EUROPEAN COMMUNITIES – MEASURES AFFECTING THE APPROVAL AND MARKETING OF BIOTECH PRODUCTS
Document: Reports of the Panel Addendum
Date: 29 September 2006
Document codes: WT/DS291/R/Add.3; WT/DS292/R/Add.3; WT/DS293/R/Add.3; WT/DS291/R; WT/DS292/R; WT/DS293/R.
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

EUROPEAN COMMUNITIES – MEASURES AFFECTING
THE APPROVAL AND MARKETING
OF BIOTECH PRODUCTS

Reports of the Panel

Addendum

 This addendum contains Annex E to the Re ports of the Panel to be found in document
, , The other annexes can be found in the following
addenda:

 – Annex C: Add.1
 – Annex D: Add.2
 – Annex F: Add.4
 – Annex G: Add.5
 – Annex H: Add.6
 – Annex I : Add.7
 – Annex J: Add.8
 – Annex K: Add.9

ANNEX E

REPLIES BY THE PARTIES TO QUESTIONS
POSED BY OTHER PARTIES IN THE CONTEXT
OF THE FIRST SUBSTANTIVE MEETING

Contents Page
Annex E-1 Replies by the United States to questions posed by the European
Communities
E-2
Annex E-2 Replies by Canada to questions posed by the European
Communities
E-4
Annex E-3 Replies by Argentina to questions posed by the European
Communities
E-8
Annex E-4 Replies by the European Communities to questions posed by
Argentina
E-10

ANNEX E-1

REPLIES BY THE UNITED STATES
TO QUESTIONS POSED BY THE EUROPEAN COMMUNITIES

For all complainants

1. Is it the position of the Complainants that new scientific information which emerges
after a scientific committee opinion should be di sregarded? How should a regulator react to a
situation where sources of information other than appointed scientific committees report the
existence of a risk in connection with a given product? Could you indicate the basis for your
position in the relevant WTO agreements?

112. In all the cases described above, the regulator of the WTO Member must undertake and
complete its approval procedures without "undue de lay." See SPS Agreement, Annex C(1)(A). The
EC has not shown that any of the scenarios in the above question justified the delays resulting from its
moratorium on biotech approvals.
2. Once a WTO Member has adopted an appropri ate level of protection, is it allowed to
change its mind and adopt a higher one?

113. Yes. The United States would note, however, that a change in the level of protection would
not justify the adoption of a general moratorium on all biotech approvals.

3. In a federal entity, have sub-entities the right to have different appropriate levels of
protection? If you do not agree, could you i ndicate the basis for your position in the SPS
Agreement?

114. Please see answer to Question 38(b) of the Panel .

4. What would it take in your opinion for th e alleged moratorium to be removed? Would
the European Communities have to grant one more approval, ten more approval, or how many?
Would the European Communities have to stop asking for more information under the
approval procedures? Would all MS have to vote in favour of proposals to grant authorisations
for the products at issues in the Regulatory Committees and in the Council? (see paras. 24 and
27 of the oral statement of Canada)

115. As the United States explained during the first substantive meeting of the Panel, questions of
compliance are not within the Panel's terms of re ference. Moreover, once the Dispute Settlement
Body has adopted a finding that a WTO Member is in breach of its WTO obligations, it is up to the
defending Member to decide how it wishes to come in to compliance with its obligations. That said,
the United States would expect that in order for the EC to bring its measures into compliance with its
obligations under the SPS Agreement, the EC would have to make decisions on agricultural biotech
applications without undue delay.

For Canada and the United States

1. Please explain why you notified the follo wing measures under both the SPS Agreement
and the TBT Agreement:

– for Canada: Living Modified Organisms Regulations, document G/TBT/N/CAN/46 of
14 October 2002 and document G/SPS/N/CAN/144 of 4 October 2002;

– for the United States: Registration of Food Facilities Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002, document G/TBT/N/USA/32
of 13 February 2003 and document G/SPS/N/USA/691 of 6 February 2003.

