.7 through the prism of "scientific 
uncertainty".
3 
17. Third, to the extent the Pane l decides to examine individual in stances of delay in the histories 
of particular product applications, the issue is whethe r or not the delay is "undue," based on the facts 
and circumstances of that particular application, a nd taking account of the fundamental fact that the EC 
adopted and applied an across-the-board moratorium.  The broad generalizations set out by the EC are 
neither accurate, nor helpful in the anal ysis of particular delays.  What is much more relevant is that for 
many products, the lead competent authorities and re levant EC scientific committees determined that 
sufficient evidence was available, conducted risk assessments, and determined that the products are 
safe.  The scientists on these committees did not co nsider additional eviden ce was necessary - indeed 
                                                      
3 Appellate Body Report,  Japan – Measures Affecting the Importation of Apples , WT/DS245/AB/R, 
adopted 10 December 2003, para. 184.    WT/DS291/R/Add.4 
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  they rejected the member States' claims of uncertainty.  It was th e EC regulatory bodies who declined 
to act on the scientific assessments that had already been conducted.  
 
18. Fourth, the EC statements could be read as supporting a view that a WTO Member may delay 
consideration of applications inde finitely while the Member searches for purely theoretical risks.  As 
the United States explained at the second substantiv e meeting, the SPS Agreement cannot be construed 
to allow Members to put impossible burdens on app licants to prove the negative – for example, to 
prove that there are no adverse impacts on any and a ll, unspecified, aspects of the environment.  Such 
types of questions necessarily result in endless dela y, which in turn must be considered "undue."  
Otherwise, a WTO Member could block all product a pprovals, indefinitely, by posing such vague and 
general questions.    19. Fifth, the United States considers that Article 5.7 could be relevant context to be examined in 
deciding how to apply the "undue delay" provision of  Annex C.  For example, delaying consideration 
of applications until the applicant responds to im possibly vague questions on theoretical risks would 
have an effect similar to the adoption of a ban on a product.  Such a ban would not likely be consistent 
with Article 5.7 because it could not be based on "a vailable pertinent information" where any risks 
raised by the Member were vague and purely hypotheti cal.  In addition, in this example, there would be 
no way for the Member to seek to obtain the add itional information necessary for a risk assessment 
within a reasonable period of time because the Member had not even identified the particular risks that 
needed further examination.    20. Finally, the very nature of science is that there will always
 be the potential for more evidence, 
there can never be an absolute certainty as to the l ack of "a" risk, and information is never "full".  
Accordingly, the EC's approach would mean that  a Member could always delay indefinitely any 
approval while awaiting "more" evidence and "full" information.  The United States also cannot help 
but be struck by the contradiction between the EC's  statements in paragraphs 17 and 19.  On the one 
hand, in paragraph 17, the EC presumes there is a risk when it refers to "appropriate risk management 
strategies."  On the other hand, the EC in pa ragraph 19 is still trying to determine if there is a risk. 
 126. In paragraph 10 of the EC Responses to th e Questions from the Panel (16 June 2004), the 
European Communities compares the definiti ons of risk assessment as used in the SPS 
Agreement and as used in Codex, and concludes th at "It is clear that the SPS definition of risk 
assessment is equivalent to 'weighing policy alt ernatives in the light of the results of risk 
assessment' which is part of the Codex Definition  to ¨'risk management'".   Do you agree with 
this conclusion?  Please explain your response.  
21. We disagree with the conclusion of the EC  that the SPS definition of risk assessment 
encompasses risk management.  The SPS Agreement provides that a risk assessment involves the 
"evaluation" of risks.  SPS Agreement, Annex A(4).  In doing so, Members may take into account 
"relevant inspection, sampling, and testing me thods," (SPS Agreement, Article 5.2), but the selection  
of appropriate risk management measures goes beyond the evaluation or assessment  of risks.
4  Rather, 
                                                      
4 The EC's citation to the Appellate Body report in EC-Hormones does not support the EC's contention 
that risk assessment includes risk management.  In Hormones , the Appellate Body was simply noting that in 
assessing  risks, a Member may take account of the effectiveness of risk management measures related to those 
risks.  Indeed, as noted above, the SPS Agreement specifically notes that risk assessment may take account of 
risk management measures such as inspection, sampling and testing methods.  However, nothing in the 
Hormones  Appellate Body report states or implies that the process of risk assessment includes decisionmaking on 
risk management measures.  See EC – Hormones , AB-1997-4, paras. 181 and 206.   WT/DS291/R/Add.4 
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  selecting appropriate risk management measures i nvolves a policy determination and the weighing of 
policy considerations.     
22. This is wholly consistent w ith the Codex definition of risk analysis, which distinguishes risk 
assessment from risk management.  The Codex defin ition specifically notes that  risk management is 
the process of weighing policy alternatives to addre ss the risks defined by the risk assessment.  In 
addition, we would note that the EC omitted a critical  part of the Codex definition of risk management:  
"The process, distinct from risk assessment
, of weighing policy alternativ es, in consultation with all 
interested parties, considering risk assessment and ot her factors relevant for the health protection of 
consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate 
prevention and control options." [emphasis added]  Codex Procedural Manual, 14th Edition; Page 48.  
 
127. At para. 42 of Canada's supplementary re buttal, Canada suggests that crop husbandry 
includes breeding and that if a scientist empl oys selective breeding meth ods in the laboratory, 
this should qualify as crop husbandry because the scientist would be performing the same 
operations as a farmer who employs selective breedi ng methods on the farm.  But is the insertion 
of a transgene part of the breeding of biotech crops?  Or is the breeding rather the re-production of the biotech seed? 
 23. Breeding includes the insertion of a transgen e as well as the reproduction of biotech seed.  As 
defined by Webster's New World Dictionary of the American Language, breeding is "the producing of 
plants and animals, especially for the purpose of improving the stock."  The introduction and selection 
of new genetic traits, irrespective of the met hod by which this is accomplished, is an essential 
component of plant breeding. Canada correctly asserts that modern methods of plant breeding, a subset 
of crop husbandry, range from techniques typica lly associated with traditional breeding to the 
utilization of modern genetics.  Current methods to  generate new and improved plant varieties include 
cross hybridization and natural selection in the fi eld but also encompass variation introduced by 
modern laboratory techniques such as tissue culture, embryo rescue and genetic transformation.  
Questions not Previously Provided to the Parties 
 
For all parties
: 
 140. With reference to (1) Codex standards 192 and 193, (2) IPPC and (3) ISPM 11: 
 
 (a) Are they "rules of international law applicable in the relations between the 
parties  to this dispute " within the meaning of Article 31(3) of the Vienna Convention on the Law of Treaties?   
  (b) May they be used as additional factua l evidence of the ordinary meaning of terms 
contained in Annex A of the SPS Agreement, as the United States appears to 
suggest in its rebuttal at para. 6 of attachment II?  (The United States is invited to 
provide elaboration on its statement at para. 6.) 
 
24. Subpart a: Whether Codex and IPPC standards are "r elevant rules of international law" 
for purposes of the Vienna Convention of the Law of  Treaties presents a theoretical question that the 
Panel need not address in the context of this disp ute.  Instead, as noted in response to Question 121 
above, Annex A of the SPS Agreement specifica lly refers to standards, guidelines, and 
recommendations adopted by the Codex and IPPC.  Accordingly, there is no need to address the 
relevance of Codex and IPPC standards under more  general rules of treaty interpretation.   
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  25. As the United States noted previously, definiti ons in Codex and IPPC documents may be used 
as additional factual evidence of the ordinary me aning of terms contained in Annex A of the SPS 
Agreement.  Delegates to organizations such as Co dex and IPPC are generally knowledgeable in their 
respective fields, and the fact that those organizati ons adopt particular defin itions of terms should be 
considered pertinent to the ordinary meaning of th ose terms.  Or, put anothe r way, it would not make 
sense to consider only definitions drafted by the authors of general purpose dictionaries while 
excluding  any consideration of definitions  adopted by persons knowledgeable  in their fields.  However, 
the evaluation of the importance of any particular definition must be made on a case-by-case basis.  For 
example, Codex or IPPC drafters may have special reasons to adopt a narrow definition of particular 
terms in order to limit the scope of a standard to issues of concern to their respective organizations.  
Such a narrowly drafted definition would not indicat e that a term lacked a broader, more common 
definition.    141. With reference to Annex (B)(1) of the SPS Agreement, please answer the following 
questions:   (a) Does the term "sanitary and phytosanitary regulations" cover administrative 
decisions which relate to the operation of approval procedures and which are 
generally applicable?   
 
 (b) May the phrase "sanitary and phytosanitary regulations which have been 
adopted" be interpreted to encompa ss also sanitary and phytosanitary 
regulations which have been adopted de facto (e.g., generally applicable decisions which have been reached informally and which are unrecorded)?    
 26. Subpart a : Yes, the term "sanitary and phytosanit ary regulations" covers administrative 
decisions which relate to the operation of approval  procedures and which are generally applicable.  
This is made clear by footnote 5 to Annex B, which provides that "sanitary and phytosanitary regulations" are "sanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable generally."  
27. Subpart b : Yes, the phrase "sanitary and phytosan itary regulations which have been 
adopted" may be interpreted to encompass also sanitary  and phytosanitary regulations which have been 
adopted de facto.  First , nothing in the text of the agreemen t provides that such measures must be 
adopted in a written form.  Second , to exclude unwritten, de facto measures would make meaningless 
the transparency obligations of Annex B.  A nnex B requires that SPS re gulations of general 
applicability must be "published pr omptly."  If unwritten measures were excluded from Annex B, a 
WTO Member could avoid its transparency obliga tions simply by adopting de facto, unwritten 
measures of general applicability.    
142. Please explain the meaning and rationale of the requirement in Article 2.2 that SPS 
measures be "based on scientific principles" and how this is different from the requirement that 
SPS measures not be maintained "without sufficient scientific evidence".   
 
28. In Article 2.2, the requirements that measures must be "based on scientific principles" and not 
be maintained "without sufficient scientific evidence" are distinct but related requirements.  Based on 
"scientific principles" means that the rationale for the measure must be based on scientific principles, 
including, for example, the use of the scientific method (that is,  posing a hypothesis and testing that 
hypothesis through experiment).  A measure based , for example, on pure superstition would not be 
based on "scientific principles."  In contrast, "suffi cient scientific evidence" relates to actual evidence 
that the product covered by the m easure poses a risk covered within th e scope of the SPS Agreement.   WT/DS291/R/Add.4 
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143. The Panel notes a number of instances wh ere the same or a related product was 
apparently submitted under separate applications for approval.  This appears to be the case for 
Monsanto Roundup Ready oilseed rape GT73 (EC-70,  EC-79);  Syngenta Bt 11 maize (EC-80, 
EC-92, and related EC-69);  Pioneer/Dow AgroSc iences Bt corn Cry1F (1507) (EC-74, EC-75, 
EC-95);  Monsanto Roundup Ready corn NK603 (EC-76, EC-96);  Monsanto Roundup Ready corn GA 21 (EC-78, EC-85, EC-91); and the various  "stacked" products.  To what extent does 
the assessment by a lead CA, the relevant EC  Scientific Committee and any information 
provided by a notifier under one application serve as a basis for consideration of another 
application for the same or a related product? 
 
29. The data provided are fundamentally simila r for submissions made under Dir 90/220 (2001/18) 
and Novel Foods Reg 258/97; however, the scope of the applications, and therefore the endpoints of 
the respective risk assessments, may be dissimilar. 
 30. Taking the Member States first, most have separate CA secretariats (often in different ministries) and separate expert committees for a pplications under the two statutes.  An assessment 
under one statute would, therefore, probably not in form an assessment under th e other.  That said, 
certain applications under Dir 90/220 in the UK, fo r example, were also seen by the CAs and/or 
experts responsible for Reg 258/97.  Similarly, cer tain national expert committees have accountability 
under both statutes, e.g. COGEM in the Netherlands.  It  is not possible, therefore, to give a generally 
applicable answer to this questi on, since national arrangements vary. 
 31. At the EC level, the two statutes were administered by separate DGs (ENV and SANCO, 
respectively) and assessed by separat e scientific committees (the SCP and SCF, respectively) until the 
creation of the joint Novel Foods/GMO working group  (early 2001) and, subsequently, the GMO panel 
of EFSA.  Since 2001, an assessment under one statut e would, therefore, inform an assessment under 
the other.  
144. The Panel notes that a number of products containing the same transgenic modifications 
as products at issue in this dispute were pr eviously approved by the European Communities 
prior to July 1998 (eg, swede rape tolerant to glufosinate ammonium (MS1, RF1) and (MS1, RF2);  swede rape tolerant to glufosinate ammoni um (Topas 19/2);  maize tolerant to glufosinate 
ammonium (T25);  maize expressing the Bt cr y1A(b) gene (MON 810);  maize tolerant to 
glufosinate ammonium and expressing the Bt cr y1A(b) gene (Bt-11);  soybean tolerant to 
glyphosate;  chicory tolerant to glufosin ate ammonium;  maize Roundup Ready NK603).  To 
what extent and how were the previous assessment s of potential risks to human, animal or plant 
health and/or the environment associated wi th these transgenic modifications taken into 
consideration in the evaluation of potential risk s arising from the products at issue before the 
Panel? 
 32. Government regulatory authorities with expe rience in regulating plants produced through 
modern biotechnology do so by evaluating data for individual products (case-by-case approach). It is 
normal practice for regulatory authorities to use th is case-by-case approach within the context of 
existing, generally accepted scientific knowledge. Thus, safety data on an individual product is 
evaluated along with what is known, for example, of the biology of a particular plant species, how 
proteins generally function, and the history of use of th e trait that has been introdu ced into the plant.  In 
other words, regulators do not evaluate product-specific safety data in a scientific vacuum.    33. If the same Bt protein (e.g. the Bt protein produced by the Bt cry1A(b) gene) is produced in different types of plants, the safety parameters of th e protein (e.g., mode of action, potential for toxicity  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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 Page F-11 
  
  to humans and allergenicity) are not likely to differ  in different types of plants. With respect to 
potential effects on non-target organisms, again, the mode of action of the protein—and therefore the 
potential for adverse effects-- would not be different in different plants but there could be different 
ranges of exposure across plant species.   Similar considerations would be given if the same mechanism 
of herbicide tolerance is introduced into different types of plants.   34. Given the paucity of  explanations presented by EC memb er States when presenting additional 
questions on applications, the extent to which EC regulators actually took account of data from related 
applications is uncertain.  However,  EC regulators did have the discreti on to consider such data, and on 
occasion EC regulators explicitly did so.  See, for example, EC 74 (Pioneer BT maize event 1507), 
attachment 36, question 11 from the lead CA to  the applicant: "Results that demonstrate the 
equivalence (e.g. amino acid sequence, molecular weight) of PAT expressed in transgenic maize line 
1507 to PAT expressed in crops previously ap proved under 90/220/EC should be supplied."   
 
For all complaining parties
: 
 
145. With reference to para. 7 of the European Communities second oral statement, is it "for 
the Complainants to rebut this evidence [submi tted by the European Communities] by putting 
forward arguments and evidence as to why reaso ns for delays put forward in the European 
Communities' submissions are unjustified"?  
35. As the United States explained at length in its oral statement at the second substantive meeting, 
the complainants do not
 have the burden or proving or dispro ving that any particular delay was 
unjustified.  Rather, the United States presented a clear and compelling case that the EC adopted an 
across-the-board general moratorium on biotech approva ls.  Under that moratorium, applications were 
allowed to make some progress, but no application was allowed to reach final decision.  In other 
words, as long as certain member States opposed th e approval of biotech products as a matter of 
principle, and as long as the Commission was unwilling to submit product applications to votes by member State and then to the Commission itself in the face of such opposition, no product could ever 
be approved under the moratorium.  Thus, the Unite d States does not have the burden of establishing 
that particular delays were justif ied or unjustified.  Moreover, as pr eviously explained, the fact that 
certain questions by EC regulators were warranted is to  be expected, and is not at all inconsistent with 
an across-the-board moratorium on final decisions.    
For the United States
: 
 
149. In your comments on the experts' replies to  the Panel's Question 4, you have indicated 
that given the availability and use of insect resist ance management (IRM) strategies, the delay of 
Bt crop applications under the EC's pre-market a pproval system "cannot be justified by alleged 
concerns over the emergence of Bt-resistance where  objecting member States failed to address 
the validity to the IRM plans already submitted by applicants, particularly when those plans 
were deemed acceptable by the relevant EC sc ientific committees."  Please identify those 
products (include the EC-chronology numbers) where you believe that an objecting member 
State failed to address the validity of plans alrea dy submitted, and particularly identify those 
products for which the relevant EC scientific committees had found the IRM plans acceptable.  
 36. IRM plans were submitted for the following produc ts, both as part of the original notification, 
and again, as part of the updated notifi cations submitted pursuant to 2001/18:   
  (1) Bt Cotton, Event 531, EC Exhibit 65.  (2) Bt-11 Corn, EC Exhibit 69 WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-12 
  
   (3) Bt Cry 1F Corn, Event 1507, EC Exhibit 75. 
 In the case of Bt cotton, 531, an amended plan w as submitted in response to Member State concerns, 
but then no action appears to have been taken for a period of over four years.  In the case of the two 
corn products, individual Member States objected, raisi ng concerns with respect to the development of 
insect resistance, without addressing the validity of  the IRM plans that had been submitted.   
   
As noted above, the applicant submitted an IRM plan as part of its original notification.
5  In 1998, in 
response to Member State concerns, the applicant adapted the plan to addr ess the "particular cotton 
cultivation conditions in Span and in Greece [and to] take into account the biology and susceptibility of 
the major European lepidopteran target-pests , the market structure, average farm size and market 
penetration in the cotton cultivation areas and the n eed to work closely with farmers and extension 
services to educate and implement the plan."6  According to the chronology, no action was taken on the 
application between 1999 and 2003,  when the applicant updated its notification in accordance with 
Directive 2001/18.    Regarding Bt-11 corn (EC Exhibit 69), the applican t submitted an IRM plan as part of its original 
notification, submitted in 1996.
7  In 1998, the French advisory  Committee issued a positive opinion 
that explicitly considered the potentia l for development of insect resistance.8  Subsequently,  both Italy 
and Denmark both raised objections relating to the possible development of insect resistance, and the 
need for further information, but wholly failed to  address the applicant's IRM plan.  Notwithstanding 
the applicant's IRM plant, Italy merely objected that "taking into account all the aspect concerning the use of a plant which expresses resistance to lepidopt ers, it is necessary to foresee a monitoring plan, 
aiming to obtain information concerni ng possible rising of resistance..."
9  Similarly, Denmark simply 
objected on the grounds that "[t]he expert group on monitoring development of insect resistance should 
end their work before any consent is given to introduce Bt plants to the market.  New information on possible development of resistance should be included in the work from the expert group."
10  
 In 2000, after evaluating the notification, including the applicant's IRM plan, the SCP also issued a 
favorable opinion.
11  In section 4.5.4, the SCP discussed its findings relating to the potential 
development of insect resistance, stating  
 
Although it is not possible to determine optim al dose until resistant insects exist in the 
field, high protein levels appear present in all important plant tissues early in the 
season and should provide season long control.  The success of the resistance 
management strategy will depend on the ability  of any monitoring program to detect 
resistance as soon as possible and the extent and quality fo advice given to farmers.  
The SCP published an opinion on 4 March 1999 on resistance monitory [citation omitted] as developed by the Expert Group on Monitoring for Insect Resistance to Bt-
                                                     
 
5 EC Exhibit 65, att. 3-17, appendix 7. 
6 EC Exhibit 65, att. 49. 
7 EC Exhibit 69, att. 3, pp 159-168 
8 EC Exhibit 69, att. 26, p 4. 
9 EC Exhibit 69, att 60, p. 4. 
10 EC Exhibit 69, att 66, p. 2. 
11 EC Exhibit 69, att. 83, p. 9.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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 Page F-13 
  
  toxins.  Such monitoring should be carried out in Bt-maize and should provide an 
adequate framework to delay the onset  of resistance in the target pest.
12   
In 2003, the applicant submitted an updated notific ation, pursuant to Directive 2001/18, that included 
an updated IRM plan.13   Shortly thereafter,  the French a dvisory Committee issued a positive opinion 
on the notification.  This opinion specifically addressed the potential for the product to cause insect 
resistance and concluded that th e applicant's plan was acceptable.14 Nonetheless, Italy objected, citing 
concerns about the potential emergence of insect  resistance, but entirely failing to address the 
particulars of the applicant's IRM plan.15  Spain also objected on the grounds that an IRM plan was 
necessary, failing in any respect to address the fact  that the applicant had submitted an IRM plan.16   
 
The case is similar with respect to Bt cry 1F Corn 15 07, (EC Exhibit 75).  As part of both the original 
application, and the updated no tification submitted pursuant to Di rective 2001/18, an IRM plan was 
submitted.17  Upon reviewing the IRM plan, the Spanish National Biosafety Committee concluded that 
"an adequate Resistance Manageme nt Plan will be applied," and recommended that the product be 
approved.18  Nonetheless, Austria objected, stating that "a complete remedial plan should be worked 
out before the placing on the market of this product."19 At no point does the objection identify a 
specific deficiency in the applican t's proposed IRM plan, or otherwise address the particulars of the 
proposal.  150. In paragraph 97 of the US Answers to Quest ions Posed in the Context of the First Panel 
Meeting (16 June 2004), you indicate that "Directive 90/220 does not precisely specify the time of each step, but appears to contemplate a time-frame from application to decision of no more than 
1 year".  What is the basis for this statement?   
 37. The conclusion that Directive 90/220 appears to contemplate a time-frame from application to 
decision of no more than 1 year is based on the follow ing analysis of the time frames in the directive.  
The directive provides roughly eight months for all timelines specified for the key steps in the approval 
process:  favourable member State opinion within 90 days (Art.12 para 2), plus member State review 
of 60 days (Art.13 para 2), plus Article 21 procedure of 3 months (A rt. 21, para 5).  The remaining 
steps in the legislation are procedural, with no d ecision element, such as forwarding dossiers from the 
member State level to the Community level.  It woul d not be sensible for those procedural steps to be 
expected to take longer than the time for the substa ntive processes, which total eight months.  Even if 
those procedural steps took one half as long, or four months, the total processing time would be no 
more than one year.    151. With reference to paragraph 12 and 14 of the US statement on 22 February 2005, for the convenience of the Panel please identify all docu ments (according to the EC exhibit/attachment 
number) which you consider contain specific statements acknowledging or attesting to the existence of a de facto moratorium. 
 
                                                     
 
12 EC Exhibit 69, att.83, p. 9. 
13 EC Exhibit 69, att. 104, pp 93-110. 
14 EC Exhibit 69, att. 95, p 5. 
15 EC Exhibit 69, att. 112, p 6. 
16 EC Exhibit 69, att. 122 
17 EC Exhibit 75, att.1; att.22 & 23, pp. 23-55.. 
18 EC Exhibit 75, att.29, p. 7. 
19 EC Exhibit 75, att. 85, p.3. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-14 
  
  38. In the attached Table 1, the United States has provided examples of the many instances in 
which the EC's own product application histories ac knowledge a de facto moratorium.  This evidence, 
of course, is in addition to the many acknowledgmen ts of the moratorium contained in the exhibits 
presented by the United States in its first submission and first oral statement.   
 
For the European Communities and the United States
: 
 
165. (EC-73):  It appears that all of the rel evant documentation was not provided in the 
context of the application contained in EC-73.   However, the chronology provided by the 
European Communities shows no action on this application between the 02/00 requests for further information from the CA, and the 1/03 relaunch of the application under Directive 2001/18.  Did the notifier fail to provide the information requested in 02/00, and if so, why?  
 39. The United States understands that the notif ier did not provide the requested additional 
information.    
166. (EC-74):  As was noted in the replies by th e experts, the complete documentation related 
to this dossier was not provided to the Panel.  In some instances, the attachment provided only 
the titles of annexes, but not their contents.  Please clarify whether the missing documentation 
had been provided to the lead CA, and if so, when?  
40. In her response to Panel's question 34, Dr. Nutti said she was unable to find the quail feeding 
study within the files.  Upon extensive review of th e EC's CDs, the United States has located this study 
in EC-74, attachment 44. 
 
41. Dr. Nutti further noted that EC-74, attachment 36 did not include all the referenced annexes.  
The Panel above similarly observes that in some attachments, only the titles of annexes have been 
provided, but not their contents.  The attachments to which Dr. Nutti and the Panel are referring are the applicant's cover letters providing further informa tion in response to the lead CA's requests for 
information.  The United States has reviewed the documents provided to the Panel relating to EC-74 
and has located all relevant annexes referenced in a ll of these cover letters.  Most annexes referred to in 
these cover letters have been provided as separate attachments  and are not included in the attachment 
containing the cover letter.  42. Thus, for example, attachment 35 is the app licant's October 16, 2001 cover letter listing further 
information being provided, including a narrative and annexes, but attachment 35 does not actually 
include the new information.  Attachment 36 is the narrative answers to the lead CA's questions.  The 
narrative lists the titles of annexes 1.B through 9.B,  but attachment 36 does not include the annexes 
themselves.  Instead, attachments 37, 40, 41, 42, 43, 44, 45, 47, and 48 are the actual annexes 1.B 
through 9.B.    
43. Another less straightforward example is attach ment 18, the applicant's February 14, 2001 cover 
letter listing further information being provided in response to the lead CA's December 15, 2000 
request.  The cover letter lists Annexes 1.A th rough 4.A, but the annexes are not included in 
attachment 18.  Instead, attachment 28 is Annex 1.A.  Annex 2.A is found in attachments 20 through 26.  Attachment 29 is Annex 3.A.  Attachments 30 and 31 are Annex 4.A.  Attachment 19 is the 
narrative answers to specific questions.  In addition,  attachment 32 appears to be a duplicate of the 
entire submission, including the cover letter, th e narrative answers, and all the annexes.   
 44. Similarly, the applicant's January 30, 2002 cover letter lists Annexe s 1C through 5C.  Although 
the cover letter is included in attachment 53, the annexes are not.  These annexes are in attachments 55  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-15 
  
  through 59, respectively (the last few pages of attachment 59 appear to be the relevant pages for 
Annex 5C).  
45. The United States also refers the Panel to EC -74, attachment 2, a document titled "Summary of 
the evaluation carried out by the Netherlands Comp etent Authority."  This document notes that two 
different agencies, the COGEM, the Committee on Genetic Modification, and the RIKILT-DLO, the State Institute for Quality Control of Agricultural Pr oducts (among others), evaluated the dossier.  The 
document notes that the COGEM requested additional information from the applicant on December 15, 
2000, March 19, 2001, and March 25, 2002 and provi ded an opinion on January 15, 2003 that no 
significant potentially negative effects were identifie d related to the proposed placing on the market of 
the product.  The document also noted that "[b]as ed on an evaluation of the complete dossier, the 
RIKILT-DLO concluded that there is no indication th at the product would not be safe when used as 
animal feed", its last opinion having been expressed  April 16, 2003.  Given these two agencies' positive 
safety assessments, the United States presumes that all relevant documentation had been provided to 
the lead CA.   46. Finally, in the experts' replies, specifically Dr. Nutti's replies to questions 33 and 34, Dr. Nutti 
stated that she was unable to recover the inform ation on tables 10A, 11A, 12A and 13A in EC-74, 
attachment 19.  The United States notes that it has been able to access the information from the copies 
of the CDs that the EC provided to the United States.  
 
167. (EC-93):  It appears that some of the do cumentation relevant to the safety assessment 
was not provided to the Panel.  Please clarif y whether the missing documentation had been 
provided to the lead CA, and if so, when? 
 
47. The United States understands as follows.  The applicant did provide the information 
requested, as indicated in the applicant's letter date d 18/07/01.  The applicant received a response from 
the EC on 31 August 2001.  The United States does not know why the information the applicant provided was not included in the product history CDs.   
48. In the 31 August 2001 letter, additional info rmation was requested regarding data about the 
composition of fibre constituents.  The applicant responded to the 31 August 2001 letter, explaining 
why the information requested had already been prov ided or could be addressed  with information that 
BCS had already provided.   
49. The 31 August 2001 letter also requested or mentioned additional information (growth 
performance study and molecular char acterisation) relating to event A5547 -127.  The original file 
submitted contained two events - A2704-12 and A 5547-127.  The applicant made the decision to 
pursue only A2704-12 at that time and therefore elected not to provide requested information with respect to A5547-127.    For Canada, European Communities and the United States
: 
 
168. (EC-72):  The Panel notes that the chrono logy provided by the European Communities 
shows no actions on this application betw een 12/99 (when according to the European 
Communities the UK CA allegedly advised the company that the dossier required substantial 
revision and clarification) and its re-submissi on in 1/03 under Directive 2001/18.  Could the 
parties please explain the lack of action?   
 
50. The United States understands that the appli cant did not provide the data requested in 
December 1999. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-16 
  
   
For Argentina, European Communities and the United States
: 
 
169. With respect to the safeguard measures invoked for Maize Bt-176, please list the scientific evidence on which the concerns raised by Austria and Germany on potential adverse 
effects on non-target organisms were based (August 2003). 
 
51. A. The scientific studies that were explicitly  cited by Austria and Germany in connection 
with the safeguard measures applicab le to Maize Bt-176, and that address issues relating to effects on 
non-target organisms have been listed below.   
Studies cited by Austria
 
 EC (European Commission):  The European Commi ssion has decided to authorize genetically 
modified maize in the light of available scientific advice.  Press release including summary conclusions of the three scientific committees.  18.12.1996.
20 
 EPA (1995a) Pesticide Fact Sheet.  Cry IA(b).  Ba cillus thuringiensis cry IA (b) Delta-Endotoxin and 
the Genetic Material Necessary for its Production (Plasmid Vector pCIB4431) in Corn.  US EPA, 
Office of Prevention, Pesticides, and Toxic Substances, 10.8.1995
21 
 EPA (1995b) Pesticide Fact Sheet.  Cry IA(b).  Bacillu s thuringiensis subsp. Kurstaki cry IA (c)  Delta-
Endotoxin and its Controlling Sequences as Expressed  in Cotton.  US EPA, Office of Prevention, 
Pesticides, and Toxic Substances, 10.8.1995.
22 
 
EPA (1996) Pesticide Fact Sheet.  Bacillus thuringi ensis  Delta-Endotoxin and the Genetic Material 
Necessary for its Production (Plasmid Vector p201502) in Corn.  US EPA, Office of Prevention, Pesticides, and Toxic Substances, 5.8.1996.
23 
 Gould, F.  (1994): Potential and Problems with High-Dose Strategies for Pesticidal Engineered Crops.  
In: Biocontrol Sci. Tech. 4(4), 451-461.
24 
 Hokkanen; H. And Deacon, J (e ds.) (1994): Special Issue: OECD Workshop on Ecological 
Implications of Transgenic Crop Plants Containing Bacillus thruingiensis Toxin Genes. In: Biocontrol. 
Science and Technology Vol.4.
25 
 
Höfte, H. and Whiteley, H.R. (1989): Insecticidal crys tal proteins of Bacillus thuringiensis.  Microbiol. 
Rev. 53, 242-255.26 
 Kaiser (1996): Pests Overwhelm Bt Cotton Crop.  Science 273, 423.
27 
 
                                                      
20 EC Exhibit C/F/94/11-03, att 1 
21 Id. 
22 Id. 
23 Id. 
24 Id. 
25 Id. 
26 Id. 
27 Id.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-17 
  
  Macilwain (1996): Bollworms chew hole in ge ne-engineered cotton.  Nature. 382, 289.
28 
 Milner, R. (ed) (1994): Special Issue: Bacillus Thuringiensis.  Agric., Ecosys. Env. Vol. 49.
29 
 
Ogunseitan OA (1995) Bacterial genetic excha nge in nature.  Sci Prog. 78: 183-204.30 
 Ow.D.W. (1996): Recombinase-directed chromosome engi neering in plants.  Curr. Op. Biotech 7, 181-
186.
31 
 
Ow.D.W. and Medberry, S.L.  (1995): Genome mani pulation through site-specific recombination.  
Crit. Rev. Plant Sci. 14, 239-261.32 
 Roush, R.T. (1994): Managing Pests and their Resist ance to Bacillus thuringi ensis: Can Transgenic 
Crops be better than Sprays?  In: Biocontrol Sci. Tech. 4(4), 501-516.
33 
 Sharma UK. (1993), Insights into plasmid biology.  Curr. Sci. 64: 283-285.
34 
Salyers AA et al (1995) Conjugative transposons: an unus ual and diverse set of in tegrated gene transfer 
elements.  Microbiol. Rev. 579-590.35  
 
Tapp, H. And Stotzky, G. (1995): Insecticidal Ac tivity of the Toxins from Bacillus thuringiensis 
subspecies kurstaki and tenebrionis Adsorbed and Bound on Pure and Soil Clays.  Appl. Env. Microbiol. 61(5), 1786-1790.
36 
 Whalon, M.E. and Norris, D.L. (1996) Resistance Ma nagement for Transgenic Bacillus thuringiensis 
plants.  Biotechnology and Development Monitor 29, 8-12.
37 
 Gould, et al.; PNAS - http://www.pnas.org/cgi/content/full/94/8/3519#abs
38 
 Tabashnik, et. al.; PNAS - http://www.pnas.org/cgi/content/full/94/5/1640
39 
 
"Biodiversity Implications of Genetically Modified  Plants", International Scientific Conference, 
Ascona/Switzerland, September 2003.40 
 Ruud de Maagd, "Molecular and biochemical analysis  of the Bt-corn/cotton leafworm/green lacewing 
trotrophic interaction"; oral presentation at "Biodivers ity Implications of Genetically Modified Plants", 
International Scientific Conference,  Ascona/Switzerland, September 2003.
41 
 
                                                      
28 Id. 
29 Id. 
30 Id. 
31 Id. 
32 Id. 
33 Id. 
34 Id. 
35 Id. 
36 Id. 
37 Id. 
38 EC Exhibit C/F/94/11-03, att 5. 
39 EC Exhibit C/F/94/11-03, att 6. 
40 EC Exhibit C/F/94/11-03, att 23. 
41 Id. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-18 
  
  Claudia Zwahlen, "Implications of transgenic Bacillus thuringiensis maize varieties in soil 
ecosystems"; oral presentation at "Biodiversity Im plications of Genetically Modified Plants", 
International Scientific Conference,  Ascona/Switzerland, September 2003.
42 
 
Zwahlen, C., Hillbeck, A., Gugerli, P. & Nentwig,  W. (2003a): Degredation of the Cry 1Ab protein 
within transgenic Bacillus thuringiensis corn tissu e in the field.  Molecular Ecology, 12, 765-775.43   
 Zwahlen, C., Hillbeck, A., Gugerli, P. & Nentwig, W. (2003b): Effects of transgenic Bt corn litter on 
earthworm Lumbricus terrestris.  Molecular Ecology, 12, 1077-1086.
44 
 Darvas, B., Kincses J., Vajdics Gy., Polgàr A., L. , Juracsek J., Ernst, A., and Székács A. (2003): 49
th 
Abs. Plant Protection Days, page 45.45 
 
Eva Vojtech, "Effects of Bt maize on the herbivor e Spodoptera littoralis and the parasitoid Cotesia 
marginiventris", oral presentation at "Biodiversit y Implications of Genetically Modified Plants", 
International Scientific Conference,  Ascona/Switzerland, September 2003.46 
 Darvas, B., Gharib, A., Csóti A., Székács A., Vajdics Gy., Peregovits, L., Ronkay , L. and Polgàr A., L. 
(2002):  48
th Abs. Plant Protection Days, page 31.47 
 
Environmental Science and Technology, July 2003, p. 249A (zeitert: Proc. Natl. Acad. Sci. U.S.A. 
2003, 100, 5004-5009)48 
 A.N.E. Birch, et al., SCIR/Dundee/Scotland, "Expecting the Unexpected"; oral presentation at 
"Biodiversity Implications of Genetically Modified  Plants", International Scientific Conference, 
Ascona/Switzerland, September 2003.
49 
 Zwahlen, et al (2003), Degradation of the Cry1Ab pr otein within transgenic Ba cillus thuringiensis corn 
tissue in the field. Molecular Ecology, 12, 765-775.
50 
 
Zwahlen, et al (2003), Effects of transgenic Bt corn litter on the earthworm  Lumbricus terrestris. 
Molecular Ecology, 12, 1077-1086.51 
 Morin, et al, PNAS – http://www.pnas.org/cgi/doi/10.1073/pnas.0831036100
52 
 
Saxena, et al (2002), Bt toxin is released in root  exudates from 12 transgenic corn hybrids representing 
three transformation events. Soil Biology & Biochemistry, 34, 133-137.53 
 
                                                      
42 EC Exhibit C/F/94/11-03, att 23. 
43 Id. 
44 Id. 
45 Id. 
46 Id. 
47 Id. 
48 Id. 
49 EC Exhibit C/F/94/11-03, att 23. 
50 EC Exhibit C/F/94/11-03, att 25. 
51 EC Exhibit C/F/94/11-03, att 26. 
52 EC Exhibit C/F/94/11-03, att 27 
53 EC Exhibit C/F/94/11-03, att 28  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
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  Darvas & Szkacs, December 2, 2003: Bt-toxin levels in DK-440-BTY (YieldGard) Bt-corn and 
stubble. Effects of DK-440-BTY (YieldGard) Bt-cor n pollen on Inachis io (Nymphalidae) larvae. Non-
target effects of DK-440-BTY (YieldGard) Bt-corn.
54 
 
Hilbeck, et al, Biodiversity Implications of Geneti cally Modified Plants: Abstract Book. September 7-
12, 2003.55 
 Nick Birch, et al, "Expecting the Unexpected: Po tential Ecological Impacts of Unintended Metabolic 
Changes in GM and Conventional Crops" (PowerPoint presentation).
56  
 
Studies/Information cited by Germany : 
 
Losey, et al., 1999, Nature 399:214.57 
 
Hilbeck, et al., (1999) Prey-mediated effects of Cr y1Ab Toxin and protoxin and Cry2A protoxin on the 
predator Chrysoperla carnea. Entomologia Experimentalis et Applicata, 91(2): 305-310.58 
 Hilbeck, et al., (1998) Toxicity of Bacillus thuri ngiensis Cry1Ab Toxin to the Predator Chrysoperla 
carnea (Neuroptera: Chrysopidae). Environmental Entomology
59. 
 
Hilbeck, et al., (1998) Effects of transgenic B acillus thuringiensis corn-fed prey on mortality and 
development time of immature Chrysoperla carn ea (Neuroptera: Chrysopidae). Environmental 
Entomology.60 
 
Saxena, et al., 1999, Nature 402:480.61 
 
                                                      
54 EC Exhibit C/F/94/11-03, att 29. 
55 EC Exhibit C/F/94/11-03, att 30 
56 EC Exhibit C/F/94/11-03, att 31 
57 EC Exhibit C/F/94/11-03, att 16. 
58 EC Exhibit C/F/94/11-03, att 17 
59 EC Exhibit C/F/94/11-03, att 18 
60 EC Exhibit C/F/94/11-03, att 19 
61 EC Exhibit C/F/94/11-03, att 20.  
  WT/DS291/R/Add.4 
WT/DS292/R/Add.4 
WT/DS293/R/Add.4 
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62 InVigor Seed 
Link and 
Liberty Link 84 The Commission regards this as an opportunity to reinforce the provisions contained in its dr aft Decisions in a number of 
respects.  It would therefore seem appropriate to suspend the current procedure and convene a meeting of the Committee as soon 
as possible. 
  117_trans [T]he existing situation could result in products being released on the market without being labelled for GMO, despite the fact  
that these products may within a rapid timeframe require such labelling. This it not satisfactory. 
    
