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.1; WT/DS292/R/Add.1; WT/DS293/R/Add.1; 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 C to the Re ports of the Panel to be found in document
, , The other annexes can be found in the following
addenda:

 – Annex D: Add.2
 – Annex E: Add.3
 – 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 C

REPLIES BY THE PARTIES TO QUESTIONS
POSED BY THE PANEL ON 3 JUNE 2004

Contents Page
Annex C-1 Reply by the United States to the question posed by the Panel on

C-2
Annex C-2 Replies by the European Communities to questions posed by the
Panel on 3 June 2004
C-4

ANNEX C-1

REPLY BY THE UNITED STATES TO THE QUESTION
POSED BY THE PANEL ON 3 JUNE 2004

For all complaining parties

4. Is there any scientific disagreement on the pa rt of the co-complainants with the scientific
arguments and facts submitted by the EC (including the member States)?

108. The United States will answer the panel's questi on in two ways – first, quite literally, and then
in a more focused manner, based on the intent of the question.
109. First, on whether the United States has any scientific disagreements with the EC, there may
well be some. The United States is in the pro cess of preparing its rebut tal submission, and had
planned in that time frame to decide whether to take issue with some of the scientific statements of the
EC. Given the length of the EC submission, the United States cannot compress that time frame and
give a definitive answer at this time. However, as the Panel will note, in the US oral statements and
interventions to date, the United States has not take n issue with any scientific statements of the EC.
This is because, to the knowledge of the United St ates, no dispositive issue in this dispute turns on a
scientific issue.
110. Second, the United States would like to an swer the Panel's question based on what we
understand to be the intent of the question. Namely, are there dispositive scientific issues with respect
to which the advice of scientific experts would be of assistance to the panel? As of this time, the
United States has not been able to identify any such issues. As the United States has explained, in our
view, the central issue in this dispute is that the EC announced and applied an across-the-board
moratorium on biotech approvals. The adoption of this nontransparent measure results in "undue
delay" under Annex C; is inconsiste nt with its obligations to publish measures promptly and to keep
applicants informed of the progress of applicati ons; is not based on a risk assessment as required
under Article 5.1; and results in arbitrary or unjustif iable distinctions in the EC's chosen levels of
protection.
 – With regard to the general moratorium and product-specific moratoria, the EC's only
defense is that the moratoria in fact never existed and that with respect to individual
applications, the lengthy delays are not " unjustified." But, whether the EC's
moratorium is a "measure" and thus subject to the disciplines of the SPS agreement is
a legal, not a scientific question.

 – Similarly, the question of whether dela ys are "unjustified" under the SPS Agreement
also is a legal, not scientific question. The EC seems to be arguing that scientific
concerns justified certain delays. But whet her or not this is true for particular
applications is not dispositive, because under the EC moratorium no products were
allowed to reach final decision, regardless of the underlying science. This is clearly
shown by, among other things, the fact that product applications were stalled for over
two years by nothing more than "interservice consultations."

 – Even aside from this fundamental problem with the EC argument, the United States
has not identified any scientific issues that would be pertinent to the question of
undue delay. In particular, science may iden tify and analyze risks. Indeed, the EC

completed risk assessments on many of the pending applications. But once the risks
have been identified, it is up to the decisionm aker, not the scientist, to decide when to
take a decision on the application.

 – As the Panel is aware, in past dis putes involving the SPS Agreement experts have
been consulted to advise on issues related to the scientific basis for a Member's
identification of risks and how this has been reflected in the Member's risk
assessments. But in this dispute, the EC has put forward no risk assessment in an
attempt to justify its moratorium.

 – With respect to the member State measur es, again the United States does not see any
question that would call for scientific a dvice. The EC has claimed that risk
assessments may support the member State measures, but it has not yet identified
those assessments.

ANNEX C-2

REPLIES BY THE EUROPEAN COMMUNITIES TO QUESTIONS
POSED BY THE PANEL ON 3 JUNE 2004

Question 1

1. Please document cases of conflicting scien tific views, including at the member States
level, with respect to at least one particular application.