116. The United States notified its Prior Notice of Imported Food, Administrative Detention, and
Records proposed rules only under the SPS Agreemen t, because the rule is designed to address SPS
risks, such as risks arising from contaminants, toxins or disease-causing organisms in foods,
beverages or feedstuffs. FDA notified its Regist ration of Food Facilities proposed rule under both the
TBT and SPS agreements, because registration woul d be used to address both SPS issues, such as
food safety, and TBT issues, such as many food labeling requirements.

For the United States

1. If a declaration of political intent by fi ve EU ministers constitutes a measure that may
constitute a violation of the WTO Agreement on the part of the European Communities, would
the same be true of a declaration by 60 Memb ers of the US Congress that they would block any
attempt to not repeal the Byrd amendment also cons titute a violation by the US of its obligation
to implement the Panel report in that case?

117. The premise of the question is false. The Un ited States did not argue that the "declaration of
political intent," standing alone, constitutes a measure. Rather, the United States submits that the EC
in fact adopted a moratorium on biotech approvals, and that the declaration of the five EU ministers is
compelling evidence of the existence of that me asure. Other compelling evidence, as the United
States has explained, includes the f act that the EC followed through on this declaration and failed to
allow any biotech product application to move to final approval for over five years.

ANNEX E-2

REPLIES BY CANADA TO QUESTIONS
POSED BY THE EUROPEAN COMMUNITIES

For all complainants

1. Is it the position of the Complainants that new scientific information which emerges
after a scientific committee opinion should be di sregarded? How should a regulator react to a
situation where sources of information other than appointed scientific committees report the
existence of a risk in connection with a given product? Could you indicate the basis for your
position in the relevant WTO agreements?

1. No, it is not the position of Canada that new scientific information s hould be disregarded.
There is nothing in the SPS Agreement that precludes a Member from considering new scientific
information. If an SPS measure is based on a risk assessment, and new scientific information emerges
that was not factored into that risk assessment, a Me mber is entitled to redo th e risk assessment in the
light of the new information. If, given this new information the conclusions of the risk assessment
change, then the Member is entitled to change its SPS measure.

2. This is apparently how the safeguard pro cedures under the relevant EC approval legislation
are supposed to work. Following the adoption of the Member State national bans ("safeguard
measures"), the Commission referred the safeguard measures to an independent scientific committee
at the community level to review the purported "new scientific evidence" cited by the Member State
in support of the invocation of the safeguard measure. In all cases, the independent scientific
committee concluded that there was no basis for th e national ban. Had the independent scientific
committee considered that there actually was "new scie ntific information" affecting the original risk
assessment, then the EC may have been justified in refusing to require the Member States to remove
the national bans. This, as the EC knows, was not the case.

2. Once a WTO Member has adopted an appropriat e level of protection, is it allowed to
change its mind and adopt a higher one?

3. Yes. This decision must not be arbitrary or unjustifiable and must be done in a manner
consistent with the SPS Agreement and, in particular, Article 5.5.

3. In a federal entity, have sub-entities the right to have different appropriate levels of
protection?

If you do not agree, could you indicate the basis for your position in the SPS Agreement?

4. Whether sub-entities in a federal entity have th e right to set different appropriate levels of
protection is a function of the internal laws of the federal entity in question, and more particularly a
matter of constitutional law and the division of powers ("competencies" in EC terminology)
established within that federal entity.

5. In terms of the SPS Agreement , the issue is not whether the sub-federal entities have the
"right" to set and apply their own appropriate leve ls of protection. The issue is whether the WTO
Members, in setting and applying their appropriate le vels of protection – whatever their constitutional
arrangement – do so in a manner consistent with the SPS Agreement.

6. This requires, inter alia , that the WTO Member concerned avoid arbitrary or unjustifiable
distinctions in the levels of protection it considers to be appropriate in different situations that are
comparable, if those distinctions result in discrim ination or a disguised restriction on international
trade.

