Document: WT/DS291/R/Add.8 WT/DS292/R/Add.8 WT/DS293/R/Add.8 Page J-1 ANNEX J TRANSCRIPT OF THE PANEL'S JOINT MEETING WITH SCIENTIFIC EXPERTS OF 17 AND 18 FEBRUARY 2005 Chairman
Date: 18 February 2005
Document codes: WT/DS291/R/Add.8; WT/DS292/R/Add.8; WT/DS293/R/Add.8
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

ANNEX J

TRANSCRIPT OF THE PANEL'S JOINT MEETING WITH SCIENTIFIC EXPERTS
OF 17 AND 18 FEBRUARY 2005

Chairman

1. Good morning. I would like to welcome the pa rties and the experts, Doctors Andow, Healy,
Nutti, Snape, Snow and Squire, to this mee ting of the Panel on the European Communities –
Measures Affecting the Approval and Marketing of Biotech Products.
2. At the outset, I would like to remind you that the meetings of panels in the WTO are tape-
recorded. I would also like to remind you that at today's meeting as well as the meeting of tomorrow,
English/Spanish simultaneous interp retation will be provided, as requested by Argentina. So please
be sure to use the microphones when addressing the Panel and, above all, speak SLOWLY. I would
like to express my sympathy with the interpreters for this meeting, considering it's extremely technical
nature. I would like to remind the experts and the parties that there are constraints and difficulties of
interpretation and therefore technical jargon will only be properly interpreted if it is delivered at a
reasonable pace.
3. May I begin by introducing the Members of the Panel: Mr Mohan Kumar, Professor Akio
Shimizu, and myself, Christian Häberli, who will be serving as Chair of the Panel.
4. I would also like to introduce the Secretariat officials who will be assisting the Panel:
Mr ***** *****, Secretary to the Panel, Mr ***** *****, Legal Officer, Ms. ***** ***** from
Agriculture Division and Ms. ***** ***** from Trade & Environment Division. Finally, I would
like to inform the parties of the presence of Mr ***** *****, Junior Economic Affairs Officer from
Agriculture Division and Mr ***** *****, an intern with the WTO Legal Affairs Division.
5. I would like the Heads of Delegations to introd uce themselves and the other Members of their
delegations. If your delegation has not yet done so, it would be appreciated if you could submit a list
of your delegation's members to the Panel secretary. In introducing the Members of your delegations,
you must indicate any individuals which are NOT aut horised to have an acce ss to SCI, if any are
present.
Argentina

Delegation of Argentina

Ernesto Martinez Gondra (Head of Delegation)
Minister
Deputy Representative
Permanent Mission in Geneva

José Luis Pérez Gabilondo,
Minister
Director of International
Economic Dispute Settlement
Ministry of Foreign Affairs, International Trade and Worship

Eduardo Tempone,
Minister
Permanent Mission in Geneva

Gustavo Lunazzi,
First Secretary
Permanent Mission in Geneva

Esteban A. Morelli,
First Secretary
Ministry of Foreign Affairs, International Trade and Worship

Gustavo H. Méndez,
Second Secretary
Ministry of Foreign Affairs, International Trade and Worship

Dr Roxana Blasetti,
Secretariat of Agriculture, Livestock, Fisheries and Food

Dr Maximiliano Moreno,
Secretariat of Agriculture, Livestock, Fisheries and Food

Dr Moisés Burachik,
Office of Biotechnology
Secretariat of Agriculture, Livestock, Fisheries and Food

Mr Martín Lema,
Office of Biotechnology
Secretariat of Agriculture, Livestock, Fisheries and Food

Canada

Delegation of Canada

Mr Torsten Ström (Head of delegation)
Senior Counsel, Trade Law Bureau
International Trade Canada/Department of Justice

Mr Kevin Thompson
Counsel, Trade Law Bureau
International Trade Canada/Department of Justice