2. Describe the chronology of what happened in this case(s).

1. The European Communities is going to reply to your question by reference to three distinct
cases:

 – sweet corn Bt11
 – maize Bt176
 – oilseed rape MS8/RF3

2. I. Sweet corn Bt11, submitted under Regulation (EC) Nr. 258/97 (Exhibit EC-092)

3. In this case, conflicting scientific views
 existed on:

 – the methodology used for the safety assessment;
 – toxicity;
 – allergenicity; and
 – molecular characterisation.

Conflicting technical views
 existed on the proposed detection method.

4. Chronology of the application:

5. After the Netherlands submitted their in itial positive risk assessment report in May
2000, the Commission circulated it to the other Member States. Several of them objected to
the Dutch risk assessment on the basis of their national scientific evaluations on the following
grounds:
– compositional analysis;
– molecular characterisation;
– toxicity; and
– allergenic effects.
6. In December 2000, the Commission referred th e matter to the Scientific Committee on Food
(SCF). On 17 April 2002, the SCF delivered its opinion in which it concluded that the product was
safe for human consumption.

7. In June 2002, the Commission agreed with th e notifier that it needed to provide reference
material and a detection method to be validated by the Community’s reference laboratory, as
requirements for an appropriate risk management of the product.

8. During the validation process, it became apparent that there were conflicting technical views
between the Community’s reference laboratory and the national reference laboratories, as well as with
the notifier, on how to comply with the requirements for an appropriate detection method. The
validation process was finally completed by the Comm unity reference laboratory after over a year of
work on 2 October 2003.

9. On 8 November 2003, the Commission submitted a draft proposal to the Regulatory
Committee. On Member States’ requ est, the Commission did not ask for its formal vote, given that
several Member States considered that the scientific questions they had formulated earlier on the basis
of their conflicting national scientific evaluations were still open, and othe rs were still awaiting
further scientific risk assessments of their national scientific committees.

10. Between October and early D ecember 2003, three new risks assessment we re issued by the
Member States, all of which conflicted with the SCF opinion. In particular:

 – the French one confirmed its earlier finding i.e. further studies were needed on
toxicity;

 – the Austrian scientific body issued a new ri sk assessment concluding that the risk of
allergenicity and toxicity of Bt11 sweet maize has not been sufficiently addressed;

 – a Belgian risk assessment was issued rais ing issues on the molecular characterisation
of the product.

The Austrian study was also presented to EFSA
1 which disagreed with its conclusions.

11. The Commission maintained its decision to follow the scientific opinion of the SCF and
submitted the draft measure again to the Regulatory Committee for an opinion on 8 December 2003.
The Committee did not deliver an opinion. The Memb er States which abstained or voted against did
so on the basis of their conflicting national scientific evaluations.

12. Against this background, the Commission finally adopted a decision for the placing on the
market of this product on 19 May 2004.

13. II. Maize Bt176, submitted under Directive (EEC) Nr 90/220
2

14. In this case, conflicting scientific views existed on:

 – presence of a non-expressed antibiotic resistance gene (Ampicillin);

 – possible effect of Bt toxin to non-target species and development resistance by target
organisms;

1 EFSA, the European Food Safety Authority, has been established by Regulation (EC) 178/2002, and
is carrying over the advisory missions of the former scientific committees, such as the SCP.
2 Chronology of the procedure outlined in Exhibit EC-139.

 – presence of an herbicide resistant gene.

15. Chronology of the application:

16. The application for placing on the market of BT176 was submitted in 1994 to France
and covered all uses of that BT maize.
17. In 1995, a scientific opinion was issued by the French relevant scientific committee, on the
basis of which France issued a positive risk assessment report and fo rwarded the application to the
Community level in 1995.

18. The Commission circulated the application a nd the risk assessment report to the competent
authorities of the other Member States according to Directive 90/220/EEC.

19. Several Member States objected to the French risk assessment on the basis of their national
scientific evaluations of BT176 on the following grounds:

 – presence of a non-expressed antibiotic resistance gene (Ampicillin);

 – possible effect of Bt toxin to non-target species and development resistance by target
organisms;

 – presence of an herbicide resistant gene.