63 Oil seed rape 99 In May 1998, the Scientific Committee on Plants (SCP) of the European Commission expressed a positive opinion on the 
notification C/BE/96/01.  They concluded that there is no eviden ce to indicate that the placing on the market of GM oilseed rap e 
MS8/RF3, with the purpose to be used as any other oilseed ra pe, is likely to cause adverse e ffects on human health and the 
environment.  ... Since then, the dossier has been blocked at European level by the de facto moratorium. 
  102_trans The Scientific Committee on Plants had also issued a positive opinion, but had raised questions concerning monitoring and 
agricultural practices. On 28 May 1999, the Commission had published a decision that had to be voted on. Given the de facto  
moratorium that had been in place since 1999, the dossier was bogged down in European procedures. 
  102_trans Mrs Janssens expressed the concern felt by the Office of Minister Aelvoet that the forwarding of this information could be 
interpreted as meaning that Belgium was pursuing the ad interim  approach suggested by the European Commission, whereas in 
a recent consultation Belgium had clearly defended the standpoint that it did not agree with that approach and did not wish to 
continue processing dossiers on the marketing of GMOs until the new Directive, 2001/18/EU, had come into effect. The 
forwarding of the additional information relating to the Aventis  CropScience dossier could come across as a signal to the 
opposite effect. 
  102_trans In order to go some way towards meeti ng the concerns of the Office of Minister  Aelvoet, it was decided to attach an 
accompanying letter to the additional informa tion, making it clear that the informa tion was being forwarded to the Commission 
as required under Directive 90/220/EEC, but that this was not to be construed as a political signal to the effect that Belgium was 
in agreement with the application of an ad hoc  approach and the lifting of the moratorium on the marketing of GMOs. 
  102_trans "... until such time as clarity is obtained regarding the moratorium and traceability, we are against field trials. The reason is 
that, while discussions are ongoing  at European level, it is difficult to give a si gnal to a company to the effect that its pro posal 
(revised to take  future legislation into account) is a good one. This would be improper government practice, as it would send 
out the wrong signals to both the company and the population. Firstly, this would give the company the impression that the 
current European proposals would not undergo any further change. And secondly, it would give the population the impression 
that only the financial interests of a company were considered to be important." 
(signed: Jean-Pierre De Leener, advisor to the Flemish Minister of Agriculture and the Environment.  
  102_trans [T]he moratorium concerned only the marketing of GMOs and not their release for experimental purposes. 
 
  106_trans The draft recommendation was approved by the members of the Bi osafety Council. [The Council emphasised] the importance of 
including a covering letter explaining that sending this update to the European Commission was not to be interpreted as a signa l 
from Belgium that it wanted the current moratorium to be lifted. 
     
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64  120 Having the revised directive fully adopted will not be sufficient .  The re-start of the regulatory process will depend on the 
willingness of the Commission to do it.  It  is commonly analysed that the Commission w ill not promote an Art 21 vote meeting, 
if there are no indications that the member-states are supporting the process and/or expected to vote positively.  Another key 
step for the member-states acceptance is the publication of Commission papers on traceability/labelling and liability that is 
expected by March 2001 (or later).  These papers are very importa nt because one of the reasons fo r the 5 member-states to start  
a moratorium was precisely labelling and traceability. 
       
65  65 Members of the CNB are reminded that these two notifications of genetically modified cottons were studied in Spain within the 
framework of Directive 90/220/EEC.  Spain drafted a favourable report, which was submitted to the European Commission, to which must be added the positive report by the Scientific Commi ttee on Plants.  However, both dossiers were put to the vote in 
1999 and a qualified majority was not reached, so they remained pending and blocked during the de facto  moratorium. 
  65 Information was updated regarding the co mplaint against the EU submitted to the World Trade Organization (WTO) by the 
United States, Canada and Argentina, and nine countries supporting them, objecting to the moratorium it has maintained since 1998 on the approval of new genetically modified products. 
       
66  65 Members of the CNB are reminded that these two notifications of genetically modified cottons were studied in Spain within the 
framework of Directive 90/220/EEC.  Spain drafted a favourable report, which was submitted to the European Commission, to which must be added the positive report by the Scientific Commi ttee on Plants.  However, both dossiers were put to the vote in 
1999 and a qualified majority was not reached, so they remained pending and blocked during the de facto  moratorium. 
  65 Information was updated regarding the complaint submitted to the World Trade Organization (WTO) by the United States, 
Canada and Argentina, and nine countries supporting them, against the EU objecting to the moratorium it has maintained since 1998 on approval of new genetically modified products. 
67  91 The company was aware of the declarations of  certain Member States in the June Coun cil and wondered what effect this would 
have on the authorisation process ... . 
       
69  121 The lead competent authority i ssued "a favourable opinion on the placing on the market of the product [...] under the following  
conditions: [...] (iii) Placing on the mark et cannot be authorised until the Community regulati ons on the traceability and 
labelling of GMOs and on GM food and feed have entered into force."  In accordance with the French position, the German CA 
is of the opinion that no consent should be  given until both regulations are in force. 
  125 Denmark also wants to draw attention to the declaration from Ma rch 2001 in which 6 Member States "reaffirmed their intention, 
when exercising the powers conferred upon them, of ensuring that the new authorisations for cultivating and marketing GMOs 
are suspended pending the adoption of effe ctive provisions concerning a complete traceability of GMOs that guarantees reliable 
labelling of all GMO products." 
  149 Traceability and labelling: Consents for mark eting GMOs should not be granted until all the requir ements of the Regulation 
concerning traceability and labelling are applicable. 
  158 Denmark finds that approval fo r placing on the market cannot take place before  the regulation on traceability and labelling is 
fully into force. 
  160 The Norwegian CAs are of the opinion that consents for marketing of genetically modified plants should not be granted until all  
the requirements of the Regulation concer ning traceability and labelling (1839/2003) have been met and the Regulation is fully 
applicable.  
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70  70 In addition, Denmark wants to draw atten tion to the declaration from March 2001 in  which 6 Member States "reaffirmed their 
intention, when exercising the powers conferred upon them, of ensuring that the new authorisations for cultivating and 
marketing GMOs are suspended pending the adoption of effective provisions concerni ng a complete traceability of GMOs that 
guarantees reliable labelling of all GMO products." 
  72 The Swedish Society for Nature Conservation objects to the application for the following  reasons: 1) products from animals that  
have eaten genetically modified feed shall be labelled, 2) th e rules on traceability and labelling have not yet been implemente d 
in national legislation, 3) the issue of liability for genetically modified organisms has not been solved at EU level, and 4) t he 
decision should await the result from the study on coexisten ce. They therefore believe that  the moratorium on genetically 
modified organisms should remain in place. 
  76 [T]he French authorities point ou t that they are committed to the establishment of a European traceabilit y and labelling system  
for GMOs and GMO-derived products and that consequently, the entry into force of the texts currently under adoption remains a prerequisite for authorizing the marketing of any new GMO. 
  77 As a matter of principle, this product should not be placed on the market before the entry into force of the Regulation of the 
European Parliament and of the Council concerning the traceability and labelling of genetically modified  organisms and the 
traceability of food and feed products produced from genetically modified  organisms and amending Di rective 2001/18/EC.  In 
addition, further issues concerning liability and the coexisten ce of genetically modified, conventional and organic crops remai n 
to be resolved. 
  79_trans [I]t seems reasonable not to base decisions authorizing the launch of the genetically modified foods on the currently applicabl e, 
yet generally considered inadequate, legislation but to wait for th e new regulations to come into force. According to the Feder al 
Government, the effective moratorium for approval of genetically modified organisms shall be terminated as soon as the 
regulations for permission and retrospective traceability of the genetically modi fied foodstuffs and fodders take effect. 
  80 The official Belgian position as expresse d during agriculture and environment coun cils is that as far as the regulation 
"Traceability and labelling of GMO and traceability of food an d feed products produced from GM O" is not entered into force, 
the conditions for risk management and public information are not fulfilled to authorize new GMOs under Directive 2001/18.  
Moreover, it was also stated that the regul ation "GM Food and Fe ed" should also enter into for ce prior to proceed to any new 
authorization. 
  100 Even though this product is only destined for import and further processing in the EU, Austria - apart from the need for furthe r 
information - maintains its objection against the putting of this product to the market, as long as all conditions for coexiste nce 
with GMO-free production me thods and the issues concerning liability are not cleared in a sound legal way. 
       
73  4 The field trials in Greece did not take pl ace after the declaration of a moratorium on the cultivation of genetically modified 
crops. 
  12 Members of the CNB are reminded that these two notifications of genetically modified cottons were studied in Spain within the 
framework of Directive 90/220/EEC.  Spain drafted a favourable report, which was submitted to the European Commission, to 
which must be added the positive report by the Scientific Committee on Plants.  However, both dossiers were put to the vote in 1999 and a qualified majority was not reached, so they remained pending and blocked during the de facto  moratorium. 
  12 Information was updated regarding the complaint against the EU submitted to the World Trade Organization (WTO) by the 
United States, Canada and Argentina, and nine countries suppor ting them, objecting to the moratorium it has maintained since 
1998 on the approval of new genetically modified products.  
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74  101 As long as the conditions for co-existence are not clarified on th e EU level, Austria holds the opinion that no consent for the  
placing on the market of 1507 maize should be given, even though this notification is concerning import only. 
  102 The German CA is of the opinion that no consent can be gi ven until the Community regulations  on the traceability and labelling 
of GMOS and on GM food and on feed ha ve entered into force.  In particular, the regulation on traceability and labelling of 
GMOs will provide for additional transparency and the possibility of choice for consumers. 
  133 Furthermore, Denmark finds that approval for placing on the market cannot take pl ace before the regulation on traceability and 
labelling is fully into force. 
      
75  83 [T]he French authorities point ou t that the entry into force of  the regulations on the traceability and labelling of GMOs and o f 
food and feed products produced from GMOs, and on genetically modified food and feed, is a prerequisite for authorizing the marketing of any new GMO. 
  85 As long as the conditions for co-existence are not clarified on th e EU level, Austria holds the opinion that no consent for the  
placing on the market of 1507 maize should be given. 
  86 Denmark also wants to draw attention to the declaration from Ma rch 2001 in which 6 Member States "reaffirmed their intention, 
when exercising the powers conferred upon them, of ensuring that the new authorisations for cultivating and marketing GMOs 
are suspended pending the adoption of effe ctive provisions concerning a complete traceability of GMOs that guarantees reliable 
labelling of all GMO products." 
  87 The German CA is of the opinion that no consent can be gi ven until the Community regulations  on the traceability and labelling 
of GMOS and on GM food and on GM feed have entered into fo rce.  In particular, the regula tion on traceability and labelling of 
GMOs will provide for additional transparency and the possibility of choice for consumers. 
  88 Norway is of the opinion that the operational parts of the ne w EU regulations on traceability and labelling, as well as on 
genetically food and feed has to enter in to force, and the management consequences  of these regulations should be in place 
before any GMOs can be placed on the marked. 
       
76  44 Irrespective of the above mentione d scientific objections raised, Austria is of the opinion, that  products shall not be placed on 
the market before the new regulations conc erning genetically modified  food and feed as well as traceability and labelling of 
GMOs will enter into force.  In addition the issue of co-exist ence of genetically modified, conventional and organic farming is  
at the moment under discussion and has to be resolved. 
  44_trans Notwithstanding the abovementioned scientific reservations, it must be stated generally that, before the new and planned 
provisions concerning the traceability and labelling of GMO, and concerning the author ization and labelling of GMO foodstuffs 
and feedstuffs, have come into force, Austria is in any case opposed to new authorizations. 
  46 In addition, Denmark wants to draw atten tion to the declaration from March 2001 in  which 6 Member States "reaffirmed their 
intention, when exercising the powers conferred upon them, of ensuring that the new authorisations for cultivating and 
marketing GMOs are suspended pending the adoption of effective provisions concerni ng a complete traceability of GMOs that 
guarantees reliable labelling of all GMO products." 
  47 The Swedish Society for Nature Conservation objects to the application for the following  reasons: 1) products from animals that  
have eaten genetically modified feed shall be labelled, 2) th e rules on traceability and labelling have not yet been implemente d 
in national legislation, 3) the issue of liability for genetically modified organisms has not been solved at EU level, and 4) t he 
decision should await the result from the study on coexisten ce. They therefore believe that  the moratorium on genetically 
modified organisms should remain in place.  
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  51 The official Belgian position as expresse d during agriculture and environment coun cils is that as far as the regulation 
"Traceability and labelling of GMO and traceability of food an d feed products produced from GM O" is not entered into force, 
the conditions for risk management and public information are not fulfilled to authorize new GMOs under Directive 2001/18.  
Moreover, it was also stated that the regul ation "GM Food and Fe ed" should also enter into for ce prior to proceed to any new 
authorization. 
  52 [T]he French authorities point ou t that they are committed to the establishment of a European traceabilit y and labelling system  
for GMOs and GMO-derived products and that consequently, the entry into force of the texts currently under adoption remains a 
prerequisite for authorizing the marketing of any new GMO. 
  54 (p. 28) In general, we believe that it is unsuitable to proceed with th e GMO authorisation process in ab sence of the final normative on  
labelling and traceability, export of GMOs (c omprising the structure of the communicat ion of information within the EU) as 
well as the new Food and Feed regulation 
       
77  93 (p. 2) Our conclusion now is that the dossiers for the evaluation of gr een hearted chicory and radicchio  rosso for market authorisatio n 
under Regulation 258/97 are a kind of a "never ending story".  The procedure, time, energy and costs are disproportionate 
compared to conventional breeding programs.  This may lead to the conclusion that development and marketing of transgenic 
vegetable crops in the European Union do not have any opportunity. 
       
78 + 85 Maize GA21 35 Lack of a coherent Community-wide traceability system.  The Fr ench authorities note that no  regulatory system ensures 
traceability until the end-user has been put in place. 
  42 [T]aking into account the declarations given by the 12 ministers at the Council meeting in June 1999 ... 
  61 Furthermore, without prejudice to this ad ditional information, the establishment of  a European traceability system for GMOs 
and GMO-derived products is, for the French authorities, a prerequisite for authorizing the marketing of new GMOs. 
  71 [T]aking into account the declarations given by the 12 ministers at the Council meeting in June 1999... 
91 Maize GA21   
       
92 Maize Bt11 23 The French authorities recall thei r position that, before any authorization, ther e must be legal and technical means whereby th e 
traceability and labelling of GM Os and GMO-derived prod ucts can be ensured. 
  27 Apart from this, however, Denmark will refer to the Declaration concerning the suspension of new GMO authorisations by five 
Member States (France, Greece, Italy, Luxembourg, and Denmark) at the Environment Council of 24 and 25 June 1999.  With 
reference to this Declaration Denmark therefore wishes to  submit a reasoned objection concerning the Bt11 maize. 
  74 In view of the entry into force of the fo od/feed regulation on 18 April 2004 imposing more stringent requirements for marketing  
and labelling and the traceability re gulation, on our view it is not at present ap propriate to hasten marketing for food under a 
regulation which will be out of date in four months. 
  75 Regulations 1829/2003 and 1830/2003 have not been implemented and as a result the novel product does not fully comply with 
the requirements ... We think there could be problems implementing the traceability systems. 
  76 Portugal voted against the auth orisation to place Bt11 on the market, since, under Community food sa fety policy, only the 
application of the traceability and labelling rules can guarantee the protection of  public health and free choice for consumers .  
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  80 In August 2000, Denmark submitted an objection to the approval  of Bt11 maize in respect of the novel food regulation with 
reference to the declaration approved by Denmark, France, Italy, Greece and Luxembourg on the suspension of new GMO 
licences (the moratorium declaration), which was made at the Council meeting (environment) on 24-25 June 1999. The 
objection included a reference to the fact that, pending th e approval of a regulation that would guarantee the labelling and 
effective tracing of GMOs and products derived from them, the moratorium countries would block any new licences for the 
cultivation and marketing of GMOs. 
  80_trans The proposal was put on the voting agenda for the meeting of the Standing Committee on the Food Chain and Animal Health on 
8 December 2003, but a qualified majority in favour of the proposal was not achieved.  Denmark voted against it on the grounds 
that it is evident from the regulation concerning traceability an d labelling (1830/2003) that rules are to be drawn up for a sy stem 
for the development and allocation of unique identifiers and tec hnical guidelines for the sampling and analysis of GMOs. At the  
time of voting these rules had not been put into effect. 
  84_trans At the session on 20.4.2004 of the Standing Committee on Foodstuffs, Austria requested that no new products be admitted until 
the interpretation of the provisions on designa tion and traceability are sufficiently clarified. 
       
95 CRY1F 25 Moreover, the rules on traceability and label ling laid down in Re gulation (EC) No 1830/ 2003 of the European Parliament and of 
the Council of 22 September 2003 must apply. 
       
96 NK603 22_trans Regardless of the scientific reservations expressed above, Au stria is fundamentally opposed to the granting of any new 
approvals before the planned le gislation on the traceability and labelling of GM Os and on the approval  and labelling of GM 
food and feed is adopted and comes into force. 
  23_trans With regard to live GMOs, it should also be borne in mind that such products must be approved in accordance with the 
Directive on the release of GMOs and that the application must be considered to be covered by the moratorium.  Denmark thus 
objects to the approval of this product ... 
  24_trans Given that the two regulations can be expect ed to enter into force fairly soon, it woul d seem appropriate to no longer take any  
decisions approving the introduction of genetically modified foods onto the market ... 
  24_trans In the German Government's view, the effective moratorium on approval for genetically modified organisms will be lifted by 
the Commission once the regulations on the approval and traceab ility/labelling of genetically modi fied foods and feeding stuffs  
have entered into force. 
  27 The French Authorities recall their position th at, before any authorization, there must  be legal and technical means whereby th e 
traceability and labelling of GMOs and GM O-derived products can be ensured . 
       
97 GM 2-28 26 Our conclusion now is that the dossiers for the evaluation of gr een hearted chicory and radicchio  rosso for market authorisatio n 
under Regulation 258/97 are a kind of a "never ending story".  The procedure, time, energy and costs are disproportionate 
compared to conventional breeding programs.  This may lead to the conclusion that development and marketing of transgenic 
vegetable crops in the European Union do not have any opportunity. 
 WT/DS291/R/Add.4 
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Page F-26 
  
  ANNEX F-2 
 
REPLIES BY THE UNITED STATES 
TO ADDITIONAL QUESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
11 MARCH 2005 
 
 For all parties
: 
 
170. With reference to EC Directive 2001/18, Annex II, Section C.2.1, please indicate for each 
of the listed potential adverse effects of GM Os whether measures applied to prevent or 
minimise such effects fall within the scope of A nnex A(1) of the SPS Agreement, and if so, why.  
The parties are also invited to address S ection D with the same question in mind.  
 
1. As the United States has previously noted,1 it not necessary for the Panel to determine that 
every  potential risk evaluated under Directive 2001/18 falls within the scope of the SPS Agreement.  
The Agreement makes clear that "any measure" applie d to protect against one of the enumerated risks 
falls within the scope of the SPS agreement.  More over, the EC has acknowledged that at least some 
of the potential risks that Directive 2001/18 was intended to address fall within the scope of the 
Agreement.2 
 2. Nonetheless, in the context of th e products at issue in this dispute
, the majority, if not all, of 
the endpoints referenced in Annex II C.2.1 would fa ll within the scope of th e risks enumerated in 
Annex A(1) of the SPS Agreement.3  
 
 -disease to humans including allergenic or toxi c effects (see e.g. items IIA(11) and IIC(2)(i) in 
Annex IIIA, and B(7) in Annex IIIB); 
 
3. While the United States would not typically c onsider toxic and allergenic effects to be 
diseases, measures taken to address concerns that  a biotech plant might cause disease to humans 
would appear to fall squarely within the scope  of paragraph 1(c)–"to protect human life or 
health...from risks arising from diseases carried  by...plants or products thereof."   
 4. To the extent allergenic a nd toxic effects are not considered to be diseases, such concerns 
would still fall within paragraph 1(c).  Because the Directive does not address the safety from the 
human consumption of biotech food, the United States assu mes that this relates to any toxic or allergic 
effects arising from occupational or residential ex posures.  These would be "risks to human health 
arising from the entry, establishment or spread of pests."  As the United States has previously 
explained, the ordinary meaning of the term "pest" is "any thing or person that is noxious, 
                                                     
 
1 US Answers to Questions Posed in the Context of the First Panel Meeting, Q. 49. 
2 EC First Written Submission, para. 433. 
3 Because the Directive is intended to  encompass a much wider variety of  products than are relevant to 
this dispute (e.g., genetically modified insects or micr obes), the effects listed in these sections are extremely 
broad, and there is consequently, some degree of ambiguity.  In general, the United States has attempted to address the effects in the context of the products at issu e in this dispute, rather than speculate on all of the 
possible adverse effects that might be encompassed with in the categories, and the degree to which they might 
fall within Annex A.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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 Page F-27 
  
  destructive, or troublesome."
4  Any plant responsible for causing allergic or toxic effects in any 
person exposed to it would certainly qualify as "destructive" or "troublesome." 
 
 disease to animals and plants including toxi c, and where appropriate, allergenic effects (see 
e.g. items IIA(11) and IIC(2)(i) in Annex IIIA, and B(7) and D(8) in Annex IIIB); 
 
5. This would appear to fall squarely within th e scope of paragraph1(a), irrespective of whether 
toxic and allergenic effects are considered to be di seases.  Whether one considers the biotech plants as 
"disease-carrying or disease-causing" or as pests, the risks would fall squarely within paragraph 1(a) 
as "risks arising from the entry, establishment, or  spread of pests, diseases, disease-carrying 
organisms, or disease-causing organisms."  
 
 effects on the dynamics of populations of speci es in the receiving environment and the genetic 
diversity of each of these populations (see e.g. items IVB(8), (9) and (12) in Annex IIIA);  
 
6. Any damage that a biotech plant could cause  to population dynamics or genetic diversity 
would typically occur due to alterations in the inv asiveness or persistence of a certain plant species, 
thereby causing changes in the relative abundances of different plant species that may secondarily 
have a negative impact on animal life.  Such chang es, should they occur, would be caused by the new 
plant species (i.e., the biotech plant), or its hybrid  progeny, establishing or spreading into new areas 
and outcompeting and displacing wild flora thereby potentially altering the availability of resources 
such as food and shelter used by wild fauna.  As the United States has previo usly noted, such plants 
would be a weed, and thus fall within the definition of a pest, pursuant to footnote 4.  Accordingly, 
measures taken to address such concerns would fall within paragraph 1(a), as measures taken to 
protect animal or plant life or health from "risks arising from the entry, establishment, or spread of 
pests." The intended breadth of the covered  risks is  confirmed by Footnote 4, which specifies that, for 
purposes of the definitions in Annex A, "'animal' in cludes fish and wild fauna; 'plant' includes forests 
and wild flora." 
 
 altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or 
creating new reservoirs or vectors;    
 
7. As a general matter, based solely on the gene ral description, this endpoint would appear to 
fall squarely within either paragra phs 1(a) or (c).  To the extent the measure was adopted to protect 
animal or plant life or health, the risk would appear to arise from "the establishment of disease-
carrying organisms, or disease-causing organisms," and would fall within the scope of paragraph 1(a).  
If, however, the concern related to human health, th e measure would appear to fall within paragraph 
1(c).    8. Alternatively, in the context of the products at  issue, the question of whether the plant has the 
potential to alter the susceptibility to pathogens or to  create new vectors, is something that the IPPC 
typically considers in determining whether an organi sm could be considered a pest.  For example, in 
ISPM 11, Pest Risk Analysis for Quarantine Pests, including Analysis of Environmental Effects and 
Living Modified Organisms,  Annex 3 specifically include the following as potential phytosanitary 
risks for LMOs:   
                                                     
 
4 The Compact Oxford English Dictionary, Oxford University Press, 24th Printing, 1971, page 2145 
(Ex. US-121). WT/DS291/R/Add.4 
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Page F-28 
  
  b. Adverse effects of gene flow or gene transfer including, for example: 
 – transfer of pesticide or pest r esistance genes to compatible species 
– the potential to overcome existing reproductive and 
recombination barriers resulting in pest risks 
– potential for hybridization with existing organisms or 
pathogens to result in pathogenicity or increased 
pathogenicity . 
c. Adverse effects on non-target organisms including, for example: 
– changes in the host range of the LMO, including the case 
where it is intended for use as a beneficial control agent or organism claimed to be beneficial 
– effects on other organisms, such  as biological control agents, 
beneficial organisms, or soil fauna and microflora, nitrogen-
fixing bacteria, that result in an phytosanitary impact 
(indirect effects) 
 – capacity to vector other pests
 
– negative direct or indirect effects of plant-produced 
pesticides on non-target organisms beneficial to plants."5 
Consequently, these risks fall within paragraph 1(a) as risks to plant health arising from pests.   
 
 compromising prophylactic or therapeutic medical, veterinary, or plant protection  
treatments, e.g. by transfer of genes conferri ng resistance to antibiotics used in human or 
veterinary medicine (see e.g. items IIA(11) e) and IIC((2)(i)(iv) in Annex IIIA);   
 9. The relevant risks described by the above pa ragraph would primarily relate to concerns to 
human and animal health arising from the presence of  the antibiotic resistance marker genes in the  
plants.   10. As the United States has previously explaine d, the risks the EC has raised relating to 
antibiotic marker genes generally fall within para graph 1(a).  The concern described is that the 
antibiotic resistance gene could be  transferred from the plant to a human or animal pathogen. For an 
animal infected with the pathogen that would ordina rily be treated with the antibiotic to which the 
pathogen had become resistant, the transfer of  the resistance gene would contribute to the 
establishment and spread of disease--the disease caused by the now resistant pathogen. 
 
11. Additionally, the antibiotic resistance gene fa lls within the definition of an additive under the 
SPS Agreement.  As such, protection against any associ ated human or animal health risks, such as the 
transfer of antibiotic resistance to human or animal  pathogens that the antibiotics would be used to 
treat, falls within paragraph 1(b). 
                                                     
 
5 ISPM 11, Pest Risk Analysis for Quarantine Pests,  including Analysis of Environmental Effects and 
Living Modified Organisms, at 36 (emphasis added) (Ex. US-123).  WT/DS291/R/Add.4 
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 Page F-29 
  
   
12. The reference to "compromising plant prot ection treatments" also appears to indicate a 
concern that a biotech plant might compromise the u se of various pesticide or herbicides.  The most 
likely concern would relate to the development of  pesticide resistance.  As the United States has 
previously explained
6, such risks would generally fall w ithin the scope of paragraph 1(a). 
 
 effects on biogeochemistry ( biogeochemi cal cycles), particularly carbon and nitrogen 
recycling through changes in soil decomposition of organic material (see e.g. items IIA(11) f) 
and IVB(15) in Annex IIIA, and D(11) in Annex IIIB). 
 
13. As Dr. Andow described, biogeoc hemical cycles relate to the e nvironmental fate of individual 
chemical elements in the environment–how these chem icals, which are generally plant nutrients, cycle 
through the environment.  These are of concern, a nd particularly the ones explicitly referenced above, 
primarily because they could affect the availability of  nutrients to plants, which is relevant to plant 
health.  In addition, changes in th ese cycles can indicate that there ha ve been effects or changes in soil 
microorganisms.  Although the experts' testimony confirmed that there is no evidence that biotech 
crops affect biogeochemical cycles, concerns that biotech plants might alter biogechemical cycles 
would generally fall within the scope of pa ragraph 1(a) as risks arising from pests. 
 
14. The Panel also requested that the parties comme nt on the effects listed in Annex II, section D;  
section D.1 applies only to "GMOs other than higher plants," and as none of the products at issue in 
this dispute fall within this category, there is no need  for the Panel to reach this question.  Section D.2, 
relating to the effects of higher plants, lists nine potential endpoints to be addressed as part of an 
environmental safety assessment.   
 
15. Section D.2, relating to the effects of highe r plants, lists nine potential endpoints to be 
addressed as part of an environmental safety assessment.   
 
 1. Likelihood of the GMHP becoming more persistent than the recipient or parental 
plants in agricultural habitats or more invasive in natural habitats. 
 
 2. Any selective advantage or disadvantage conferred to the GMHP.   3. Potential for gene transfer to the same  or other sexually compatible plant species 
under conditions of planting the GMHP and any selective advantage  or disadvantage 
conferred to those plant species 
 
16. The first three points would primarily relate to  the potential for the plant to become invasive 
or weedy.  The Agreement explicitl y provides that pests include weeds
7, and measures applied to 
address such concerns would generally fall within th e scope of paragraph 1(a) as a measure to protect 
plant life or health from risks arising from the entry,  establishment or spread of pests.  It is also 
theoretically possible that the risks would fall within the scope of paragraph 1(c), depending on 
whether the biotech plant presented a hazard to human or animal health.   
 
 4. Potential immediate and/or delayed en vironmental impact resulting from direct and 
indirect interactions between the GMHP and target organisms, such as predators, 
parasitoids, and pathogens (if applicable). 
                                                      
6 US Answers to Questions Posed in the Context of the First Panel Meeting, Response to Q. 75, 
paras. 103-107. 
7 SPS Agreement, Annex A, note 4. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-30 
  
   
 5. Possible immediate and/or delayed en vironmental impact resulting from direct and 
indirect interactions of the GMHP with non-target organisms, (also taking into account 
organisms which interact with target organisms), including impact on population levels of 
competitors, herbivores, symbionts (w here applicable), parasites and pathogens.  
 
17. These two concerns relate to direct and indirect effects on n on-target organisms caused by the 
biotech plant.  Measures taken to address such eff ects would generally fall within paragraph 1(a) as 
measures to protect animal life or health  from the establishment of pests.    
 
 6. Possible immediate and/or delayed effe cts on human health resulting from potential 
direct and indirect interactions of the GMHP and persons working with, coming into contact with or in the vicinity of the GMHP release(s).  
 
18. Measures taken to address an y risks from occupational or residential exposure to the biotech 
plants would generally fall with in paragraph 1(c), as measures "to protect human life or health...from 
risks arising from...the establishment or spread of pest s."  In addition, to the extent the concern relates 
to the presence of the Bt toxin/pesticidal substance in the plan t, the measure would fall within para 
1(b) as a "measure to protect human life from a risk arising from...a contaminant in foods." 
  7. Possible immediate and/or delayed effect s on animal health and consequences for the 
feed/food chain resulting from consumption of th e GMO and any products derived from it if it 
is intended to be used as animal feed.  
 19. Concerns relating to effects on animal health  resulting from the consumption of feed derived 
from a biotech plant would generally fall within the sc ope of paragraph 1(b).  This would also include 
any effects on the feed/food chain, which could relate  to concerns that the biotech feed would contain 
contaminants or toxins that would pass through th e animal and remain in the meat or milk.   
 
 8. Possible immediate and/or delayed e ffects on biogeochemical processes resulting 
from potential direct and indirect interacti ons of the GMO and target and non-target 
organisms in the vicinity of the GMO release(s).  
 
20. As discussed in other responses, measures take n to address concerns that a biotech plant may 
adversely affect biogeochemical processes or non-target  organisms, either directly or indirectly, 
would generally fall within  paragraph 1(a).    
 
 9. Possible immediate and/or delayed, direct  and indirect environmental impacts of the 
specific cultivation, management and harvesting techniques used for the GMHP where these 
are different from those used for non-GMHPs . 
 
21. These are specific examples of potential indirect effects of biotech crops, and as such, would 
generally fall within the scope of pa ragraphs 1(a) or (c), relating to risks arising from pests.     
 
171. In Japan - Apples, the Appellate Body in terpreted Article 5.7 of the SPS Agreement and 
notably the phrase "in cases where relevant scientifi c evidence is insufficient".  It stated at 
para. 179 that:  
 
Article 5.1 [...] informs the other provisions of Article 5, including Article 5.7.  We note, as well, that the second sentence of Article 5.7 refers to a "more objective assessment of risk s".  These contextual elements militate in favour of a  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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 Page F-31 
  
  link or relationship between the firs t requirement under Article 5.7 and the 
obligation to perform a risk assessment under Article 5.1:  "relevant scientific evidence" will be "insufficient" within the meaning of Article 5.7 if the body of 
available scientific evidence does not allow, in quantitative or qualitative terms, 
the performance of an adequate assessm ent of risks as required under Article 
5.1 and as defined in Annex A to the  SPS Agreement. [...] The question is whether the relevant evidence [...] is sufficient to permit the evaluation of the likelihood of entry, establishment or spread of, in this case, fire blight in Japan. 
In this regard, please answer the following questions: 
  (a) Is there a reason to believe that a lack of relevant scientific evidence could 
prevent a Member from performing a risk assessment "as required under 
Article 5.1 and as defined in Annex A to the  SPS Agreement"?  Or is it rather a 
question of that Member perhaps being unable, due to the insufficiency of 
scientific evidence, to conduct a fully obj ective risk assessment, such that any 
measure based on that assessment migh t be maintained without sufficient 
scientific evidence? 
  (b) Does the phrase "more obj ective assessment of risks" in Article 5.7 support the 
view that a provisional measure adopted in accordance with Article 5.7 must be 
based on risk assessment, as required by Article 5.1? (Canada may wish to elaborate further on what it has alread y said in its supplementary rebuttal in 
relation to this point.)  
 22. This question pertains to the relationshi p between the following phrases used in the SPS 
Agreement:    (1) "assessment of ... risks" (Article 5.1) and "risk assessment" Annex A(4);  
  (2) "cases where relevant scientific evid ence is insufficient" (Article 5.7); and 
 
 (3) "more objective assessment of risk" (Article 5.7).    23. The Appellate Body in the above quote from Japan – Apples  explicates the relationship 
between (1) assessment of risk/risk assessment, as those phrases are used in Article 5.1 and Annex A; 
and (2) "insufficient" scientific ev idence as used in Article 5.7.  Th e key statement is as follows:   
 
These contextual elements militate in favour of a link or relationship between the first 
requirement under Article 5.7 and the oblig ation to perform a risk assessment under 
Article 5.1:  "relevant scientific evidence" w ill be "insufficient" within the meaning of 
Article 5.7 if the body of available scientif ic evidence does not allow, in quantitative 
or qualitative terms, the performance of an  adequate assessment of risks as required 
under Article 5.1 and as defined in Annex A to the  SPS Agreement.8   
24. The first sentence in Question 171(a) above – "Is there a reason to believe that a lack of 
relevant scientific evidence could prevent a Member from performing a risk assessment "as required under Article 5.1 and as defined in Annex A to the  SPS Agreement"? – is largely consistent with the 
Appellate Body's explication as set out above.  It is  important, however, to clarify that the question is 
                                                     
 
8 Japan – Apples , para. 179.   WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-32 
  
  not whether the evidence is suffi cient to perform a risk assessmen t in the abstract.  Rather, the 
pertinent question is whether the evidence is suffi cient for a Member to meet its obligation of 
performing a risk assessment in relation to the sp ecific risk at issue.  Or, as the Appellate Body 
summarized the issue above, was the evidence sufficient to perform an "adequate" risk assessment, as 
required under Article 5.1 and as defi ned in Annex A.  So, for example, in light of the fact that the 
measure at issue in the Apples case was intended to st op the spread in Japan of fire blight (a plant 
disease), the Appellate Body explained that:  
Thus, the question is not whether there is sufficient evidence of a general nature or 
whether there is sufficient evidence relate d to a specific aspect of a phytosanitary 
problem, or a specific risk.  The question is whether the relevant evidence, be it "general" or "specific", in the Panel's parl ance, is sufficient to permit the evaluation 
of the likelihood of entry, establishment or spread of, in this case, fire blight in 
Japan.
9 
25. The second sentence in Question 171(a) above – "Or is it rather a question of that Member 
perhaps being unable, due to the insufficiency of sci entific evidence, to conduct a fully objective risk 
assessment, such that any measure based on that ass essment might be maintained without sufficient 
scientific evidence?" – is somewhat inconsistent with the Appellate Body's explication as set out 
above.  As noted, the question is whether the evid ence is sufficient for the Member to perform an 
adequate risk assessment, as requi red under Article 5.1 and as defined in Annex A.  The term "fully 
objective risk assessment" is not used in the SPS Agreement, and the meaning of this phrase is 
uncertain.  In addition, the second part of the a bove question – such that any measure based on that 
assessment might be maintained without sufficient scientific evidence – is incomplete.  Article 5.7 
applies where the scientific evidence is not sufficient for the Member to complete an adequate risk 
assessment, as required under Article 5.1 and as defined in Annex A.  However, the measure must still 
be based on "available pertinent information," a nd the Member must also meet the additional 
requirements in the second sentence of Article 5.7.  26. With regard to Question 171(b), the United States does not agree that " the phrase 'more 
objective assessment of risks' in Article 5.7 support[ s] the view that a provisional measure adopted in 
accordance with Article 5.7 must be based on risk assessment, as required by Article 5.1 ".  As noted 
above, the Appellate Body explained that "insufficien t" scientific evidence, as used in Article 5.7, 
means "insufficient" scientific evidence for a Memb er to perform an adequate risk assessment, as 
required under Article 5.1 and as defined in Annex A.  Since a precondition for the application of 
Article 5.7 is the insufficiency of evidence for an  adequate risk assessment, it would not make sense 
to conclude that a provisional measure under Article 5.7 must nonetheless be based on a risk 
assessment (as required under Article 5.1 and as defined in Annex A to the SPS Agreement).  
However, a measure under 5.7 cannot be adopted on an  arbitrary basis.  To the contrary, Article 5.7 
explicitly provides that a provisional measure must be adopted on the basis of "available pertinent 
information."    
27. In Japan – Agricultural Products , the Appellate Body addressed the interpretation of "more 
objective assessment of risk," as used in Article 5.7:   
Neither Article 5.7 nor any other provisi on of the  SPS Agreement  sets out explicit 
prerequisites regarding the additional info rmation to be collected or a specific 
collection procedure.  Furthermore, Article 5.7 does not specify what actual results 
must be achieved; the obligation is to "seek to obtain" additional information.  
                                                     
 
9 Id.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-33 
  
  However, Article 5.7 states that the additiona l information is to be sought in order to 
allow the Member to conduct "a more objec tive assessment of risk".  Therefore, the 
information sought must be germane to c onducting such a risk assessment, i.e., the 
evaluation of the likelihood of en try, establishment or spread of, in casu , a pest, 
according to the SPS measures which might be applied.  We note that the Panel found 
that the information collected by Japan do es not "examine the appropriateness" of the 
SPS measure at issue and does not address th e core issue as to whether "varietal 
characteristics cause a divergency in quaran tine efficacy".   In the light of this 
finding, we agree with the Panel that Jap an did not seek to obtain the additional 
information necessary for a more objective risk assessment.10   
As confirmed by the above interpretation, Article  5.7 does not call for a "fully objective" risk 
assessment.  Rather, Article 5.7 uses the term "more objective assessment" to highlight that a Member 
applying an Article 5.7 provisional measure has an  ongoing obligation to seek to obtain more and 
better information that is germane to performi ng an adequate risk assessment, as required under 
Article 5.1 and as defined in Annex A.   
 