4. What would it take in your opinion for th e alleged moratorium to be removed? Would
the European Communities have to grant one more approval, ten more approval, or how many?
Would the European Communities have to stop asking for more information under the
approval procedures? Would all MS have to vote in favour of proposals to grant authorisations
for the products at issues in the Regulatory Committees and in the Council? (see paras. 24 and
27 of the oral statement of Canada)

7. Canada considers that there is no "magic" numbe r of approvals that has to be reached before it
can be said that the moratorium has been lifted. As a start, it would be helpful if the European
Communities and its Member States acknowledged that a de facto moratorium on approvals on
biotech products was put in place as of October 1998, and stated their commitment to lift this
moratorium. Given the de facto nature of the moratorium, whether the moratorium has been lifted can
only be determined with referenc e to demonstrable progress being ma de on individual applications at
the Community level, with key reference points being the relevant regulatory committee. In
particular, speedy decisions on those applications for which multiple risk assessments have already
been completed would be helpful.

For Argentina and Canada

1. Do you agree with the United States' position as stated at DSB meeting of 10 December
2003 and again implied in its oral statement of last week (para. 56) that the burden of proof for
Article 5.7 of the SPS Agreement is on the Complainants and not on the European Communities
as the defendant?

8. Paragraph 56 of the US oral intervention does not imply that the burden of proof under
Article 5.7 is on the complainants. Rather, it de monstrates systematically that none of the EC
Member State measures meets any of the four requir ements of Article 5.7. Canada made the same
points at paragraphs 80-85 of its Oral Statement at the first hearing.

9. In any event, where the burden of proof falls with respect to Article 5.7 must be determined
with reference to the text of the WTO Agreement, and the relevant jurisprudence, and not individual
Member statements in the DSB.

For Canada and the United States

1. Please explain why you notified the following measures under both the SPS Agreement
and the TBT Agreement:

– for Canada: Living Modified Organisms Regulations , document G/TBT/N/CAN/46 of
14 October 2002 and document G/SPS/N/CAN/144 of 4 October 2002;

– for the United States: Registration of Food Facilities Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 , document G/TBT/N/USA/32 of
13 February 2003 and document G/SPS/N/USA/691 of 6 February 2003.

10. Notifications of measures are made for the purposes of transparency and do not have any
legal effect. This has been r ecognized in the jurisprudence (EC – Asbestos, Report of the Panel, para.
8.60). Canada is committed to transparency with in the WTO, and to the notification process as the
appropriate means by which to advise WTO Members of potential regulatory changes within Canada.
These notifications cannot in any way be interpreted as being representative of Canada's legal position
as to which measures are covered by which WTO agreements.

For Canada

1. The European Communities takes note of Cana da's view that risks posed by GM plants
are the same as or similar to risks posed by conv entionally bred plants. It also notes that in
describing the potential risks of GMOs in its su bmission Canada does not mention the issue of
antibiotic resistance markers? Does Canada believe that this potential risk does not exist?

If Canada is of the opinion that the risk does not exist could Canada explain why its own
scientific expert committee (the Royal Society of Canada) has identified this issue to be a
potential risk?

Does Canada not agree with its own scientific experts' Committee?

11. Canada considers that there could be a poten tial risk, however unlikely, posed by antibiotic
resistance markers. This risk is typically assessed through the risk assessment process for each
product, taking into consideration the clinical and ve terinary importance of the antibiotic in question,
the likely occurrence of horizontal gene transfer fro m genetically modified plants to microbes and the
potential impact of horizontal gene transfer wher e naturally occurring resistance to the relevant
antibiotics exists in the microbial gene pool.

12. For the biotech products in question, the scien tific evidence (including that from the relevant
EC Scientific committees) demonstrates that there is , no risk to human or animal health posed by the
antibiotic resistance markers used in those products.

2. In its Oral Statement (para. 102), CAN su ggests that the safety of the BT11, Mon810
and BT176 maize is comparable because "they rely on the same gene for their insect resistance
trait". This statement has flaws as regards the scientific grounds for their case by case risk
assessment (for instance as regards the known differences between these products in respect of
the presence or not of antibiotic resistance genes or parts thereof).

Would Canada not agree that, if, as a working hypothesis, it had followed an independent
scientific risk assessment opinion, such as the one issued on antibiotic resistance marker genes
of its Royal Society, it might have come to different conclusions on these three products?