Furthermore, they objected to the absence of appropriate labelling requirements.

20. The Member States maintained their opini ons based on their conflicting national scientific
evaluations and their other concern on labelling throughout the decision making process in the
Regulatory Committee and in the Council. Therefore the Commission decided to seek the opinion of
the three following scientific committees:

 – scientific committee on pesticides on possible effect of Bt toxin to non-target species
and development resistance by target organisms;

 – scientific committee on food on presence of a non-expressed antibiotic resistance
gene; and

 – scientific committee on animal nutrition on the same issue.

21. The committees requested the applicant to provide additional information.

22. On the basis of the new information provided , that included a new molecular characterisation
of the antibiotic marker gene, these three committees concluded that there were "no reasons to believe
that the introduction of the genes concerned into the maize would have any adverse effect on human
health and environment".

23. The Commission decided to follow the opini on of the scientific committees and on 23
January 1997 it adopted a decision for the placing on the market of this product.

24. Luxembourg and Austria invoked on 14 February 1997, measures based on Article 16 of Dir.
90/220 in order to prohibit the use and/or the sale of these products on their territory on the grounds of
their conflicting risk assessments on possible effect of Bt toxin to non-target species, development
resistance by target organisms, and presence of a non-expressed antibiotic resistance gene. Germany
also adopted a similar measure on 4 April 2000 for the same reasons.

25. The Commission consulted its relevant sci entific committees on the national measures and
these committees confirmed their initial opinions.

26. On 2 April 2004, EFSA issued a new opinion dealing with the use antibiotic marker genes.
There, it recommended, in line with the previous risk assessments of the Member States which
maintained national measures, the phasing out of the use of Ampicillin resistant marker gene.

27. III. Oilseed rape MS8/RF3, submitted under Directive (EEC) Nr. 90/220 and
2001/18 (Exhibit EC-063)

28. Finally, the EC would like to come back to the case wh ich it mentioned as an example
yesterday because it illustrates another problem that this Panel has to take into consideration: how
evolving scientific views
 have also affected the lapsing of time in the application processes.

29. As the chronology underneath will show, the issue at stake in this case does not relate so
much to the existence of conflicting scientific vi ews but rather to the evolution of scientific
knowledge with regard to:

 – molecular characterisation and detection method;
 – monitoring plan and stewardship programme; and
 – good agricultural practices.

30. Chronology of the application:

31. Belgium transmitted its initial positive risk assessment report to the Commission on 7 January
1997. The Commission transmitted it to other Member States.

32. Between March and April 1997, AU, DE, DK, ES, FI, FR, UK, IT , NL, SW raised several
objections to the Belgian risk assessment on the b asis of their national scientific evaluations on the
following grounds:

 – out-crossing, gene flow;
 – molecular characterisation of the product;
 – compositional analysis; as well as
 – potential unintended and long te rm effects on the environment.

33. In the light of these objec tions, in January 1998 the Commission decided to consult the
Scientific Committee on Plants (SCP). The SCP issued an opinion on 19 May 1998, where it
concluded that there was no evidence to indicate that the marketing of the product was likely to cause
adverse effects on human health and the environment. However, the SCP highlighted the existence of
scientific uncertainty on potential long terms ef fects on the environment and thus recommended that
the authorisation of the product be conditioned to the availability of a Code of Good Agricultural
practices and a monitoring programme. In addition, the SCP requested to be kept informed of the
results of the monitoring programme as well as research studies in Member States.

34. In January 1999, the applicant provided a stewardship plan for post-market guidance and
monitoring, which was reviewed by the compet ent Belgium scientific committee, the Biosafety
Council in March of the same year.

35. Following an "interim approach" to anticipate the new requirements of the forthcoming
directive 2001/18, the Commission and the Member States in October 1999 agreed with the notifier
that it needed to provide further information than that considered sufficient by the SCP and relating an
updated environmental risk assessment, post ma rket monitoring, agricultural guidelines and
identification and detection method.