172. Annex A(1) of the SPS Agreement sugg ests that "approval procedures" are SPS 
measures.  When a Member decide s to delay the completion of such an approval procedure for 
a number of days, would such action be another SPS measure within the meaning of 
Annex A(1), or would such action rather need to be characterized as an application of an SPS 
measure (the application of the approval procedure)? 
 
28. This question addresses the analysis to be used under the SPS Agreement of a Member's 
decision "to delay the completion of an approval pr ocedure."  The United States submits that in the 
context of the facts and circumstances of this disp ute, such a decision to delay completion of approval 
procedures should be analyzed both : 
  (1) under the provisions of Annex C, incl uding the "undue delay" provision of 
Annex C(1)(A); and  
 
 (2) as a distinct SPS measure that must be consistent both with the obligations in 
Annex C of the SPS Agreement and with the obligations outside of Annex C, 
including the obligations in SPS articles 2.2, 2.3, 5.1, 5.5 and 7.   
 29. Annex C Obligations
:  Article 8 of the SPS Agreement provides that "Members shall observe 
the provisions of Annex C in the operation of control, inspection and approval procedures ... ."11  A 
decision to delay the completion of an approval proce dure fits squarely within Article 8's disciplines 
on the "operation of ... approval procedures," including the "undue delay" discipline in Annex C(1)(a).   
 30. SPS Obligations Outside of Annex C, including Articles 2.2 and 5.1
:  The United States has 
not contended that a decision to delay the comple tion of an approval procedure for a particular 
product for a day, or a week, would amount to a di stinct SPS measure that requires analysis of SPS 
obligations outside of Annex C.12  Rather, the United States submits that a decision to delay 
completion of approval procedures for biotech products  for an indefinite period of time – in this case 
                                                      
10 Japan – Agricultural Products , AB-1998-9, para. 92 (emphasis added).   
11 Question 172 uses the phrase "application of an approval procedure."  Given the text of SPS 
Agreement Article 8, perhaps a more precise phrasing would be "operation of an approval procedure."   
12 Such delays in the operation of approval procedures would, of course, have to be consistent with the 
"undue delay" obligation in Annex C(1)(A).   WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-34 
  
  from late 1998 up through at least August 2003 – and wh ich consequently has the effect of preventing 
the sale or marketing of new biotech products – am ounts to both a single distinct SPS measure (the 
general moratorium) and separate distinct SPS measures for each cove red product (the product-
specific moratoria) and that these measures must meet obligations outside of Annex C.
13  T h e  
reasoning is straightforward:  a decision to dela y approval procedures for an indefinite period is 
effectively equivalent to decision to adopt bans on the import and marketing of  all products subject to 
the approval procedure.  The requirement that pr oduct bans must, for example, not be "maintained 
without sufficient scientific evidence"14 lies at the core of the object and purpose of the SPS 
Agreement.   
 
173. May the fact that existing approval legislation does not permit a Member to adopt certain risk management measures which that Member considers appropriate serve as a justification, for purposes of an analysis under Annex C(1)(a) of the SPS Agreement, for 
delaying approval procedures conducted pursuant to the existing legislation?  Are the 
provisions of Article 27 of the Vienna Convention on the Law of Treaties relevant to such a situation?  
 
31. As an initial matter, the United States notes th at it does not accept the premise that any delays 
in the EC's processing of biotech applications were  due to any need by the EC to adopt additional 
legislation authorizing new or different risk manageme nt measures.  In fact, this premise is directly 
contrary to the EC's own contention that it adopt ed an "interim approach" in 2000, under which 
products could be cons idered and approved
 under the legal authority of Directive 90/220 while 
applying the (allegedly different) standards of Dire ctive 2001/18 (which did not enter into force until 
2003).15  Furthermore, the EC has denied  that the EC delayed all final decisions on biotech approvals 
until the April 2004 entry into force of the GM  Food and Feed and Traceability and Labelling 
legislation.    32. As the United States has explained previously, questions of "undue delay" must be determined on the basis of the facts and circumstanc es of any particular delay.  In this case, the EC 
has not shown that the moratorium lasting fro m October 1998 through at  least August 2003 was 
justified by any purported need for additional legisl ation (nor has the EC shown that the moratorium 
was justified for any other reason).  Likewise, the EC has not shown that any particular delays in 
processing applications were delayed by any pur ported need to await new legislation.   
 33. Although questions of "undue  delay" must be addressed on a case-by-case basis, there is an 
important legal principle that is implicated by the Panel's question:  the United States submits that a 
Member's supposedly inadequate legislation cannot excuse  a member from its obligation under 
Annex C(1)(A) to undertake and complete approval procedures without "undue delay."  A finding to 
the contrary would render the "undue delay" obl igation a nullity:  a Member could avoid the 
obligation to undertake and complete approval proce dures without "undue delay" simply by failing to 
take the steps necessary under its domestic la w to adopt the necessary legislation.   
 
                                                     
 
13 See First US Submission, sections IV(b)(1)(f), (g),  (h), and (i) (discussion of general moratorium) 
and IV(b)(2)(e),(f), and (g) (discussion of product-specific moratoria).   
14 SPS Agreement, Article 2.   
15 EC Answers to First Set of Questions, para. 35.  Furthermore, as Canada explained in Part II.B.1 of 
its  Second Written Submission, the EC has entirely faile d to show that Directive 2001/18 was adopted for the 
purpose of authorizing additional risk management measures.    WT/DS291/R/Add.4 
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 Page F-35 
  
  34. An analogy to provisional measures under Article 5.7 is also instructive.
16  A decision by a 
Member to suspend approval procedures until the Member adopts new legislation has an effect 
equivalent to the adoption of a provisional ban on all new products covered by those procedures.  
When the drafters of the SPS Agreement consider ed provisional bans, the only circumstance included 
in Article 5.7 for the adoption of provisional measures  is "in cases where relevant scientific evidence 
is insufficient."  If inadequate legislation were also considered to be a justification for the adoption of 
provisional measures, Article 5.7 could have stat ed "in cases where relevant scientific evidence or 
domestic legislation is insufficient."  But, of c ourse, Article 5.7 includes no such statement.   
 
35. With regard to Article 27 of the Vienna C onvention on the Law of Treaties, the United States 
agrees that the principle  set out in Article 27 – namely, that "A  party may not invoke the provisions of 
its internal law as justification for its failure to perfo rm a treaty" –  is relevant for a consideration of 
whether inadequate domestic legislation excuses  a Member from its WTO obligations.  The United 
States submits, however, that the principle in Article  27 is already fully reflected in the text of the 
WTO Agreement and is confirmed in Appellate Body re ports.  Accordingly, there is no need to turn to 
general principles of international law in orde r to support a finding that inadequate domestic 
legislation does not excuse a WTO Member from its WTO obligations.    36. The text of the SPS Agreement explicitly states that SPS measures include "all relevant 
laws,"
17 and the Agreement sets out specific obligations  with regard to those measures (including a 
Member's domestic laws).  By imposing obliga tions on "all relevant laws" of a Member, the 
Agreement is clear that inadequate laws cannot  serve as an excuse for non-performance of SPS 
obligations.    
37. In addition, in one of its first reports – US – Reformulated Gasoline  – the Appellate Body 
confirmed that a WTO Member is responsible for the actions of its legislative branch.  In that case, 
the United States explained that it had adopted the measure at issue (a measure found to be inconsistent with GATT Article III) because of "di fficulties of verification and enforcement."  The 
Appellate Body agreed with the Panel that coope rative, non-discriminatory measures were available 
to overcome those difficulties.  The Appellate Body acknowledged that such  cooperative measures 
required the US Congress to provide funding, but explained that "of course" this fact did not excuse 
the United States from compliance with its GATT obligations:  
The fact that the United States Congress might have intervened, as it did later 
intervene, in the process by denying fundi ng [for the cooperative verification and 
enforcement measures], is beside the point :  the United States, of course, carries 
responsibility for actions of both the ex ecutive and legislative departments of 
government.
18 
38. In sum, even if the EC could show that  it adopted the moratorium and delayed product 
applications in order to await th e legislative enactment of revised SPS legislation, this showing could 
not justify a five-year moratorium and resulting delays, or otherwise bring the measure into 
compliance with the EC's obligations under the SPS Agreement.  The principle that inadequate 
legislation does not justify a Member's noncomplian ce with WTO obligations is plainly reflected in 
the text of the WTO Agreement and is c onfirmed in Appellate Body reports.   
                                                      
16 As noted in response to the Panel's Question No. 12 5, the United States considers that Article 5.7 can 
serve as relevant context to be examined in deciding how to apply the "undue delay" provision of Annex C.   
17 SPS Agreement, Annex C(1).   
18 United States - Standards for Reformulated and Conventional Gasoline , AB-1996-1, at 27.   
 WT/DS291/R/Add.4 
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Page F-36 
  
   
174. With regard to Article 2.2 of the TBT Agreement:  
 (a) Please explain the phrase "the risks no n-fulfilment [of a legitimate objective] 
would create" and illustrate using an example. 
  (b) Article 2.2 refers to "scientific informat ion" which must be taken into account in 
assessing risks.  Article 5.2 of the SPS Agreement, on the other hand, refers to 
"scientific evidence".  Are these different concepts?  Why?  
 
39. As the United States has previously shown, and as the EC does not contest, each measure at 
issue in this dispute was adopted for at least so me reasons covered within the scope of the SPS 
Agreement.  This fact brings the measures within the scope of the SPS Agreement, and – pursuant to 
Article 1.5 of the TBT Agreement
19 – the TBT Agreement does not appl y to the measures at issue.  
Accordingly, the United States respectfully submits that the Panel need not engage in an analysis 
under the TBT Agreement of the measures at issue.    
175. Are measures applied to ensure co-existen ce of biotech crops and non-biotech crops 
covered by Annex A(1) of the SPS Agreement or do they fall, in whole or in part, outside of the 
scope of Annex A(1)?   
40. As an initial matter, the United States notes th at the EC has not shown or even claimed that 
any measures at issue in this dispute are applied so lely to ensure "co-existence" of biotech and non-
biotech crops.  The EC has denied even the existe nce of the general and product-specific moratoria, 
and the EC has conceded that each of the member  State measures was adopted for at least some 
reasons that the EC agrees are covered with in the scope of the SPS Agreement.   
 41. Also, the United States notes that the concep t of "co-existence" is not well-defined.  
Accordingly, the analysis of whether any particul ar "co-existence" measure would fall within the 
scope of the SPS Agreement would turn on th e details of the particular measure.   
 
42. However, the United States would make th e following two points on the application of the 
Annex A definition of an SPS measure to a hypothetical EC measure addressed only to "co-existence."  In the event that the entry, establis hment or spread of a biotech crop created a risk of 
damage to other crops (be they other biotech or non-biotech crops) – by, for example, reducing the 
quality of such other crops – such risks would be covered by either Annex A(1)(a) (covering risks to 
plant life or health) or A(1)(d) (covering other damage within the territory of a Member).  It should be 
noted that the United States is not aware of any evid ence that the entry, establishment, or spread of a 
biotech crop poses the risk of causing such damage.  43. The United States has serious concerns, however , with the notion that merely mixing biotech 
crops with non-biotech crops could amount to a "risk to plant life or health" or to "other damage"  – 
either as a matter of fact, or for purposes of applyi ng Annex A(1) of the SPS Agreement.  Every time 
any new crop variety is introduced into a Member, there are possibilities that the new varieties will 
mix with existing varieties by mechanisms such as  cross-pollination, delaye d germination of the new 
seeds in fields subsequently used for existing va rieties, and mixing in handling and transportation 
facilities.  The United States understands that such mixing normally would not cause "damage" to 
                                                     
 
19 "The provisions of this Agreement do not apply to sanitary and phytosanitary measures as defined in 
Annex A of the Agreement on the Application of Sanitary  and Phytosanitary Measures ."  TBT Agreement, art. 
1.5.    WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-37 
  
  either the new varieties or to the existing varie ties.  The United States would need to evaluate 
carefully any EC argument to the contrary.    For Argentina, the United States and the European Communities
: 
 176. With reference to Austria's safeguard meas ure on Bt-176 maize, please comment on the 
reference in exhibit EC-158 att. 7 to insuffi cient labelling requirements laid down in the 
Commission Decision relating to the relevant produc t.  In particular, what is the basis for the 
concern expressed about insufficient labelling (e.g ., food safety, consumer information, etc.), 
and how does the labelling issue affect the analys is of whether the Austrian safeguard measure 
falls within the scope of the SPS Agreement and/or the TBT Agreement? 
 
44. The Austrian reference to insufficien t labeling requirements is unclear.  Since 
Regulation 258/97 already included a labeling requirement for biotech foods,
20 Austria's concern is 
particularly puzzling.    45. Based on Austria's statement in the cover not e, Austria's rationale for labeling may relate 
solely to the provision of information about the method used to produce BT-176 maize, and may not have any purported rationale based in food sa fety.  On the other hand, the accompanying 
memorandum also refers to a concern that biotech co rn seed will be bred, and that subsequent progeny 
will not be labeled, even though they cont ain antibiotic resistance marker genes.
21  To the extent this 
was intended to express a concern that the products should be labeled to communicate a potential risk 
from the presence of the antibio tic marker, the concern would fall within the scope of the SPS 
Agreement–either pursuant to subparagraph 1(a) or  (c), depending on the precise nature of the 
concern.   
 46. But ultimately, the reference to concerns re garding the adequacy of labeling does not affect 
the conclusion that Austria's safeguard measure fa lls within the scope of the SPS agreement.  As 
outlined in the accompanying eight-page memorandum, the Austrian safeguard measure was adopted 
to address concerns relating to human and animal  health risks arising from the presence of the 
antibiotic resistance marker gene in the plant, a nd concerns relating to the development of insect 
resistance to the Bt toxin.  As previously discussed, these
 concerns fall within the scope of the SPS 
Agreement–under Annex 1(a) or (b) and under subparagraph (c). 
 
For the United States and the European Communities : 
 
177. At para. 336 of Canada's first writte n submission and paras. 570 and 544-545 of 
Argentina's first written submission, the allegation is made that certain member State safeguard measures are inconsistent with Article 2.1 of  the TBT Agreement because imported biotech 
products subject to the safeguard measures ar e treated less favourably than like domestic 
non-biotech product varieties which may be sold freely in the relevant member States.  Do the 
United States and the European Communities sh are the interpretation of the concept of less 
favourable treatment underlying Argentina's and Ca nada's claims?  In answering this question, 
please discuss the relevance of para. 100 of the Appellate Body report on EC - Asbestos.  If it is relevant, could the United States and the Euro pean Communities (a) indicate whether they 
agree with the interpretation offered at para. 100, and (b) explain in detail how this 
interpretation could be applied in practice?  
                                                     
 
20 Regulation 258/97, Article 8(d). 
21 EC Exhibit 158, att. 7, p. 8. WT/DS291/R/Add.4 
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Page F-38 
  
  47. The United States respectfully refers the Pa nel to the US response to Question 174 above. 
 
For all complaining parties
: 
 
178. Please indicate whether the following allege d effects of biotech products fall within any 
of the subparagraphs of Annex A(1) of the SPS Agreement:   (a) Environmental components of biodiversi ty "outside human, animal or plant life 
or health, such as the ecological comple xes referred to in the Convention on 
Biodiversity" (EC rebuttal, para. 266). 
 
48. It is unclear what effects the above phrase would encompass that would be relevant to the 
products at issue in this dispute.  A biotech pl ant can only damage biodiversity or the ecological 
balance of an area through its ability to adversely aff ect, directly or indirectly, the wild flora or fauna 
of the area.  And as the United States has previously explained, such effects are generally covered by 
paragraph 1(a), as risks to animal or plant life or  health "arising from the entry, establishment, or 
spread of pests."    49. To the extent this phrase is intended to a ddress the health of the entire web of life in a 
particular environment--such as the ecological rela tionship among plants and animals, apart from the 
life or health of individual plants and animals--thi s ultimately does relate to life and health of the 
members of the individual species within that web, su ch that a particular species or subtype within a 
species in a particular environment would not survive.    
50. Moreover, the pertinent question is not whet her the SPS agreement covers every conceivable 
environmental risk, but whether the risks that the EC has raised with respect to the products at issue in 
this dispute, either in whole or in part, fall w ithin the scope of the SPS Agreement.  And as the United 
States has previously explained, the text of Anne x A clearly encompasses the full range of adverse 
environmental effects that a biotech plant might present.   
51. Any damage that a biotech plant might cause to biodiversity or the ecological balance of an 
area would typically occur due to alterations in th e invasiveness or persistence of a certain plant 
species, thereby causing changes in the relative abundances of different plant species that may 
secondarily have a negative impact on animal life.  Such changes, should they occur, would be caused 
by the new plant species (i.e., the biotech plant), or  its hybrid progeny, establishing or spreading into 
new areas and outcompeting and displacing wild flor a thereby potentially altering the availability of 
resources such as food and shelter used by wild fauna .  Further, to the exte nt the issue relates to 
concerns regarding direct or indirect effects on non-target organisms, the measure would generally 
fall within the scope of paragraph 1(a).   
 
 (b) "A predator insect eating another insect because it is itself growing better on a 
diet of Bt maize" (EC rebuttal, para. 266). 
 
52. This hypothetical effect is simply a speci fic example of a possible indirect effect of a Bt crop.  
To the extent the crop is either directly or indir ectly responsible for an adverse ecological effect, it 
would fall within the definition of a pest.  Measu res taken to address risks arising from pests fall 
squarely within Annex A.   
 
 (c) Human health risks arising from occupational exposure to a substance in a 
biotech product that is a toxin for insects (e.g., the Bt toxin) as opposed to risks arising from the consumption of the biotech product  (EC rebuttal, para. 316).   WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-39 
  
  (The United States may elaborate on its response to Panel Question 73 or 
comment on the European Communities' response).   
 53. As the United States originally noted in its response to Panel Question 73, given that footnote 
4 clearly identifies pesticide residues as contaminants , such a measure would fall within the scope of 
paragraph A(1)(b).  In this regard, it should be noted  that paragraph A(1)(b) is not limited to the risks 
from the "consumption" of contaminants in foodstuffs.    
54. In addition, as the United States has noted  above in response to these questions, measures 
taken to address risks from occupational or residentia l exposure to the biotech plants would generally 
fall within paragraph 1(c), as measures "to protect human life or health...from risks arising from...the 
establishment or spread of pests." 
 
179. Please comment on the European Communi ties' statement that "for the purposes 
specifically of proving a 'moratorium' that ap plies across the board,  it does not suffice to 
address only a limited selection of product applications" (EC rebuttal, footnote 212). 
 
55. The EC's argument is without merit,  and based on two false premises.   
 
56. The first false premise is that the complain ants have defined the general moratorium as a 
decision to suspend all processing of all applications, regardless
 of where those applications stand in 
the EC's complex approval process.  However, as the complainants have explained repeatedly, the 
general moratorium was a political decision to prevent any products from reaching the final  stage of 
approval.  Thus, nothing in the theory of the US case requires an  examination of each and every delay 
for each and every product.  Moreover, the fact that some applications made some progress in the 
EC's complex approval procedures is entirely consistent with the ad option of a general moratorium on 
final approvals.  57. The second false premise is that the complain ants "address only a limited selection of product 
applications."  This is untrue:  the United States has shown that no
 biotech product application under 
consideration in the period October 1998 to A ugust 2003 completed the EC's community-level 
approval procedures.22  (Indeed, the EC does not even contest this fundamental fact.)  Because the 
complainants assert that the general moratorium wa s a decision not to allow any product to reach the 
final stage of the approval process, a showing that indeed no product  reached a final decision is 
precisely  the evidence the complainants  needed to support complainants' contention that the EC 
adopted a general moratorium.  
 
For Canada and the United States : 
 182. Could Canada and the United States provide  examples of why and how allergens in food 
can be said to "destroy[] life or injure[] heal th" (US rebuttal, attachment II, para. 27)or 
"destroy[] life or impair[] seriously the functions of organs or tissues" (Canada's supplementary 
rebuttal, para. 51)? 
 
58. An allergen present in food can cause a variety of symptoms in individuals allergic to that 
allergen.  Some examples of food  allergic reactions include angioe dema (swelling and redness of the 
skin), urticaria (itchy hives), allergic rhinitis (runny nose), asthma, and anaphylaxis (a sudden and 
                                                     
 
22 First US Submission, Part III.C.1.   WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
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  severe reaction characterized by a sudden drop in  blood pressure and breathing difficulties that may 
be fatal).
23 
 For the United States
: 
 191. In relation to antibiotic marker gene s, please answer the following questions: 
  (a) With reference to para. 22 of atta chment II of the US rebuttal and Codex 
standard 192, (i) what is the "technological purpose" for which antibiotic 
marker genes are added to food and (ii) in what way does the antibiotic marker gene become a "component" or "otherwise affect the characteristics" of the food to which it is added? 
 59. (Question 191(a)(i)):  Antibiotic resistance marker genes are used in the development of 
biotech food crops. They aid the developer in isolatin g and amplifying the gene of interest, so that the 
gene of interest can be introduced into the plant.  In some cases, it may also be used to isolate plant 
cells that have incorporated the newly introduced gene  of interest. Those plant cells are then used to 
generate the bioengineered plant.  Thus, the t echnological purpose of antibiotic resistance marker 
genes is to aid in the manufacture of the food from the biotech plant.  
60. (Question 191(a)(ii)):  The marker gene becomes a part of the DNA of the plant, and of food 
from the plant.  Thus, it is a component of the food from the plant, the addition of which to food for a 
technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or ho lding of such food results, or may be reasonably expected to result 
(directly or indirectly), in it or its by-products  becoming a component or otherwise affecting the 
characteristics of such foods. 
 
 (b) Please comment on the European Comm unities' assertion that "there is concern 
about the development of antibiotic resistance in connection with 'plants' as such" (EC rebuttal, para. 64) and on whether a measure applied to address this 
concern would fall within the scope of Annex A(1). 
 
61. As noted in answer to 191(a)(i) above, an antib iotic resistance marker gene can be considered 
an additive in foods and feedstuffs, under Annex A(1)(b), and as such, measures applied to address 
risks in foods and feedstuffs from such marker genes is covered under Annex A(1).  Whether the 
European Communities believes that  antibiotic resistance marker genes pose additional risks in 
"plants as such," and whether those risks are or are not covered by the SPS Agreement, in no way 
alters the fact that risks posed by antibiotic resi stance marker genes include risks covered by the SPS 
Agreement.    62. However, we would note that the main (if not onl y) risk that can be posed by "the persistence 
of plant-derived DNA in the environment during crop cultivation and harvesting, and in soil residues," 
(EC rebuttal, para. 64) such that there could be "concern about the development of antibiotic 
resistance in connection with "plants" as such" (EC rebuttal, para. 64) is that resistance will pass to 
microbial pathogens that would ot herwise be treatable by the antibiotic at issue if the pathogens 
should infect and cause disease in humans or animals.  As noted by the food safety expert to the panel, 
there is no evidence that such transf er occurs at a biologically significant rate so as to pose a real risk 
                                                     
 
23 Additional information on food allergy and its impacts on human health can be found in HA 
Sampson. Food allergy Part 1: Immunopathogenesis and Clinical Disorders, J Allergy Clin Immunol 1999; 
103:717-28, attached to these responses as Exhibit US-149.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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  to life or health of plants or animals.  However, whatever risk is posed would be posed similarly from 
food on the plant and from parts of the plant that are not used as food.  We would further note that animals eat almost all parts of the crops at issue in this dispute. Therefore, there is little real 
distinction for the purposes of this discussion be tween "plants as such" and "food from plants." 
 
192. With reference to paras. 16 and 17 of th e US supplementary rebuttal, please clarify 
whether a measure applied to protect against ri sks to wild fauna from increased use of the 
herbicide associated with a biotech crop or another herbicide, due to the development of 
herbicide resistance, falls within the scope of Annex A(1) of the SPS Agreement.  If so, please 
indicate the relevant subparagraph.  
 
63. A measure applied to protect against risks to wild fauna from increased use of an herbicide in 
the circumstances described above would fall within  the scope of Annex A( 1), subparagraph (a)–a 
measure to protect "animal ... life or health ... fro m risks arising from the en try, establishment, or 
spread of pests."  64. In the circumstances described in paragraphs 16 and 17 of the US rebuttal, the pest against 
which the measure was directed would be the herbicid e resistant crop.  As previously explained, the 
phrase, "arising from" does not require that the risk be direct or immediate. The critical question is 
whether the risk results from the presence of the organism, and in the scenarios described in 
paragraphs 16 and 17, the risks "arise from" the organism in that it is the presence of the organism that triggers the necessary sequence of events. Here, th e herbicide resistant crop would ultimately be 
responsible for any increased potential for risks to an imal life or health that resulted from either the 
increased use of an herbicide, or the applica tion of a more toxic alternative, because the 
herbicide-resistant crop would have been responsible for the need to  apply the additional herbicide. 
 
193. With reference to paras. 62 and 63 of the US supplementary rebu ttal, did the United 
States submit evidence that the UK supported th e alleged moratorium at the time it completed 
its initial assessment of GA21?  If not, what is th e basis for the assertion that the alleged inaction 
by the UK was "politically motivated"? 
 
194. With reference to paras. 52 and 59, 102-103, 159, 168 and 195-196 of the US supplementary rebuttal, did the United States su bmit evidence that the Netherlands supported 
the alleged moratorium at the time at i ssue in the aforementioned paragraphs?  
 
195. With reference to paras. 72, 95, 150-151 an d 190 of the US supplementary rebuttal, did 
the United States submit evidence that Spain suppo rted the alleged moratorium at the time at 
issue in the aforementioned paragraphs?    
65. (Combined response to questions 193, 194, and 195) :  In its prior submissions, the United 
States has submitted overwhelming evidence of the ex istence of the de facto moratorium.  Such 
evidence consisted of, inter
 alia, statements from EC member States and EC officials that openly 
acknowledged a general moratorium on the approval of biotech products.  And, as the United States 
has detailed in its prior answer to Panel's ques tion 151, the EC's own evidence provide numerous 
additional examples of EC member States confirming the existence of the moratorium.  That evidence includes numerous examples of countries other th an the above five "moratorium countries" 
acknowledging the moratorium and even stating thei r support for the moratorium.  For example, EC 
Exhibit 92, attachment 24_trans, provides:  
In the German Government's view, th e effective moratorium on approval for 
genetically modified organisms will be lif ted by the Commission once the regulations WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-42 
  
  on the approval and traceability/labelling of genetically modified foods and feeding 
stuffs have entered into force. 
66. Spain likewise recognized the moratorium.  For example, in EC Exhibit 73, attachment 12, 
the Spanish authority stated: "Sin embargo, en  el año 1999 se votaron ambos expedientes y no se 
alcanzó la mayoría cualificada, quedando pendient es y paralizados durante la moratoria de facto." 
 67. Such statements against interest are particular ly compelling evidence.  In this regard, at least 
Austria, France, Belgium, Germany, Spain, Italy, Luxembourg, Denmark, Sweden, and the 
Commission have all made statements or made reference to the fact that a moratorium existed.  As the 
United States said in its oral statement at the second s ubstantive meeting of the panel, it is only in the 
context of this case that the EC denies the existence of a moratorium.    68. In its supplementary rebuttal, the United St ates has complemented th is core evidence with 
further examples, culled from the information s ubmitted by the EC during the course of this 
proceeding, of various actions by member States that  resulted in undue delay, were wholly consistent 
with the moratorium, and reflected the impact of the moratorium.  When assessed within the context 
of all the prior evidence Complainants have  already provided, these numerous examples of 
unexplained delays and gaps across the spectrum of biotech applications, and of unjustified requests 
for additional data, serve to further confirm the mo ratorium's existence and to confirm that biotech 
applications were unduly delayed.  As the United St ates stated in its supplementary rebuttal, once the 
EC had made a political-level decision to adopt a moratorium on biotech approvals, EC and member 
State regulators understandably were in no hurry to process pending biotech applications.    
 69. Thus, for example, in paragraphs 62 and 63 of  its supplementary rebuttal, the United States 
pointed out a 7 month delay by the UK competent authority in forwarding the application on to the 
Commission after the UK authority had reached a pos itive safety assessment on the product at issue.  
Many EC member States, including the UK, are di vided internally on their position related to 
biotechnology.  On the one hand, elements of  the UK government have been supportive of 
agricultural biotechnology.  On the other hand, cer tain political figures are not supportive.  In 
particular, the UK Environment Minister at the ti me of the delay in question was Michael Meacher, 
and Mr. Meacher was and is strongly opposed to the introduction of genetically modified foods in the 
UK.
24  Thus, such examples show that countries ot her than the "moratorium countries" allowed the 
moratorium to continue, recognized its political rea lity, and that this reality at times affected the 
manner in which they conducted thei r assessments of biotech applications. 
 
196. With reference to para. 38 of the European  Communities' second oral statement, does 
the United States agree that the assessment of a hybrid cannot be concluded as long as the 
assessment of one of its parental lines is still op en, such that a competent authority would be 
justified in awaiting the outcome of the missing assessment?  
 
70. No, the United States does not agree.25  The general approach to assessing the safety of a new 
plant variety developed through biotechnology is to perform a molecular characterization, a safety 
                                                      
24 See attached Exhibit US-150 (a rticle by Mr. Meacher comparing his anti-biotech stance with the 
more pro-biotech stance of "the Pr ime Minister, ministers on the rele vant cabinet sub-committee, Defra 
officials, and the Go vernment's chief scientific advisers.") 
25 The United States also notes that the above assertio n by the EC appears to be inconsistent with the 
EC's positions as stated during the meeting with the expert s.  In particular, at the experts' meeting, the United 
States understood the EC to be asserting that a de novo safety evaluation of hybrids was necessary even if the 
parental lines had been favorably assessed.    WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-43 
  
  assessment of any newly expressed substances, and compositional analysis.  The compositional 
analysis consists of a comparison of the levels of key compositional components (e.g., key nutrients, 
key anti-nutrients, and key toxicants) of the new va riety with those of conve ntional varieties of the 
same crop. One way that is often done is to compar e the composition of the new variety with that of 
its parents.  However, if the safety of one or both of the parental varieties has not been established for 
use as a comparator, one might use other closely related lines.  For example, para. 44 of the Codex Plant Guideline (CAC/GL 45-2003) states: "The comp arator(s) used in this assessment should ideally 
be the near isogenic parental line.  In practice, th is may not be feasible at all times, in which case a 
line as close as possible should be chosen." 
 
197. For the purposes of demonstrating the existe nce of the European Communities' alleged 
failure to consider specific biotech products for approval ("product-specific moratoria"), is the 
United States seeking to rely on the evidence and argument adduced in support of the existence 
of a general moratorium?  In other words, is th e United States arguing that the existence of a 
general moratorium necessarily implies the exis tence of product-specific moratoria?  Please 
clarify.  
 
71. The United States submits that the EC has adopted a general moratorium on biotech approvals, under which no biotech application was al lowed to reach final decision up through August 
2003 (the time of the establishment of the Panel) .  Since the general moratorium applied to all 
products , a necessary corollary is that the EC also a dopted product-specific moratoria on each of the 
product applications covered in the US panel request.26   Thus, the evidence and arguments that the 
United States adduced in support of the existence of a general moratori um also establish the existence 
of the product-specific moratoria,  and that the EC did not under take and complete its approval 
procedures for each individual product without "undue delay."   
 72. In addition, the evidence and arguments a dduced by the United States include examples of 
unwarranted delays in the processi ng of particular applications,
27 as well as delays specifically arising 
from scientific questions posed by member States that were not required for completion of the EC's 
approval procedures.28  Such evidence and arguments, like the non-product-specific evidence and 
arguments adduced by the United States, serves tw o purposes.  First, the showing of particular, 
product-specific delays is further confirmation of th e existence of the general moratorium, and rebuts 
the EC's contention that all applications subject  to the moratorium were processed normally and 
without undue delays.  Second, the showing of pa rticular, product-specific delays provides further 
confirmation of the existence of the product-specifi c moratoria, and establishes specific instances of 
"undue delay" for those particular products.   
                                                      
26 As the United States noted previously, the United States is not requesting findings on the 
product-specific moratoria for appli cations that were withdrawn prior  to the establishment of the Panel in 
August 2003.   
27 See, e.g ., US Rebuttal Submission, Part V.A; US Supplementary Rebuttal, Part III. 
28 See US Supplementary Rebuttal, Part IV. WT/DS291/R/Add.4 
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Page F-44 
  
  ANNEX F-3 
 
COMMENTS BY THE UNITED STATES ON THE REPLIES 
OF THE EUROPEAN COMMUNITIES TO QUESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
18 MARCH 2005 
 
 
1. The United States appreciates this opportuni ty to comment on the EC's responses to the 
questions posed by the Panel in connection with th e second substantive meeting.  Many of the points 
raised by the EC have already been addressed by the United States in prior oral and written 
submissions, or are not relevant to the resolution of  this dispute.  In the responses below, the United 
States will focus on new points raised by the EC that are pertinent to the resolution of this dispute and 
which have not been addressed in prior US submissions.   
For all parties
: 
 119. With reference to exhibit US-123 (reproduced  at para. 9 of attachment II of the US 
rebuttal), do the references in ISPM 11 to "indirectly affect plants … by other processes such as 
competition" (page 34) and "significant reduction, displacement, or elimination of other plant 
species" (page 19) support the view that the term "injurious" in the IPPC definition of "pest" ("any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants or plant products") should be given a broad interpretation?    
2. Generally, the EC responses that concern the scope of the SPS agreement present few issues 
that have not already been fully addressed in prev ious filings.  Of these, the United States will focus 
primarily on two overarching points, before addressing some of the individual arguments.  
3. First, the EC acknowledges that many of the ri sks alleged to be relevant to this dispute fall 
within the SPS agreement.
1  Consequently, the Panel does not need to engage in a sweeping 
examination of whether every risk the EC has raised  falls within the scope of the SPS Agreement.  
The SPS Agreement explicitly provides that "any me asure" applied to protect against one of the 
enumerated risks falls within its scope.  The Ag reement does not require that an SPS measure be 
exclusively applied to protect against enumerated risks.  
4. The second point relates to the EC's repeated  attempts to confuse the question before the 
Panel by arguing that "biodiversity and environmen tal issues do not fall within the scope of the SPS 
agreement."2  This argument attempts to create an ar tificial distinction between effects on the 
environment and biodiversity in the abstract, and the specific effects on biodiversity and the 
environment that the EC has alleged are relevant to the products at issue in this dispute.    
5. While it is clear that, as a general matter, th e text of the Agreement does not support the EC's 
categorical exclusions of "risks to biodiversity and the environment," the Panel need not reach the 
question of whether the SPS Agreement covers all envi ronmental risks to resolve this dispute.  Even 
assuming some need to examine whether individual  risks fall within the scope of Annex A, the 
pertinent question is whether the risks the EC has id entified as relevant to th is dispute, based on the 
characteristics of the products at issue, fall with in the risks in Annex A,  not whether the SPS 
Agreement generally covers every c onceivable environmental risk.  T hus, for example, the Panel need 
                                                      
1 EC Answers of March 11, 2005, paras. 1-52. 
2 EC Answers of March 7, 2005, para. 8.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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  not find that all risks to non-target organism s are necessarily covered under the SPS Agreement in 
order to conclude that any risks to soil microorgani sms from a biotech plant falls within the ordinary 
meaning of a risk to animal or plant life or  health from a pest, pursuant to Annex A.1(a). 
6. Accordingly, the Panel should only consider th e facts presented in this dispute,  not the 
hypothetical facts the EC has presented.  As the Un ited States has previously explained, the specific 
environmental effects that the EC has raised fall within the scope of Annex A.
3  And as discussed 
more specifically below, none of the EC's responses effectively rebuts this conclusion. 
7. A central flaw in the EC categorization of risk s is the EC's inconsistent and illogical treatment 
of IPPC and Codex definitions.  As the United Stat es has explained, the Panel is to interpret the 
Agreement "in accordance with the ordinary meaning to  be given to the terms of the treaty in their 
context and in the light of its object and purpose."4 The United States has also explained that 
definitions in Codex and IPPC doc uments may be used as additional factual evidence of the ordinary 
meaning of terms contained in Annex A of the SPS Agreement, but that IPPC and Codex definitions 
cannot control  the interpretation of the Agreement.  Thus, the point is not that environmental issues 
fall within the SPS Agreement because  ISPM 11 addresses environmental risks.  Rather, the point is 
that the ordinary meaning of the SPS Agreement encompasses the specific risks that the EC has 
alleged to be relevant–for example, because the term "pest" encompasses organisms that pose both 
direct and indirect risks.  Consequently, for example, measures adopted to address risks to animal or plant health arising from changes in the biogeochemical  cycles, as a result of the biotech plant, would 
fall squarely within Annex A.1(a). 
8. With respect to the EC's use of IPPC and Codex definitions, however, no logical, consistent 
underlying principle can be discerned from the EC 's responses.  For example, the responses 
simultaneously argue that the Panel is, in some cases, bound
 by a subset of the IPPC definition:  "If a 
GMO crop adversely affects the biogeochemical cycle, for example, it is simply not behaving as a 
"pest" within the meaning of the IPPC–and in this r espect the European Commun ities also refers to its 
answer to question 119.  These matters therefor e fall outside the scope of the SPS Agreement."5  Yet 
in other cases, the EC argues it would be "legal error to simply transpose [the IPPC] definition [of a pest] into Annex A.1 of the SPS Agreement."
6   
9. In yet other responses, the EC argues that the Panel may consider "parts  of [Codex and IPPC 
standards as] relevant context."7  However, the sole basis the EC articulates for how the Panel is to 
determine the "parts" that provide relevant context appears to be whether the EC has any "particular 
difficulty" with the standards.8  
10. In its most recent submission, the EC raises several objections to consideration of ISPM 11, 
attempting to discount the fact that the IPPC's inte rpretation of the term "pest" contradicts the EC's 
attempts to rely on the IPPC definition of a pest to support its categorical exclusions.  These include 
the arguments that ISPM 11 (rev. 2) should be rejected because (1) it  post-dates the Panel's 
establishment, and (2) that the envi ronmental risks described in ISPM 11 were  merely "designed to 
reflect the Biosafety Protocol."  The EC is wrong on both counts. 
                                                      
3 US Rebuttal Submission, Attachment II; Responses of  the United States to the Questions by the Panel 
Posed During and After the Second Substantive Meeting with  the Parties; Responses of the United States to the 
Additional Questions Posed by the Panel on March 4, 2005. 
4 Vienna Convention on the Law of Treaties, Article 31(1). 
5 EC Answers of March 7, 2005, para. 57. 
6 EC Answers of March 7, 2005, para. 5. 
7 EC Answers of March 7, 2005, para. 91 (emphasis added); see also para. 5. 
8 EC Answers of March 7, 2005, para. 5, 91. WT/DS291/R/Add.4 
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Page F-46 
  