13. Canada disagrees with the EC, if it is s uggesting that corn derived from events Bt-176,
MON 810 and Bt-11 are not comparable situations for the purposes of Article 5.5.

14. According to the Appellate Body, whether situations are comparable for the purposes of
Article 5.5 depends on whether they present some co mmon element or elements sufficient to render
them comparable.
1 In Australia – Salmon, the panel concluded that:

1 EC – Hormones, para. 217.

… in the circumstances of this dispute, we can compare situations under Article 5.5 if
these situations involve either a risk of ‘entry, establishment or spread' of the same or
a similar disease or of the same or similar ‘associated biological and economic
consequences' and this irrespective of wh ether they arise from the same product or
other products.
2
15. The Appellate Body agreed with this statement. 3

16. This approach is equally applicable when the risks involved relate to the potential adverse
effects on human or animal health arising from th e presence of additives, contaminants, toxins or
disease-causing organisms in food, beverages or feedstuffs.

17. Bt-176, Bt-11 and MON810 can all be legally ma rketed as food or in food products in the EC.
All have been assessed for potential risks relating to human toxicity, including allergenicity, and
horizontal gene transfer of antibiotic-resistant marker genes. In its opinion in response to Austria's
invocation of Article 16 of Directive 90/220 as a basi s for its national ban on MON810, the Scientific
Committee on Plants grouped all genetically modi fied corn/maize lines derived using the CRY1A-
proteins together. The conclusion to its opinion with respect to Austria's invocation of Article 16 with
respect to MON810, stated that "there is no reason to change [the Committee's] previous advice to the
[European] Commission on the risk assessments of the Bt crops which it has evaluated to date".
4

2 Australia – Salmon, Report of the Panel, para. 8.117.
3 Australia – Salmon, Report of the Appellate Body, para. 146.
4 Opinion of the Scientific Committee on Plants on the Invocation by Austria of Article 16 ('safeguard'
clause) of Council Directive 90/220/EEC with respect to the placing on the market of the Monsanto genetically
modified maize (MON810) expressing the BT cry1a(b) gene, notification C/F/95/12-02 (Opinion expressed by
the Scientific Committee on Plants on 24 September 1999), at p. 5. (Exhibit US-55)

ANNEX E-3

REPLIES BY ARGENTINA TO QUESTIONS
POSED BY THE EUROPEAN COMMUNITIES

A. For all complainants

1. Is it the position of the Complainants that new scientific information which emerges
after a scientific committee opinion should be di sregarded? How should a regulator react to a
situation where sources of information other than appointed scientific committees report the
existence of a risk in connection with a given product? Could you indicate the basis for your
position in the relevant WTO agreements?

Argentina states that scientific evidence -rather than a broad concept as "scientific information"- is the
one to be regarded whenever there is any former scientific evidence at hand. A mere reference to
information with "concerns", " possibilities", "hypothe tical risks" rather than evidence do not match
against scientific evidence on specific products made on a case-by-case basis, and does not entitle any
general measure on all agricultural biotech products as the " de facto" moratorium by the EC.

Argentina's position is based on the SPS Agreemen t, which specifically establishes that sanitary and
phytosanitary measures be based on scientific evidence.

2. Once a WTO Member has adopted an appropri ate level of protection, is it allowed to
change its mind and adopt a higher one?

Any Member is entitled to adopt a higher level of protection, as long as it complies with its
obligations under the SPS Agreement.

3. In a federal entity, have sub-entities the right to have different appropriate levels of
protection?

If you do not agree, could you indicate the basis for your position in the SPS Agreement?

This is a theoretical question, which Argentina believ es is not related to the measures at issue in this
case.

4. What would it take in your opinion for th e alleged moratorium to be removed? Would
the European Communities have to grant one more approval, ten more approval, or how many?
Would the European Communities have to stop asking for more information under the
approval procedures? Would all MS have to vote in favour of proposals to grant authorisations
for the products at issues in the Regulatory Committees and in the Council? (see paras. 24 and
27 of the oral statement of Canada)

The question refers to implementation issues. In Ar gentina's view, these issues are not to be discussed
at this stage.