36. In February 2000, the company informed the Commission of its intension to modify the scope
of the application and to proceed with gradual commercialisation in order to collect data to finalise the
agricultural guidelines as well as the post-market monitoring.

37. In March 2000, in a meeting of the Regulat ory Committee, additional questions were raised
by Member States on the updated environmental risk assessment with regard in particular to:

 – potential effect of the protein expressed from the transgene on physiological
processes of the GMO;

 – potential effect of the same protein on soil biological and chemical processes;

 – gene transfer and effects on other plants.

38. In the period leading up to September 2001, the company supplied further information, as
well as reference material and a detection method. This data was assessed by the Belgium scientific
committee and concluded that molecular characterisa tion needed to be further elaborated. In Nov
2001, the company informed Belgium that additiona l work was still needed to answer the pending
questions on characterisation of flanking regi ons. The Company provided the information in
December 2001.

39. In March 2002, the Belgium scientific comm ittee assessed the new information and requested
additional clarification on the molecular data. In May 2002, the company replied to the request for
clarifications and in January 2 003 submitted an updated dossier in accordance with the new Directive
2001/18.

40. During 2003, a further series of exchang es of correspondence took place between Belgium
and the applicant to clarify further issues such as molecular characterisation (i.e. bioinformatics
analysis of so called Open Reading Frames), detection method, conditions of the marketing, etc.

41. In October 2003, the results of a 3 years farm scale evaluation research carried out in the UK
were published. The product MS8 x Rf3 oilseed rape wa s part of the trial. The FSE showed that the
large scale cultivation of the product in accordance with its intended use (i.e. in combination with the
herbicide) would affect on-farm biodiversity to a greater extend than conventional oilseed rape
cultivation, a risk that had been raised by some Me mber States’ risk assessment but that had not been
addressed by the SCP’s opinion.

42. The Belgian scientific body took account of the new scientific data to complete its assessment
report which was transmitted to the Commission in February 2004. The dossier is currently being
reviewed by the other MS scientific bodies.

2. Is the EC requesting a meeting with scien tific experts? If so, what would be the
appropriate time for such a meeting?

43. The European Communities requested the Pane l to seek appropriate scientific and technical
advice in their submission of 27 May but considered that the issues in dispute were not yet sufficiently
defined for this to be done at that stage. On the b asis of the hearings over the past two days, where the
complainants admitted to be in agreement only w ith the favourable, positive scientific opinions of the
scientific committees at community level, the Commun ities is confirmed in its view of the need for
such advice, and repeat its request for a meeting with scientific and technical experts.

44. The Communities consider that, in line with its first submission on this issue and some
comments from the complainants, that it might be counterproductive to draft questions too early, and
to request such advice before scientific and technical issues in dispute have be en well identified. The
Communities is therefore of the view that it is n ecessary to do so after the reception of the written
rebuttal submissions of the Parties, where such issues in dispute will be identified.

45. The Communities can therefore accept that su ch a meeting with scientific and technical
experts be held back to back, before the second s ubstantive meeting of the parties, provided (i) that
sufficient preparatory work on the identification of the experts and of the questions could have been
set aside, and (ii) that it would leave the possib ility open for the Panel to seek further scientific and
technical advice, in particular on the basis of th e outcome of the second substantive meeting of the
parties, and its follow up.

3. Please prepare for consideration by the Pa nel suggested terms of reference for expert
consultation.

I. INTRODUCTION
46. The Communities are at the disposal of th e Panel to be consulted in identifying the
appropriate areas of scientific and technical expe rtise on which input will be needed and on the
identification of appropriate persons and/or institu tions whose advice or input may be sought once the
scientific and technical issue in dispute would be identified.

47. The Panel now asks the EC to propose draft term s of reference for this scientific and technical
advice.

II. TERMS OF REFERENCE
48. In previous cases, panels have always referred technical and scientific questions to a series of
individual experts rather that to an expert review group or international organisations. The terms of
reference have been very cursory. The EC is not suggesting that the panel should follow these
precedents but if they did, each expert could be requested, for example:

• To advise the panel, in the areas of his rele vant expertise, on the questions submitted to
him.
• To act in his individual capacities and maintain independence and impartiality
• To submit an opinion in written form within the time specified by the panel
• To consider the written comments of the othe r experts and the parties on his own opinion
and revise his opinion as appropriate
• To discuss the opinion with the other experts, the panel and the parties at a meeting.