  11. First, with regard to the timing of the IPPC document, the IPPC also articulated the 
interpretation that the term "pest" applies to organism s that have indirect effects on plants in ISPM 11, 
Rev 1
, Pest Risk Analysis for Quarantine Pests In cluding Analysis of Environmental Risk in April 
2003 , prior to the date the Panel was establis hed.  Annex 1 of that document reads: 
"COMMENTS ON THE SCOPE OF THE IPPC IN REGARD TO 
ENVIRONMENTAL RISKS  
"The full range of pests covered by the I PPC extends beyond pests directly affecting 
cultivated plants.  The coverage of the I PPC definition of plant pests includes weeds 
and other species that have indirect effects on plants, and the Convention applies to 
the protection of wild flora.  The scope of the IPPC also extends to organisms which are pests because they: 
– directly affect uncultivated/unmanaged plants  
Introduction of these pests may have few commercial consequences, and therefore 
they have been less likely to be evaluate d, regulated and/or placed under official 
control.  An example of this type of pest is Dutch elm disease ( Ophiostoma novo-
ulmi) 
– indirectly affect plants  
In addition to pests that directly affect host plants, there are those, like most 
weeds/invasive plants, which affect plants primarily by other processes such as 
competition ( e.g., for cultivated plants: Canada thistle ( Cirsium arvense ) [weed of 
agricultural crops], or for uncultivated/ unmanaged plants: purple loosestrife ( Lythrum 
salicaria ) [competitor in natural and semi-natural habitats]).   
– indirectly affect plants through effects on other organisms  
Some pests may primarily affect other organisms, but thereby cause deleterious 
effects on plant species, or plant health in habitats or ecosystems.  Examples include 
parasites of beneficial organisms, such as biological control agents."
9 
12. Similarly, the IPPC document elsewhere makes cl ear that part of the evaluation of whether an 
organism is a quarantine pest includes considerati on of both an organism's direct and indirect 
effects.10  For example, section 2.3.1.1 "Direct pest effects," provides: 
"In the case of the analysis of environmental risks, examples of direct pest effects on 
plants and/or their environmental conseque nces that could be considered include: 
– reduction of keystone plant species – reduction of plant species that are major components of ecosystems (in terms 
or abundance or size) and endangered na tive plant species (including effects 
below species level where there is evid ence of such effects being significant) 
                                                     
 
9 ISPM 11, Rev 1, Pest Risk Analysis for Quarantine Pests Including Analysis of Environmental Risk 
(2003), p. 29 (Ex. US-151).   
10 ISPM 11, Rev 1, Pest Risk Analysis for Quarantine Pests Including Analysis of Environmental Risk 
(2003), pp. 18-20 (Ex. US-151).  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-47 
  
  – significant reduction, displacement or elimination of other plant species 
The estimation of the area potentially endange red should relate to these effects."   
13. The EC also has no basis for its second argument – that  the environmental risks described in 
ISPM 11 were merely "designed to reflect the Biosafety Protocol."  In fact, the earlier, 2003 version 
of ISPM 11 (rev. 1) did not even specifically address biotech organisms.  Accordingly, there is no reason to believe that ISPM 11's inclusion of an  organism's direct and indirect effects on the 
environment related to the adoption of the Protocol.  
120. With reference to Annex A(1)(d) of th e SPS Agreement, please answer the following 
questions: 
 
(a) What is the meaning of the term "other damage"?   
(b) Does the term "other" imply that Annex A(1)(a) through (c) are also 
about "damage"?  If so, does the term "other damage" cover damage sustained 
by plants, animals or humans other than damage to their "life or health"?  
Please provide examples. 
(c) Is "other damage" limited to damage sustained by plants, animals or 
humans?  If not, please provide examples.       
14. In it answer to Question 120, the EC ag ain makes the unsupported – and unsupportable – 
assertion that "environmental damage is not covered by the SPS Agreement."
11  As the United States 
previously explained, the SPS Agreement contains no such exclusion of environmental damage.  To 
the contrary, SPS Agreement specifically provides that  for purposes of the definitions in  Annex A, 
"'animal' includes fish and wild fauna ; [and] 'plant' includes forests and wild flora ."12  
15. In its answer, the EC for the first time cit es to a late 1990 draft text of the SPS Agreement, 
and argues that the changes from th at draft to the final SPS text s upports the EC's view regarding a 
purported exclusion of environmen tal damage.  As an initial matter, the United States notes that 
where, as here, the text of the agreement explicitly  covers damage to wild flora and fauna, there is no 
ambiguity and thus no need to examine negotiating history on whether damage to wild flora and fauna 
is covered within the scope of the SPS Agreement.13  That said, the EC's citation to the negotiating 
history is incomplete and misleading, and in no way supports the EC's contention.   
16. The EC's citation to the late 1990 draft te xt includes no footnotes, document numbers, or 
exhibits.14  However, based on the quotations in the EC submission, the EC is apparently referring to 
"Negotiating Group on Agriculture: Working Group on Sanitary and Phytosanitary Regulations and 
Barriers; Draft Text on Sanitary and Phyt osanitary Measures," MTN.GNG/NG5/WGSP/7 (20 
November 1990).  The cover note to  this document does include the following language quoted by the 
EC: "the brackets in the note to definition 1 an d in definition 4 (Annex A) are all linked to the 
                                                      
11 EC Answers of March 7, 2005, para. 21.   
12 US Rebuttal Submission, Attachment II.   
13 See Vienna Convention on the Law of Treaties, Article 32 ("Recourse may be had to supplementary 
means of interpretation, including the preparatory work of  the treaty and the circumstances of its conclusion, in 
order to confirm the meaning resulting from the application of article 31, or to determine the meaning when the interpretation according to article 31:  (a) leaves the me aning ambiguous or obscure; or (b) leads to a result 
which is manifestly absurd or unreasonable."). 
14 EC Answers of March 7, 2005, para. 22.   WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-48 
  
  question of whether or not this agreement should a pply to measures taken for the protection of animal 
welfare and of the environment, as well as of consumer interests and concerns".   
17. The EC then goes on to assert "The bracketed  text (which included a reference to the 
environment) disappeared in the final text of  the agreement, as we all know. As a result, 
environmental damage per se does not fall under the sc ope of the SPS Agreement."  What the EC fails
 
to explain, however, is precisely what that "bracket ed text" contained.  As a result, and as explained 
below, the EC's assertions are completely baseless. 
18. The "bracketed text" referred to above is actually two  different bracketed phrases.  Both of 
these phrases are contained in the concluding pa ragraph of the Annex A(1) definition of "SPS 
measure" (that is, in the paragr aph following lettered paragraphs a) to d ) – a paragraph which (in its 
final form) describes types  of measures – such as labelling and quarantines – as opposed to describing 
particular types of risks.15  One of the bracketed phrases would have expressly included  animal 
welfare, environment, and consumer interests and concerns.16  The second bracketed phrase would 
have expressly excluded  those issues.17   
19. The final text of the SPS Agreement drops both the proposal for an explicit inclusion and  the 
proposal for an explicit exclusion of environmental and animal welfare concerns.  Thus, contrary to 
the EC's assertions, this change is not the least bit instructive on whether the drafters of the agreement 
intended to include or exclude environmental issues.  On the other hand, this change could support an 
interpretation that the drafters decided to leave the last paragraph of Annex A(1) to describe types of 
measures (such as labelling and quarant ines) and to place the types of covered risks within the lettered 
paragraphs a to d.    
20. Moreover, the EC does not make note of a more  relevant and significant change between the 
late 1990 draft text and the final SPS Agreement.  The late 1990 draft text did not include footnote 4, 
which defines "animal" to include "w ild fauna" and "plant" to include "wild flora."  The fact that these 
clarifications were added to the text means that the issue of environmental damage was in fact 
considered by the drafters, and that the drafters purposely and specifically decided to include damage 
to wild flora and fauna within the scope of the SPS Agreement.  Thus, contrary to the EC's assertions, 
the negotiating history of the SPS Agreement provide s no support for the EC's contention that the SPS 
Agreement was not intended to c over damage to the environment.18   
                                                      
15 That paragraph, in its final form, states "Sanitary or phytosanitary measures include all relevant laws, 
decrees, regulations, requirements and procedures includ ing, inter alia, end product criteria;  processes and 
production methods;  testing, inspection, certification and approval procedures;  qu arantine treatments including 
relevant requirements associated with the transport of an imals or plants, or with the materials necessary for their 
survival during transport;  provisions on relevant statistical methods, sampling procedures and methods of risk assessment;  and packaging and labelling requirements directly related to food safety."   
16 The first bracketed phrase, which followed "packaging and labelling requirements directly related to 
food safety" in the concluding paragraph to Annex A(1), was "[measures for the protection of animal welfare 
and of the environment, as well as of consumer interests and concerns]."  MTN.GNG/NG5/WGSP/7, Annex A 
(20 November 1990).  This phrase would have explicitly included these issues within the scope of an SPS measure.   
17 The second bracketed phrase was in a new sentence at the end of the concluding paragraph to 
Annex A(1): "Requirements concerning quality, compos ition, grading, [consume r preferences, consumer 
information, animal welfare, the environment or ethi cal and moral considerations] are not included in the 
definition of sanitary or phytosanitary measures."  MTN.GNG/NG5/WGSP/7, Annex A (20 November 1990). 
18 The EC also asserts that the "negotiating hist ory of the SPS Agreement supports the European 
Communities view that Annex A.1 must be interpreted st rictly and not in a broad manner."  EC Answers of  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-49 
  
  For the European Communities
: 
 135. In paragraph 52 of the EC Responses to the Questions from the Panel (16 June 2004) 
that "Since the late '80s, the EC institutions are required to provide an explanation of the 
reasons for not following the opinion of the spec ific scientific committee relevant to the matter 
under consideration".  Are these explanations  made public or provided to the notifier 
concerned? 
 21. The United States notes that the EC answer to  this question – "yes" – needs more of an 
elaboration than the EC gave in order not to leave a misimpression.  In the context of this dispute, the 
situation referred to in this question arises when  member States continue to oppose approvals of 
biotech applications after those applications have  received positive assessment s by EC-level scientific 
committees.  As the EC's product histories show , in many cases member States requested more 
information without providing any explanations (public or otherwise) for why that member State did 
not accept the scientific committee's positive assessment.   
22. Perhaps the EC's answer was intended to mean that had
 the EC actually made a final decision 
on a biotech application during the period October 1998 through August 2003 – instead of imposing a 
moratorium on final decisions – then the EC ins titution involved would have had to issue a reasoned 
decision if that decision departed from the view of the EC scientific committee.   
136. In the context of paragraph 195 of the EC  Responses to the Questions from the Panel 
(16 June 2004), does the EC maintain that the appropriate level of protection that might be relevant to a definitive action is different from the ALOP that would be relevant to a provisional 
measure taken in the face of insufficient scientific evidence? 
 23. The United States has two comments on the EC's response to this question.  First, the EC 
answer assumes that EC member States and the EC itself have adopted different levels of protection.  However, there is no basis in the record for this assertion by the EC.  In fact, when the Panel in 
Question 162 asked the EC to elaborate on any suppo sed differences in levels of protection, the EC 
did not provide a specific response, and did not e xplain how the EC member States might have a 
different level of protection than that adopted by th e EC itself.  Instead, the EC asserted only that:    
                                                                                                                                                                    
 
March 7, 2005, para. 20.  The United States does not agree that the negotiating history supports any such view.  
The United States also notes that the EC statement is inconsistent with the EC's own position elsewhere in the 
same submission, where the EC states that: "In shor t, the European Communities does not consider that 
Annex A.1 of the SPS Agreement should be given either a narrow interpretation or a 'broad' interpretation."  EC 
Answers of March 7, 2005, para. 12.  The most instructive factor in interpreting Annex A(1) is of course the text itself.  In this regard, the United States notes that the text uses inclusive  language.  In particular, footnote 4 is 
drafted to make clear that the definitions in the footnote are inclusive and not limiting:  
 
"animal"  includes  fish and wild fauna;  "plant"  includes forests and wild flora;  "pests" include  
weeds;  and "contaminants" include  pesticide and veterinary drug residues and extraneous 
matter. 
 
Also, paragraph (d), covering "other damage", is plainly a catch-all provision, and undermines any EC 
contention that Annex A(1) is to be  construed "strictly" or "narrowly." WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-50 
  
  "It is not possible to describe an 'appropriate level of protection' in  general terms.  It 
is clear from the terms of the above measur es that they seek to secure a high level of 
protection."
19   
24. Second, the EC seems to be stating that th e appropriate level of protection for provisional 
measures may differ from the level of protection fo r other (non-provisional) measures.  The United 
States fails to see any basis in logic or in the te xt of the SPS Agreement for this assertion.  Members 
must select an appropriate level of protection, a nd then must ensure that any measures adopted to 
meet that level "are not more trade-restrictive th an required to achieve their appropriate level of 
sanitary or phytosanitary protection."20  
For all parties : 
 140. With reference to (1) Codex standards 192 and 193, (2) IPPC and (3) ISPM 11: 
 
(a) Are they "rules of international law applicable in the relations between 
the parties  to this dispute " within the meaning of Article 31(3) of the Vienna Convention on the Law of Treaties?   
(b) May they be used as additional factual evidence of the ordinary meaning 
of terms contained in Annex A of the SPS Agreement, as the United States appears to suggest in its rebuttal at para. 6 of attachment II?  (The United States 
is invited to provide elaboration on its statement at para. 6.) 
25. Please see the above US comments in relation to Question 119.   
141. With reference to Annex (B)(1) of th e SPS Agreement, please answer the following 
questions:  
(a) Does the term "sanitary and phytosanitary regulations" cover 
administrative decisions which relate to the operation of approval procedures and which are generally applicable?   
(b) May the phrase "sanitary and phytosanitary regulations which have 
been adopted" be interpreted to enco mpass also sanitary and phytosanitary 
regulations which have been adopted de facto (e.g., generally applicable 
decisions which have been reached info rmally and which are unrecorded)?    
26. The EC's answer to this question – that a measure like the moratorium on biotech approvals 
cannot be "adopted de facto" (as the term "de facto" is used in the question) – is completely without 
merit.  The EC's entire argument is based on th e EC's unsupported assertion that the word "adopted" 
connotes some sort of "formal context."
21  The EC has no basis for this assertion.  The normal 
meanings of the verb "adopt" are to "choose for one's own practice, take up"; or "approve, accept."22  
Nothing in the normal usage of the verb "adopt" entails a "formal context."  Thus, the EC has presented no reason why a measure like the morato rium – which was adopted and applied to all 
                                                     
 
19 EC Answers of March 7, 2005, para. 120.   
20 SPS Agreement, para. 5.6.   
21 EC Answers of March 7, 2005, para. 95.   
22 New Shorter Oxford English Dictionary (1993), p. 29.    WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-51 
  
  pending biotech product applications – cannot be "adopted," as that phrase is used in Annex B of the 
SPS Agreement.   
27. The United States also makes note of the EC's  statement that "the European Communities can 
only repeat that it is not possible, in the Community ju risdiction, to adopt an act with legal effects that 
is 'unrecorded'."
23  This assertion, however, is directly contradicted by the EC's own claim that it 
adopted an "interim approach."  As the EC d escribed it, under that approach the EC would not 
approve products unless those products met standard s of new, yet to be enacted legislation (and 
changing approval standards is certainly an act with a "legal effect").  Yet, this approach apparently 
went "unrecorded" – it certainly was never published in the EC's official journal nor notified to the 
WTO.   
144. The Panel notes that a number of products containing the same transgenic modifications 
as products at issue in this dispute were prev iously approved by the European Communities 
prior to July 1998 (eg, swede rape tolerant to glufosinate ammonium (MS1, RF1) and (MS1, 
RF2);  swede rape tolerant to glufosinate ammonium (Topas 19/2);  maize tolerant to 
glufosinate ammonium (T25);  maize expressing  the Bt cry1A(b) gene (MON 810);  maize 
tolerant to glufosinate ammonium and expressi ng the Bt cry1A(b) gene (Bt-11);  soybean 
tolerant to glyphosate;  chicory tolerant to glufosinate ammonium;  maize Roundup Ready 
NK603).  To what extent and how were the prev ious assessments of potential risks to human, 
animal or plant health and/or the environment associated with these transgenic modifications 
taken into consideration in the evaluation of po tential risks arising from the products at issue 
before the Panel?  
28. The United States notes that it does not agree with the EC's claim that "as explained in 
previous EC submissions and confirmed by Dr. Nutt i at the hearing, the understanding of the concept 
of substantial equivalence has greatly evolved since 1998."
24  The EC has not established, as it 
implies, that  "substantial equiva lence [was] recognised to constitute  a risk assessment in itself."  
Likewise, the United States did not understand Dr. Nu tti to be supportive of this claim, nor did the 
United States understand that Dr. Nutti agreed w ith the EC's more general claim that "the 
understanding of the concept of substantial equivalence has greatly evolved since 1998." 
154. At paras. 27 and 30 of the European Communities' second oral statement, reference is 
made to concerns regarding "regulatory requirements outside the scope of this dispute 
(traceability and labelling)".  Is it the European  Communities' view that any delays that may 
have occurred as a result of member States invok ing the need for legislation on traceability, 
labelling or coexistence were justified?  Why?   
 29. The EC's response to this question is illogical, and lacking in any legal or factual basis.  The 
EC's entire response is as follows:  
"When referring to 'regulatory requireme nts outside the scope of this dispute 
(traceability and labelling)' the European Co mmunities was referring to the fact that 
the Complainants have not claimed that the requirements relating to traceability and 
labelling set out in its GMO legislation were unjustified. Accordingly, delays 
                                                     
 
23 EC Answers of March 7, 2005, para. 97.   
24 EC Answers of March 7, 2005, para. 103.   WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-52 
  
  resulting from the need to satisfy these requirements cannot be considered to be 
"undue" or contrary to the WTO Agreements."
25   
30. First, the EC is correct that the United Stat es in this dispute has not taken issue with the 
specific requirements contained in the traceability and labelling legislation.  However, the EC has not 
explained what the relevance of the particular requi rements of such legislation might be to the present 
dispute.  The traceability and labelling legislati on did not even enter into force until April 2004 – 
which is eight months after  the terms of reference of this Panel were established.  Moreover, the EC 
has denied  that it delayed any final decisions on product approvals until such legislation entered into 
force.   
 31. Second, to the extent that the EC is arguing that it would be entitled to adopt a moratorium 
until traceability and labelling legislation entered into  force in April 2004, the United States submits 
that such a delay would indeed be "undue" under Annex C of the SPS Agreement.  As explained in 
the US answer to Question 173 , a Member's supposedly inade quate legislation cannot excuse
 a 
member from its SPS obligations, including the ob ligation under Annex C(1)(A) to undertake and 
complete approval procedures without "undue delay."    
158. In paragraph 313 of the EC Responses to the Questions from the Panel (16 June 2004) 
the European Communities states that the absence of final consent from the lead CA does not 
mean that the applicant is not entitled to pla ce the product on the market.  Has the product at 
issue (canola/oilseed rape MS1/RF1 and MS1/RF2) been sold in all of the European Community, including in France, and if not, why not? 
 
32. It is remarkable that the EC asserts that canola/oilseed rape MS1/RF1 and MS1/RF2 have 
been approved for sale in the EC.  As the complain ants have explained, the EC deliberate release 
legislation clearly provides that the lead competent authority must take the final step of placing the 
product on the market.
26   The United States would also note that the Commission's own official status 
document on biotech approvals shows that France has failed to take the final step of placing the 
product on the market.27   
 
                                                      
25 EC Answers of March 7, 2005, para. 110.   
26 Directive 90/220, art 13.4 "(Wh ere the Commission has taken a favourable decision, the competent 
authority shall give consent in writing  to the notification so that the pr oduct shall be placed on the market  . . . .); 
Id. art. 13.5 (Once a product has received a written consent, it ma y be used without further notification 
throughout the Community ").  Directive 2001/18 includes  comparable provisions.  2001/18, art. 18.2 ("Where a 
favourable decision has been taken, the competent authority which prepared the report shall give consent in 
writing to the placing on the market . . . ."); Id. art. 19.1 ("only if a written consent has been given for placing on 
the market of a GMO as or in a product may that product be used without further notification throughout the 
Community ...").   
27 Questions and Answers on the Regulation of GMOs in the EU, MEMO/02/160 Rev., Brussels 4 
March 2003 (Ex. US-107), at page 14 (MS1/RF1 "not fi nally approved by F"); page 15 (MS1/RF2 "not finally 
approved by F").    WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-53 
  
  160. What is the current status of Italy's safeguard measures on maize Bt11, MON 809, 
MON 810 and T-25?  If these products are now permitted to be marketed in Italy, as of when was this marketing permitted? 
 
33. The United States does not understand the EC's contention that this safeguard measure adopted by Italy was repealed in July 2004.
28  To the contrary, the United States understands that the 
safeguard remained in force at least through Nove mber 2004, because at that time the measure was 
subject to a ruling by the Regional Administrative Tribunal.29  The United States further notes that 
although the Tribunal ordered that the safeguard measure be annulled, the United States has no 
information indicating that the Government of Ital y has actually implemented the tribunal's order by 
annulling the safeguard.   34. In any event, however, the central fact remain s that the Italian safeguard was in force at the 
time the Panel was established in August 2003.  The United States, as explained previously, submits 
that the Panel should make findings on the EC measu res as of August 2003.  The DSU contemplates 
separate proceedings for determining whether a meas ure found to be inconsistent with a Member's 
WTO obligations remains in existence or has been made consistent with a covered agreement.   
 For Argentina, European Communities and the United States
: 
 
169. With respect to the safeguard measures  invoked for Maize Bt-176, please list the 
scientific evidence on which the concerns raised by Austria and Germany on potential adverse 
effects on non-target organisms were based (August 2003). 
 35. The United States has three comments on the EC's response to Question 169.   
 36. First
, the EC response states that the EC "again summarises" the reasons given by Austria and 
Germany for adopting these safeguards.  The EC's Marc h 7, 2005 answer to question 169, however, is 
the first  time in this dispute that the EC has described in any detail the purported rationales for any of 
the member State safeguard measures.   
 
37. Second , the EC does not assert that any of the ratio nales put forth by Austria or Germany are 
in fact correct,30 nor that such rationales provide the basi s for a product ban (as would be required for 
such a measure under the obligations set out in th e SPS Agreement).  The reluctance of the EC to 
make such claims is understandable, in light of th e fact that the Commission itself disagrees with the 
member States' decisions to adopt safeguards.  Fu rthermore, the EC does not dispute that the EC's 
own scientific committees examined and rejected a ll of the rationales put forward by the member 
States.  The EC also does not discuss whether, or  how, the analysis of the EC's own scientific 
committees was in any way inadequate.    38. Third
, the EC does not address whether the member States sought "to obtain the additional 
information necessary for a more objective assessm ent of risk" or "review[ed] the sanitary or 
                                                      
28 The EC's supporting exhibit (EC-166) contains a copy of a letter from the Government of Italy to the 
Commission, but the exhibit does not  include an official document from the Italian health ministry repealing the 
safeguard measure. 
29 The ruling, which  appears to be included in the Ex. EC-166, resulted from a legal proceeding 
brought by seed companies and a biotech association.   
30 To the contrary, the EC's language – by using phrases such as "Austria and Germany consider" and 
"According to Austria and Germany," – is  carefully qualified so as not to indicate whether the EC even agrees 
with the rationales put forth by the member States.   WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-54 
  
  phytosanitary measure accordingly within a reasonabl e period of time," as required under Article 5.7.  
Nor does the EC discuss whether there may have been less trade-restrictive measures (such as 
measures other than complete product bans) that would have met the concerns expressed by the 
member States.  For example, the member State concerns are addressed to purported risks associated 
with planting, but the safeguards ban all uses  of the biotech products, including import and 
processing.    39. Thus, although the EC for the first time has described purported rationa les for certain member 
State safeguards, the EC has not begun to develo p the information and arguments that would be 
needed for the Panel to consider a claim that these safeguards met all the requirements of Article 5.7.  
Rather, the most pertinent information on the record  remains that the EC's own scientific committees 
found that the available evidence was sufficient fo r the completion of risk assessments, that those 
committees made positive assessments, and those comm ittees reviewed and rejected the rationales put 
forth by the member States in rela tion to the safeguard measures.    
 
For all parties
: 
170. With reference to EC Directive 2001/18, Annex II, Section C.2.1, please indicate for each 
of the listed potential adverse effects of GM Os whether measures applied to prevent or 
minimise such effects fall within the scope of Anne x A(1) of the SPS Agreement, and if so, why.  
The parties are also invited to address Sect ion D with the same question in mind.  
 
40. Please see the above US comments in relation to Question 119.   
For Argentina, the United States and the European Communities : 
176. With reference to Austria's safeguard meas ure on Bt-176 maize, please comment on the 
reference in exhibit EC-158 att. 7 to insuffi cient labelling requirements laid down in the 
Commission Decision relating to the relevant produc t.  In particular, what is the basis for the 
concern expressed about insufficient labelling (e.g ., food safety, consumer information, etc.), 
and how does the labelling issue affect the analys is of whether the Austrian safeguard measure 
falls within the scope of the SPS Agreement and/or the TBT Agreement? 
 
41. The EC response on Austria's purpose for requiring food labelling is not supported by the 
exhibits.  The EC reasoning is as follows: 
"The second concern (the insufficient labelli ng for the purpose of effective and fair 
consumer information) is also an issue th at is independent and not related to any 
component of the risk analysis process to t ackle any of the risks to human, animal or 
plant life or health, which may be at stak e in the Austrian provisional measure."  
"Indeed, the Commission Decision for this product states (fifth recital, 6th indent) 
that 'there are no safety grounds for mentioning on the label that the product has been obtained by genetic modification techniques'."
31  
42. To be sure , the Commission  found that there were no food safety grounds for labelling the 
product.  But the question posed by the Panel is why Austria  wanted additional labelling.  And 
Austria, of course, disagreed with the Commissi on on many issues – that is why it adopted the 
safeguard.  And, as the United States noted in its prior answer to this question, the Austrian 
                                                      
31 EC Answers of March 11, 2005.    WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-55 
  
  memorandum does
 indicate an Austrian concern with purpor ted risks to human health from antibiotic 
resistance marker genes.  Thus, the EC has no basis for asserting that Austria's concerns regarding 
labelling were unrelated to purported risks to human health.   
200.  With reference to para. 20 of the European Communities' second oral statement 
(concerning Bt cotton 531), is the European Communities asserting that the applicant was formally required or requested to submit the in formation in question?  If so, please provide 
support.   
43. The issue with Bt cotton 531 is that the Regulatory Committee voted on the application in 
February 1999 and failed to reach a qualified majori ty to approve or disappr ove; that the EC did not 
follow its own procedures by then sending the appl ication on to the Council and if necessary, the 
Commission, for final decision; and that the application then languished for over 3 years
, without any 
activity other than purported "interservice consultations," until the application was updated in early 
2003 to meet the requirements of Directive 2001/18.32  This delay, as the United States has explained, 
is a clear example of the EC applying its moratori um to a product that under EC law, should have 
proceeded promptly to a final decision.   
44. At the second substantive meeting, the EC trie d to justify this lengthy delay by claiming that 
in fact there were outstanding requests for informati on that justified the delay of more than 3 years, 
and that those requests for information were refl ected in the comments of the member States during 
the vote of the Regulatory Committee.   
45. In its response to Question 200, the EC now retreat s from this assertion.  In particular, the EC 
claims that in its oral statement, it only meant to  make the point that member State objections before  
"February 1999" – that is, prior to the Regulatory Committee vote – were transmitted to the applicant.  
The United states appreciates that the EC is no longer contending that a non-decision in the 
Regulatory Committee is equivalent to a request for info rmation.  In fact, elsewhere in its answers, the 
EC states that the Regulatory Committee voting procedure cannot serve as a request for information: 
"The role of a Regulatory Committee is to  vote on a proposal for a decision presented 
by the Commission.  It cannot itself propose any decision nor amend the one proposed by the Commission.  Equally, it does not itself have any power to seek 
further information from the applicant.  If the Regulatory Committee does not 
endorse the Commission's proposal, the procedure moves up to the next level."33 
Having dropped its argument that the Regulatory Committee vote served as a request for additional 
information, the EC simply has no rationale for claimi ng that the delay of more than three years in the 
consideration of Bt cotton 531 was justified.  The only explanation for this delay is that it reflected the 
EC's decision to adopt a moratorium on making fi nal decisions on biotech product applications. 
 
 
                                                      
32 See EC Exhibit 65, Chronology.  As the United States explained in its Supplementary Rebuttal 
(paras. 40-51), the applican t took the initiative to provide some update d information in 2002, although this 
information was not requested by the EC. 
33 EC Answers of March 7, 2005, para. 124 (emphasis added).   WT/DS291/R/Add.4 
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Page F-56 
  
 ANNEX F-4 
 
REPLIES BY CANADA TO QUESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
7 MARCH 2005 
 
 
For all parties
: 
 
119. With reference to exhibit US-123 (reproduced at para. 9 of attachment II of the US 
rebuttal), do the references in ISPM 11 to "indirectly affect plants […] by other processes such 
as competition" (page 34) and "significant re duction, displacement, or elimination of other 
plant species" (page 19) support the view that th e term "injurious" in the IPPC definition of 
"pest" ("any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants 
or plant products") should be given a broad interpretation?   
 
1. Yes.  The references in ISPM No. 11 support th e view that the term "injurious" in the IPPC 
definition of "pest" should be given a broad interpreta tion.  In turn, the broad interpretation given to 
the term "pest" in ISPM No. 11 confirms that the ordinary meaning of the term "pest" in the SPS 
Agreement , in its context and in the light of the object and purpose of the SPS Agreement , should be 
given a broad interpretation.  Such a broad interpreta tion is consistent with the definition of "pest" in 
the SPS Agreement  which has been defined to include "weeds" .  The references in ISPM No. 11 cited 
in the Panel's Question are examples of the type of inju ry to plant life and hea lth that can be caused by 
weeds or other invasive plant pests. 
 2. That being said, for something to qualify as a "pest" for the purposes of ISPM No. 11 it must be "injurious" to plants or plant products in the sense of causing damage, either directly or indirectly, 
to plant life or health.  Similarly, in the light of the object and purpose of the SPS Agreement , for 
something to be considered a "pest" for the purposes of the SPS Agreement , it must be "injurious" to 
plants, animals, or humans in the sense of causing damage, either directly or indirectly, to life or health.  The presence of a biotech seed or crop woul d not be "injurious" to plants or plant products 
merely because that presence caused  an economic loss resulting from a legal restriction imposed on 
the marketing of a product.  Such an economic loss is a consequence of the decision to impose 
arbitrary thresholds for the admixture of transgen ic and non-transgenic products – a decision relating 
to the marketing of a product, rather than to protect plant life or health. 
 3. Canada wishes to anticipate Question 140 of the Panel regarding the relevance of the IPPC 
and ISPM No. 11 to the interpretation of the term "pest" in the SPS Agreement .   Canada notes that the 
1997 revised text of the IPPC ("IPPC 1997"), whic h contains the definition of "pest" cited above in 
Question 119, is not yet in force, as the requisite two- thirds of the contracting parties to the IPPC have 
not yet deposited their instruments of acceptance of the amendments to the IPPC, as reflected in IPPC 
1997.
1  Consequently, the IPPC 1997 cannot be considered  to be a "rule[] of international law" under 
Article 31(3)(c) of the Vienna Convention on the Law of Treaties .  If the IPPC is to be considered a 
"rule[] of international law", it is the 19 79 version that must be so considered.2 
 
                                                      
1 See Article XIII of the IPPC 1979.  Also see Canada's Answers to Questions from the Panel (16 June 
2004), Question 4. 
2 The IPPC 1979 defines "pest" as "any form of plant or animal life, or any pathogenic agent, injurious 
or potentially injurious to plants or plant products;".  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-57 
  
 4. That being said, ISPM No. 11 incorporates th e updated definition of "pest" used in the IPPC 
1997.
3  As Canada explains in its response to Qu estion 140, ISPM No. 11 may be considered as a 
supplementary means of interpretation for terms in the SPS Agreement  pursuant to Article 32 of the 
Vienna Convention .  Although the IPPC 1997 is not yet in force, it nonetheless would be consistent 
with the object and purpose of the SPS Agreement  to consider the updated version of the definition of 
"pest" as a supplementary means of interpretation given that the ISPM No. 11 has been endorsed by 
the Interim Commission on Phytosanitary Measures as an international phytosanitary standard. 
 120. With reference to Annex A(1)(d) of th e SPS Agreement, please answer the following 
questions:   (a) What is the meaning of the term "other damage"?  
 (b) Does the term "other" imply that Annex A(1)(a) through (c) are also about 
"damage"?  If so, does the term "oth er damage" cover damage sustained by 
plants, animals or humans other than damage to their "life or health"?  Please provide examples.  
  (c) Is "other damage" limited to damage su stained by plants, animals or humans?  
If not, please provide examples.  
 
5. As the answers to the three above questions tend to overlap, Canada will group its answers to 
these questions together.  
6. The ordinary meaning of the term "damage" is "harm done to a thing…; esp. physical injury 
impairing value or usefulness."
4  The context of the term "damage"  includes the definitions set out in 
Annex A of the SPS Agreement , in particular the definition of "risk assessment", and other provisions 
of the Agreement , in particular Article 5.3.  The defin ition of "risk assessment" requires an evaluation 
of both the likelihood of an event occurring ( e.g. the entry, establishment or spread of a pest) as well 
as the "associated potential biological and econo mic consequences".  Article 5.3 requires WTO 
Members to take into account, in assessing the risk to animal or plant life or health, "the potential 
damage in terms of loss of producti on or sales in the event of the entry, establishment or spread of a 
pest or disease; the costs of control or eradicati on…and the relative cost-effectiveness of alternative 
approaches to limiting risks."  
7. Thus, the context suggests that "damage" means the injurious or harmful potential biological 
and economic consequences that result from the occurren ce of an event.  The concept of "damage" in 
the SPS Agreement  is subsumed within the concept of "risk" . "Risk" refers to the likelihood of an 
event occurring as well as the extent of poten tial damage associated with that event.
5 
 8. The term "other" implies that Annex A(1)(a ) and (c) are also about "damage".  However, 
while Annex A(1)(a) and (c) involve an evalua tion of the likelihood of the event occurring ( e.g. entry, 
establishment and spread of pests or diseases) as well as any associated damage to life or health, 
Annex A(1)(d) is only concerned with the "other da mage" that flows from the entry, establishment or 
                                                     
 
3 ISPM No. 11, "Pest Risk Analysis for Quarantine Pests, Including Analysis of Environmental Risks 
and Living Modified Organisms", April 2004, p. 6. (Exhibit EC-130) 
4 The New Shorter Oxford English Dictionary , vol. 1 (Oxford: Clarendon Press, 1993), p. 588. (Exhibit 
CDA-202) 
5 See Australia – Salmon ,  Report of the Panel, para. 8.72 and 8.116, where the Panel considered the 
two types of risks to be evaluated in a risk assessment: (i) the risk of entry, establishm ent or spread and (ii) the 
risk of the associated potential biological and economic consequences. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-58 
  
 spread of pests.  Annex A(1)(d) presupposes that da mage to animal or plant life or health from the 
entry, establishment or spread of pests has been  established.  Consequently, Annex A(1)(d) is 
concerned only with "other damage."  
 
9. The use of the term "other" in Annex A(1)(d) suggests that the type of damage contemplated 
in Annex A(1)(d) is distinct from the damage to animal or plant life or health (Annex A(1)(a)) and 
human life or health (Annex A(1)(c)) arising from th e entry, establishment and spread of pests.  
Canada recalls that the terms "animal" and "plant" are defined broadly in the SPS Agreement .
6  
Accordingly, many of the risks to biodiversity or the environment cited by the EC falls within the 
risks to animal and plant life or health contemplated by Annex A(1)(a).7  In terms of the second 
question in Question 120(b), Canada does not consid er that plants, animals, or humans can be 
"damaged" unless there is damage to their "life or health".  In the light of Canada's response to 
Question 119, it would be inconsistent  with the object and purpose of the SPS Agreement  to extend 
the definition of damage to plants, animals or humans to include so-called damage that is not  based on 
injury or harm to their life or health.  In this par ticular context, reduced yield of a crop, as a result of 
competition from a pest such as a weed, would be c onsidered impairment to the health of the crop 
plant.  10. In terms of Question 120(c), "other damage" is not limited to damage sustained by plants, 
animals or humans.  "Other damage" includes damage  from the entry, establishment or spread of pests 
to the functioning of the environment or the ecosyst em taken as a whole, inde pendent of damage to 
the life or health of specific plants or animals.   This would include, for example, damage resulting from ecosystem destabilization and from control, er adication or management programs that would be 
needed if a quarantine pest was introduced, and impacts of such programs (e.g. pesticides…) on 
biological diversity.  Canada refers the Pane l to paragraphs 64-65 of  Canada's Third Written 
Submission, which discusses the Interim Commission on Phytosanitary Measures' Guidelines On The 
Understanding of Potential Economic Importan ce and Related Terms Including Reference To 
Environmental Considerations .
8 
 11. Specific examples of "other damage" may include: 
 
 – environmental and other undesired effects of control measures;  – capacity to act as a vector for other pests;  – significant effects on designated environmentally sensitive or protected areas;  – significant changes in ecological processes and the structure, stability or processes of 
an ecosystem (including further effects on pl ant species, erosion, water table changes, 
increased fire hazard, nutrient cycling etc.); 
 – effects on human use (water quality, recreational uses, tourism, animal grazing, 
hunting, fishing); and  
 – costs of environmental restoration.
9 
 
                                                      
6 SPS Agreement , Annex A, footnote 4. 
7 Canada Third Written Submision, paras. 55 to 65. 
8 Exhibit CDA-151, pp. 2-3. 
9 ISPM No. 11, "Pest Risk Analysis for Quarantine Pests, Including Analysis of Environmental Risks 
and Living Modified Organisms", April 2004, pp. 23-24. (Exhibit EC-130)  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-59 
  
 121. With reference to Article 5.1 of the SPS Agreement, what were the relevant risk 
assessment techniques developed by the relevant international organizations that the European Communities had to take into account in the relevant period (October 1998 – August 2003)?  
 
12. During the period in question (October 1998 – August 2003), there were no "relevant risk 
assessment techniques" that had been developed by "r elevant international organizations".  While risk 
assessment guidelines were in the process of being de veloped in "relevant inte rnational organizations" 
such as the Codex Alimentarius Commission (Codex)  and under the auspices of the International 
Plant Protection Convention (IPPC), during the relevant period, these guidelines remained in the draft 
stages.  13. Even if we assumed, for the sake of argument, that Annex III of the Cartagena Protocol on 
Biosafety  (BSP) constituted a "relevant risk assessment t echnique" and that it had been developed by a 
"relevant international organization" – and Ca nada does not agree with either of these two 
propositions – the BSP was not in force during the rele vant period of time.  It only came into force on 
September 11, 2003.  
122. Please explain your views as to the relatio nship between a Member's appropriate level of 
protection and the requirement in Article 5.1 to en sure a measure is based on a risk assessment, 
as appropriate to the circumstances.  Is the appropriate level of protection relevant to the 
conduct of the risk assessment? 
 