B. For Argentina and Canada

1. Do you agree with the United States' position as stated at DSB meeting of 10 December
2003 and again implied in its oral statement of last week (para. 56) that the burden of proof for

Article 5.7 of the SPS Agreement is on the Complainants and not on the European Communities
as the defendant?

Argentina is not aware of any reference by the US in its oral statement, paragraph 56, to any burden
of proof allocated to the complainants' side. Neve rtheless, paragraph 56 proves that the EC did not
satisfy the requirements of Article 5.7 of the SPS Agreement. Paragraph 56 discharges the burden of
proof from the United States and the co-complainants.

D. For Argentina

1. Argentina argues that special differenti ated treatment (SDT) obligations are not
subordinate to other obligations. The Euro pean Communities agrees, but could Argentina
explain what the EC must do pursuant to SDT provisions? Are such obligations independent of
the issues of possible SPS risks and related risk assessments? In other words, if one forgot the
other claims (5.1, 5.6, …), what would Argentina claim under the SDT provisions ?

Precisely, other claims -in particular 2.2 and 5.1 of the SPS Agreement- should not be forgotten. Even
if the EC measure had had scientific basis, the EC would have had an obliga tion to take into account
the interest of Argentina -being a developing count ry that produces and exports GMO's- anyway. Not
having the EC measure any scientific support, the absence of any reference to the interest of
developing countries (i. e. Argentina) infringes the SPS Agreement.

2. Is it the position of Argentina that the deci sion of the Appellate Body in the US Shrimps
Case permitting recourse to other rules of int ernational law interpreting WTO Agreements was
wrongly decided?

If not, why would this approach not apply to the current case?

Argentina will not make any comments on whether a decision by the Appellate Body was correct or
not. Additionally, the EC is stating in its question something that Argentina did not express
1. In casu,
it is not necessary to resort to other tool of inte rpretation to define the scope of the obligations
embodied in the covered Agreements.

1 Argentina's First Oral Intervention, paragraphs 6 and 7.

ANNEX E-4

REPLIES BY THE EUROPEAN COMMUNITIES
TO QUESTIONS POSED BY ARGENTINA

Regarding the impact of the new Directive 2001/18/EC on the approval procedures.

1. Did the coming into force of Directive 2001/18/EC imply any step-back with respect to
the stage of the approval procedure in which applications were under Directive 90/220/EEC?

2. Did the applicants have to submit additional information, as a consequence from the
coming in force of Directive 2001/18/EC?

3. If yes, could the EC please precise what this additional information consisted in?

1. Please refer to the response to question 12 from the Panel to the European Communities.

2. The pending applications were only required to be up-dated ("complemented"), not to be re-
submitted as a whole. Hence all results and conclu sions reached on the existing data were still valid
and would not be re-examined again. However, with regard to the up-dated information a new
assessment was required and that assessment was to follow the normal stages of procedure. There was
thus no "step-back". There was rather a step forward, in terms of changes in the legislation to meet the
legitimate concerns of scientists and legislators. Na turally pending applications were also to benefit
from the improved rules and procedures. The additional information to be submitted would depend on
the precise product in question – it would be what was needed to satisfy the additional requirements of
the new legislation.

Regarding the evidence in addition to the scientific opinions.

The EC mentions in paragraph 36
1 that the scientific opinions would require additional evidence to
complete the risk assessment.

4. Apart from the opinions of the scientific committees, what are the other elements that
the EC's authorities do consider for the approval of the respective biotech product?

3. Please refer to the response to questions 17 and 18 from the Panel to the European
Communities.

4. The scientific committees give opinions on wh at they are asked. If it subsequently appears
that further questions might be elucidated by sci entific opinion, such questions may be put to the
committee. If an opinion of the scie ntific committee is limited or qualified in some way, the legislator
may take the view that definitive legislative action is premature.