Ms. Chris Moran
Senior Trade Policy Officer, Technical Barriers and Regulations Division
International Trade Canada

Ms. Jodi Robinson
Trade Policy Officer, Technical Barriers and Regulations Division
International Trade Canada

Ms. Elizabeth Macaulay
Paralegal, Trade Law Bureau
International Trade Canada

Ms. Chantal Sicotte
Senior Trade Policy Analyst
Agriculture and Agri-food Canada

Ms. Nora Lee
A/Chief, Nutrition Evaluation Division
Health Canada

Mr Phil Macdonald
National Manager, Environment Release Assessments, Plant Bio-safety Office
Canadian Food Inspection Agency

Ms. Kathleen Mackay
Counsellor (Agriculture)
Permanent Mission of Canada to the European Union

Mr Rambod Behboodi
Senior Legal Advisor
Permanent Mission of Canada, Geneva

Mr Vasken Khabayan
Legal Officer
Permanent Mission of Canada, Geneva

United States

Delegation of the United States

Office of the United States Trade Representative

William Busis (Head of delegation)
Associate General Counsel
Washington, D.C.

Steven F. Fabry
Senior Legal Advisor
Geneva

Stephen Kho
Legal Advisor
Geneva

United States Department of Agriculture

Dr Bernice Slutsky
Special Assistant to the Secretary for Biotechnology
Office of the Secretary
Washington, D.C.

Bobby Richey
Deputy Director
Biotechnology Group
Foreign Agricultural Service
Washington, D.C.

Rebecca Fecitt
International Trade Specialist
Foreign Agricultural Service
Washington, D.C.

Nancy Kao
Attorney
Washington, D.C.

Dr John Cordts
Biotechnologist
Animal and Plant Health Inspection Service
Washington, D.C.

Mary Revelt
Minister-Counselor
Geneva

Mr Gregg Young
Foreign Agricultural Service
Geneva

United States Food and Drug Administration

Dr Eric Flamm
Senior Science Policy Adviser
Washington, DC

Dr Kathleen Jones
Consumer Safety Officer
Washington, DC

United States Environmental Protection Agency

Laurel Celeste
Attorney
Washington, D.C.

Steve Wolfson
Attorney
Washington, D.C.

Dr John Kough
Senior Scientist
Washington, DC

United States Department of State

Jack Bobo
Deputy Chief
Biotechnology and Textile Trade
Policy Division
Washington, D.C.

United States Mission to the European Union

Kristina Kvien
First Secretary (Economic Affairs)
Brussels

European Communities

Delegation of the European Communities

Brussels

Eric White, Legal Adviser of the Legal Service

James Flett, Member of the Legal Service

Sybilla Fries, Member of Legal Service

Elisabetta Righini, Member of Legal Service

Eric Schoonejans, Member of Legal Service

Luis Portero Sanchez, DG Trade

Jean Ferriere, DG Trade

Andreas Klepsch, DG Sanco

Paivi Mannerkorpi, DG Sanco

Sylvie Mestdagh, DG Environment

Barbara Weber, DG Environment

Stephen Langrell, JRC (17 & 18)

Philippe Sands, External consultant

Experts

Gijs Kleter (17-18)

Angelika Hilbeck (17-18)

Nicholas Birch (17-18)

Jeremy Sweet (17-18)

Arne Holst-Jensen (17-18)

Philippe Sands

Sue Hartley (17-18)

G. Fandan Aider, Joint Research Centre

Geneva

Raimund Raith, Minister-Counsellor/Legal Adviser

Lars Berner, First Secretary

Franz-Rudolf Schloeder, Counsellor

Marie-Pierre Nicora, Attaché

Member States

France

Cédric Pene, Counsellor, Agriculture

Germany

Ursula Holzhauser, Counsellor

Malte Hauschild, First Secretary

Tobias Maass, Intern

Italy

Dario Ciccarelli

Finland

Jukka Pesola, Counsellor

Chairman

6. Thank you EC. I believe Argentina has not respond ed to my question on strictly confidential
information. Would you care to respond? Thank you
Argentina