14. The appropriate level of protection (ALOP) is not directly relevant to the conduct of the risk 
assessment.  It is, however, relevant once the risk assessment has been completed and, assuming that a 
risk has been identified, a risk ma nagement measure has to be selected. 
 15. This is reflected in the international standa rds for risk assessment that have been developed, 
for example, in Codex and under the auspices of the IPPC.  A review of the Codex Principles for the 
Risk Analysis of Foods Derived from Modern Biotechnology
10 (Codex Principles) reveals that the 
ALOP is not a relevant consideration in conducting either the safety assessment or the risk 
assessment.  For instance, under Section 3 – Principles, paragraph 10 states that: 
 
Risk assessment includes a safety assessment, which is designed to identify whether a 
hazard, nutritional or other safety concern is present, and if present, to gather information on its nature and severity…If a ne w or altered hazard, nutritional or other 
safety concern is identified by the safety asse ssment, the risk associ ated with it should 
be characterized to determine its relevance to human health.
11 
16. It is noteworthy that in the quoted statement, which sets out the basic principle with respect to 
the conduct of a risk assessment under the Codex Principles, there is no indication that the level of protection chosen by the country conducting the risk assessment is a factor to be taken into account. 
 
17. Similarly, ISPM No. 11 makes no mention of the ALOP as a factor or determinant in the 
conduct of a pest risk assessment.  It is at Stage 3 – Pest Risk Management – that ISPM No. 11 addresses the role of acceptable levels of risk.
12 
 
                                                      
10 Exhibit EC-44. 
11 Ibid., p. 44. 
12 ISPM No. 11, "Pest Risk Analysis for Quarantine Pests, Including Analysis of Environmental Risks 
and Living Modified Organisms", April 2004, p. 28. (Exhibit EC-130) WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-60 
  
 18. In short, neither the Codex Principles, nor I SPM No. 11, support an argument that the conduct 
of the risk assessment is affected in any way by the ALOP.  To the contrary, they confirm that the 
conduct of a risk assessment relies on the best and mo st complete scientific information available in 
order to enable the risk assessor to identify the hazards and characterize the risks with as much 
certainty as is possible.  19. Put differently, a risk assessment is conduc ted according to pre-established parameters.  
These parameters reflect the range of hazards that c ould arise from the activity or product in question.  
According to present international standards, th e risk assessor should have the best available 
information at his or her disposal in order to assess the hazards and characterize the potential risks 
with as much certainty as is possible.  The va lue of the risk assessment hinges on the degree of 
certainty with which the risk assessor can state his or her conclusions.  This is true regardless of the 
ALOP sought to be achieved. 
 
20. The risk manager, in turn, weighs the conclusi ons of the risk assessment  in light of the ALOP 
and, on that basis, selects the risk management me asure that is expected to achieve that level of 
protection.  21. It is true that the first part of the defi nition of risk assessment in  paragraph 4 of Annex A 
refers to "the evaluation of the likelihood…accord ing to the sanitary or phy tosanitary measures which 
might be applied", but this language does not im ply that the conduct of the risk assessment is 
influenced by the level of protection sought to be achieved.  It simply requires the WTO Members to 
examine the range of risk management measures av ailable in light of the risks that have been 
identified.  The chosen level of protection may influence the range of risk management measures 
available, but it does not affect the identifica tion of hazards and the characterization of any 
consequent risks.  22. In short, whether the chosen level of protection is low or high does not affect the risk assessor's need to have sufficient information at his or  her disposal to come to a conclusion that is as 
certain as possible.  A risk assessment that is characterized by significant uncertainty as to the 
likelihood or magnitude of adverse ef fects occurring is less helpful to the risk manager, regardless of 
the level of protection sought to be achieved because  it is less likely to serve as an accurate predictor 
with respect to whether that level of protection will actually be achieved.  
123. Please assume for the sake of argument that Article 5.7 of the SPS Agreement provides 
for an exception in the nature of an affirmative defence: 
  (a) Could the Panel assess the merits of an y such defence without having previously 
found an inconsistency with Article 2.2 of the SPS Agreement?  
 
23. Technically, the Panel could assess a measure against Article 5.7 without first making a 
determination whether that measure was inconsistent with Article 2.2.    However, the first question 
that would have to be answered is whether ther e was insufficient evidence to complete a risk 
assessment.  It is only if there is insufficient eviden ce to complete a risk assessment that Article 5.7 is 
available as a defence.  The insufficiency of the evidence means that the measure cannot be based on 
a risk assessment, and that it is being maintained without sufficient scientific evidence.  In other 
words, the measure is ipso facto  inconsistent with Articles 5.1 and 2.2, at least on a provisional basis.  
Conversely, if there is sufficient
 scientific evidence to complete a risk assessment, the measure cannot 
benefit from the protection afforded by Article 5.7, a nd the analysis has to revert to the question of 
whether the measure is in fact based on a risk assessment and therefore maintained with sufficient 
scientific evidence. 
  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-61 
  
 24. Hence, in a practical sense, the need to assess the merits of a defence under Article 5.7 should 
not logically arise unless the defending party concedes that its measure does not meet the 
requirements of Article 2.2.  That is, the defendi ng party would have to assert that its measure was 
being maintained without sufficient scientific ev idence because sufficient sci entific evidence did not 
exist to complete a risk assessment.  Having invoke d Article 5.7, it would then be for the defending 
party to establish a prima facie  case that the circumstances were su ch that the "relevant scientific 
evidence is insufficient" to complete a risk a ssessment, and that the measure meets all of the 
requirements of Article 5.7. 
 
25. Thus, an inconsistency with the requirement s of Article 2.2 – whether conceded by the 
defending party or determined by th e Panel through its own analysis – is a natural precursor to turning 
to Article 5.7 to see if the measure cannot be justified on other grounds. 
 
26. That this is correct seems clear fro m the approaches taken by the panels in Japan – 
Agricultural Products II  and Japan – Apples .  In both cases, the complain ing party alleged a violation 
of Article 2.2.  In neither case did the complaining party assert a violation of Article 5.7 as part of its claim.  The defending party raised Article 5.7 as an alternative defence, predicated on a finding by the 
panel that the measure was being maintained without  sufficient scientific evid ence.  The panels in 
those two cases came to the conclusion, on a provisiona l basis, that the measure in question was being 
maintained without suffi cient scientific evidence.
13  The panel in each case then noted that Japan had 
invoked Article 5.7 as an alternative defence.  That is, the panels concluded that if the measure met 
the requirements of Article 5.7, then they could not conclude that Article 2.2 had been violated.  Both 
panels went on to conclude that the measures in qu estion did not meet the requirements of Article 5.7, 
and, on that basis, the panel in each case confirmed the violation of Article 2.2. 
 
27. In other words, in both cases, the question of whether Article 5.7 applied was meaningful or 
relevant only because the panels had first determ ined that the measure in question was being 
maintained without sufficient scientific evidence.  
 (b) If not, in a case such as this one where a claim of inconsistency with Article 2.2 of 
the SPS Agreement is based on a claim of inconsistency with Article 5.1 of the 
SPS Agreement, would it be correct for the Panel to begin its analysis with the Article 5.1 claim, then move to the co nsequential Article 2.2 claim and finally 
turn to the Article 5.7 defence? 
 28. Yes.  Given the jurisprudence,
14 it seems axiomatic that a measure that is not based on a risk 
assessment is necessarily inconsiste nt with Article 2.2, third element (likely also second element).  
Therefore, determining whether the measure is not based on a risk assessment, that is, whether 
Article 5.1 has been violated, logically precedes a determination whether Article 2.2 has been 
violated.  Once a provisional finding has been made that the measure is being maintained without sufficient scientific evidence, contrary to Article 2. 2, it is for the defending party, if it so chooses to 
invoke Article 5.7 as a defence on the initial grounds th at insufficient evidence exists to complete a 
risk assessment.  Thus, the question of whether the measure meets the requirements of Article 5.7 arises, with the burden of proof falling on the defend ing party as the party who "asserts the affirmative 
of a particular claim or defence".
15 
 
                                                      
13 Japan – Agricultural Products II , Report of the Panel, para. 8.43; Japan – Apples , Report of the 
Panel, para. 8.199. 
14 Australia – Salmon , Report of the Appellate Body, para. 138. 
15 US – Wool Shirts and Blouses , Report of the Appellate Body, p. 14. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-62 
  
 For all complaining parties:
 
 
124. With reference to para. 19 of the Europe an Communities supplemen tary rebuttal, do 
the complaining parties agree that the Panel "i s not asked to determine whether a prudent 
government, in the abstract, should  have behaved or not in a certain manner thus causing delay.  
It merely needs to find whether, in the concrete case and in light of the factual information and 
the legal arguments before the relevant authorities, that behaviour which in the end caused a delay could  justifiably have been adopted"? 
 
29. As it has already indicated in its Second Oral Statement, Canada does not agree with the EC's 
view of the standard of review with resp ect to paragraph 1(a) of Annex C of the SPS Agreement .
16  
Canada specifically disagrees with the EC's assertio n in paragraph 19 of its Supplementary Rebuttal.  
In particular, the distinction that the EC seeks to create between the so-called "more general wording" 
of paragraph 1(a) of Annex C and the, presumably, mo re specific wording of Article 5.2, is a false and 
ultimately irrelevant dichotomy.  30. Thus, in Canada's view, the standard of re view with respect to whether the EC's measures 
amount to undue delay under paragr aph 1(a) of Annex C is not a question of whether the EC's 
"behaviour… could  justifiably have been adopted; it is a question of whether a reasonably diligent 
government would and should have acted in view of the factual information at its disposal.  This 
characterization is consistent with the Appellate Body's statement in EC – Hormones  that "the 
applicable standard is neither de novo review as su ch, nor 'total deference', but rather the 'objective 
assessment of the facts'".
17 
 
31. Furthermore, a determination as to whether a WTO Member has violated the obligation in 
paragraph 1(a) of Annex C to undertake and comple te approval procedures "with out undue delay" is a 
question of mixed law and fact.  As such, there is no reason for the Panel to adopt a deferential 
approach to its determination as to what constitut es "undue delay".  As the Appellate Body noted in 
EC – Hormones : 
 
In so far as legal questions are concerned – that is, consistency or  inconsistency of a 
Member's measure with the provisions of the applicable agreement – a standard not found in the text of the SPS Agreement itsel f cannot absolve a panel (or the Appellate 
Body) from the duty to apply the customary rules of interpretation of public international law.
18 
32. In any event, the EC's proposed "standard of  review" in paragraph 19 of its Supplementary 
Rebuttal sounds eerily similar to the standa rd of review that the EC proposed in EC – Hormones .  In 
that case, the EC pointed to Article 17.6(i) of the Anti-Dumping Agreement  as the basis for what it 
called a "deferential reasonableness standard" to  be applied to factual issues in the SPS Agreement .  
Article 17.6(i) states, in part, that:  
In its assessment of the facts of the matter, the panel shall determine whether the 
authorities' establishment of the facts w as proper and whether their evaluation of 
those facts was unbiased and objective.  If the establishment of the facts was proper 
and the evaluation was unbiased and objectiv e, even though the panel might have 
reached a different conclusion, the evaluation shall not be overturned. 
                                                     
 
16 Canada Second Oral Statement, paras. 97-100. 
17 EC – Hormones , Report of the Appellate Body, para. 117. 
18 Report of the Appellate Body, para. 118.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-63 
  
 33. The EC argued in that case that this standa rd is applicable in "all highly complex factual 
situations, including the assessment of the risk s to human health arising from toxins and 
contaminants".
19 
 
34. A review of the EC's argument in paragraph 19, including its assertion that "the Panel merely 
needs to look at the applications to satisfy itself th at such delays that may have occurred were based 
on reasonable justification ",20 and its contention that the panel me rely needs to determine whether the 
"behaviour which in the end caused a delay could  justifiably have been adopted",21 calls to mind the 
language in Article 17.6(i). 
 35. The Appellate Body soundly rejected the EC 's proposed "deferential reasonableness standard" 
in EC – Hormones .
22  This Panel should reject any effort by the EC to resurrect that standard in this 
dispute. 
 
125. The European Communities' opening statemen t at the Panel's meeting with the experts 
includes the following statements:    
• "[T]he European Communities' approach is  to seek more evidence to establish 
whether or not there is a risk […] in order to make a definitive decision on the 
basis of full information – even if that  takes a little more time".  (para. 19) 
 
• "The European Communities reacts [to uncertainty as to the appropriate risk 
management strategies ] by saying 'let's take our time and reduce the 
uncertainty".  (para. 17)  
 
Do the complaining parties consider that it woul d be consistent with Annex C(1)(a) of the SPS 
Agreement to delay making a definitive decision based on the approach outlined by the European Communities?  In answering this questio n, please take into account the provisions of 
Article 2.2 of the SPS Agreement
23 and Article 5.7 of the SPS Agreement (adoption of 
provisional measures based on available pertinent information).  
 36. Canada refers the Panel to paragraphs 148-150 of Cana da's Third Written Submission. 
 37. Canada agrees that, while there may be circumstances in which the application of a 
precautionary approach in the selection of the risk management measure is warranted, this must be 
qualified so as to ensure that th e purported application of the precautionary approach does not become 
a disguise for protectionism.  As the Appellate Body found in EC – Hormones , while the 
precautionary approach finds reflection in several of the provisions of the SPS Agreement , the 
precautionary approach does not override the provisions of Articles 5.1 and Article 5.2.
24  Similarly, 
in Canada's view, the precautionary approach ca nnot override the requirements of Annex C or 
Article 2.2.  
                                                      
19 Quoted in EC – Hormones , Report of the Appellate Body, para. 113. 
20 EC Supplementary Rebuttal, para. 19. (Emphasis added) 
21 Ibid. (Emphasis in the original) 
22 EC – Hormones , Report of the Appellate Body, para. 114 and 119. 
23 (This footnote appeared in the Panel's question)  In EC – Hormones , the Appellate Body stated in 
relation to Article 2.2 that "a panel charged with determin ing [...] whether 'sufficient evidence' exists to warrant 
the maintenance by a Member of a particular SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly act from perspectives of prudence and precaution where 
risks of irreversible, e.g. life-terminating, damage to human health are concerned" (para. 124). 
24 EC – Hormones , Report of the Appellate Body, paras. 124-125. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-64 
  
  
38. As Canada set out in its Second Oral Stat ement, in determining whether a Member has 
complied with its obligations under the SPS Agreement , the question is not whether scientific 
uncertainty exists, but whether there is sufficient sci entific evidence to enable the completion of a risk 
assessment.
25  By raising the spectre of "uncertainty" a nd a lack of "full information", the EC is 
suggesting that insufficiency of scientific evidence justifies a prolonged delay in the completion of an 
approval procedure.  This is nothing other than an indirect attempt to justify the product-specific 
marketing bans  under Article 5.7.   
 
39. Where pre-marketing approval is required for a product to be marketed, the decision by a 
regulatory authority not to complete the approval pr ocedure on the basis of insufficiency of relevant 
scientific evidence amounts to a ban on the product.26  Whether or not this ban is adopted in the form 
of a legal instrument does not affect the application of Article 5.7 to the approval procedure.  Thus, a 
ban arising from a decision not to complete th e approval procedure will be exempted from the 
requirements of Article 2.2, third element, only if the Member is able to demonstrate that the ban 
satisfies the requirements of Article 5.7.  Similarl y, in order to justify the delay in completing the 
approval procedures under Annex C of the SPS Agreement , the defending WTO Member would have 
to demonstrate that the ban satisfies the requirements of Article 5.7.  If the ban does not satisfy those 
requirements, then the delay in completing the approval procedures is "undue".  
 
40. However, despite asserting scientific uncertain ty, the EC has not claimed the protection of 
Article 5.7, let alone demonstrated that its require ments have been satisfied.  Instead, the EC appears 
to assume that Article 5.7 does not apply to th e operation of inspection, control and approval 
procedures.  As Canada has previously argued,27 this assumption is invalid.  It is incumbent on the EC 
to demonstrate that the requirements of Article 5.7 have been met where it argues that a risk 
assessment cannot be completed on the basis of insufficiency of scientific evidence. 
 
126. In paragraph 10 of the EC Responses to the Questions from the Panel (16 June 2004), 
the European Communities compares the definitions of risk assessment as used in the SPS Agreement and as used in Codex, and concludes th at "It is clear that the SPS definition of risk 
assessment is equivalent to 'weighing policy alternatives in the light of the results of risk 
assessment' which is part of the Codex Definition  to ¨'risk management'".   Do you agree with 
this conclusion?  Please explain your response. 
 
41. Canada does not agree.  Cana da refers the Panel to paragr aphs 80-95 of Canada's Second 
Written Submission and paragraphs  15-20 of Canada's Third Writte n Submission where Canada has 
responded in detail to the EC's assertions in this regard.  Canada's arguments can be summarized as 
follows.  42. First, to the extent that a risk arises from the entry, establishment or spread of a pest or 
disease, the risk assessment must eval uate the likelihood of entry, establishment or spread of a pest or 
disease according to the sanitary and phyto sanitary measure which might be applied
.  Building on the 
framework adopted by the Appellate Body in Australia – Salmon , such a risk assessment must 
evaluate both (1) the likelihood of entry, establi shment or spread and the associated potential 
biological and economic consequences  and (2) evaluate such likelihood according to the SPS 
measures which might be applied .  It is not sufficient to merely identify and evaluate the risks and 
biological and economic consequences.  The re ference to "according to the SPS measures which 
might be applied" implies that different risk management measures or, to use the EC's language, 
                                                      
25 Canada Second Oral Statement, para. 32. 
26 Canada First Written Submission, paras. 159 and 255. 
27 Canada Third Written Submission, para. 149.  WT/DS291/R/Add.4 
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 "policy alternatives", that might be applied to control the identified risks – what the Panel in Australia 
– Salmon  referred to as "risk reduction factors"
28 – must also be evaluated in order for the risk 
assessment to meet the requirements of the firs t definition in paragraph 4 of Annex A of the SPS 
Agreement .  The reference in Article 5.3 to "the rela tive cost-effectiveness of alternative approaches 
to limiting risks" as a relevant economic factor to be taken into account in conducting a risk 
assessment supports this conclusion.  43. Second, it is important to note that the "polic y alternative" that is selected beco mes the SPS 
measure.  Pursuant to Article 5.1, the SPS measur e in question must be based on the risk assessment, 
that is, there must be a rational connection betw een the so-called "policy alternative" and the 
evaluation of the risks.  44. Third, the EC stresses the distinction between risk assessment strictu sensu  and risk 
management and the respective roles of the scientific committees and Regulatory Committee.
29   The 
EC divides the term "risk assessment" into thr ee components: "(1) risk assessment in the narrow 
sense, i.e. as a 'scientifically based process ', and (2) risk management, and (3) risk communication."30  
The EC stresses that risk management decisions  are made by the Regulatory Committees and risk 
assessment strictu sensu  falls to the scientific committees.  In  other words, the scientific committees 
are responsible for evaluating the risks while th e Regulatory Committees are responsible for selecting 
the appropriate SPS measure.31 
 45. To the extent that the EC s uggests that only the "risk assessme nt in the narrow sense" must be 
a "scientifically based process", Canada disagrees.  This is tantamount to claiming that only part of 
the "risk assessment" in the SPS Agreement  must be science-based, an assertion at odds with the 
definition of "risk assessment" in Annex A and the requirement to base an SPS measure on a risk 
assessment.  46. If one accepts, for the sake of argument, that  the Regulatory Committees are responsible for 
"weighing policy alternatives", it follows logica lly that the Regulatory Committees must have 
evaluated the various risk management options that mi ght be applied in the light of the risks that were 
identified in the risk assessment as is required by the SPS Agreement .  Ironically, the EC quotes in its 
Responses to Questions from the Panel (16 June 2004)  from a decision of the European Court to the 
effect that if the Regulatory Committee disregards  the scientific opinion, "it must provide specific 
reasons for its findings by comparison with those ma de in the opinion and its statement of reasons 
must explain why it is disregarding the latter.  The st atement of reasons must be of a scientific level at 
least commensurate with that of the opinion in question."
32  
 
                                                      
28 Australia – Salmon , Report of the Panel, paras. 8.89 and 8.90.  The Appellate Body endorsed this 
approach in para. 134 in concluding that Australia failed to fulfil the third requirement of the first definition of 
risk assessment, namely "the required evaluation of the likelihood of entry, establishment or spread of the 
diseases of concern according to the SP S measures which might be applied." 
29 See generally EC Responses to Questions from the Panel following the First Substantive Meeting (16 
June 2004), Question 2, para. 12 and EC Second Written Submission, paras. 27-31. 
30 EC Second Written Submission , para. 21. [emphasis added] 
31 It should be noted that the EC has consistently de-emphasized the role of the Commission.  The 
Commission is responsible for drafting the measure to be placed before th e Regulatory Committee after inter-
service consultation; if the Regulatory Committee fails to act, the Commission is oblig ated to refer the draft 
measure to Council without delay; if Council fails to act  within three months, the Commission is obligated to 
adopt the measure. 
32 EC Responses to Questions from the Panel following the First Substantive Meeting (16 June 2004), 
Question 17, para. 57. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-66 
  
 47. In not one instance has the EC itself put forth information of this nature that would justify 
ignoring the advice of its own scientific committ ee.  In the more than six years since the moratorium  
was imposed, the EC has failed to evaluate the SPS meas ures that might be applied.  In a sense, this is 
not surprising given that with the possible excep tion of a few cases, the risk assessments have not 
identified any risks of a different nature or magnitude than those arising from conventional 
counterparts of the biotech products in question.  
127. At para. 42 of Canada's supplementary re buttal, Canada suggests that crop husbandry 
includes breeding and that if a scientist employs  selective breeding methods in the laboratory, 
this should qualify as crop husbandry because the scientist would be performing the same operations as a farmer who employs selective breeding methods on the farm.  But is the insertion of a transgene part of the breeding of biotech crops?  Or is the breeding rather the re-
production of the biotech seed? 
 
48. The insertion of a transgene is part of the br eeding of biotech crops.  As Dr. Andow has stated 
"breeding involves two important processes: (1) finding and introducing usable genetic variation into 
the breeding population and (2) improving and selecting desired varieties from the breeding 
population." 
33   Dr. Andow indicated that transgenesis,  as well as mutagenesis, is a process to 
introduce genetic variation into the breeding population.   He indicated that transgenesis is "a part of 
the breeding process", although only one part.  Once th e transgene has been in serted, the transgenes 
are introgressed into an elite, adopted germplasm.  49. Dr. Andow's description of modern plant breedi ng is supported by scientific reports before the 
Panel.  For instance, in Exhibit CDA-195, th e authors refer to "breeding" as encompassing 
conventional breeding techniques as well as breeding using rDNA technology.  
 50. Thus, in the light of modern plant breeding techniques, it would be artificial to exclude one 
method for introducing genetic variation – transgen esis – from the concept of "breeding" and crop 
husbandry.  Questions not Previously Provided to the Parties
 
 For all parties
: 
 
140. With reference to (1) Codex standards 192 and 193, (2) IPPC and (3) ISPM 11: 
 
 (a) Are they "rules of international law applicable in the relations between the 
parties [to this dispute ]" within the meaning of Article 31(3) of the Vienna 
Convention on the Law of Treaties?   
 
51. Canada does not consider Codex Standards 192 and 193, or ISPM No. 11 to be "rules of 
international law".  Hence they do not fall w ithin the scope of Article 31(3)(c) of the Vienna 
Convention .  With respect to the IPPC, Canada refers th e Panel to Canada's response to Question 119.  
 52. Canada also questions the Panel's apparent  assumption that the reference to "parties" in 
Article 31(3)(c) is a reference to the parties in a given dispute.  Canada is of the view that the 
reference to "parties" is a reference to the parties to the treaty that is being interpreted.  In the case of 
the WTO Agreement, the rules of international law in question would have to be applicable in the 
relations among all the WTO members.  
                                                     
 
33 Dr. Andow, Responses to Questions, para. 102.01.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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  (b) May they be used as additional factual evidence of the ordinary meaning of 
terms contained in Annex A of the SPS Agreement, as the United States appears to suggest in its rebuttal at para. 6 of attachment II?  (The United States is 
invited to provide elaboration on its statement at para. 6.) 
 
53. Notwithstanding the fact that Codex Sta ndards 192 and 193, and ISPM No. 11 are not 
captured by any of the categories of Article 31 of the Vienna Convention , they may be relevant as 
supplementary means of interpretati on pursuant to Article 32 in order to confirm the meaning of terms 
resulting from the application of Article 31, or to  determine the meaning when the interpretation 
according to Article 31 leaves the meaning ambiguous  or obscure, or leads to a result which is 
manifestly absurd or unreasonable ( e.g., the EC's argument that risks arising from allergens in the 
context of food safety is excluded from the scope of the SPS Agreement  because the specific term 
"allergen" is not explicitly included in paragraph 1(b) of Annex A). 
 
141. With reference to Annex (B)(1) of the SPS Agreement, please answer the following 
questions:   (a) Does the term "sanitary and phytosani tary regulations" cover administrative 
decisions which relate to the operation of approval procedures and which are 
generally applicable?  
 
54. Yes.
34  The definition found in footnote 5 indicates that the list ("laws, decrees or 
ordinances") is illustrative rather than exhaustive.  Article 7 states clearly that "Members shall notify 
changes in their sanitary or phyto sanitary measures"; this obligation is elaborated upon in paragraph 1 
of Annex B, where it states "Members shall ensure that all sanitary and phytosanitary regulations 
which have been adopted are published promptly…".  This would include "administrative decisions 
which relate to the operation of approval procedures and which are generally applicable".  As Canada 
has already demonstrated, the moratorium  is a measure that falls within the scope of Article 7 and 
paragraph 1 of Annex B; therefor e the EC was under an obligation to "notify" the "change" in its 
existing regulatory regime for the assessment a nd approval of biotech pr oducts for environmental 
release and for food safety purposes. 
 
 (b) May the phrase "sanitary and phytosanitary regulations which have been 
adopted" be interpreted to encompa ss also sanitary and phytosanitary 
regulations which have been adopted de facto  (e.g., generally applicable decisions 
which have been reached informally and which are unrecorded)?    
 
55. Yes.  This is precisely the purpose of Article 7 and Annex B of the SPS Agreement .  As the 
Appellate Body stated:  
The object and purpose of paragraph 1 of A nnex B is 'to enable interested Members 
to become acquainted with' the sanitary and phytosanitary regulations adopted or 
maintained by other Members and thus to  enhance transparency regarding these 
measures.  In our opinion, the scope of a pplication of the publication requirement of 
paragraph 1 of Annex B should be interpreted in the light of the object and purpose of 
this provision.
35  
56. If the provision were to be given a more restrictive scope, for example, by only including 
measures that had been formally adopted ( de jure ), WTO Members could easily evade their 
                                                      
34 Canada First Written Submission, paras. 246-253. 
35 Japan – Agricultural Products II , Report of the Appellate Body, para. 106. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-68 
  
 obligations under Article 7 and para graph 1 of Annex B by structuring their decision-making in such a 
way as to avoid formal decisions with respect to SPS measures.  This would be contrary to one of the 
central principles underlying the WTO Agreement as a whole, that is, the promotion of transparency 
with respect to all measures affecting trade.  The EC would be able to claim that, because the 
moratorium  was not formally adopted via a decision of one of the Community organs, there was no 
obligation on the EC to notify the moratorium or to publish it promptly.  Such an argument would be completely at odds with both the letter and the spirit of the WTO rules.  142. Please explain the meaning and rationale of the requirement in Article 2.2 that SPS measures be "based on scientific principles" and how this is different from the requirement that SPS measures not be maintained "without sufficient scientific evidence".  
 
57. Generally speaking, the reference in Article 2.2 to "scientific principles" relates to the 
methodological soundness and rigour of the process wh ereby the "scientific evidence" relied upon to 
support the measure in question is adduced.  "Scien tific principles" are reflected to some degree 
reflected in the requirements set out in Articles 5.1 through 5.3 and in the definition of "risk assessment" found in paragraph 4 of Annex A.  58. "Scientific" is, in relevant part, defined as "of,  pertaining to, or of the nature of science" and 
"valid according to the objective principles of scientific method".
36  "Science" is defined as "a branch 
of study that deals either with a connected body of demonstrated truths or with observed facts 
systematically classified and more or less comprehended by general laws, and which includes reliable methods for the discovery of new truth in its own domain".
37  "Principle" has a variety of meanings, 
the most relevant definitions be ing "a fundamental truth or propo sition on which others depend" and 
"a general or inclusive theorem or law, having nu merous special applications across a wide field".38 
 59. The foregoing suggests that "scientific principles"  as used in Article 2. 2 relates to the use of 
scientific methods of analysis, such as empirici sm, objectivity, peer review and falsifiability 
(hypotheses can be tested and previous results verified  or refuted).  It is important that the data and 
other information put before the risk assessor is free from bias.  In other words, it addresses the 
scientific rigour of the knowledge relied upon by the ri sk assessor.  This can be distinguished from the 
term "scientific evidence", which focuses on the re lationship between the conclusions of the risk 
assessment – rather than its conduct per se  – and the risk management (SPS) measure selected. 
 60. To some degree, the notion of "scientific princi ples" is reflected in the requirements set out in 
Article 5.2 and 5.3 with respect to the conduct of th e risk assessment, and in  the definition of "risk 
assessment" found in Annex A. The two provisions speci fy, to a certain degree, the types of factors 
that must be included in the risk assessment, a nd the definition establishes the rigour that must be 
observed in its conduct.  
143. The Panel notes a number of instances where the same or a related product was 
apparently submitted under separate applications fo r approval.  This appears to be the case for 
Monsanto Roundup Ready oilseed rape GT73 (EC-70,  EC-79);  Syngenta Bt 11 maize (EC-80, 
EC-92, and related EC-69);  Pioneer/Dow AgroSc iences Bt corn Cry1F (1507) (EC-74, EC-75, 
EC-95);  Monsanto Roundup Ready corn NK603 (EC-76, EC-96);  Monsanto Roundup Ready corn GA 21 (EC-78, EC-85, EC-91); and the various  "stacked" products.  To what extent does 
the assessment by a lead CA, the relevant EC  Scientific Committee and any information 
                                                     
 
36 The New Shorter Oxford Dictionary , vol. 2 (Oxford: Clarendon Press, 1993), p. 2717. (Exhibit 
CDA-203) 
37 Ibid. 
38 Ibid., p. 2356. (Exhibit CDA-204)  WT/DS291/R/Add.4 
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 provided by a notifier under one application serv e as a basis for consideration of another 
application for the same or a related product? 
 61. There are many cases in which the data provi ded by the notifier in support of applications 
under both the Directives 2001/18  (and 90/220 ) and Regulation 258/97  is fundamentally similar.  For 
instance, in relation to risk assessments for food,  feed or environmental release, the molecular 
characterization data, including data regarding the inserted gene, the nature and level of proteins 
expressed by that gene, the toxicology or allergenic ity of the new expressed proteins, is essentially the 
same.  Consequently, the assessment of a product by  one scientific committee could have and should 
have served as a basis for consideration of another application for the same or related product to the 
extent that the risks being assessed were the same or similar.  
144. The Panel notes that a number of products containing the same transgenic modifications 
as products at issue in this dispute were prev iously approved by the European Communities 
prior to July 1998 (eg, swede rape tolerant to glufosinate ammonium (MS1, RF1) and (MS1, 
RF2);  swede rape tolerant to glufosinate ammonium (Topas 19/2);  maize tolerant to 
glufosinate ammonium (T25);  maize expressing  the Bt cry1A(b) gene (MON 810);  maize 
tolerant to glufosinate ammonium and expressi ng the Bt cry1A(b) gene (Bt-11);  soybean 
tolerant to glyphosate;  chicory tolerant to glufosinate ammonium;  maize Roundup Ready 
NK603).  To what extent and how were the prev ious assessments of potential risks to human, 
animal or plant health and/or the environment associated with these transgenic modifications 
taken into consideration in the evaluation of po tential risks arising from the products at issue 
before the Panel? 
 62. This question highlights the extent to wh ich the products with pe nding applications are 
similar to products that have already been approved by the EC in terms of their genetic modification.  
Indeed, the range of transgenic modification in currently commercialized products is very limited 
(tolerance to specific herbicides and the expressi on of specific toxins).  These transgenic 
modifications, and their associated potential risks, are well-understood.    
63. To the extent that there are similarities betw een different products with the same transgenic 
modification, such as the transformation method used, the type of protein expressed, the plant biology, the end use to which the product will be put, the previous risk ass essments evaluating these 
elements are relevant to and s hould have been taken into consideration in the evaluation of the 
potential risks arising from the products at issue before  the Panel.  For instan ce, where the toxicology 
of the expressed protein had already been examined for one product ( e.g. soybean tolerant to 
glyphosate or oilseed rape Ms1xRf1 and Ms1xRf2 to lerant to glufosinate ammonium), this should 
have simplified considerably the toxicological ev aluation where the same protein was expressed by a 
second product ( e.g. NK603 maize and Ms8xRf3 oilseed rape, respectively).  
 64. In the evaluation of potential risks arising fro m the products at issue before the Panel, the EC 
does not appear to have given much weight to th e previous assessments of potential risks associated 
with these transgenic modifications undertaken by its  own scientific bodies.  Had credible scientific 
evidence existed to bring into question the scientif ic conclusions regarding the previously approved 
products, one would have expected the EC to have  revoked the approval of these products.  In no case 
did the EC do so.  Indeed, where EC Member Stat es adopted safeguard measures, in no case did the 
EC consider the additional information put forth by  the Member State in attempting to justify its 
safeguard measure sufficient to warrant th e revocation of the initial approval.   
 WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-70 
  
 For all complaining parties
: 
 
145. With reference to para. 7 of the European Co mmunities second oral statement, is it "for 
the Complainants to rebut this evidence [submi tted by the European Communities] by putting 
forward arguments and evidence as to why reaso ns for delays put forward in the European 
Communities' submissions are unjustified"? 
 
65. Canada disagrees.   Canada and th e other complainants have established a prima facie  case 
that the moratorium  and product-specific marketing bans  are not based on a risk assessment contrary 
to Articles 5.1 and 2.2 of the SPS Agreement  and that the resulting delay in processing applications 
under the EC's approval regime for biotech products is  undue contrary to Annex C.  The onus shifts to 
the EC to demonstrate that the moratorium  and product-specific marketing bans  are either (a) based 
on a risk assessment or (b) justified under Article 5. 7.  The EC cannot do the former because there is 
no risk assessment upon which the bans can be based  and has not even advanced an argument in 
relation to the latter.  66. In terms of undue delay, Canada has demonstrated that there has been undue delay in the completion of the approval procedures for all specific products of interest to Canada.  In fact, the 
chronologies for individual applications, rather than refuting the prima facie  case established by 
Canada, confirm the validity of Ca nada's arguments regarding the moratorium  and resulting product-
specific marketing bans . 
 
For Canada
: 
 
147. With reference to exhibit CDA-118, how does this exhibit support Canada's assertion at 
para. 38 of its rebuttal? 
 
67. The second sentence of paragraph 38 should r ead: "[a]t a 28 January 2003 meeting of the 
Agriculture Ministers, several Member States stated their opposition to lifting the moratorium until the regulations on genetically modified food and feed
 were adopted."  In terms of traceability and 
labelling, Canada refers the Pa nel to paragraphs 29 and 30 of its Second Written Submission, and 
exhibits referred to therein, for support for the asser tion that EC Member States continued to refuse to 
lift the moratorium  until new legislation regarding traceability and labelling was in place.    
 
148. Please explain your contention, in paragraph 73 of your Third Written Submission, that 
"in the only instance where an EC member St ate raised concerns about "biogeochemical 
cycles", the concern was not pursued." 
 
68. On 14 March 2000, the EC Member State in ques tion, Italy, made identical requests for more 
information on "biogeochemical cycles" in relati on to both oilseed rape Falcon GS40 and Ms8xRf3.  
Indeed, the documentation provided by the EC  in relation to each request is identical  – see Exhibits 
EC-62 – attachment 95 and EC-63 – attachment 87. Given that the two products, Falcon GS40 and 
Ms8xRf3, both oilseed rape cultivars with a tr ansgenic modification conferring tolerance to 
glufosinate-ammonium, were being assessed in paralle l, Canada considers the Italian requests, made 
on the same date in relation to oilseed rape products  with the same transgenic modification, to be a 
single request.   
 
69. The notifier's response to the Italian request, sent on November 13, 2000,39 was transmitted to 
all EC Member States.40  The notifier explained that the proteins  that confer tolerance to glufosinate-
                                                      
39 Exhibit EC-63 – attachment 88.  Also, see Exhibit EC-62 – attachment 97. 
40 Exhibit EC-63 – attachments 89 and 90.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
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 Page F-71 
  
 ammonium (the PAT enzyme) are highly specific a nd hence there is no reason to expect that the 
product would have any impact on biogeochemical cycles.
41  Following receipt of this response, it 
does not appear that the any Member State disputed  the notifier's explanation or raised additional 
concerns in relation to "biogeochemical cycles".  Tw o years later, the notifier re-stated its conclusion 
in this regard in its revised environm ental risk assessment submitted pursuant to Directive 2001/18 .42  
Again, the relevant EC authorities do not appear  to have disputed this specific conclusion. 
 70. Canada is unaware of any other specific re quest for information concerning "biogeochemical 
cycles" in relation to a specific pending application. 
 
For Canada, European Communities and the United States
: 
 
168 (EC-72). The Panel notes that the chrono logy provided by the European Comunities 
shows no actions on this application betw een 12/99 (when according to the European 
Communities the UK CA allegedly advised the company that the dossier required substantial 
revision and clarification) and its re-submission  in 1/03 under Directive 2001/18.  Could the 
parties please explain the lack of action?   
 
71. Canada has not made any claims in relation to  this particular product – oilseed rape T45 and 
accordingly is not in a position to  comment on this application. 
 
                                                      
41 Exhibit EC-63 – attachment 88. 
42 Exhibit EC-63 – attachment 112, p. 40. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-72 
  
 ANNEX F-5 
 
REPLIES BY CANADA TO ADDITIONAL QUESTIONS POSED BY THE PANEL  
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
11 MARCH 2005 
  
For all parties:
 
 170. With reference to EC Directive 2001/18, Annex II, Section C.2.1, please indicate for each 
of the listed potential adverse effects of GM Os whether measures applied to prevent or 
minimise such effects fall within the scope of A nnex A(1) of the SPS Agreement, and if so, why.  
The parties are also invited to address Sect ion D with the same question in mind.  
 
1. Measures applied to prevent or minimize each of the following "potential adverse effects of 
GMOs," as set forth in Directive 2001/18 , Annex II, Section C.2.1, fall within the scope of 
Annex A(1) of the SPS Agreement . 
 