5. Please also refer to the response to qu estion 102 from the Panel to the European
Communities.

1 Oral Intervention of the European Communities in the First Audience of the Panel with the Parties,
2 June 2004.

6. Article 26(1) of the Biosafety Protocol provides as follows:

"The Parties, in reaching a decision on im port under this Prot ocol or under its
domestic measures implementing the Protocol, may take into account, consistent with
their international obligations, socio-economic considerations arising from the impact
of living modified organisms on the conservation and sustainable use of biological
diversity, especially with regard to the valu e of biological diversity to indigenous and
local communities."
7. By virtue of their signature of the 2 000 Protocol and Article 18 of the 1969 Vienna
Convention on the Law of Treaties, Argentina a nd Canada are bound to "refrain from acts which
would defeat the object and purpose" of Article 26. By participating in the Protocol's Clearing House
Mechanism the United States recognises the validity of Article 26 of the Protocol.

8. The object and purpose of socio-economic consid erations have been ass essed by the head of
the Indian delegation in the final negotiations of th e Biosafety Protocol. Article 26: as he puts it, "the
fundamental purpose of Article 26 is to empower parties of import to analyse carefully what possible
adverse impacts the import of LMOs would have on their socio-economic conditions", and it reflected
an exercise of "inherent sovereign powers".
2 Socio-economic considerations include implications for
existing patterns of agricultural practises, having re gard to the effects of biotech products for
biodiversity.

5. What is the legal basis within the SPS Agreement which allows the EC to consider
elements additional to the opinion of the scientific committee?

9. Nothing in the SPS Agreement precludes a Member from seeking scientific opinions several
times, or on a continuous basis. Under the SPS Agreement the level of acceptable risk is fixed by the
Member, and is likely to influence a legislator's view of the science available to-date, and the
measures it is therefore appropriate to take or th e manner in which it is appropriate to proceed. The
Appellate Body has stated that science includes the assessment of risk in human societies as they
actually exist, in the real world, where people live and work and die. The SPS Agreement refers
expressly to international agreements – as to which, please see the response to the previous question,
and to question 11 below.

6. With respect to the products of interest to Argentina with positive scientific opinion -
Bt531 cotton, RRC 1445 cotton, NK603 maize and GA21 maize-:

 (a) What were the elements that determined that the positive scientific opinion was
not sufficient?

 (b) Were those elements of a scientific nature?

 (c) Where are those elements memorialized?

 (d) Could the EC provide the Panel and the parties with those elements which
determine that, up to the present, these products did not receive any approval or
rejection?

2 Rajen Habib Khwaja, "Socio-economic considerations", in C. Bail, R. Falkner and H. Marquard, The
Cartagena Protocol on Biosafety – Reconciling Trad e in Biotechnology with Environment and Development?"
(2002), 361 at 361 and 364.

10. The European Communities has described in details the develo pments of each notification
procedures, including the products which are at st ake in the Argentinean case, in its first written
submission (Section II.D and Exhibits EC-62 to EC-110). Further available evidence will be
submitted to the Panel by the European Commun ities on 18 June 2004. However, for the sake of
clarity, the European Communities will explain again what happened, as requested by Argentina.

11. Bt531 cotton is dealt with in section II.D.1(a)(iv) and Exhibit EC-65 of the EC first written
submission. There it is explained that

Following the opinion of the SCP, the notifier entered in discussions with some CAs
on an insect-resistance management plan and on rat feeding.
3
 These are clearly issues of a scientific nature.

 The chronology for this product then highlight s that Monsanto provided information to the
Member States competent authorities on insect-resistance monitoring plan on 29 September 1998 (the
letter is attached as attachment 18) and on 06 October 1998 a requested study on rat feeding
(attachment 19). Further issues, documented in att achments 20 and 21, were raised by the competent
authorities of Denmark and the United Kingdom.

 With regards to the elements necessary to determine why, up to the present, these products
have not received any approval or rejection, the European Communities refers Argentina to the above
mentioned parts of its first written submission.

12. RRC 1445 cotton , is dealt with in section II.D.1(a)(v ) and Exhibit EC-66 of the EC first
written submission. There it is explained that

Following the opinion of the SCP, the notifier entered in discussions with the lead CA
on rat feeding.
4
 This is clearly an issue of a scientific nature.