49. The European Communities believes it is too ear ly to address precisely and definitively all of
the questions which might be put to the experts. It gave a number of reasons for this in its submission
of 27 May but will now elaborate.

50. It is evident that there are different approach es to the legal and factual issues in this case. The
European Communities follows a very different appr oach to that of the Complainants. Even the
Complainants do not agree on the analysis of the issues between themselves.

51. However, different approaches will require diffe rent kinds of scientific and technical advice
for the Panel to be able to decide properly this case. For example the issues that may justify delay
differ from those that might justify an outright susp ension of procedures. Also, if the Panel agrees
that the national safeguard measures are provisional measures under Article 5.7, it would not need to
ask questions on these measures since the Complainants have not raised this in their panel requests.
Even if this issue were within the jurisdiction of the Panel, the relevant questions would depend on
who has the burden of proof. If the Complainants have the burden of proof but have not made a prima
facie case, there is no need to pursue the claims. But if it were on the EC, the situation may be
different.

III. PROVISIONAL QUESTIONS
52. In order to assist the Panel in its reflecti ons, the European Communities is however prepared
to advance, by way of example, some technical a nd scientific questions that could potentially be put
to experts (on the basis of the issues that presently appear to divide the parties).

53. One series of questions might be designed to assist the Panel to come to a view on the length
of time that might be needed for, inter alia:

• The validation of an appropriate detection method for a specific GMO;
• The development of an appropriate plan for monitoring the development of resistance to
the Bt toxin in target insects; or
• The measurement of appropriate baselines before the implementation of monitoring
plans.

54. Another series of questions might be designe d to assist the Panel to come to a view on
whether there was material scientific uncertainty on certain issues such that it could justify seeking
further scientific and technical evidence on speci fic GMO products for the purposes of considering
their authorisation:

• What is the state of scientific understandi ng and how has it evolved on the risk of
horizontal transfer of antibiotic resistance genes from GMO food or feed into bacteria?
• What is the state of scientific understanding and how has it evolved on the risk of out
crossing of herbicide resistance genes from GM O plants into the same or other plants
species, and in particular into wild relatives?
• What is the state of scientific understanding and how has it evolved on adverse effects of
the consequences of the expression of Bt t oxins from GMO plants on target and non-
target organisms?
• What is the state of scientific understanding, and how has it evolved, on the extent of the
information necessary for a proper molecular characterisation of a GMO and the issues

that may arise from any changes in the data to be provided by an applicant on the
molecular characterisation of a specific product?

55. Another possible series of questions that the Panel could ask would focus on the specific GM
applications and aim to identify whether the poten tial risks that may be in dispute in the 23
outstanding product applications for approval may be of relevance for the conduct of the approval
procedures by the EC.

56. Yet another possible series of questions that the Panel could ask would focus on the possible
scientific and technical unique properties of GMOs , that would justify addressing them differently
from their traditional counterpart.

57. The EC offers these examples in order to assist the discussion. It does not suggest that all of
these are, or relate to, all of the scientific and techni cal issues in dispute, or that answering all these
questions are relevant to the resolution of the legal issues. The hearings have indicated that the parties
are also divided on important definitional issues (e .g. toxins, allergens, etc). In the view of the
Communities the resolution of these differences would be assisted by independent scientific advice.

IV. CONCLUSION
58. The EC hopes that the above comments are of assistance. It would recall that it has discussed
a series of other issues, including the form in which advice could be sought and the potential sources
of expertise in its submission of 27 May. Rath er than repeat these issues now, the EC would
respectfully refer the Panel to that submission.

59. The European Communities remains at the disp osal of the Panel to be consulted for any
further help that the Panel may deem appropriate in identifying the appropriate expertise and the
issues requiring such advice.