 – disease to humans including allergenic or toxic effects (see for example items II.A.11. 
and II.C.2(i) in Annex III A, and B 7 in Annex III B); 
  – disease to animal and plants including toxic,  and where appropriate, allergenic effects 
(see for example items II.A.11 and II.C.2 (i) in Annex II A, and B 7 and D 8 in 
Annex III B); 
  – altered susceptibility to pathogens facilita ting the dissemination of infectious diseases 
and/or creating new reservoirs or vectors; 
 
2. Measures to protect against these three types of adverse effects fall squarely within 
Annex A(1)(b) of the SPS Agreement , which refers to measures applied "to protect human or animal 
life or health … from risks arising from … toxins or  disease-causing organisms in foods, beverages or 
feedstuffs."  The "adverse effects" set forth above  concern the potential that a GMO product could be 
toxic to or cause disease in (directly or by increasing susceptibility to disease) humans or animals, 
which are the same risks as those enumerated in A nnex A(1)(b).  This conclusion is confirmed by 
each of the following information requirements for GMO notifications referenced in the first two 
provisions above: (1) item II.A.11 in Annex III A, wh ich relates to "pathological traits" of GMOs, 
including "infectivity, toxigenicity , virulence [and] allergenicity," (2) item II.C.2(i) in Annex III A, 
which relates to "considerations for human health and animal health," arising from the compromised 
clinical efficacy of such antibiotics including "toxi c or allergenic effects" of GMOs, (3) item B 7 in 
Annex III B, which relates to "potential interacti ons, relevant to the GMO…including information on 
toxic effects on humans," and (4) item D 8 in Annex III B, which relates to "toxic, allergenic or other 
harmful effects" arising from GMO crops when u sed for "animal feedstuffs."  For these reasons, 
measures to address these effects fall within the Annex A(1)(b) of the SPS Agreement . 
 
3. Measures to prevent the second and third types of adverse effects above also could fall within 
Annex A(1)(a) of the SPS Agreement , which refers to measures applied "to protect animal or plant life 
or health … from risks arising from the entry, est ablishment or spread of pests, diseases, disease-
carrying organisms or disease-causing organisms."  A measure falls within this provision if the 
adverse effects to animal health against which th e measure seeks to protect arise from exposure to a 
GMO product other than a feedstuff. 
  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-73 
  
 4. Annex II, Section C.2.1 also includes the following "adverse effects": 
  – effects on the dynamics of population species in the receiving environment and the 
genetic diversity of each of these populations (see for example items IV B 8, 9 and 12 
in Annex III A); 
  – effects on biogeochemistry (biogeochemical  cycles), particularly carbon and nitrogen 
recycling through changes in soil decomposition of organic material (see for example 
items II.A.11(f) and IV.B.15 in Annex A, and D 11 in Annex III B). 
 5. Measures to prevent these two types of adverse effects fall within the scope of Annex A(1)(a) 
of the SPS Agreement , which refers to measures applied "to pr otect animal or plant life or health … 
from risks arising from the entry, establishment or  spread of pests," or Annex A(1)(d) of the SPS 
Agreement , which refers to measures applied "to prevent or limit other damage within the territory of 
the Member from the entry, establishment or spread of pests."  Each of these adverse effects concerns 
the impact of a GMO product as a "pest," which the SPS Agreement  defines to include "weed."  More 
specifically, these adverse effects refer to the risk that a GMO product becomes a "weed," that is, a 
persistent and invasive plant that grows in envi ronments where it is not wanted and overtakes other 
plant species, raising broader ecological concerns.
1  The adverse effects, therefore, relate to "other 
damage" caused by the "entry, establishment or spread of pests."  This conclusion is confirmed by the 
following information requirements for GMO notifica tions referenced in the two provisions above: 
(1) items IV B 8 in Annex III A, which relates to  the "potential for excessive  population increase in 
the environment," and (2) item IV B 9, which rela tes to the "competitive advantage of the GMOs in 
relation to the unmodified [organisms]."  Accordingl y, measures to prevent or minimize these adverse 
effects fall within the scope of Annex A(1)(d) of the SPS Agreement .    
 
-compromising prophylactic or therapeutic medical, veterinary, or plant protection 
treatments, for example by transfer of gen es conferring resistance to antibiotics used 
in human or veterinary medicine (see for example items II.A.11(e) and II.C.2(i)(iv) in 
Annex III A); 
6. Measures to prevent such adverse effects fa ll within the scope of Annex A(1)(a) of the SPS 
Agreement , which refers to measures applied "to protect animal or plant life or health … from risks 
arising from the entry, establishment or spread  of…diseases, disease-carrying organisms or disease-
causing organisms."  If the antibiotic marker gene compromises the clinical efficacy of antibiotics 
used to protect animal life or health, then th e measure would fall clearly within Annex A(1)(a).2 
 
7. To the extent that the antibiotics in questi on are used to treat diseases arising from "disease-
causing organisms" found in food, beverages or f eedstuffs, the risks to human and animal life or 
health arising from the compromised clinical e fficacy of such antibiotics would be covered by 
Annex A(1)(b).  To the extent that the antibioti cs in question are used to treat diseases in humans 
arising from "diseases carried by animals, plants or  products thereof, or from the entry, establishment 
or spread of pests", the risks to human life or hea lth arising from the compromised clinical efficacy of 
such antibiotics would be covered by Annex A(1)(c).  
                                                     
 
1 See Canada Answers to Panel Questions (7 March 2005), Question 120, paras. 10, 11. 
2 See Canada Answers to Panel Questions (16 June 2004), Question 40, para. 74. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-74 
  
 171. In Japan – Apples , the Appellate Body interpreted Article 5.7 of the SPS Agreement and 
notably the phrase "in cases where relevant scientifi c evidence is insufficient".  It stated at 
para. 179 that:   
Article 5.1 [...] informs the other provisions  of Article 5, including Article 5.7.  
We note, as well, that the second sentence of Article 5.7 refers to a "more 
objective assessment of risks".  These co ntextual elements militate in favour of a 
link or relationship between the first requirement under Article 5.7 and the 
obligation to perform a risk assessment under Article 5.1:  "relevant scientific evidence" will be "insufficient" within the meaning of Article 5.7 if the body of available scientific evidence does not allow, in quantitative or qualitative terms, 
the performance of an adequate a ssessment of risks as required under 
Article 5.1 and as defined in Annex A to the  SPS Agreement . [...] The question is 
whether the relevant evidence [...] is sufficient to permit the evaluation of the likelihood of entry, establishment or spread of, in this case, fire blight in Japan. 
In this regard, please answer the following questions: 
 
 (a) Is there a reason to believe that a lack of relevant scientific evidence could 
prevent a Member from performing a risk assessment "as required under 
Article 5.1 and as defined in Annex A to the SPS Agreement "?  Or is it rather a 
question of that Member perhaps being unable, due to the insufficiency of scientific evidence, to conduct a fully obj ective risk assessment, such that any 
measure based on that assessment migh t be maintained without sufficient 
scientific evidence? 
 
8. Canada is not sure that it fu lly understands the nature of the Panel's question, but it will do its 
best to respond to what it believes the question to be.  
9. Yes.  It is possible that a lack of releva nt scientific evidence could prevent a Member from 
performing a risk assessment as required under Article 5. 1 and as defined in para graph 4 of Annex A.  
In the quoted passage, Canada understands the Appell ate Body to be indicating that the threshold for a 
finding that the "relevant scientific  evidence is insufficient" and that Article 5.7 therefore might be 
applicable is linked to the obliga tion to perform a risk assessment foun d in Article 5.1.  Thus, it is 
only when the relevant scientific ev idence is insufficient to perform a risk assessment as required by 
Article 5.1, and as defined in Annex A(4) of the SPS Agreement , that Article 5.7 can be successfully 
invoked.  Earlier in the paragraph, the Appellate Body refers to Article 5.1 as a "key discipline".  The 
Appellate Body's reference to the phrase "a more objective assessment of risk" implies a connection 
between this phrase and a risk assessment as defined in  Annex A(4).  Hence, the two questions posed 
in paragraph (a) are in reality two sides of the same coin, with the proviso that Canada doubts that 
there is such a thing as a "fully objective" risk assessment.  Risk assessments, like all processes of 
observation and evaluation involving human bei ngs, inevitably involve a certain amount of 
subjectivity.  
 (b) Does the phrase "more obj ective assessment of risks" in Article 5.7 support the 
view that a provisional measure adopted in accordance with Article 5.7 must be 
based on risk assessment, as required by Article 5.1? (Canada may wish to elaborate further on what it has alread y said in its supplementary rebuttal in 
relation to this point.) 
 10. The structure and relationship between Articl es 2.2, 5.1 and 5.7 suggest that the phrase "a 
more objective assessment of risk" in Article 5.7 refers  to a risk assessment as defined in Annex A(4).   WT/DS291/R/Add.4 
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 However, this does not mean that th e initial "measure adopted in acco rdance with Article 5.7" must be 
based on a risk assessment of the same standard as that required by Article 5.1.  That would be 
contrary both to the logic underlying Article 5.7, a nd the text of that provision, which refers to the 
adoption of a measure "on the basis of available pe rtinent information".    As Canada has already 
argued, the reference in the second sentence of Arti cle 5.7 to a "more objective" assessment of risk 
implies that "on the basis of available pertinent information" means that a risk assessment of some 
form must be carried out, even if it does not meet the standard set out in Annex A(4).
3   It is also clear 
from the context that the "available pertinent inform ation" refers to scientific information concerning 
risks to human, animal or plant life or health. 
 11. Furthermore, the text of Article 5.7, as well as logic, suggests that the phrase "a more 
objective assessment of risk" means a risk assessment of a standard  that will enable the Member 
concerned to shift the legal basis for its measure , unless it repeals it entirely – from Article 5.7 to 
Articles 5.1 and 2.2.  This inference is supported by  the following considerations.  First, measures of 
the type covered by Article 5.7 must be adopted provisionally.  Second, a duty is imposed on the 
WTO Member concerned to "seek to obtain the a dditional information necessary for a more objective 
assessment of risk".  Third, the Member concerned is required to review its measure according to the 
"more objective assessment of risk".  In other words,  the initial, or provisional, measure is intended to 
be a temporary solution while the Member gathers th e scientific evidence necessary to complete a risk 
assessment that meets the standard set out in Article 5.1 and Annex A(4). 
 
172. Annex A(1) of the SPS Agreement sugg ests that "approval procedures" are SPS 
measures.  When a Member decides to delay the completion of such an approval procedure for 
a number of days, would such action be another SPS measure within the meaning of 
Annex A(1), or would such action rather need to be characterized as an application of an SPS 
measure (the application of the approval procedure)? 
 
12. Canada refers the Panel to Part V II of Canada's First Written Submission. 
 13. Canada understands the ques tion to be:  under what circumstances can a delay in the 
completion of an SPS approval procedure become an  SPS measure.  The answer, of course, depends 
on the factual circumstances.  14. First, Canada agrees with the Panel that approval procedures are SPS measures.  Annex A(1) 
of the SPS Agreement  not only suggests that they are SPS measu res; it states it explicitly: "Sanitary 
and phytosantiary measures include all releva nt…procedures including…testing, inspection, 
certification and approval procedures…".  15. Second, the scenario set out in the Panel's question differs considerably from the factual 
situation in the present case.  Canada would agree with the proposition that, if a Member simply 
delayed making a final decision on the approval of  a given product for a few days, and communicated 
this in clear terms to the applicant, explaining wh y it was delaying the decision, how much time was 
involved, and informed the applicant what, if an ything, it could do to expedite the process, this 
appropriately would be characterized as "an applicat ion of an SPS measure", rather than a separate 
SPS measure.  
16. However, that is not the situation in this dis pute.  In general, a delay in the completion of an 
SPS approval procedure becomes an SPS measure when the source of the delay supersedes the approval procedure as the measure that exerts eff ective control over subject matter of the approval 
procedure, in this case the product applicati ons.  The EC has decided not to decide.  The moratorium  
                                                     
 
3 Canada Third Written Submission, para. 114. WT/DS291/R/Add.4 
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Page F-76 
  
 is a conscious decision on the part of the EC not to  approve biotech products for an unspecified period 
of time.  The moratorium  is a separate SPS measure, distinct from the approval procedure.  Although 
the moratorium is inextricably linked to the approval pro cedure by virtue of its motivation, and 
through its effect on the approval procedure, the moratorium  essentially renders that procedure 
irrelevant, in the sense that it prevented the biotech  products with outstanding applications from being 
approved.  In this light, the various product applica tions are subject not merely to a delay, but to 
decisions not to approve (which is not the same as  a decision to reject) the products.  These decisions, 
or product-specific marketing bans , are a direct consequence of the moratorium , but constitute 
separate SPS measures.  They also represent strong evidence of the existence of the moratorium . 
 17. Furthermore, Canada draws the Panel's atten tion to Canada's answer to Panel Question 45, 
wherein Canada made the point that the EC's "decision not to decide", in many instances, can be equated with a complete deni al to approve a given product.
4   Given the limited commercial shelf-life 
of many of these products, a prolonged delay in a pproval – and by any reasonable measure delays of 
five years or more must be considered prolo nged – has led to lost and irretrievable market 
opportunities.  By the time these products receive approval, if they ever do, the market will have passed them by.  
173. May the fact that existing approval legislation does not permit a Member to adopt 
certain risk management measures which that Member considers appropriate serve as a 
justification, for purposes of an analysis under Annex C(1)(a) of the SPS Agreement, for 
delaying approval procedures conducted pursuan t to the existing legislation?  Are the 
provisions of Article 27 of the Vienna Convention on the Law of Treaties relevant to such a situation?  
 
18. To a degree, this question is related to the Panel's Question 48(f), and Canada refers the Panel 
to paragraph 98 of Canada's Answers to  the Panel's Questions (June 16, 2004). 
 19. The issue is not whether the WTO Member considers the risk management measures appropriate, but whether the risk management measur es (SPS measures) are justified in relation to the 
outcome of a risk assessment that meets the require ments of Article 5.1 and Annex A(4), and viewed 
in the light of the Member's appropriate level of pr otection.  That is, in the words of the Appellate 
Body, "a panel has to determine whether an SPS measure is sufficiently supported or reasonably 
warranted by the risk assessment".
5 
 
20. If a risk management measure that is "suffi ciently supported or reasonably warranted by the 
risk assessment" does not fall within the scope of th e Member's "existing approval legislation" and no 
other risk management measure exists that would also achieve the Member's appropriate level of 
protection, and which falls within the scope  of the approval legislation, then it may  be justified for the 
Member concerned to delay approving the produc t until the approval legislation can be amended 
accordingly.  In other words, it may not cons titute "undue delay" within the meaning of 
Annex C(1)(a). 
 21. However, this conclusion must be subject to the proviso  that the Member concerned is also 
under an obligation to make the necessary legislativ e changes "without undue delay" so as to be in a 
position to make a final decision as quick ly as possible in the circumstances. 
 
22. In the context of the above situation, Article 27 of the Vienna Convention  would not be a 
relevant consideration to the extent that it is not a situation where a party to a treaty is failing to 
                                                     
 
4 Canada's Answers to Questions from the Panel, 16 June 2004, para. 86. 
5 EC – Hormones , Report of the Appellate Body, para. 186.  WT/DS291/R/Add.4 
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 perform its obligations.  The scenario described in Ca nada's answer is one where the party is acting in 
a manner consistent with its treaty obligations, once again, subject to the proviso  that it must make the 
necessary legislative changes as quickly  as possible in the circumstances. 
 
23. If, on the other hand, the risk management m easure in question is not sufficiently supported or 
reasonably warranted by a risk assessment that meet s the requirements of Article 5.1 and Annex A(4) 
or the existing legislation allows for the impositi on of the risk manageme nt measure in question,
6 any 
delay in the completion of an approval procedure in order to make legislative changes to allow such a 
risk management measure to be adopted in a manner consistent with the Member's internal law would 
be undue, and Article 27 of the Vienna Convention  would apply. 
 
174. With regard to Article 2.2 of the TBT Agreement: 
 
 (a) Please explain the phrase "the risks no n-fulfilment [of a legitimate objective] 
would create" and illustrate using an example. 
 
24. The phrase "the risks non-fulfilment [of a le gitimate objective] would create" can only be 
understood with reference to the underl ying purpose of Article 2.2 of the TBT Agreement , which is the 
proscription of "unnecessary obstacles to interna tional trade".  Technical regulations can be 
unnecessary obstacles to international trade in several  ways.  Measures that are not related to a 
"legitimate objective", or that do not fulfill or materially contribute to the fulfilment of, a "legitimate objective", are unnecessary obstacles to international trade.  If the objective is legitimate and the 
technical regulation fulfills it or materially contri butes to its fulfilment, it can still be an unnecessary 
obstacle to trade if it is more trade-restrictive than is necessary.  This would be the case if an 
alternative measure exists that would achieve the same objective and is less trade-restrictive.  The 
requirement to "tak[e] account of the risks non-fulfilment would create" imposes an obligation of proportionality that is linked to the legitimate objectiv e.  In other words, whether a given measure is 
more trade-restrictive than is necessary depends, in  part, on the specific risks being addressed.  The 
nature and magnitude of the risks involved must be taken into account in determining how trade-
restrictive a technical regulation can be without b ecoming an unnecessary obstacle to trade.  In this 
context, the "risks non-fulfilment would create" m eans the risks that would be realized, in other 
words, the occurrence of adverse effects.  25. As an example, let us say that a technical regulation is designed to protect human beings from 
the risks arising from using a certain household ch emical cleaning product.  However, the hazards 
inherent in the chemical are mild; although the ch emical has toxic properties, it does not cause any 
serious acute impairment of health, nor does it give rise to any chronic negative health effects.  At 
most, upon inhalation or ingestion at a given dose,  a person might suffer from a mild headache and 
nausea that passes quickly.  To seek  to prevent even these negative ef fects, the regulator has several 
choices: it can require labelling to warn prospectiv e users; it can require the concentration of the 
chemical to be so low that the adverse effect is essentially neutralized, keeping in mind that the higher 
the concentration, the more effective the cleaning product is; and/or it can require a child-proof cap 
and spraying mechanism.  It can also ban the use of  the chemical for this pur pose.  In this scenario, 
the objective is legitimate and all of the proposed measu res either fulfill or materially contribute to the 
fulfilment of the objective.  Some are more trade -restrictive than others.  The determination of 
whether any one measure is "more trade-restrictive than necessary to fulfil [the] legitimate objective" 
has to take into account the risks – identified above  as being fairly mild – that non-fulfilment of the 
legitimate objective would create.  
                                                     
 
6 Canada Second Written Submission, Part II.B.1 and 2. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-78 
  
  (b) Article 2.2 refers to "scientific informat ion" which must be taken into account in 
assessing risks.  Article 5.2 of the S PS Agreement, on the other hand, refers to 
"scientific evidence".  Are these different concepts?  Why?  
 
26. The difference between "scientific information"  and "scientific eviden ce" can be seen in the 
ordinary meanings of the words "information" and "evidence."  The ordinary meaning of "information" is "[k]nowledge or facts communicat ed about a particular subject, event, etc."
7  T h e  
ordinary meaning of "evidence" is "facts or test imony supporting a conclusion, statement or belief".8  
It is logical that the SPS drafters would use the term "scientific evidence" in an agreement where a 
core obligation is to base SPS measures on a scientific  risk assessment.  This obligation requires WTO 
Members to provide specific factual support that meets a higher standard of quality and reliability, that is, "evidence", for their SPS measures.  The specific reference to "scientific evidence" in 
Article 5.2 is a reflection of the requirements of Ar ticle 2.2 that a measure not be maintained without 
sufficient scientific evidence, and the defin ition of a risk assessment in Annex A(4). 
 27. The TBT Agreement , by contrast, does not require, as an explicit obligation, that technical 
regulations be based on a risk assessment.  TBT draf ters used the term "scientific information" in 
respect of an obligation that requires Members to take account of scientific facts, where they are 
relevant to the selection of a particular measure.  However, the TBT Agreement  does not necessarily 
require those facts, as a matter of legal obligation per se , to be of a quality commensurate with that 
inherent in a risk assessment as defined in the SPS Agreement .  In basic terms, the distinction between 
"scientific evidence" in Article 5.2 of the SPS Agreement  and "scientific information" in Article 2.2 of 
the TBT Agreement  relates to the differences in the respectiv e obligations of the two agreements for 
measures to have a factual and/or scientific basis. 
 
28. This does not mean, however, that a technical  regulation would never need to be based on a 
full risk assessment.  It is quite possible, in Canada 's view, that some types of technical regulations 
will need to be based on a full risk assessment, and that, as a matter of an evidentiary burden, the 
WTO Member whose technical regulation is in issue will not be able to demonstrate that its measure 
is in fact based on such a risk assessment.  Whethe r a technical regulation, as a matter of fact, needs to 
be based on a risk assessment can only be determined on a case-by-case basis. 
 29. In the particular case of the product-specific marketing bans  and the EC Member State 
national measures , risk assessments are necessary in order for demonstrate that these measures are 
indeed not more trade-restrictive than is necessar y to achieve a legitimate objective, taking into 
account the risks that non-fulfilment would create.  As Canada has already demonstrated,
9 there is no 
evidence to support the need for complete bans on e ither the biotech products of interest to Canada 
that are subject to the product-specific marketing bans , or the biotech products that are subject to the 
EC Member State national measures . 
 
175. Are measures applied to ensure co-existen ce of biotech crops and non-biotech crops 
covered by Annex A(1) of the SPS Agreement or do they fall, in whole or in part, outside of the 
scope of Annex A(1)?  
 
30. Canada understands co-existence to be about  reducing the unintended admixture of biotech 
and non-biotech seeds or crops.  In the EC, the intentional or adventitious presence of biotech 
                                                      
7 The New Shorter Oxford Dictionary, vol. 1 (Oxford: Clarendon, 1993), p. 1364. (Exhibit CDA-205)) 
8 Ibid., p. 867. (Exhibit CDA-206) 
9 Canada First Written Submission, paras. 337-352 and 486-499.  WT/DS291/R/Add.4 
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 products above a prescribed threshold triggers the need for crops to be labelled as containing GMOs.
10  
This is a requirement that has been imposed by EC legislation.  The consistency of this legislation 
with the EC's WTO obligations has yet to be determined  and is not an issue in this case.  What is in 
issue, however, is whether the absence of EC me asures relating to co-existence can be a legitimate 
reason for delaying an SPS approval procedure.11 
 31. A distinction must be made between risks to  plant life and health arising from the admixture 
of biotech and non-biotech seeds or crops and the "potential economic impact " arising from the 
imposition of labelling requirem ents.  A measure applied for the purpose  of protecting plant life or 
health from risks arising from the admixture of biotech and non-biotech seeds or crops would fall within the scope of Annex A(1)(a) or (d) of the SPS Agreement .  For example, where a biotech 
product could be considered a "pest" for purposes of the SPS Agreement  (e.g. if the biotech crop had 
traits that conferred greater fitness resulti ng in enhanced "invasiveness" or "weediness"
12), the 
economic impact  of introduction  of such pest could be considered "other damage" within the scope of 
Annex A(1)(d) of the SPS Agreement .  On the other hand, a measure applied solely to reduce or 
prevent the "potential economic impacts " of the admixture of biotech and non-biotech products 
resulting from the imposition of labelling thresholds  for biotech products would not fall under the SPS 
Agreement.    
 32. Were the EC's co-existence measures adopted solely  to reduce or prevent the "potential 
economic impacts " of the admixture of biotech and non-biotech products resulting from the 
imposition of labelling thresholds for GM products, the pertinent question in this case would be 
whether or not the economic aspects of co-existen ce can be a legitimate justification for delaying 
indefinitely an SPS approval procedure.  In Canada 's view, concerns about co-existence, arising from 
labelling thresholds for marketing purposes, cannot serve as a legitimate reason for delaying an 
approval procedure under the SPS Agreement .  For instance, the adoption of future measures to 
enhance consumer or producer choice ( e.g. a quality grading system for canned vegetables or 
labelling purely for consumer information purposes) w ould not be a legitimate justification to delay 
the approval of a product under an SPS approval pro cedure pursuant to Annex C(1)(a).  As the panel 
concluded in Indonesia – Autos , "the obligations contained in the WTO Agreement  are generally 
cumulative, can be complied with simultaneously and ... different aspects and sometimes the same 
aspects of [a measure] can be subj ect to various provisions of the WTO Agreement ."
13  Just as the 
panel in Indonesia – Autos  found that compliance with one WTO Agreement  would not excuse a 
Member from violating another WTO Agreement , so too must the Panel find here that EC must meet 
its obligations under the SPS Agreement  even if another WTO Agreement  were also to apply to the 
measure at issue. 
 33. Tellingly, the European Commission itself has stated that the economic aspects of co-existence must be distinguished from "the envi ronmental and health aspects dealt with under 
Directive 2001/18/EC ".
14  It logically follows that the EC and its Member States cannot block 
approvals under Directive 2001/18  on the basis of a putative "economic impact" of the admixture of 
                                                      
10 EC, Commission Recommendation of 23 July 2003 on guidelines for the d evelopment of national 
strategies and best practices to ensure the co-existence of genetically modified crops with conventional and 
organic farming , C(2003), pp. 6 and 7. (Exhibit CDA-165) 
11 See the Belgian Competent Authorities rational for failing to approve Ms8xRf3, Exhibit EC-63 – 
attachment 167, p. 3. 
12 Canada Third Written Submission, paras. 68 – 75. 
13 Indonesia – Autos , Report of the Panel, para. 14.56. 
14 EC, Commission Recommendation of 23 July 2003 on guidelines for the d evelopment of national 
strategies and best practices to ensure the co-existence of genetically modified crops with conventional and 
organic farming , C(2003), pp. 6 and 7. (Exhibit CDA-165) WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-80 
  
 biotech and non-biotech crops where no risks to human health and the environment have been 
identified.  To do so, would not only violate the EC's obligations under the SPS Agreement , but would 
seemingly violate the EC's own internal law.   
 
34. In any event, the EC itself has failed to distinguish between the economic aspects and the 
environmental health aspects of co-existence a nd has instead, when it suits its own purposes, 
attempted to distort an economic issue, of its own cr eation, into an issue concerning risks to the plant 
life and health. 
 
35. Canada has demonstrated that the purposes of the moratorium  and the product-specific 
marketing bans  must be inferred from the context, that the declarations – repeated and consistent – of 
the EC Member States confirm that the purpose of the moratorium  is to protect human health and 
environment from risks arising from biotech products, and that it is reasonable to infer the purpose of 
the moratorium  and the product specific marketing bans  is to protect against the same risks to human 
health and the environment against which the EC's  approval legislation is intended to protect.
15  In its 
First Written Submission, Canada demonstrated that  the purpose of the legislation, as expressed in 
preambular language and in its legislative history, is  the protection from risks of the type described in 
Annex A of the SPS Agreement .16  Similarly, the nine Member State national measures subject to 
challenge in this dispute fall with in the scope of Annex A of the SPS Agreement .17 
 
36. Throughout these proceedings, the EC has conced ed that its measures are designed to address 
risks to human health and the environment.  Ind eed, in its First Written Submission, the EC entitled 
the relevant section "Possible harmful eff ects on human health and the environment."18   
 
37. Yet in the face of the many statements by EC Member States and the overwhelming evidence 
that the EC's measures are SPS measures, the EC now  comes before the Panel and appears to suggest 
instead that the measures were and are taken to a ddress the economic risk to farmers arising from co-
existence.  As the economic risk to farmers as a result of the EC's own labe lling legislation would not 
be covered by the SPS Agreement , the EC would have the Panel conclude that the measures are 
therefore not subject to the disciplines of the SPS Agreement . 
 
38. Such a conclusion would be patently inco rrect.  The evidence presented by Canada during 
these proceedings and admitted by the EC in its own legislation demonstrates that these measures 
were taken to address the risks identified in Annex A of the SPS Agreement .  That they might also be 
taken to address other policy objectives is not relevant to their coverage under the SPS Agreement .  
The drafters of the SPS Agreement  could have written that an SPS measure was one that is applied 
"solely" or "primarily" or "chiefly" to one of the enumerated policy objectives.  They did not do so.  They provided that a measure that "is applied" to  accomplish one of the enumerated policy objectives 
and that affects trade would fall under the scope of the SPS Agreement , as set forth in Article 1. 
 
                                                     
 
15 Canada First Written Submission, paras. 160-162. 
16 EC – Hormones , Report of the Panel, para. 8.25. ("That the EC measures are, inter alia , "applied to 
protect human ... life or health" can be inferred from the preambles to, and legislative history of, [the relevant 
EC Directives].") 
17 Canada First Written Submission, paras. 376-385. 
18 EC First Written Submission, p. 14.  WT/DS291/R/Add.4 
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 For all complaining parties
: 
 
178. Please indicate whether the following allege d effects of biotech products fall within any 
of the subparagraphs of Annex A(1) of the SPS Agreement:  
 (a) Environmental components of biodiversi ty "outside human, animal or plant life 
or health, such as the ecological comple xes referred to in the Convention on 
Biodiversity" (EC rebuttal, para. 266). 
 
39. If humans, animals, and plants comprise the universe of living things and biodiversity is 
concerned with the diversity of living things, then  it is difficult to understand what component of 
biodiversity is "outside human, animal or plant life or health."  A measure taken to protect the 
"environmental components of biodiversity" certainly  could fall within Annex A(1), depending on the 
type of risks against which the measure seeks to pr otect.  Ecological processes, for instance, could fall 
within "other damage" under Annex A(1)(d).  See Canada's Answers to Panel Question 120. 
  (b) "A predator insect eating another insect because it is itself growing better on a 
diet of Bt maize" (EC rebuttal, para. 266). 
 
40. It is unclear to Canada to what the EC is referring in para. 266 as the EC fails to identify any 
concrete example of this type of risk, much l ess identify a risk assessment conducted by one of its 
scientific committees where this risk is evaluated.  In Canada's view, this is yet another example of 
the EC resorting to hypothetical concerns that b ear no relationship to the actual risks posed by the 
biotech products in question.  Such hypothetical concerns cannot serve to transform an SPS measure 
into a non-SPS measure.  41. In any event, "a predator insect eating a nother insect because it is itself growing better on a 
diet of Bt maize" would fall within "other damage…f rom the entry, establishment or spread of pests."  
If the introduction of a biotech plant facilitates the "spread of pests", the resulting damage could be 
considered "other damage from … the spread of pest s."  The biotech product does not have to be the 
pest in issue.    (c) Human health risks arising from oc cupational exposure to a substance in a 
biotech product that is a toxin for insects (e.g., the Bt toxin) as opposed to risks arising from the consumption of the biot ech product  (EC rebuttal, para. 316).  
(The United States may elaborate on its response to Panel Question 73 or 
comment on the European Communities' response).   
 
42. Canada agrees with the response of the Unite d States to Panel Question 73.  A measure to 
protect humans against occupational exposures from Bt toxins in corn, which is consumed as either a 
food or feedstuff, are measures to "protect human or  animal life or health fro m "risks arising from … 
toxins … in foods … or feedstuffs" and are accordingly, subject to the SPS Agreement .  
Annex A(1)(b) does not specify or restrict the mode of exposure.  Not surprisingly, the EC disagrees, 
suggesting that such a proposition might mean that "a heavy bar containing highly toxic 
concentrations of lead" would be subject to the SPS Agreement .  As a "heavy bar" is unlikely to be 
consumed as a food or feedstuff, the EC example is simply specious.  43. Canada also notes that the Italian authorities have put forth no evidence of human health risks 
arising from occupational exposure to Bt toxins in ma ize or any other food for that matter.  The study WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-82 
  
 that the Italians appear to rely on involved the application of Bt pesticides in spray form.
19  This study 
did not appear to the Italian scientific experts to be  relevant to the determination of the safety of Bt 
maize.20  This is yet another example of the EC reso rting to hypothetical concerns that bear no 
relationship to the actual risks posed by the biotech  product in question, and which have already been 
rejected by its own scientists.  Such hypothetical concerns cannot serve to transform an SPS measure 
into a non-SPS measure.  
179. Please comment on the European Communi ties' statement that "for the purposes 
specifically of proving a 'moratorium' that ap plies across the board, it does not suffice to 
address only a limited selection of product applications" (EC rebuttal, footnote 212). 
 
44. Canada does not agree.  As Canada  has stated on numerous occasions, the moratorium  did not 
result in the complete shutdown of the EC biotech approval procedures.  There was some progress 
made in respect of some applications.  However, the moratorium  meant that regardless of the merits 
of particular product applications, not a single deci sion was made by the EC to approve or reject a 
biotech product under the relevant approval procedures, not just for a "limited selection of products".  
The EC made a decision not to decide, or in other words, not to complete its approval procedures for all biotech products.  
45. The complainants need not provide eviden ce of the status of each and every product 
application that is lodged at some point in the EC's  approval procedures to establish the existence of a 
moratorium  on the consideration of applications for, or  granting of, approval of biotech products.  
Apart from the fact that not a single product application was either approved or definitively rejected between October 1998 and May 2004, Canada has pr ovided ample evidence of the existence of the 
moratorium  and the product-specific marketing bans , being the manifestation of the moratorium  in 
the context of the approval procedures of the four specific products of concern to Canada.  Having 
established a prima facie  case, it is for the EC to refute the existence of the moratorium  and product-
specific marketing bans .  
 
For Argentina and Canada
: 
180. In relation to antibiotic marker gene s, please answer the following questions: 
  (a) Do you agree with the United States that antibiotic marker genes can be 
considered as food "additives" within the meaning of Annex A(1)(b) of the SPS Agreement (see para. 22 of attachment II of  the US rebuttal)?  If not, is the 
protection against any human health risk s arising from the development of 
diseases which relevant antibiotics would be  used to treat covered by another 
subparagraph of Annex A(1)? 
 
46. Canada is of the view that the United St ates' interpretation of the term "additive" is 
linguistically plausible.  An antibiotic resistance ma rker gene is a "substance" in the basic sense of 
that term, and nothing in the Codex definition serv es to exclude the possib ility that an antibiotic 
resistance marker gene can be considered an add itive.  Canada also observes that the EC has not 
offered any concrete evidence or argumentation to refute the interpretive approach offered by the 
United States.  
                                                     
 
19 L. Bernstein et al., "Immune Responses  in Farm Workers after Exposure to Baccillus Thuringiensis 
Pesticides" Environmental Health Perspectives, 107:575, 1999. (Exhibit CDA-201) 
20 Exhibit EC-157 – Attachment 002, pp. 6-7.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-83 
  
  (b) Please comment on the European Comm unities' assertion that "there is concern 
about the development of antibiotic resistance in connection with 'plants' as such" (EC rebuttal, para. 64) and on wh ether a measure applied to address this 
concern would fall within the scope of Annex A(1).  
 
47. The phrase "there is concern about the deve lopment of antibiotic resistance in connection 
with 'plants' as such" is unclear .  The absence of any kind of documentation or other supporting 
evidence contributes to the obscurity of the statemen t.  If Canada understands the thrust of the EC's 
argument correctly, the EC is referring to the transfer  of antibiotic resistance directly from plants to, 
presumably animals and humans.  This seems to be  borne out by the two preceding sentences, which 
suggest that antibiotic resistance may develop in humans and animals through uptake of antibiotic 
resistance genes through means other than food and feed.  The EC does not explain specifically how 
this would occur, or why this "may" be an "important factor". 
 
48. In any event, the EC's comment is not rele vant to this dispute unless the source of this 
antibiotic resistance is materials fro m a transgenic plant carrying the an tibiotic resistance marker gene 
(ARM) gene.  To the extent that these ARM genes inadvertently find their way into food and feed, 
they might be considered contaminants and therefore Annex A(1)(b) would apply. 
 
49. Canada also notes that this appears to be a nother of the EC's many hypothetical scenarios 
involving, at worst, a minute risk relative to the ready transfer of antibiotic resistance genes among 
bacteria, and relative to the emergence of novel resistance genes which are (a) increasingly frequent, 
and (b) have nothing to do with ARM genes in plants  at all.  The EC even admits in its Comments on 
the Scientific and Technical Advice that "since marker  genes are the same as those already spread in 
nature, it is difficult to trace them."
21  In such a case, it is difficult to  see what risk they could pose. 
 
181. With reference to Argentina's and Canada's  claims in respect of the member State 
safeguard measures under Article 2.1 of the TBT Agreement, do the relevant safeguard measures apply to the relevant biotech products when imported into the territory of the relevant member States and when produced in the relevant member States, or do they apply 
only when the products are imported?  
50. In the case of the two French bans, on oilseed  rape Topas 19/2 and Ms1/Rf1, the ministerial 
decrees specify that commerciali zation is suspended, product shall be withdrawn from sale, and 
importation is prohibited.
22  In the case of the Austrian ban on maize T25, the ordinance banned 
commercialization.23  The Italian ministerial decree ba nning maize MON809, MON810, T25, and 
Bt11 specified that it was suspending the commercialization and utilization.24 
                                                      
21 EC Comments on the Scientific and Technical Advice to the Panel (28 January 2005), para. 105. 
22 France, Minister of Agriculture and Fishing, Decr ee of 16 November 1998 involving suspension of 
the commercialization of genetically modified colza by virtue of article 16 of directive 90/220/CEE of 23 April 1990, pursuant to decision 98/291/CE of 22 April 1998, J.O., 18 November 1998, 17379 (English translation 
and French original) (Exhibit CDA-64);  France, Minister of Agriculture an d Fishing, Decree of 16 November 
1998 involving suspension of the commercialization of genetically modified colza by virtue of article 16 of 
directive 90/220/CEE of 23 April 1990, pursuant to decision 96/158/CE of 6 February 1996, J.O., 18 November 
1998, 17379 (English translation and French original). (Exhibit CDA-68) 
23 Austria, Federal Minister of Social Security and Generations, Ordinance issued 28 April 2000 
prohibiting the commercialization of the genetically altered corn Zea Mays L. T25 in Austria, approved by the 
European Commission on 22 April 1998 under Decision 98/293/EC, Federal Gazette, vol. 2000, 28 April 2000 (English translation and German original). (Exhibit CDA-76) 
24 Italy, President of th e Council of Ministers, Pr ecautionary suspension of the commercialization and 
utilization of certain transgenic products (Corn BT 11 , Corn MON 810, Corn MON 809 and CORN T25) in the WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-84 
  
  
51. In fact, with the exception of the Greek import ban, none of the measures specify that they apply only when the products are imported.  Give n the broad language used, it must be assumed that 
the measures apply to the relevant biotech products when imported into the territory of the respective 
Member States and when they are produced in those Member States.  
For Canada and the United States
: 
 
182. Could Canada and the United States provide  examples of why and how allergens in food 
can be said to "destroy [] life or injure [] health" (US rebuttal, attachment II, para. 27)or 
"destroy[] life or impair [] seriously the functions of organs or tissues" (Canada's supplementary 
rebuttal, para. 51)?  
52. An allergen present in food can cause a variety of symptoms in individuals susceptible to that 
allergen.  Some examples of food allergic reactions include angioe dema (swelling and redness of the 
skin), urticaria (itchy hives), allergic rhinitis (runny nose), asthma, and anaphylaxis (a sudden and 
severe reaction characterized by a sudden drop in blood pressure and breathing difficulties that can be 
fatal).  Thus, an allergen can "destroy life or impa ir seriously the functions of organs or tissues". 
 