7. I confirm that they are all authorized.
Chairman

8. I am turning to the establishment of the Panel's te rms of reference. I wish to recall that at its
meeting on 29 August 2003 the Dispute Settlement Bo dy has decided in accordance with Article 6 of
the DSU to establish a panel pursuant to a request of the US, Canada and Argentina, documents
referring are WT/DS291/23, WT/DS292/17, WT/DS293/17 . I recall that the Panel held the first
substantive meeting with the parti es on 2 and 3 June 2004. Both the Panel and the parties recognized
the need for the Panel to consult with experts possessing specialized and scientific expertise on the
issues arising in the dispute. In consultation with the parties the Panel agreed working procedures for
its consultations with scientific and technical experts. These working procedures were communicated
to the parties on 13 August 2004.
9. We have consulted with six international or ganizations such as the CODEX Alimentarius,
FAO, WHO, IPPC, OIE and the Convention on Biological Diversity and having received the views of
the parties the Panel has appointed Dr Andow, Dr Heal y, Dr Nutti, Dr Snape, Dr Snow and Dr Squire
to serve as scientific experts in this dispute. Initially only Dr Andow, Dr Nutti, Dr Snow and
Dr Dr Squire were appointed, but it turned out th at there are two issues which cannot be covered by
any of the four experts which are detection methods and molecular characterization. The Panel, after
having had the views of the parties, therefore appointed Dr Snape and Healy. Dr Snape was invited to
answer questions concerning molecular characteriz ation only. Dr Healy was invited to do so
concerning molecular characterization and detection me thods only. This applies for this meeting as
well.
10. In accordance with the working procedures and after comment by the parties, the Panel,
communicated questions to the experts, the experts were requested to reply in writing by 5 January
and these replies were communicated to the par ties. Comments received from the parties on the
expert replies were circulated to the experts. Th e purpose of today's meeting is for the Panel to meet
the experts to discuss their written responses to the qu estions and to provide further clarification as
appropriate. The parties will also be given an oppor tunity to discuss these responses by the experts to
the questions.
11. This is a two day meeting and it will proceed in the following manner. First I will give the
experts an opportunity to make introductory or gene ral remarks. The experts may wish in particular
to address any point where they believe further clarif ication is needed in the light of the parties'
comments on an earlier response to a question. Th en I will give the parties a brief opportunity no
more than 15 minutes for any general introductory re marks they may wish to make. Note has already
been taken of the remarks they have expressed in wr iting. Then for each issue I will open the floor to

the parties to ask questions. The Panel will also ask questions of the experts. Finally when we have
concluded with each issue I shall allow the experts time to make closing remarks should they so wish.
12. Concerning the questions by the parties to the experts the Panel will proceed as follows. For
each issue the Panel will first give the complaining pa rties a period of time within which to ask their
questions of the experts. The complaining parties would ask their questions in alphabetical order.
Thereafter the EC will be given approximately equa l periods of time to ask their questions to the
parties including any follow-up questions to those asked by the complaining parties. After the EC has
exhausted its time the complaining parties will be gi ven again a very short opportunity to ask specific
follow-up questions on their own. Subsequently the Panel will address its own questions to the
experts.
13. In making their remarks both the parties a nd the experts are requested to minimize
redundancy with what they have already submitted to the Panel in writing. We can take it that the
Panel has read your submissions, your remarks, and your questions so there is no need to repeat them.
With regard to the issues to be co nsidered as requested by the EC th e Panel would like to proceed as
follows. On this first day the meeting will address the general questions and then move on to Issue 2
(safeguard measures) and Issue 3 (c omparison of biotech pr oducts to other types of products). This
we expect will take the whole day and will probabl y move into Issues 2 and 3 only in the afternoon
depending on how it goes this morning. Tomo rrow on the second day we will start again at 10 and
start with Issue 1 that is the all product specifi c questions and then if necessary any remaining time
can be used for discussing further on any of the issues addressed today before moving to closing
remarks by the experts.
14. I should further remind the parties and the expe rts that the proceedings of this Panel are
confidential as provided for in Article 18 of the DS U. I would like to request the parties and the
experts to state in advance if they are going to refe r to the SCI information when they do so. This is
important to ensure the proper handling of this information including in the preparation and the
transcript of this meeting. The experts may want to refer to various documents including the parties'
submissions and exhibits. These documents are e ither filed in the binders placed on the cart over
there or in the CD ROMs which can be opened a nd viewed in the laptop computers which are near
your seats. The Secretariat staff is ready to help you locate these documents if you wish so. Unless
there are any comments or questions on this pro cedure we can now proceed to hear the experts'
introductory remarks. There are no questions from th e floor. I will therefore suggest that we hear
from the experts in alphabetical order starting with Dr Andow. You have the floor.
Dr Andow