 The chronology for this product then highlights that Monsanto provided further information
after the opinion of the Scientific Committee on Plants that was circulated to Member States on 20
November 1998. Further issues, documented in atta chments 20 and 21, were raised by the competent
authorities of Denmark and the United Kingdom.

 With regards to the elements necessary to determine why, up to the present, these products
have not received any approval or rejection, the European Communities refers Argentina to the above
mentioned parts of its first written submission.

13. NK603 maize is dealt with in section II.D.1(a)(xv) and Exhibit EC-76 of the EC first written
submission. There it is explained that

Following the positive opinion rendered by EFSA, in February this year the
Commission has presented a draft decision for market authorisation of the product to
the Regulatory Committee. In the absen ce of a qualified majority vote in the

Committee, the Commission has presented its proposal for a decision authorising
NK603 to the Council on 26 March. The C ouncil's position on this draft decision is
expected for late June.
5
 No issue was therefore raised on the sufficiency the opinion of EFSA and the notification is
proceeding steadily through the various steps of the procedure foreseen in the EC legislation towards
a decision.

14. GA21 maize is dealt with in section II.D.2(a)(i) and Exhibit EC-91 of the EC first written
submission. There it is explained that the Scie ntific Committee on Food gave its opinion February
2002 and that

In view of the pending legislative proposal for "Food and Feed" Monsanto, in June
2002 on a voluntary basis committed to pr oviding detection and validation methods
for its product in collaboration with the Co mmission's Joint Research Centre (JRC).
The amount of data and material and the circumstances of their submission to the
JRC had to be negotiated and laid down in an agreement, the conclusion of which
took a considerable amount of time (Februar y 2003). All the necessary data were
received in proper condition in mid-September of 2003. The pre-validation study was
initiated in October and coul d be concluded only after Monsanto delivered the full
data set in the end of November. So me additional testing on the method and
materials was carried out in early 2004 th e collaborative study of method validation
was launched on the 14/04/2004 and is foreseen to be finished by the end of June
2004.
6
 In this case, therefore, the elements which determined the insuffici ency of the scientific
committee's opinion related to the issues of detection and validati on methods, which were
requirements to be included in the new legisla tion and on whose importance the applicant agreed.
The relevant correspondence with Monsanto on these issues is recorded in the chronology and in its
attachment.

Regarding the "case by case" assessment

7. How do the EC explain that, if the assessment of agricultural biotech products is to be
made on a "case by case" basis, there has been not a single approval for over five years? How
does the EC explain, as it confirmed in the oral hearing, that during the same period there has
been no rejection either?

15. For each product the explanation for the time elapsed is different. The European Communities
refers in this respect to the summaries in its firs t written submission. If there is something in any one
of these summaries that is unclear to Argentina, the European Communities invites Argentina to pose
a specific question, to which the European Communities would be happ y to give a specific response.
It is, in any event, inaccurate to state that there ha ve been no approvals or rejections for five years.
The European Communities refers in this respect to paras. 547 to 552 of its first written submission.

8. In paragraph 36 of the EC's Oral Statement during the first substantive meeting of the
Panel with the parties, the EC stated the following:

".. the views of the European Communities' scientific committees, now
regrouped under the European Food Safety Authority, have no formal
overriding effect on the opinions of the corresponding national committees ..."
Upon a question by the Panel in that meeting on whether there was any hierarchy between the
different scientific committees, the EC answered:

"There is no hierarchy in science"
Afterwards, in its answer to question number 1 by the Panel, the EC held that after the positive
opinion of the Scientific Committee on Food on the Bt 11 maize, there were three opinions by
national scientific committees (France, Austria and Belgium) which rejected the opinion of the
SCF, and that after the rejection of one of those national opinions (the Austrian) by the EFSA,
the Commission, despite the fact that the Regu latory Committee had not issued its opinion,
upheld the opinion of the SCF.