For Canada
: 
 
184. At para. 24 of Canada's second oral statement it is stated that if there is credible 
scientific evidence that the continued "processing " of applications under an existing approval 
regime would give rise to actual risks to human he alth or the environment, a suspension of an 
approval regime may be warranted.   (a) What does Canada mean by "pro cessing" of applications?  Their final 
approval?  
 
53. Canada means the final approval of the product resulting in the placing on the market of the product.    
 (b) If so, and if there was scientific evidence of an actual risk, why should a Member 
not be expected, in the light of Annex C(1)(a) of the SPS Agreement, to complete 
its approval procedures and either grant marketing approvals subject to appropriate conditions, or to deny marketing approvals temporarily, with a possibility to review the continued justification of denying marketing approval once relevant circumstances change (e.g., the regulatory regime has been 
updated)?   
 
54. Canada agrees that, if there was scientific ev idence of an actual risk, a Member should, in the 
light of its obligations under Annex C(1)(a) of the SPS Agreement , complete its approval procedure 
and either grant marketing approvals subject to  appropriate conditions, or to deny marketing 
approvals temporarily, with the view to review ing the continued justification for denying the 
marketing approval once the regulatory regime has been updated.   The type of circumstances to 
which Canada alluded in paragr aph 24 of its Second Oral Statement are addressed in Canada's 
response to Question 173 above.  
                                                                                                                                                                    
 
national territory, according to art. 12  of the regulation (EC) No. 258/97, 4 August 2000, Official Gazette, 8 
August 2000, 184 (English translation and Italian original). (Exhibit CDA-78)  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-85 
  
 185. Canada's submissions on the alleged produc t-specific marketing bans are complex.  At 
paras. 121 and 123 of its supplementary rebutta l, Canada says that "[i]n relation to the 
product-specific marketing bans, the measure at i ssue is the moratorium", even though Canada 
also maintains that the alleged bans are measures in their own right.  Similarly, at para. 203 of 
its supplementary rebuttal, Canada says that "[i]n relation to the product-specific marketing 
bans, one of the central issues before this Panel is  whether, in the light of the moratorium and 
given the resulting excessive delays in the proces sing of the applications in question, there was 
an effective 'political' decision on the part of  the EC not to approve these products".  These 
statements appear to suggest that the alleged pr oduct-specific marketing bans are the result of 
the alleged decision on the part of the EC to stop authorizing any biotech product (general moratorium).  Later in the same submission, at para. 225, Canada argues that in respect of one 
particular product (Ms8xRf3), a marketing ban arose only in March 2000.  And Canada suggests that any delay following that date was undue.  In a similar vein, para. 192 of the same 
submission states that the alleged product-speci fic marketing bans have caused undue delay in 
the completion of the approval procedures for th e relevant products.  Is Canada arguing that 
the alleged product-specific bans, i.e., the measu res it is challenging, may have been adopted 
after the alleged adoption, in 1998, of the decision to stop authorizing any biotech products (general moratorium)?  And is Ca nada arguing that once the alleged bans were adopted, they 
gave rise to undue delays contrary to Annex C(1)(a) of the SPS Agreement? 
 
55. The product-specific marketing bans  are a direct consequence of the moratorium  as applied to 
individual product applications.  They are also proof of the moratorium  and, for Canada, the most 
injurious manifestation of the moratorium .
25  They are however, distinct measures from the 
moratorium  and give rise to distinct violations of the WTO Agreement.  The arguments in relation to 
product-specific marketing bans  are intended to focus on the direct and detrimental impact  of the 
moratorium  on specific product applications.   
 56. In principle, the adoption of the moratorium  led to the adoption of the product-specific 
marketing bans .  However, in some cases, it appears that the Commission attempted, unsuccessfully, 
to convince the EC Member States to lift the moratorium .  In the case of Ms8xRf3, in order to give 
the Commission the benefit of the doubt in its attempt to break the moratorium  and convince EC 
Member States to adopt the Commission so-called interim approach, Canada has indicated the 
alternative date of March 2000 as the date the product-specific marketing ban  in relation to this 
product was unquestionably imposed.    
57. Canada is arguing that the product specific marketing bans  imposed on each product have 
caused undue delay in the completion of the approval pr ocedures.  In respect of  each of the specific 
products, Canada has demonstrated specific instan ces of undue delay.  The delay was not simply 
because of inadvertence or neglect, but because of a decision not to complete the approval procedure. 
 
186. Please explain the contrast between Canada 's statement that in determining whether a 
delay is undue within the meaning of Annex C(1)(a) of the SPS Agreement, both the reason for 
the delay and its duration must be taken into  account (Canada's supplementary rebuttal, 
para. 188) and the assertion that "a delay of seven  years in approving this product [...] is, by any 
reasonable standard, 'undue'" (Canada's second or al statement, para. 57 [similar statement at 
para. 63]).   
 
58. To the extent that there is a contrast between Canada's statements in pa ragraph 238 of its First 
Written Submission and paragraph 188 of its Supplementary Rebuttal, and its assertions regarding the 
                                                     
 
25 Canada First Written Submission, para. 255. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-86 
  
 failure of the EC to approve the product applicati ons for GT73 and Ms8xRf3 in  paragraphs 57 and 63 
of its Second Oral Statement, that c ontrast is more apparent than real. 
 
59. As Canada noted in para graphs 57 and 63 of its Second Oral Statement, these product 
applications have been in the system for approximate ly seven and nine years, respectively.  In the case 
of GT73, if the time is counted from the date wh en the notifier first submitted its application to 
France, the amount of time that the product has been  in the system actually rises to almost 10 years!
26  
The length of time it has taken, so far, for these pr oducts to move through th e approval system has to 
raise serious questions about whether the failure to make a decision amounts to undue delay, keeping 
in mind that they still have not been approved.  60. However, the amount of time these product a pplications have languished  in the EC's approval 
procedure is not the sole reason for Canada's clai m that the delays have been, by any reasonable 
standard, undue.  First and foremost, the EC has had in place, since October 1998, a moratorium  on 
the approval of new agricultural biotech products.  Th e EC has failed to demonstrate why this across-
the-board marketing ban on these products was neces sary.  Furthermore, in the case of each product 
application, Canada has demonstrated that the EC  has not put forward a cogent rationale, based on 
scientific evidence, for why it has refused to approve  these products.  In other words, the refusal to 
approve these products is not based on a risk assessment, despite numerous favourable risk 
assessments conducted by the EC's own scientific comm ittees.  Canada has also demonstrated that the 
EC's refusal to approve these products amounts to an  arbitrary and unjustifiable distinction in the 
application of its appropriate level of  protection.  It is for these reasons, as well, that the EC's failure 
to approve GT73 and Ms8xRf3 (as well as Ms1xRf1  and Ms1xRf2) is both ex cessive and unjustified, 
and therefore amounts to undue delay, contrary to paragraph 1(a) of Annex C and Article 8 of the SPS 
Agreement .
27 
 
187. With reference to para. 76 of Canada's supplementary rebu ttal, please clarify whether a 
measure applied to protect against risks to wild  fauna from increased use of the herbicide 
associated with a biotech crop or another herb icide, due to the development of herbicide 
resistance, falls within the scope of Annex A(1) of the SPS Agreement.  If so, please indicate the 
relevant subparagraph.   
61. First, Canada would like to emphasize that  the introduction of a biotech product does not 
necessarily result in the increased use of the associated herbicide.  While herbicide-tolerant crops 
permit greater flexibility in applica tion of the associated herbicide, ( e.g. the application of the 
herbicide can be tailored to the actual we ed pressure after the crop has emerged),
28 this does not imply 
that herbicide use will increase or that wild fa una will be affected.  If one is concerned about 
increased herbicide use, one could impose r estrictions on the use of the herbicide. 
 62. Second, the EC attempts to conflate risks as sociated with herbicide use with risks "arising 
from" biotech crops.  At the same time, the EC atte mpts to rely on an artificial distinction about the 
cause of the risks to avoid compliance with the SPS Agreement .   The EC is attempting to have it both 
ways – suggesting that the risks arising from the u se of herbicides is a legitimate justification for 
denying approval of a biotech product while also suggesting that such risks do not "arise from" the introduction of the biotech product.  
                                                     
 
26 Canada First Written Submission, para. 86. 
27 Canada First Written Submission, paras. 292-97. 
28 See for example Exhibit EC-63 – attachment 163.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-87 
  
 63. Canada does not agree that the EC can have  it both ways. Contrary to the EC's assertions,
29 
the phrase "arising from" does not require that the risk  be direct or immediate.  If the biotech product 
qualifies as a "pest" that needs to be controlled with herbicides, any resulting risks to wild fauna "arise 
from" the pest.  It is the presence of that pest that triggers the sequence of events that ultimately leads 
to damage to wild fauna, if any such damage actua lly exists (the absence of evidence of such a risk 
implies it is yet another purely specu lative risk raised by the EC).  Consequently, measures applied to 
protect against risks to wild fauna from increased or altered use of herbicides, would fall within either 
Annex A(1)(a) as measures applied to protect "animal [including wild fauna] life or health…from 
risks arising from  the entry, establishment or spread of pests " or, for good measure, Annex A(1)(d) as 
measures applied to "prevent or limit other dama ge…from the entry, establishment or spread of 
pests."   
188. Please comment on para. 14 of the European Communities' second oral statement.  Does 
para. 20 imply that if the use of glufosinate-ammonium has not already been authorized in 
Belgium under the relevant pesticide legislation, the potential effects of its use is a justification 
for failing to grant approval of MS8xRF3 (see paras. 235, 240 and 246 of Canada's supplementary rebuttal)?  In this context, plea se also address the EC assertion that "the use of 
the herbicide may affect the composition of the food or feed resulting from the HTGM crop as compared with its non-GM equivalent" (EC se cond oral statement with regard to expert 
meeting, para. 11).  
64. Canada understands that when the Panel refe rs to paragraph 20 of the EC's Second Oral 
Statement it intended to refer to para graph 14.  Paragraph 20 does not appear to relate to this issue. 
 
65. In paragraph 14, the EC stated "as can be seen from the authorisation cited in footnote 208 of 
Canada's supplementary rebuttal submission, that au thorisation is for a different use (seed production 
only) for a different transformation event (MS1xRF2). "  The EC claims that this has no relevance to 
the authorization for Ms8xRf3.  Th is assertion is without foundation. 
 66. First, "seed production" refers to the use to which the seeds may be put.
30  Regardless of the 
end use of the seeds (whether for seed production, hu man food or animal feed), one still has to grow 
the crop.  The end use of the seeds has no effect  on the use pattern of the herbicide (timing, 
application method, frequency, dosage etc) and consequently no impact on the risks to the 
environment from the use of the herbicide.  The EC's attempt to dismiss the relevance of this 
herbicide authorization on the basis that it i nvolves "seed production" is devoid of logic.  
 
67. The authorization of gluf osinate ammonium was limited to seed production because at the 
time it had yet to be assessed for food and feed purposes.   As the Belgian scientific experts, reviewing 
the application for approval of Ms8xRf3, observed:  
In 1996, questions were raised concerning the lack of toxicological tests for the 
metabolites and residues derived from glufosinate ammonium herbicides.  At that 
time, the use of glufosinate ammonium as a total herbicide was authorized in 
Belgium, but not the use of the herbicide on herbicide-tolerant plants.  For this 
reason, AgrEvo handed in a dossier for the broadening of the use of the herbicide 'Liberty' under the Directive 91/414/EEC.  The risk assessment of the herbicide use 
                                                      
29 EC Rebuttal Submission, para. 63. 
30 See for example Commission Decision 96/158/EC , authorizing oilseed rape Ms1xRf1.  That  
Decision  limited the consent to "cover the notified use of the product for growing for obtaining seed , but does 
not extend to the use for human food or animal food, without prejudice to any future assessment of the product 
for such use."  Exhibit CDA-62, p. 2, para. 2(b). WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-88 
  
 and thus the toxicity of glufosinate amm onium and metabolites were assessed by the 
Belgian Health Council within the framew ork of the plant protection products 
Directive 91/414/EEC .  End 2000 [sic], the Health Council gave a positive opinion 
for the use of glufosinate ammoni um on herbicide-tolerant plants .  The final 
authorization of the Ministry is not yet granted.31 
68. Thus, the use of herbicide for other uses has now been assessed, although the final 
authorization has yet to be granted.  Perhaps the EC  could provide the Panel with a copy of the Health 
Council's positive opinion and explain why the Ministry  has not yet granted final authorization.   
 
69. Second, in terms of the EC's attempt to dism iss the relevance of the herbicide authorization on 
the basis of a "different transformation" event, the Belgian authorization for glufosinate-ammonium 
for use on genetically modified oilseed rape does not limit the application of the herbicide to a 
specific transformation event.32  To the contrary, the herbicide authorization merely states "for 
genetically modified oilseed rape."  The statem ent by the Belgian scientific experts quoted above 
supports the conclusion that the authorization for the use of the herbicide glufosinate ammonium is for 
oilseed rape generally and is not limited to a singl e transformation event.  Yet again, the EC appears 
to be advancing specious claims.  70. In any event, the potential impact on the e nvironment or "biodiversity" from the use of the 
herbicide with oilseed rape Ms1xRf2 is equivalent to the use of that herbicide with oilseed rape 
Ms8xRf3.  The only significant difference between Ms 8xRf3 and Ms1xRf2 is that Ms1xRf2 contains 
the nptII  antibiotic resistance marker gene, while Ms 8xRf3 does not.  Consequently, the different 
transformation event has no impact on the pattern of  use of the herbicide or potential risks to the 
environment. 
 
71. Paragraph 14 of the EC Second Oral Statem ent should be seen for what it is – a groundless 
attempt to confuse in order to distract the Panel from the Belgian authority's patent inconsistency of 
basing its failure to approve Ms8xRf3 on the puta tive risks from herbicide use while Belgian's own 
pesticide authorities expressly authorized the he rbicide for use with GMHT oilseed rape.   
 
72. With that as background, Canada will now r espond to the Panel's Question.  The absence of 
the authorization of a particular herbicide use ca nnot serve as a justification for refusing to grant 
approval for a biotech product.  As the EC has r ecognized on numerous occasions, the approval of the 
biotech product is independent of the approval of the use of chemical herbicides.
33  The Belgian 
scientific experts also recognized that the risks associated with herbicide use are assessed by the 
relevant pesticide authorities under Directive 91/414/EEC .34  Risks arising from the use of the 
herbicide should not be considered as legitimate reasons for denying the approval of a HT biotech 
product.  The two are not related given that the risks arising from herbicide use are influenced by numerous variables independent of the crop itself (application method, dosage, timing, frequency of 
application etc.).  Conflating the two provides a conven ient pretext for disguising the fact that the EC 
is imposing a dramatically higher le vel of scrutiny and level of protection for herbicide use associated 
with biotech products than for herbicide use generall y.  This is yet a further example of, what Dr. 
Squire describes as the EC's "inconsistency" in  terms of scrutiny of agricultural practices. 
 
                                                     
 
31 Expertise Report of the Group of Experts Mandated by the Biosafety Advisory Council, Exhibit 
EC-63 – attachment 167, p.18, Section 3.8.2 "Residue Assessment". 
32 Canada Third Written Submission, para. 246,  footnote 208, Exhibits CDA-152 and 160. 
33 Canada Third Written Submission, para. 240 and footnote 199. 
34 Exhibit EC-63 – attachment 166, p. 18.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-89 
  
 73. In terms of the question regarding the impact  of the herbicide on the composition of food and 
feed, Canada notes that the "food" derived from oilseed rape is oil.  The oil has been notified for food 
use in the EC since 1999 as being substantially  equivalent to conventional oilseed rape.
35  Had there 
been compositional changes in the oil as a result of  the use of glufosinate-ammonium on the crop, 
presumably the oil could not have been notified as substa ntially equivalent.  Alternatively, if this is a 
genuine risk the EC overlooked back in 1999 that has only now come to light, one would expect the 
EC to take some action to suspend the marketing of  the oil.  Tellingly, the EC has not because it has 
no scientific basis to do so. 
 
74. In fact, the impact of the herbicide on the composition of the food and feed derived from oilseed rape tolerant to glufosinate-ammonium has been extensively reviewed by the EC's own 
scientific committees.  The SCP reviewing Ms8xRf3  in May 1998 assessed the safety of the gene 
products, herbicide residues and metabolites.
36  The SCP specifically referred to the SCP opinion on 
oilseed rape Topas 19/2 in relation to the assessment of herbicide residues  and the metabolites  
resulting from the interaction of the herbicide with the plant.  There are two metabolites – one major 
metabolite (3-methylphosphinico-propionic acid (MPP)) and one minor metabolite (N-acetyl-
glufosinate).37    In the latter opinion, the SCP stated the following: 
 
6.2.2. Safety of Gene Products/Metabolites (Food and Feed Aspects): 
Safety of gene products:  PAT protein is ubiquitous in  nature but represents only 
0.005% of protein in finished canola meal. It is heat and acid labile and the enzyme activity is always destroyed in toasted canola meal. 
Additional in vitro tests demonstrated the in activity of PAT and npt II in gastric juice 
of farm animals and it is hypothesised that it does not survive ingestion. In vivo tests 
performed on broiler chickens fed canol a in their diets confirmed the safety 
established in rats with purified protein. 
Data concerning the chemical analysis de monstrated substantial equivalence with 
control seeds for major nutrients including protein, oil, amino acids, fatty acids, tocopherols and sterols. The content of gl ucosinolates and erucic acid in glufosinate 
tolerant rape was identical with that of  control seeds. Sequence comparisons show 
that PAT protein does not have homology to known allergens. Acute toxicity tests on 
PAT protein in rats showed no negative effects. 
These results lead the Committe e to conclude that there is no significant risk to 
human and livestock following ingestion of the GM seeds . 
Residue assessment:  The metabolism of glufosinate am monium in transgenic plants, 
carrying the pat gene, has been thoroughly studied . The gene enables the plant to 
rapidly metabolise the herbicidal active mo iety into a non-toxic metabolite, N-acetyl-
L-glufosinate. The metabolism studies on ge netically modified canola (rape) showed 
                                                      
35 Canada First Written Submission, para. 78 and EC , Summaries of Article 5 notifications received by 
the Commission for the years 1997 [1998] O.J. C. 200/ 16, 1998 [1999] O.J. C. 181/22, 1999 [2000] O.J. C. 
71/2, 2000 [2001] O.J. C. 46/8, 2002 [2003] O.J. C. 33/6, and 2003 [2004] O.J. C. 58/9, product No. 10.  (Exhibit CDA-25). 
36 EC, Scientific Committee on Plants, Opinion regarding the Glufosinate tolerant, hybrid rape derived 
from genetically modified parental lines (MS8 x RF 3) notified by Plant Genetic Systems (Notification 
C/B/96/01), submitted 19 May 1998, pp. 4-5. (Exhibit CDA-35-A) 
37 Opinion of the Scientific Committee on Plants Regarding the Genetically Modified, Glufosinate-
Tolerant Rape Notified by Agrevo Co mpany (C/UK/95/M5/1), (Exhibit CDA-63). WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-90 
  
 a rapid conversion of glufosinate to N-acetyl-glufosinate
. In the immature canola 
plant the principal residue identified was N-acetyl-glufosinate followed by 
glufosinate with lesser quantities of 3-me thylphosphinico-propionic acid (MPP). In 
seeds and hulls MPP was the major metabolite  and the N-acetyl-glufosinate a minor 
metabolite. 
Magnitude of residues in gluf osinate tolerant rape seed : Many trials were conducted 
in various Canadian regions during 1992 a nd 1993 with different application rates. In 
no case were residues of the metabolite MPP found at levels above the limit of 
determination ; residues of parent glufosinate were found only in one trial; N-acetyl-
glufosinate was found in samples of 5 trials  up to 0.14 mg/kg. The residue behaviour 
in tolerant oilseed rape processed fraction was also studied in a trial conducted in 
Canada. No detectable residues were found in crude/refined/refined bleached/refined 
bleached deodorised/oil.  N-acetyl-glufosinate was found in soapstock at a 
concentration of up to 0.1 mg/kg after a pplication at an exaggerated rate only. 
Magnitude of residues in food of animal origin:  Ruminant and poultry feeding studies 
were conducted to determine the magnitude of glufosinate-derived residues in the 
tissues and milk of dairy cows and in the ti ssues and eggs of chic ken hens which were 
dosed for 28 consecutive days with a mixture of parent glufosinate and the metabolite 
N-acetyl-glufosinate in a ratio which repr esents the terminal residues in relevant 
animal feed (15% / 85%) at 3 dose levels. No detectable residues were found in meat, 
milk or eggs at the dose calculated to re present the highest residues in livestock feed 
under Good Agricultural Practice and taking into account the potential use of 
glufosinate herbicide in several tolerant crops.  
Conclusion on residue assessment:  On the basis of the available data, a maximum of 
0.2 mg/kg of residues of glufosinate ammonium and its metabolites, N-acetyl-
glufosinate and 3-methylphosphinico-propionic acid (expressed as glufosinate-free 
acid equivalents) can be calculated for im ported seed of tolerant swede rape. In food 
of animal origin derived from livestock an imals fed with feedstuffs after application 
of glufosinate herbicide in tolerant rape , no residues above the limit of determination 
can be expected.  In Canada, the MRL for glufosin ate-derived residues in tolerant 
canola is covered under the existing MRL of  3.0 mg/kg for canola from desiccation 
use (information by the applicant). The US EPA uses a Reference Dose of 0.02 mg/kg b.w. in the human dietary risk assessment for glufosinate-derived residues in commodities from non-transgenic plants as we ll as from transgenic plants (Federal 
Register, Vol. 62, No. 24, p.5333, 1997). 
6.2.3. Substantial Equivalence:  Compositional analysis on seed harvested from trials 
at a number of locations within Canada in  several successive years provided data on 
oil content, fatty acid composition (including  erucic acid content) and glucosinolate 
levels. Those for the seed from the genetically  modified plants fall within the range 
for non-GM control varieties. 
For food purposes the product is likely to be  highly processed so that both the genetic 
material introduced into the transgenic pl ant and its protein products would be absent 
from the refined product.  
On the basis of substantial equivalence, it can be concluded th at refined products 
from plants derived from this glufosinate tolerant plant would be safe for food use.   WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-91 
  
 75. Other EC scientific committees have also assess ed the impact of glufosinate- ammonium on 
the composition of other types of food and feed (maize), finding no adverse effects.
38  Lastly, Canada 
recalls the statement of the Belgian scientific e xperts of January 2004 in the assessment of Ms8xRf3 
quoted above: 
 
The risk assessment of the herbicide use and thus the toxicity of glufosinate 
ammonium and metabolites were assessed by  the Belgian Health Council within the 
framework of the plant protection products Directive 91/414/EEC .  End 2000 [ sic], 
the Health Council gave a positive opinion for the use of glufosinate ammonium on 
herbicide-tolerant plants .  The final authorization of the Ministry is not yet granted.39 
76. In the light of the comprehensive assessment of the impact of glufosinate-ammonium on the 
composition of food and feed conducted by the EC's own regulatory authorities , for the EC to suggest 
that this issue is only "now" coming to light and has yet to receive such a comprehensive assessment 
is plainly disingenuous.  More troubling is the failure  by the EC to address, let alone refer the Panel 
to, the detailed analysis directly relevant to this issue  undertaken by its own scientists .  The EC's 
arguments in this regard are not only without scien tific justification but are patently misleading and 
should be rejected.  
189. At para. 254 of its supplementary rebuttal, Canada states that "[i]n the light of the 
moratorium, it is reasonable to infer that the regulatory authorities were taking a decidedly go-
slow approach".  The member State referred to in this statement is notably the Netherlands.  
Did Canada submit evidence that the Netherlands supported the alleged moratorium at the time 
it completed its initial assessment of GT73?  If  the Netherlands did not support the alleged 
moratorium, why would the Netherlands take  "forty-two months to conduct the initial 
assessment, instead of the ninety days foreseen in  the EC's approval procedures" if this was not 
to resolve scientific or technical issues?    
 
77. It is reasonable to infer from the surrounding  circumstances, that The Netherlands, with the 
knowledge that there was a moratorium  in place and that the speed of its review would therefore have 
little impact upon the eventual date of approval, in stead took the extended time to request information 
from the notifier in an effort to upgrade the dossier  to the anticipated new information requirements 
(especially the detection method) of Directive 2001/18 .  Rather than being an active participant in the 
moratorium , it is reasonable to conclude that The Neth erlands was placed in th e position of having to 
accept it and to act or react, as the case may be.  It w ould have been futile for The Netherlands to have 
issued its favourable report and circulated the dossier  to the Community level prior to the entry into 
force of the Directive 2001/18  (October 2002) because the EC Member States, qua Regulatory 
Committee, would, in the light of the moratorium , have simply stalled the application. 
 
190. With reference to Greece's safeguard meas ure, Canada refers to this measure as an 
"import ban" (Canada's first written submission, para. 114).  Are import bans subject to Article 2.1 of the TBT Agreement? 
 
78. No.  The language of Article 2.1 of the TBT Agreement , particularly the reference to 
"products imported from the territory of any Member …", indicates that this provision is intended to 
                                                     
 
38 Opinion of the Scientific Committee on Plants on the Submission for placing on the market of 
genetically modified insect resistant and glufosinate ammonium tolerant (Bt-11) maize for cultivation.  (Exhibit 
CDA-35-H). 
39 Expertise Report of the Group of Experts Mandated by the Biosafety Advisory Council, Exhibit 
EC-63 – attachment 167, p.18, Section 3.8.2 "Residue Assessment".  
 WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-92 
  
 operate much like Article III:4 of the GATT 1994.  Th at is, its disciplines apply to measures affecting 
the product in question once it has entered into the territory of the Member whose measure is being 
challenged. 
 
79. This is why Canada, in its First Written S ubmission, does not make a claim that the Greek 
import ban violates Article 2.1 of the TBT Agreement .
40  Notwithstanding the EC's argument in its 
First Written Submission that "it is clear that the nature and aim of the Greek measures does not differ from those of the other national measures",
41 the explicit wording of the measure itself establishes 
incontrovertibly that the measure extends solely to a prohibition on the importation of the product in 
question.42
                                                      
40 Canada First Written Submission, para. 485. 
41 EC First Written Submission, para. 640. 
42 Greece, Minister of the Environment, Regional Planning and Public Works, Prohibition on the 
importation of seeds of a genetically modified rape line bearing the reference number C/UK/95/M5/1 , 
Government Gazette, 1008, 25 September 1998, pp. 11941-11942 (English translation and Greek original). 
(Exhibit CDA-72)  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-93 
  
 ANNEX F-6 
 
COMMENTS BY CANADA ON THE REPLIES OF OTHER PARTIES 
TO QUESTIONS POSED BY THE PANEL IN THE CONTEXT OF 
THE SECOND SUBSTANTIVE MEETING 
18 MARCH 2005 
 
 
TABLE OF CASES 
 
Short Form Full Case Title and Citation 
Australia – Salmon  Australia – Measures Affecting the Importation of Salmon , Report of the 
Appellate Body, WT/DS18/AB/R, adopted 6 November 1998. 
EC – Asbestos European Communities - Measures Affecting the Prohibition of Asbestos and 
Asbestos-Containing Products,  Report of the Appellate Body, 
WT/DS135/AB/R, adopted 5 April 2001.  
Japan – Alcohol II Japan – Taxes on Alcoholic Beverages , Report of the Appellate Body, 
WT/DS8/AB/R; WT/DS810/AB/R; WT/DS11/AB/R, adopted 1 November 
1996.  
Korea – Beef Korea – Measures Affecting Imports of Fresh, Chilled, and Frozen Beef , 
Report of the Appellate Body, WT/D S161/AB/R, WT/DS169/AB/R, adopted 
10 January 2001.  
US – FSC (Article 21.5 – EC) United States – Tax Treatment for "Foreign Sales Corporations" – Recourse 
to Article 21.5 of the DSU by the European Communities , Report of the 
Appellate Body, WT/DS108/AB/RW, adopted 29 January 2002.  
US – Section 337 United States – Section 337 of the Tariff Act of 1930 , Report of the Panel, 
BISD 36S/345, adopted 7 November 1989.  
 
 
Question 119 :  
 1. The EC's assertion that ISPM No. 11 (2004) is not relevant to the SPS Agreement  is without 
merit.  
2. First, its arguments on timing are both factually misleading and legally wrong.  ISPM No. 11 
was endorsed by the Interim Commission on Phytosan itary Measures (ICPM) in April 2001.  In April 
2003, the ICPM endorsed a supplement to ISPM No. 11 on the analysis of environmental risks
 and 
agreed that it should be integrated into ISPM No. 11.  These resulted in ISPM No. 11 Rev. 1 ( Pest risk 
analysis for quarantine pests including analysis of environmental risks ).  In April 2004, the ICPM 
endorsed a further supplement to ISPM No. 11 Rev. 1 on pest risk analysis for living modified 
organisms (LMO) and agreed that this should be  integrated into ISPM No. 11 Rev. 1. These 
supplements are annotated in ISPM No. 11 (2004) with "S1" and "S2" respectively.1 
 3. The references to environmental risks in Anne x 1 of ISPM No. 11 (2004) were incorporated 
as a result of the April 2003 supplement.  Thus, any attempt by the EC to dismiss references to 
environmental risks on the basis that these were adopted  after the establishment of the Panel is wrong.  
The suggestion that environmental risks, include d by virtue of the April 2003 supplement, are 
somehow related to the Cartagena Protocol  is also wrong.  It is the April 2004 supplement, not the 
April 2003 supplement, which deals with LMOs.   
                                                     
 
1 "Endorsement", ISPM No. 11 (2004), p. 1 (Exhibit EC-130). WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-94 
  
 4. Second, the suggestion that the April 2004 supplement is not relevant to the SPS Agreement  
merely because it deals with similar subject matter to the Cartagena Protocol , is a recasting of the 
EC's equally unmeritorious earlier argument that GMOs should be dealt with "outside" the WTO 
Agreement because they have thei r own "special agreement", the Cartagena Protocol .
2  By its own 
terms, the April 2004 supplement concerns those LM Os that "may present a phytosanitary risk and 
therefore warrant a PRA [pest risk analysis]."3  The April 2004 supplement identifies the specific 
types of risks to plant life that may arise from LMOs that may constitute "pests".   
 
5. Third, the EC's arguments with respect to the legal relevance of ISPM No. 11, including the 
April 2004 supplement are equally flawed.  The compla inants are not arguing that the definitions in 
ISPM No. 11 are legally dispositive of the interpretation of terms in the SPS Agreement .  However, 
given the fact that the SPS Agreement  refers specifically to "inter national standards, guidelines and 
recommendations developed under the auspices of the S ecretariat of the International Plant Protection 
Convention", it is illogical and contra ry to the object and purpose of the SPS Agreement  to dismiss 
such standards, guidelines and recommendations simply  on the basis that one party (the EC) does not 
like what they say.  As Canada has demonstrated , ISPM No. 11 (2004) may be considered by the 
Panel as a supplementary means of interpretation for terms in the SPS Agreement .4  
 6. Fourth, Canada has addressed the EC's atte mpts to extract "environmental risks" from the SPS 
Agreement  in paragraphs 52 to 67 of  Canada's Third Written Submission.  Suffice to say, the SPS 
Agreement  was intended to discipline a specific sub-set of "environmental" measures, namely those 
applied to protect animal (including wild fauna), pl ant (including wild flora) and human life or health 
from risks arising from pests and diseases and those applied to prevent or limit other damage from pests.  To claim that these measures are not "e nvironmental" because the term is not used is 
semantics.  While it may be true that "measures for environmental protection, per se " are not 
necessarily SPS measures ( e.g. pollution abatement, emissions control, trans-boundary movement of 
hazardous wastes etc.), it cannot be credibly argued that measures to protect certain components of the environment (plants and animals, defined broadly) from the entry, establishment and spread of pests 
and diseases are not
 SPS measures.  ISPM No. 11 (2004) elaborates on the types of risks to plant, 
animal and human life or health and other dama ge intended to fall within the scope of the SPS 
Agreement .   The fact that such risks are also refe rred to as environmental risks, because reasonable 
people would view them as such, does not ma gically transform them into non-SPS risks. 
 7. Finally, the EC's efforts to conjure up an interpretive rationale based on the negotiating 
history of the SPS Agreement  is flawed because the materials to which the EC refers do not indicate 
whether the WTO Members intended for all types of environmental measures to be excluded; indeed, 
the more plausible reading of those materials is that the WTO Members intended for more general types of environmental measures, such as those relating to air an d water quality, waste management, 
and the like, to be excluded from the coverage of the SPS Agreement , but that environmental effects 
related to SPS-type risks would remain within the scope of that agreement. 
 
Question 120 : 
 8. In relation to paragraphs 13 to 16 of the EC's Answers to Panel Questions (7 March 2005), 
while economic damage resulting from the presence of pests that affects the quality of plant products 
(fruits and vegetables) may fall within the scope of "other damage" in Annex A(1)(d), this type of 
damage does not exhaust the type of damage c ontemplated under Annex A(1)(d).  The EC has 
presented no principled basis for limiting "other damage" to these situations. 
                                                     
 
2 Canada Second Written Submission, paras. 96-104. 
3 Ibid, p. 35. 
4 Canada Answers to Panel Questions (7 March 2005), para. 4.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-95 
  
  
9. In relation to the EC's ill-founded argum ents relating to "environmental risks" in 
paragraphs 19 and 20, Canada  refers the Panel to Canada's commen ts with respect to Question 119 at 
paragraph 6. 
 Question 121 :  
 10. Canada may have misunders tood the Panel's Question as referring only to relevant risk 
assessment techniques relating expressly to products of biotechnology.  If the Panel's Question relates 
to generally applicable relevant risk assessment t echniques, Canada agrees with the response of the 
United States to this Question.  11. In relation to paragraph 39 of the EC's An swers to Panel Questions (7 March 2005), Canada 
has already indicated that it does not agree with the EC that the Cartagena Protocol  is a "relevant risk 
assessment technique" developed by a "relevant international organization".
 5  Neither the Cartagena 
Protocol  itself, nor the Convention on Biological Diversity  can be said to be "international 
organizations".  Furthermore, given the fact that the Cartagena Protocol  is a treaty that has not been 
ratified by any of the complainants, it is not legally relevant to this case.6 
 
Question 122 : 
 12. Canada does not agree with the EC's charact erization of the relationship between the conduct 
of a risk assessment and a WTO Member's chosen le vel of protection.  In responding to the Panel's 
question, the EC has confused two distinct and separate issues: the level of protection and the 
presence of a potential risk. 
 13. In particular, the EC's first reason does no t support its argument, and the illustrative example 
set out in paragraph 48 of the EC's Answers to Pa nel Questions (7 March 200 5) actually demonstrates 
how the EC misperceives the two issues.  In its ex ample, the EC confuses the absence of a risk from 
the Mediterranean fruit fly with the concept of a low le vel of protection.  In reality, the absence of risk 
may affect the scope of the risk assessment, but this  is not dependent on the level of protection, as 
such.  It arises from a determination that the fruit fly does not pose a risk because in a cold climate 
there is no risk of establishment and spread.  14. The EC's second "reason" for why the level of  protection purportedly can affect the conduct 
of the risk assessment can only be read as a veile d attack on what the EC has suggested is the 
complainants' lower level of protection.  In reality , the EC is once again confusing the scope of the 
risk assessment, which relates to the presence of a poten tial risk, and the chosen le vel of protection.  It 
is illogical to suppose, as the EC seems to do, th at a responsible government will simply ignore 
potential risks just because its level of protection may be lower than that of another country.  
Regardless of the level of protection, the risk manager will want complete information about all 
potential risks, in order to make as informed a decisi on as is possible in the ci rcumstances, even if the 
risk management measure ultimately chosen re flects a comparatively high tolerance for risk. 
 15. The EC's third "reason" betrays a failure on th e part of the EC to understand the distinction 
drawn by the Appellate Body between "scientific un certainty" and "insufficient scientific evidence".  
Risk assessment is defined in the SPS Agreement , not with reference to the appropriate level of 
protection, but with reference to an "evaluation of the likelihood of entry, establishment or spread of a 
pest or disease…according to the sanitary or phyto santiary measures which might be applied" or an 
                                                     
 
5 Canada Answers to Panel Questions (7 March 2005), Question 121, para. 13. 
6 Canada Second Written Submission, paras. 96 to 104. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-96 
  
 "evaluation of the potential for adverse effects on human or animal health".  In the hypothetical 
scenario created by the EC these criteria are not respected.  We are not given sufficient details to determine what factors influence the conclusion of th e risk assessment with respect to the 5% to 20% 
variance.  Nor are we given any indication as to what risk management measures beyond a simple 
approval might be available to address the apparent scientific uncertainty faced by both country A and 
country B.  In effect, the EC's scenario is a straw man, intended, not so much to respond to the Panel's 
question, but to advance the EC's ag enda with respect to its contenti on that the scientific evidence in 
this dispute, despite the evidence of the scientific experts, is uncertain, incomplete, quickly changing 
and, of course, very complex. 
 16. The reality, of course, is that the EC's hy pothetical scenario bears no relation to reality.  
Scientific risk assessments – as mandated and pr escribed via detailed requirements – have been 
performed for all the products in issue.  In no case  can the EC demonstrate that the risk managers 
were or are faced with the kind of "dilemma" concoc ted by the EC in paragraph 53 of its answer to 
Panel Question 122.  Question 128 : 
 17. In relation to paragraph 56 of the EC's An swers to Panel Questions (7 March 2005), Canada 
agrees with the EC that the "words ‘arising from' indicate a degree of causality" between the product 
or organism in question and the risk to animal, plan t and human life or health.  However, the EC is 
interpreting "arising from" in an overly restric tive manner by limiting the degree of causality to 
immediate and direct effects.  As Canada explained in its answer to Panel Question 187,
 7 the EC 
cannot have it both ways; it cannot, on the one hand, claim that certain risks are legitimate reasons for 
stalling the applications of biotech  products, while, on the other, claim that these same risks do not 
"arise from" the biotech product in question.   As ide from being inconsistent and illogical, the EC's 
unduly restrictive interpretative approach to "ari sing from" finds no support in the text of the SPS 
Agreement , in the light of its context and object and purpose. 
 18. In paragraph 57 of the EC's Answers to  Panel Questions (7 March 2005), the EC treats 
"biogeochemical cycles" in a vacuum as if they are important in and of themselves.  Its equation "if A 
[GMO] injures B [biogeochemical cycles], A is a "pest" vis à vis  B" is fundamentally flawed.  A
 
would not be a "pest" simply because A  adversely affects biogeochemical cycles.  Biogeochemical 
cycles cannot be in and of themselves adversely  affected.  An effect on biogeochemical cycles may 
cause adverse effects on plant or animal life or health.  In such a case, the B  in the EC's equation is 
plant or animal life or health, not biogeochemical cycles.  It does not make sense scientifically to 
claim that biogeochemical cycles have been adversely  affected if plant or animal life or health has not 
been adversely affected.  19. In any event, as Canada indicated in para graph 73 of its Third Written Submission, the EC 
has failed to point to a single instance where a biotec h product in question materially affects a relevant 
biogeochemical cycle.  Hypothetical concerns that bear no relationship to the actual risks posed by 
biotech products in question cannot serve to tran sform an SPS measure into a non-SPS measure.  The 
EC is simply inventing ex post ad hoc  excuses to maintain its moratorium .  
 Question 129 : 
 
20. Canada has three comments in relation to the EC's answer to Panel Question 129.  First, the 
EC's response that the Regulatory Committee proce dure could not have been used to establish 
harmonized risk assessment objectives and methodology is  patently at odds with statements in the 
                                                     
 
7 Canada Answers to Panel Questions (11 March 2005), Question 187, para. 63.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-97 
  
 very report relied on by the EC in these proceed ings to explain the alleged inadequacies of Directive 
90/220  ("1996 Report").
8  In the 1996 Report, the Commission stated: 
 
At the same time, while undergoing th e procedure for adopting an amended 
Directive, which will involve a co-decisi on of the Council and the Parliament, the 
Commission is committed to making full use of all the tools and flexibility of the 
current Directive.  More specifically, the Commission will intensify the work of the 
Risk Assessment Group established in th e framework of the Committee of the 
Competent Authorities, so that a common approach to risk assessment objectives and 
methodology can be adopted as guidance in March 1997 ;9 
21. Tellingly, the EC fails to address directly these statements in the 1996 Report (which were 
quoted in paragraph 61 of Canada's Second Writte n Submission) when responding to the Panel's 
question.  The EC is taking a selective approach to the facts in order to suit its present purposes. 
 