15. Thank you very much Mr Chairman. I would lik e to make just a few very short comments.
The first is to indicate my very great pleasure at being able to serve at the Panel's request as an expert
to the Panel on this important issue and I greatly appreciate the opportunity. Second, I would like to
address the parties and say that I was quite pleased to read all the comments on all the experts' replies
and was very interested to see how these comments have developed the issues . I hope that through
the questioning that occurs today we can clarify some of these issues further. On that point I would
like to start with a bit of an apology regarding the cl arity and language in some of my comments. It is
clear from some of the comments that I read that - let me put it this way - as the Panel Chair told us
this morning there is WTO language and there is biot ech language. It is pretty clear that many of my
questions/answers were written more in biotech language. I will try my best to make the translation
more clear so that my point is clear to the various parties. That is my introductory piece.

16. Let me say a little bit about myself. I was traine d as an ecologist at Cornell University with
my PhD in ecology with a minor emphasis in evolutionary biology. My training is an environmental
science. I tried as much as possible to emphasize the environmental aspects in terms of the answers
my responses to the questions from the Panel. I woul d simply like to say in the 25 years since taking
my PhD I have been involved in many of the envi ronmental issues associated with biotech issues
starting primarily with the USEPA and some of their work. I then assisted th e USDA in an advisory
panel to the Secretary of Agriculture. More recently I have been doing work associated with
international dimensions of these issues. I am please d to be able to be here and I am looking forward
to interacting with you all. Thank you very much.
Dr Healy

17. Thank you Mr Chairman. I also would like to th ank the Panel for inviting me to contribute to
this process. I found it both interesting but also very challenging even though I have had a more
narrow focus than some of the other experts. Now having read the responses of all the experts and the
comments that have been provided by the countries th ere quite clearly appears to have been different
approaches adopted by the different experts to an swering the questions. I think this comes out
especially in relation to the product-specific ques tions. I want to make a few comments on how I
approach the task and in doing so to raise some of the issues that I think are pertinent to the
interpretation and perhaps the intent of the questi ons and the subsequent responses. A number of the
questions that I addressed around molecular characterization identified a particular request for
information and asked if it was necessary to ensure the safety of the product. The approach that I took
to this task was to review all the relevant in formation up until the time of the request that was
identified in the questions.
18. I considered the molecular characterization info rmation in the context of all the relevant
available information up until this time. I point out th at this approach is consistent with the current
international standard as well as the long standing practice and consensus around the world. But what
I did not do was a retrospective analysis of information that had been provided after the date identified
in the question. Differences in approach to hand ling information have lead to confusing responses by
different experts to the questions and commentaries coming from the countries.
19. In addressing questions I considered if the a dditional information was likely to have an
impact on the safety assessment. There are also critical differences of approach in the criteria that are
used for assessing safety. The criteri a that I used are generally those set out in the Codex documents.
However, it has to be recognized that those Code x documents in relation to food were adopted in
2003, while many of the discussions of the data re quirements in the questions were referring in the
late 1990s as well as in the early 2000s. The question of the criteria by which to judge safety is quite
an important point. Nonetheless, in terms of us ing the Codex documents I think it is a reasonable
approach. While the agreement of Codex was reached only in 2003 there was a general view in the
years prior to that about how to approach this i ssue. The Codex documents are actually using those
principles.
20. Another point relating to the judgement of the data comes to whether we should judge the
data by today's standards or by the standards that were in place at the time. This is particularly
important in the case of the molecular characterization because the technologies have changed
considerably through the period that we are talking. This was a question on my mind at the time of
answering the questions. Often I decided that I would place greater emphasis on the state of
knowledge at the time the discussion was happening and when various data requests were coming into
play. That is another point of difference that come s through in some of the replies of experts, as well
as some of the commentary from the different countries.