 (a) How do the EC explain that there is no "hierarchy in science" when the
Commission gave priority to the scientific opinion of the EFSA?

 (b) On the contrary, if the EC holds that there is no hierarchy in science, how could
it be affirmed, in consistence with th e SPS Agreement, that the opinions of the
EC's own scientific committees be rejected?

16. Please refer to the response to questions 17 and 18 from the Panel to the European
Communities.

17. The European Communities does not always and sy stematically give priority to any particular
scientific opinion – it considers and weighs them a ll, taking into account any legislative changes
designed to meet the legitimate concerns of scientists and legislators.

Regarding the "Inter-Service Consultation"

9. Is the period of suspension during the "Inter-Service Consultation" regulated
anywhere?

10. If not, and given that the "Inter-Service Consultation" implies more than two years of
suspension for two products of interest of Argentina -Bt531 cotton and RRC 1445 cotton-, in
what provision of the SPS Agreement the EC beli eves that "Inter-Service Consultations" are
based on?

18. Argentina will know that in a government admi nistration competence for the various different
activities of government is generally broken down in a structured way to make it manageable – as in
any large organization with a diversified portfolio . Argentina will also know that, along these lines,
the European Commission is divided up into abou t 40 departments or services. Argentina will also
know than when a new matter comes to be consid ered, one or two departments or services will
generally take the lead role, and co-ordinate with the other interested services. "Inter-service
consultations" are, as the name suggests, the pr ocess by which the "lead" services consult with the
other interested services. When a matter is in inter-service consultation, one may say that the

organization is "thinking about" the problem. The time necessary is a function of the nature of the
problem. See generally the Commission Rules of Procedure ( Official Journal of the European
Communities L 308/26 of 8.12.2000, as amended and implemented).

19. This process takes place in the context of th e control, inspection a nd approval procedures
referred to in Annex C SPS Agreement.

20. For more details, the European Communities re fers Argentina to its response to question 94
from the Panel to the European Communities.

Regarding the precautionary principle

11. Given that the EC state that the precauti onary principle has become a general principle
of international law
7, what is the formal source -creating International Law- that determines
that "the precautionary principle is a general principle of International Law"?

21. The precautionary principle is a general princi ple of international law applicable to decision-
making in relation to biotech products (GMOs).

22. The 1992 Convention on Biological Diversity obliges Contracting parties "to regulate,
manage or control the risks associat ed with the use and release of living modified organisms resulting
from biotechnology" (Article 8(g)). In the preamble to that Convention the parties note that "where
there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty
should not be used as a reason for postponing measures to avoid or minimize such a threat". The
Contracting Parties thus accept the language of th e precautionary approach (see Principle 15 of the
Rio Declaration on Environment and Development). Ar gentina, Canada and the EU are parties to the
1992 Convention, and the United States is a signatory (and is thus bound to "refrain from acts which
would defeat the object and purpose" of the 1992 Convention: see 1969 Vienna Convention on the
Law of Treaties, Article 18).

23. The precautionary principle is then expressly applied in the 2000 Biosafety Protocol. Article 1
states that the Protocol's objective is to be pur sued "in accordance with the precautionary approach
contained in Principle 15 of the Rio Declarati on on Environment and Deve lopment" (see generally
First Written Submission by the European Communiti es, paras. 105-108, and ain particular Articles
10(6) and 11(8) of the 2000 Protocol). The EU is a party to the 2000 Protocol and Argentina and
Canada are signatories. The United States is pa rticipating in the Protocol's Clearing-House
Mechanisms (under Articles 11 and 20) and must th erefore be taken to have no objection to the
precautionary principle is applicable (for the protection of biodiversity) as treaty or customary
international law to decision-making in relation to biotech products. As such the principle must be
relied upon in construing and applying WTO law. As one leading commentator has put it:

"WTO law thus requires that measures based upon the precautionary principle or any
other rule of the protocol must respond to the needs of conserving biodiversity."
8
C. Bail, R. Falkner and H. Marquard, The Cartagena Protocol on Biosafety – Reconciling Trade in
Biotechnology with Environment and Development?" (2002), 467 at 475.