22. Second, the intent of Directive 90/220  clearly was to allow for such harmonization beyond the 
formalistic approach the EC now choos es to describe. The preamble to the Directive  states, in part, as 
follows:  
Whereas disparity between the rules which are in effect or in preparation in the 
Member States concerning the deliberate rel ease into the environment of GMOs may 
create unequal conditions of competition or barriers to trade in products containing 
such organisms, thus affecting the func tioning of the common market; whereas it is 
therefore necessary to approximate the laws of the Member States in this respect;… 
Whereas it is necessary to establish harmonized procedures and criteria
 for the case-
by-case evaluation of the potential risks ar ising from the deliberate release of GMOs 
into the environment;… 
Whereas a Committee should be set up to assist the Commission on matters relating 
to the implementation of this Directive and to its adaptation to technical progress. 
23. It seems odd indeed that the Directive woul d refer specifically to the necessity to establish 
harmonized procedures and criteria and not empower  the Regulatory Committee to adopt the same. 
 
24. Third, the EC's argument that the Regulatory Committee procedure was "limited to ‘adaptation' of Annex II and III" is  unconvincing.  Annex II and III of Directive 90/220  set out the 
information that must be contained in the notificati on.  In addition, the notifier was required to include 
in the notification "an assessment of any risks for human health and the environment related to the 
GMOs or a combination of GMOs."
10   Similarly, the new Annex II of Directive 2001/18  (Principles 
for the Environmental Risk Assessment) refers to  the information that must be included in the 
environmental risk assessment submitted with the notification.11  Under both Directives , the notifier 
conducts the risk assessment and submits the resu lts of the risk assessment as a part of the 
notification.  Consequently, the EC has simply specified under Directive 2001/18  the type of 
information relating to the environmental risk assess ment that is required now to be submitted in the 
                                                      
8 EC, Commission, Report on the Review of Directive 90/220/EEC , Com(96) 630 final 
(Exhibit CDA-119).  See Canada Second Written Submission, paras. 58-61. 
9 Ibid, p. 11. [emphasis added] 
10 Directive 90/220 , Art. 11(1). 
11 Directive 2001/18 , Art. 13(2)(b). WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-98 
  
 notification.  This is no different in effect from "adapting" the information requirements specified in 
Annexes II and III of Directive 90/220 .  
 
Question 130 :  
 25. The EC's response to Question 130 is without mer it.  First, the EC is incorrect when it states 
that the term "food safety" is not used in the SPS Agreement .  In fact, the term is found in the 
definition of an SPS measure in Annex A(1), when it  states that "Sanitary and phytosantiary measures 
include…packaging and labelling requireme nts directly related to food safety
" and in Annex A(3)(a), 
when elaborating on international standards, guidelines and recommendations relevant to the SPS 
Agreement : "for food safety , the standards, guidelines and recomm endations established by the Codex 
Alimentarius Commission."  In the face of this explicit language, the EC's assertion that the WTO 
Members excluded food safety from the scope of the SPS Agreement  is plainly wrong.  Furthermore, 
it would be illogical to suppose, and therefore ca nnot be reasonably argued, that the WTO Members 
included packaging and labelling requirements related to food safety, but not requirements relating to 
food safety per se . 
 26. Having established that food safety indeed falls squarely within the scope of the SPS 
Agreement , and that allergenicity is a central food safety concern, the conclusion that the term 
"toxins" can comfortably be read as including alle rgenicity is a simple matter of logic and the 
application of the rules of treaty interpretation.  Even if the EC's convoluted argument about a 
"continuum between food quality and food safety" is accurate in principle, its attempt to equate 
concerns about nutritional composition – i.e. whether the consumer is getting enough vitamin C in his 
or her diet – and allergenicity – i.e. whether the consumer will have an anaphylactic reaction to the 
presence of peanuts, go into a coma and die – must be rejected as comparing "apples and pears".  
 27. Finally, the EC's suggestion that allergenicity can arise from sources other than food does not vitiate the arguments that allergenicity  is a food safety concern, that the SPS Agreement  includes food 
safety issues within its ambit, and th at the ordinary meaning of "toxins", when read in its context and 
in the light of the object and purpose of the SPS Agreement , should be understood to include 
allergens, at least in so far as they arise in food, beverages or feedstuffs. 
 28. As for the allergenicity issues raised by th e EC in paragraph 64 of its Answers to Panel 
Questions (7 March 2005), the EC has failed to presen t any evidence that such concerns were raised 
by either the EC Member States or any of the ma ny scientific committees that actually examined the 
biotech products in issue in this dispute.  It seems  to Canada that this is yet another of the many 
hypothetical scenarios conjured up by the EC in  an attempt to evade its responsibilities under the SPS 
Agreement .   
 Question 131 : 
 
29. It is questionable whether the EC's suggesti on that the term "condition" is limited only to 
those conditions of use and handlin g defined by the applicant is correct.  However, assuming, for the 
sake of the argument, that the EC could only im pose conditions proposed by the applicant, nothing 
prevented the EC (the Commission or the Compet ent Authorities of the Member States) from 
requesting applicants to amend their applications to  contain such conditions.  Indeed, this occurred in 
relation to maize MON 810.  The notifier, at the request of the Commission, undertook to develop an 
insect resistance management strategy. This undert aking was subsequently noted in the approval 
decision, Commission Decision 98/294/EC .
12 
 
                                                      
12 Canada Second Written Submission, para. 55 and Exhibit CDA-81).  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-99 
  
 Question 132 :  
 30. The EC's assertion in paragraph 72 of its An swers to Panel Questions (7 March 2005) that the 
Panel experts suggested that "risk assessment of fo od uses and feed uses are notably different" is not 
correct.  To the contrary, for the products in issue in this dispute, Dr. Nutti stated that if the results of 
the food safety assessment confirm the safety of the f ood, these results would be directly relevant to 
feed safety.  In response to a question from the Pane l, Dr. Nutti further clarified that she is not aware 
of any case, for the products at issue in this disput e, where a food that is safe for human consumption 
was not also determined to be safe for animals.  The long line of EC scientific opinions under 
Directives 90/220  and 2001/18  that have reviewed food and feed safety support this conclusion.
13 
 Question 136 : 
 
31. Canada disagrees with the EC's contention that  "one cannot, in the context of Article 5.5 of 
the SPS Agreement , meaningfully compare the actions of th e European Communities with those of the 
Member States, given the different ALOPs".  The EC is fully responsible under the WTO Agreement 
for the actions of EC Member States.  If individua l Member States apply levels of protection that 
differ from each other, or from the level of pr otection sought by Community-wide laws, and the 
situations in which these ALOPs are applied ar e comparable, the possibility of a violation of 
Article 5.5 arises.  The EC is in violation of its obligations if the application of different ALOPs, 
whether by the EC as a whole or by its individual Member States, is arbitrary or unjustifiable and 
results in discrimination or a disguised restriction on international trade.   32. Furthermore, despite the EC's semantic effo rts, Article 5.5 does not draw any distinction, 
whether explicit or implicit, between "provision al" and "definitive" measures, or "provisional 
approvals" and "unconditional defin itive approvals", whatever the EC might have in mind in coining 
these terms.  33. In any event, the EC's response is entirely ab stract; no attempt is made to link the "reasoning" 
set out by the EC to the facts in this case, or any of the EC Member State national measures.  This is 
consistent with the EC's approach throughout this dispute; as Canada has noted elsewhere,
14 the EC 
has yet to put forward a cogent argument that links ALOPs, facts, measures and law together with respect to the EC Member State national measures.  Question 137 : 
 
34. Once again, the EC engages in a semantic exercise while failing to address the facts.  
Regardless of whether scientific evidence is changi ng – and the EC has not demonstrated that relevant 
scientific evidence was changing in a manner that stood to affect the original multiple risk assessment 
conducted in relation to the EC Member State na tional measures – a WTO Member remains obligated 
to ensure that the application of different AL OPs does not amount to arbitrary or unjustifiable 
                                                     
 
13 See for example Exhibit CDA-35-A, pp. 4 to 5 ("Because virtually no protein is present in the oil 
extracted from the plants, the risk for human consumption are non-existent.  The amounts of PAT present in 
seed meal fed to animals would be too low to cause even  theoretical concern.").  Al so, see Exhibit CDA-63, pp. 
5 to 6 ("These results lead the Committee to conclude that there is no significant risk to human and livestock 
following ingestion of the GM seeds…In food of animal origin derived from livestock animals fed with feedstuffs after the application of glufosinate herbic ide in tolerant rape, no residues above the limit of 
determination can be expected…Compositional analysis on seed harvested from trials at a number of locations 
within Canada in several successive years provided data on oil content, fatty acid composition and glucosinolate levels.  Those for the seed from the genetically modified plants fall within the range for non-GM control 
varieties.") 
14 Canada Second Oral Statement, para. 66. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-100 
  
 distinctions in comparable situations, where such  distinctions give rise to discrimination or a 
disguised restriction on international trade.  
35. In implying that Canada is arguing that an  ALOP, once established, is frozen in time, the EC 
is misleading the Panel as to the real issues in this  dispute.  The fact remains that the EC Member 
States are applying different ALOPs to comparable s ituations.  Canada has already demonstrated this 
with reference to actual facts and measures.
15  The distinctions being made in this respect are arbitrary 
and unjustifiable, and they give rise to discrimination or a disguised restriction on international trade. 
 
36. Furthermore, the EC's argument that "every product is different, and every product needs to 
be considered on its own merits", is absurd.  It is both factually inaccurate and would, if heeded, 
render Article 5.5 meaningless as no comparison would ever be possible.  It is also completely contrary to the jurisprudence established by the Appellate Body in Australia – Salmon .
16 
 
Question 139 :  
 37. In paragraphs 86 to 88 of the EC's Answ ers to Panel Questions (7 March 2005), the EC 
suggests that the Commission would not have known  of EC Member State concerns prior to the 
submission of the draft measure to the Regulatory Committee, and that submitting the draft measure 
was the only way to gauge those concerns.  This is pa tently false.  EC Member States' concerns were 
typically raised once the Competent Authority's favourable assessment had been circulated at the 
Community-level.  In order to evaluate the leg itimacy of these concerns, the Commission typically 
would seek the advice of the relevant Community-level  scientific committee.  Only after the scientific 
committee rendered its favourable opinion would the Commission submit draft measures to the 
Regulatory Committee.  To suggest, as the EC does, th at prior to the submission of the draft measure 
a full airing of the Member State concerns had not taken place is again playing fast and loose with the 
facts.  In all relevant cases, the Commission failed to call for a formal vote as it was apparent to the 
Commission that the qualified majority necessary to  support the measure could not be mustered 
because of the moratorium . 
 
38. In short, the EC's suggestion that only by submitting draft measures to the Regulatory 
Committee could the Commission find out whether th e Member States had outstanding concerns is 
patently inconsistent with the facts and contradict s the EC's own statements that "…in the Regulatory 
Committees the Commission and the Member States discu ss the applications at length, e.g. present 
questions and answers" found in paragraph 88 of its Answers to Panel Questions (7 March 2005). 
 
Question 141 : 
 39. In addition to what follows, Canada refers th e Panel to paragraphs 152 to 159 and 249 to 252 
of Canada's First Written Submission, which establish that the moratorium  is an SPS measure and that 
it is subject to Article 7 and Annex B of the SPS Agreement . 
 
40. The EC's response to this question miss es the point of Canada's argument.  The moratorium  is 
"applicable generally" in that it su spends all final decision-making unde r the EC's approval procedure.  
This is not a question of an "administrative decisi on in a specific case" but of the procedure not being 
allowed to function as designed.  It is not, as the EC  asserts, a measure that is "adopted at the end of a 
specific administrative procedure", nor does it represent "the outcome of a specific approval 
procedure in relation to a specific product".  It is  the adoption (more about this word later) of a 
measure of general application that affects all products subject to the procedure.  The moratorium  is 
                                                     
 
15 Canada First Written Submission, paras. 412-42. 
16 Report of the Appellate Body, paras. 139-178.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-101 
  
 therefore a "sanitary [or] phytosanitary regulation[]"  and the EC's failure to publish it promptly is a 
violation of Article 7 and Annex B(1).  
41. In regard to paragraphs 94 to 97 of the EC's Answers to Panel Questions (7 March 2005), 
Canada simply observes that, notwithstanding the EC 's somewhat intemperate attack on the wording 
of the Panel's question, it cannot disguise or detract  from the essential facts that Canada has already 
established.  A moratorium  was not only "adopted", it has had the effect of halting approvals of 
biotech products since October 1998.  Whether the measure was adopted de facto  or de jure  is really 
beside the point, just as it is beside the point wh at EC law requires in the way of recording such 
measures.  The EC cites Orwell in its  efforts to evade this obvious point.
17  It might better have 
invoked Kafka as the inspiration for its strategy of surreal obfuscation in this case.   Question 142 : 
 
42. Although Canada has little difficulty, in principle,  with the EC's depiction of the distinction 
between principles and evidence, the digression in paragraph 99 of the EC's answer to Panel Question 142 misrepresents both the f acts and the legal position of Canada. 
 43. Contrary to the EC's assertions, the evidence h as revealed that, in the case of the EC Member 
State national measures – the only measures for which the EC has invoked Article 5.7 – the scientific 
evidence was more than sufficient to complete a ri sk assessment, and that the alleged concerns noted 
by the EC in paragraph 99 were not a relevant fact or.  To imply, as the EC does, that there was little 
or no scientific evidence, and that scientific principles were irrelevant, is to distort utterly the factual 
situation in relation to these products. 
 
44. Furthermore, the EC's suggestion that pot ential risks to biogeochemical cycles were an 
overriding concern in the EC is simply a flight of fa ncy.  There is in fact no evidence to suggest that 
any of the biotech products in question affect biogeochemical cycles in a manner that adversely 
affects plant or animal life or health.
18  Finally, even if such evidence existed, the risk could only arise 
in the case of products approved for cultivation.  This is only a frac tion of the product applications 
currently suspended in the EC's approvals process. 
 Question 144 :  
 45. The EC avoids answering the Panel's Question by discussing products that have been notified 
under the simplified procedure of Article 5 under Regulation 258/97  (e.g. GT-73).  This misses the 
point entirely and is yet a further attempt by the EC to avoid addressing the pertinent issues in this 
dispute by focussing on issues that are at best margina lly relevant.   Furthermore, the EC is incorrect 
to characterize these products as having been "approv ed" under the Community legislation.  The EC 
knows full well that these products were assessed only at the individual EC Member State level, that 
an opinion was rendered as to whether they met the cr iteria for substantial equivalence, and that this 
fact was notified to the other EC Member States through the European Commission.   
 Question 152 :  
 46. The EC's answer to Panel Question 152 act ually confirms Canada's assertion that the 
Rapporteur had merely re-requested information that  it had previously received from the applicant.  
Specifically, the EC admits that the "blots from the three reports" had already been transmitted to the 
                                                     
 
17 EC Answers to Panel Questions (7 March 2005), para. 97. 
18 See Canada Answers to Panel Questions (7 March 2005), Question 148, paras. 68-70.  Also see 
Canada's answer to Panel Question 128, above. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-102 
  
 lead CA.  Moreover, the EC admits that the working document submitted by the notifier on 17 May 
2000 "contained information submitted over the past two years
".19  Indeed, the working document was 
"taking into account all the supplemental informa tion submitted to the Dutch Competent Authority in 
the last two years"20 and consolidating that information for th e convenience of the Dutch authorities.  
In the light of the prolonged delays caused by the moratorium , one can hardly expect a notifier to 
simply sit on its hands and do nothing.  Question 154 :  
 
47. The EC's response to this question indicates that it cannot justify delays resulting from the "need" for new legislation.  Whether or not the EC's traceability and labelling legislation, per se , 
conforms to the EC's WTO obligations has yet to be determined and is not an issue in this case.  The 
fact that the complainants have not challenged the EC's traceability and labe lling legislation (which 
Canada notes only entered into force in April 200 4, well after the Panel was established) or co-
existence legislation (which has not even been propo sed) is irrelevant and does not imply that delays 
caused by the imposition of a moratorium  pending the adoption of such legislation are justified under 
Annex C(1)(a) of the SPS Agreement . 
 Question 158 : 
 
48. Canada refers the Panel to paragraphs 189 to 193 of Canada's Second Written Submission, 
where it demonstrates why the refusal of France to issue the letters of consent for oilseed rape 
Ms1xRf1 and Ms1xRf2 gives rise to a violation of the EC's obligations under the SPS Agreement . 
 
49. The obvious answer to this question is that  neither product has been marketed in the EC 
because neither product received final approval fro m the sponsoring EC Member State.  Under 
Directive 90/220 , a product could not be marketed unless it had received the written consent from the 
sponsoring Member State.  Article 11(5) of Directive 90/220  specified that "the notifier may proceed 
with the release only when he has received the written consent of the competent authority in 
accordance with Article 13…".  Article 13(4) states, in  turn, that "…the competent authority shall give 
consent in writing  to the notification so that the pr oduct may be placed on the market …".21  In other 
words, the issuance of the written consent by the sponsoring Member State competent authority was a 
legal condition precedent to the product being marketed.  50. The proposition that Articles 11(5) and 13(4) of Directive 90/220  have a legal effect is further 
supported by the fact that the European Commission issued reasoned opinions to France in relation to 
its refusal to issue the letters of consent – a necessary precursor under EC law to the Commission 
bringing legal action against a Member State that  has breached its legal obligations – in 1999.
22  If the 
provision in the EC legislation requiring the sponsor ing Member State to issue a letter of consent had 
no legal effect, there would be no need nor indeed a basis for the issuance of reasoned opinions by the 
European Commission. 
 
Question 159 : 
 51. Canada has no comment other than to observe that it is curious that the EC seems better 
informed about the status of the transgenic vari eties in other jurisdictions than in its own. 
 
                                                     
 
19 EC Answers to Panel Questions (7 March 2005), para. 106 and 107. 
20 Exhibit EC-70 – attachment 21. 
21 Emphasis added. 
22 Exhibit CDA-52.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-103 
  
 Question 160 : 
 52. Canada appreciates the EC's effort to clarify th e legal status of Italy's Decree banning the use 
of maize MON809, MON810, T25 and Bt11.  Howeve r, Exhibit EC-166 is, in Canada's view, less 
than satisfactory as confirma tion of that legal status. 
 53. If, in fact, the Decree has been repealed, as the letter in Exhibit EC-166 indicates, the EC 
should provide the Panel with a copy of the Italian legislative instrument repealing it.  If the ruling by 
the Regional Administrative Court of Lazio had the effect of rendering the Decree null and void, 
independently of any action by the Italian government , a translated copy of the court ruling should be 
submitted to the Panel and the parties, and, if necessa ry, an explanation of how Italian law operates in 
this respect, including confirmation that the ruli ng has not been, and will not be, appealed by the 
Italian government. 
 
Question 161 :  
 54. Canada notes that the EC response to Questi on 161 is incomplete.  The EC states that the 
EFSA evaluation of Ms8xRf3 began as of 10 January 2005.  Alt hough EFSA received the 
Commission's request for an evaluation on 11 January  2005, the request is still marked "registration 
not yet completed."
23 Consequently, the EFSA evaluation has not yet started.  Not surprisingly, the 
EC fails to provide any explanation as to the reason for the delay or  offer any explanation for why it took six months after receiving the last of the Member States' objections for the Commission to 
request EFSA to review the dossier.
24 
 
Question 162 : 
 55. Canada notes that, even at this late stag e of the proceedings, the EC remains unable – 
independently of the EC Member State national measures – to articulate the specific level of 
protection being applied by its respective Member States.  Furthermore, Canada disagrees with the EC's vague assertion that it is clear from the measures that they "seek to secure a high level of 
protection".  If anything is clear from the meas ures – which amount to complete bans on these 
products – it is that they aim for an acceptable level of risk that is tantamount to zero.  Question 163 :  
 
56. Canada has maintained since the outset of these proceedings that the EC has violated 
Article 5.5 of the SPS Agreement  by adopting different appropriate levels of protection in different 
situations, namely in respect of pending biotech applications subject to the moratorium  and novel 
non-biotech products (such as herbicide-tolera nt crops developed through mutagenesis).
25   However, 
the source of the difference in the appropriate level of protection is not the existence of an approval 
regime for biotech products, per se , but the fact that the EC, by adopting and maintaining a 
moratorium , has effectively prevented the approval proce dure from functioning.  In the light of the 
evidence of the experts concerning the comparability of the risks of these two groups of products, the 
EC's superficial attempt at avoiding this issue by s uggesting that it is outside the terms of reference of 
this Panel is truly a last desperate attempt to address a losing argument.   
                                                     
 
23 EFSA, Register of Requested Opinions, EFSA-Q-2005-005,  
http://www.efsa.eu.int/registe r/qr_dateofreceipt_12_en.html .   
24 According to the EC Chronology  for Ms8xRf3, the last comment received by a Member State was 
received from Italy on June 22, 2004. 
25 Canada First Written Submission, paras. 209-210. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-104 
  
 Question 164 :  
 57. The EC responds to Question 164 by claiming that  the legal principle that legal acts need to 
be reasoned does not apply to the Regulatory Comm ittee because it is an auxiliary body "that is 
merely involved in preparing such an act".  The argument appears to be that because no final decision or "acts that have (external) legal effect" have  been adopted, the obligation to explain why the 
institution disregarded the opinion of the scientific  committee does not crystallize.   This argument 
parallels the EC's argument that it has not violated Article 5.1 of the SPS Agreement  because the risk 
assessment process has yet to be completed.  In  other words, so long as the EC can prolong the 
approval process (even indefinitely ) without taking a final decision, the EC should be able to 
circumvent its legal obligations.  At least with re spect to the EC's WTO obligations, this position is 
without merit.  
58. Canada notes that, in responding to this questi on, the EC attempts to downplay the role of the 
Regulatory Committee.  The EC relies on a formalistic distinction between the EC Member State and Commission representatives sitting qua Regulatory Committee, and the Regulatory Committee itself 
in suggesting that regulatory committees do not themselves have any power to seek further 
information.  This is little more than semantics.  Whether a request for additional information comes 
from a Member State, the Commission or the formal  entity referred to as the Regulatory Committee is 
immaterial for the purposes of this dispute.  The unmistakeable fact is that the Regulatory Committee 
stage of the process, whether one refers to this as the Community-level stage or  the first step in the 
Comitology procedure, has been used by the EC Member States and the Commission to effectively 
stall the approval procedure.  
59. Second, the EC's characterization of the role  of the Regulatory Committee is at odds with its 
previous description of its regulatory bodies.  For instance, earlier in its Answers to Panel Questions 
(7 March 2005), the EC states that the "authorization for the product under question is scrutinized by 
the Regulatory Committee "26 and refers to the fact that th e Regulatory Committee "had not only a 
regulatory  but also an advisory  role."27  Similarly, in earlier submissions, the EC has repeatedly 
characterized the activity of the regulatory co mmittees as related to the consideration of risk 
management measures.  By way of example, the EC re fers to the fact that "risk management decisions 
are left to regulatory bodies"28 and states that "[i]n the risk analysis process, it is up to the risk 
management level (the Commission and the Member  States together) to take appropriately into 
account all the independent risk assessment information and opinions."29  It is clear that the EC is 
referring to the activity that takes place at the Community level, under the guise of the relevant 
Regulatory Committee.  It is equally clear that bloc kage of biotech applications, as a result of the 
moratorium , has been most pronounced at the Re gulatory Committee stage of the process. 
 60. Whether or not the EC community institutions are able to circumvent legal obligations under 
the EC's internal law by merely claiming that th e process has yet to be completed has no impact on 
the EC WTO obligations: the requirement to base its  SPS measures on a risk assessment by virtue of 
Article 5.1 of the SPS Agreement  and to undertake and complete its approval procedures without 
undue delay pursuant to Annex C.  The EC cannot ci rcumvent these obligations by claiming that its 
regulatory bodies ( e.g. Regulatory Committees) were still in the process of considering supposed risk 
management measures.
30 
 
                                                      
26 EC Answers to Panel Questions (7 March 2005), para. 83. 
27 Ibid, para. 86. 
28 EC Answers to Panel Questions (16 June 2004), para. 12. 
29 EC Answers to Panel Questions (16 June 2004), Question 86, para. 240. 
30 Canada Third Written Submission, paras. 26-37.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-105 
  
 Question 171 : 
 61. Canada has already refuted the EC's arguments  set out in paragraphs 57 and 58 of the EC's 
answer to Panel Question 171.  Canada would simply refer the Panel to paragraphs 103 to 112 of its 
answer to Panel Question 50(a), paragraphs 230 to 256 of its Second Written Submission, and 
paragraphs 79 to108 of its Third Written Submission, which demonstrate that: Article 5.7 constitutes 
an exemption from the requirement in Article 2.2 not to maintain an SPS measure without sufficient 
scientific evidence; the burden is on the EC, as the party invoking Article 5.7, to demonstrate its 
applicability for each of the EC Member State natio nal measures; and the EC has not discharged this 
burden.  Question 172 : 
 
62. Canada disagrees with the EC's contention that a bifurcation can be established between 
Article 8 and Annex C on the one hand, and the rest of the SPS Agreement  on the other hand, on the 
basis of whether the SPS measure in question is bei ng "applied" or "developed".  If this bifurcation 
was intended by the WTO Members, they would not have used the term "applied" in Article 2.2. 
 63. Furthermore, the text of Article 8 does not st op after "the operation of control, inspection and 
approval procedures".  It goes on to extend the oblig ation to "procedures…for establishing tolerances 
for contaminants in foods, bevera ges or feedstuffs" and to require WTO Members to "otherwise 
ensure that their procedures are not inconsistent w ith the provisions of this Agreement."  Procedures 
for establishing tolerances for contaminants must be  distinguished from procedures to ensure such 
tolerances are not exceeded.  The former would be a normative measure of general application while 
the latter is the application (or operation) of a control, inspection or approval procedure, yet no 
distinction is drawn between them for the purposes of either Article 8 or Annex C. 
 64. In any event, Canada has already explaine d why the particular facts in this dispute go 
considerably beyond the scenario envisaged in th e Panel's question of short delays in making a 
decision,
31 and has demonstrated how the EC's moratorium  is inconsistent with both Articles 2, 5, 8 
and Annex C(1)(a) of the SPS Agreement .32  
 Question 173 : 
 65. The EC misrepresents Canada's position in  paragraph 64 of the EC's response to 
Question 173.  Canada refers th e Panel to paragraphs 18 to 23 of Canada's Answers to Panel 
Questions (11 March 2005), and pa ragraph 94 of its Answers to Pa nel Questions (16 June 2004) for 
an accurate rendition of Canada's position.  In those paragraphs, Ca nada makes it clear that delaying 
the approval of specific products is only justifiabl e where a valid risk assessment has revealed the 
existence of risks for which the existing legisla tion does not provide risk management measures. 
 
66. In this regard, the EC suggests that because  the complainants have not challenged the EC's 
new legislation, "it must be accepted as is fo r the purposes of assessing what may be ‘undue'".
33  This 
is entirely beside the point.  The issue is not whether the new legislation is in itself consistent with the 
WTO rules, but whether the EC was justified in  suspending its approva ls procedure pending the 
adoption of that legislation.     
 
                                                      
31 Canada Answers to Panel Questions (11 March 2005), paras. 13-17. 
32 Canada First Written Submission, Part VI.A and Part VII.A. 
33 EC Answers to Panel Questions (11 March 2005), para. 69. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-106 
  
 Question 177 : 
 
67. The EC's assertions regarding the issue of whether biotech products  and their conventional 
counterparts are "like products", and whether the EC measures accord less favourable treatment to 
imported biotech products, do not reflect the jurisprudence on these points.  68. In particular, the EC suggests that because th ere is different general legislation for biotech 
products and their conventional counterparts, they cannot be considered like products.  The EC also 
points to the Cartagena Protocol  as evidence that biotech products and their conventional 
counterparts are not like products.  However, neither  criterion is relevant, much less dispositive, of 
whether biotech products and their conventiona l counterparts are like products or not. 
 69. The EC also argues that the Appellate Body has not said that "the competitive relationship in 
the market place" is the sole criterion for determin ing likeness, and that one Member of the Appellate 
Body in the asbestos dispute was of the view th at a "purely economic assessment of likeness is not 
always appropriate".
34  However, these remarks have to be weighed against the underlying purpose of 
Article III of GATT (and, theref ore, also Article 2.1 of the TBT Agreement ), which is "to avoid 
protectionism in the application of internal … regulatory measures …".35 
 
70. The test for whether two products are "like" under Article III:4 has been set out in the 
jurisprudence.36  Based on that jurisprudence, Canada has demonstrated in its earlier submissions why 
specific biotech products and their conventional coun terparts are like products  in the relevant sense.37  
The EC has not presented any arguments or evidence, as regards the Appellate Body-mandated test for likeness, to counter Canada's prima facie  case in this regard. 
 
71. Turning to the specific issue raised by the Panel in its question – l ess favourable treatment – 
the EC's arguments and assertions are without merit.  72. The departure point for a determination of  whether an imported like product has been 
accorded less favourable treatment is, as has been not ed repeatedly in the ju risprudence, the question 
of whether the imported and domestically-p roduced goods enjoy "equality of competitive 
conditions".
38  In Korea – Beef , the Appellate Body elaborated on this point, stating that: 
 
A formal difference in treatment between imported and like domestic products is thus 
neither necessary, nor sufficient, to show a violation of Article III:4.  Whether or not 
imported products are treated "less favourably " than like domestic products should be 
assessed instead by examining whether a measure modifies the conditions of 
competition in the relevant market to  the detriment of imported products.39 
73. Canada does not question th e Appellate Body's statement that WTO Members may draw 
distinctions between products that have been fo und to be "like" without, for that reason alone, 
according less favourable treatment to imported products  as compared to their domestic counterparts.  
However, this statement does not alter in any wa y the basic requirement that WTO Members must 
offer equality of competitive conditions.  
                                                     
 
34 EC Answers to Panel Questions (11 March 2005), para. 101. 
35 Japan – Alcohol II , Report of the Appellate Body, p. 16. 
36 EC-Asbestos , Report of the Appellate Body, paras. 87-99. 
37 Canada First Written Submission, paras. 304-20 and 451-65. 
38 Japan – Alcohol II , Report of the Appellate Body, pp. 16-17. 
39 Korea – Beef , Report of the Appellate Body, para. 137.  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-107 
  
 74. The EC also misunderstands the Appellate B ody's comments in paragraph 100 of its report in 
EC – Asbestos .  The Appellate Body's use of the word "group" did not signify that "like products" 
could somehow be broken down into sub-categories.  If a finding is made that a biotech product – for 
example, a Bt maize variety – is "like" conven tional maize, then the WTO Member concerned is 
required to provide equality of competitive opportuni ties to the Bt maize and the conventional maize, 
respectively.  Thus, the EC's suggestion that the point of comparison must be between imported and 
domestic biotech products is non-sensical.  
75. The Appellate Body has also noted that: 
 
The examination of whether a measure involves "less favourable treatment" of imported products within the meaning of Article III:4…must be grounded in close 
scrutiny of the "fundamental thrust and effect of the measure itself".  This 
examination cannot rest on simple assertion, but must be founded on a careful 
analysis of the contested measure and of its implications in the marketplace.  At the same time, however, the examination need not be based on the actual effects  of the 
contested measure in the market place.
40 
76. In this particular case, careful analysis of the contested measure reveals, both in the case of 
the product-specific marketing bans  and the EC Member State national measures, that the effect is to 
prohibit entirely the biotech products in question from being sold and used in the marketplace.  In 
contrast, the conventional/non-transgenic products continue to enjoy unfettered access to the 
marketplace.  It is difficult to conceive of a situation where "equality of competitive conditions" has 
been more completely eradicated.  Canada is not re quired to demonstrate the "actual effects" of the 
EC's measure. 
 
77. Finally, Canada observes that, in US – Section 337 , the Panel stated that, where differential 
treatment has been established, "it is incumb ent on the [WTO Member] applying differential 
treatment to show that, in spite of such differe nces, the no less favourable treatment standard of 
Article III:4 is met".41  This suggests that the initial burden is on the complaining party to establish 
differential treatment.  Once differen tial treatment has been shown, th e burden shifts to the responding 
party to demonstrate that the differential treatment do es not result in less favourable treatment.  In the 
specific circumstances of this dispute, Canada h as indeed demonstrated differential treatment.  In 
contrast, the EC has not met its burden of demonstrat ing that the differential treatment has not resulted 
in less favourable treatment.  It has not because it cannot.  
Question 198 : 
 78. In paragraph 37 of Canada's Second Oral Stat ement, Canada was referri ng to concerns raised 
by EC Member States such as the following raised by the Belgian Group of experts:  "[o]ne can only 
speculate on the effects in the long-term and on th e effects of a large-scale cultivation of the GM-
herbicide tolerant crops."
42   The experts appear to assume th at the cultivation of GM-herbicide 
tolerant crops will result in "cleaner" fields, that is to say, fields with fewer weeds.  Whether this is 
true depends on the herbicide to which the plant is tolerant as well as, critically, the application of the 
herbicide. Thus, the source of the alleged concerns  about farmland biodiversity  results from better 
weed control associated with GMHT crops.  Obviously, if the extent of GMHT cropping was limited to a smaller scale, the putative impact on farmla nd biodiversity would be less pronounced.  In any 
event, the EC avoids the question of whether or not a smaller and progressive introduction of the 
                                                     
 
40 US – FSC (Article 21.5 – EC) , para. 215. 
41 US – Section 337 , para. 5.11. 
42 Exhibit EC-63 – attachment 166, p. 14. WT/DS291/R/Add.4 
WT/DS292/R/Add.4 WT/DS293/R/Add.4 
Page F-108 
  
 biotech crop is a feasible option and conspicuously avoids discussing the successful examples cited in 
paragraph 37 of Canada's Second Oral Statement.  
 
Question 199 : 
 79. The EC's response to Question 199 reveals yet again just how "inconsistent", to use Dr. Squire's term, the EC has been in addressing its concerns about "farmland biodiversity."  
 
80. The EC's attempt in paragraph 110 to complicate the issue of farmland biodiversity in the 
context of GMHT cropping is misplaced.  The EC seek s to obscure the fact that, when stripped of its 
jargon, the putative impact on farmland biodiversity fro m herbicide-tolerant crops  is related to more 
effective in-crop weed control.
43  Whatever other concerns the EC may have about the impact of 
modern agriculture on farmland biodiversity ( e.g. agricultural intensification, crop specialization and 
monoculture, increased drainage of wetlands, elimina tion of non-farming habitats etc.), these have 
nothing to do with GMHT crops and cannot be used to colour this issue.  81. In paragraphs 111 and 112, the EC yet agai n seeks to uproot biotech crops from the broader 
agricultural context.  The EC offers no factual support  for its assertion that limiting "the rate of use of 
the herbicide, while achieving an acceptable level of efficacy, would in practice be as ineffective as a 
voluntary measure.  Indeed, such requirements would be extremely difficult to enforce or let alone 
police."  The EC completely fails to explain wh y conditions imposed on the use of herbicides in 
conjunction with biotech HT crops would be any more  difficult to enforce than conditions imposed on 
the literally hundreds of other herbicide uses approved in the EC, including the use of herbicides with 
non-biotech herbicide-tolerant crops  developed through mutagenesis.  For instance, in the UK, over 
550 pesticide products are approved fo r use with oilseed rape alone.
44   Unsubstantiated assertions are 
not sufficient to meet the EC's burden of proof in the face of the prima facie  case that Canada has 
established.   82. If protecting farmland biodiversity by requiring farmers to leave more in-crop weeds was in 
fact a genuine policy objective (the EC's selective ap plication of this concern to biotech HT crops, and 
nothing else, suggests that it is not), the asserti on that measures adopted to achieve this objective 
would be more difficult to enforce for herbicide us e in conjunction with biotech HT crops than with 
any other herbicide use is groundless.  Yet again, the EC advances unsupported assertions in an effort 
to explain away glaring inconsistencies in the ma nner in which it treats biotech crops and all other 
forms of agricultural practice. 
 
83. Indeed, contrary to the EC assertion, requiri ng farmers to apply herbicides in a manner that 
leaves more weeds in the field has been recognized as a plausible option by scientists involved in the 
UK FSE:  
If the environmental disbenefits of very clean fields are in future judged to be 
unacceptable in Britain, then additional ma nagement practices, such as band spraying
 
(Dewar et al. 2003) or leaving unsprayed strips along field margins , could be used to 
                                                      
43 See, for example, Exhibit EC-38, p. 5 ("The resear chers confirmed that the mo re weeds there are in a 
field, the more insects there are."; "The researchers th ink that conventional beet and spring rape fields were 
richer in wildlife than their GM counterparts becaus e the broad-spectrum herbicides were more effective on 
weeds than the specific herbicides used on the conventional crops.") 
44 See Pesticide Safety Directorate Database - Pes ticides Register Database (Crop:oilseed rape  
(https://secure.pesticides.gov.uk/pestreg/ProdSearch.asp).  WT/DS291/R/Add.4 
 WT/DS292/R/Add.4 
 WT/DS293/R/Add.4 
 Page F-109 
  
 reduce the negative impacts of cleanliness.   The possibilities for mitigation are 
numerous , but are beyond the scope of this paper.45 
84. The EC's arguments should be seen for what th ey are – a convenient pretext for continuing 
the moratorium  and product-specific marketing bans . 
                                                      
45 Heard, M.S., C. Hawes,  G.T. Champion, et al., Weeds in fields with cont rasting conventional and 
genetically modified herbicide-tolerant crops.  I.  Effects on abundance and diversity . Phil. Trans. R. Soc. Lond. 
B (2003) 1819-1832, p. 1831.  (Exhibit EC-63 – attachment 154). [emphasis added]