21. Different types of molecular techniques are available in common practice today. The
standard of molecular characterization that you might expect in response to a question asked today is
quite different to that which would have been exp ected at the time the questions were actually asked.
I want to summarize the principles that I adopted in addressing the product-specific questions. Firstly
I took a case-by-case approach and examined all the av ailable information for each of the products in
relation to the question that was being asked. I cons idered the totality of the information also taking
into account what information was missing. I want to put some emphasis again on this totality of
information approach.
22. I also took a weight of evidence approach. Thinking about what position the weight of
evidence supported, recognizing that there are possi bilities of other effects. I focused on addressing
the question whether the additional requested in formation was necessary to ensure the safety
assessment. It is important to recognize that a view about the safety assessment is not necessarily a
view about the technical excellence of the informat ion that is provided. The information has to be
obviously sound but there are quite clearly some techni cal deficiencies at various places. This relates
to the issue of considering the totality of the information and the weight of the information.
23. The final point I want to raise is that ther e was some commentary in the country comments
about the fact that I worked for a government agency. I want to highlight that this is a matter of
record. In relation to food this has been the case since 1998. It was certainly in my CV. However, in
the capacity which I have been undertaking these act ivities I have been providing independent advice
to the Panel as was required and in fact for the ma jority of the time that I have worked on the written
responses I stood aside from my government position or was undertaking the work over the Christmas
period. This is true aside from several days from the beginning of January, the 4th and 5th of January.
I need to point out in turn that in attending this meeting I am also here as an independent expert and
not as a government representative and so my commen ts will be confined to those matters that the
Panel has asked me to comment on. Thank you.
Dr Nutti

24. Thank you. I also would like to say that I am glad to be an expert in this Panel and that it was
a unique opportunity to be in contact with all the documents that were submitted to us. I would like to
tell a little bit about my background because I asked to answer about food safety and nutrition. I am a
food engineer with a background in nutrition. I work for the Brazilian Research Agriculture
Corporation where I am responsible for the bio-saf ety of GMOs project. We are a network of 120
scientists that are evaluating the saf ety of the GMOs being developed in Brazil. I don't work for the
government, I work for a research centre that is linked to the government. I am here as an
independent expert. In the beginning I pointed out to the Panel that I was not going to address any
issue related to environmental and molecular char acterization. As far as detection matters were
concerned I would try to find some literature to he lp with the answers but not given any conclusions
on that because even that was not my field of expertise.
25. With respect to some of the comments that th e countries sent I would like to point out that
although there might be some misunderstanding about substantial equivalence we use it as a step for
risk assessment and not for the risk assessment itself. In my responses I was looking at the
composition as the first step and not as a conclusion. It is the first step that you need to take into
account. After the compositional analysis you go to the toxicological and animal feeding studies. I
have been in the Codex these last ten years and also in the WHO, FAO expert consultations as one of
the roster of experts. I will be happy to answer your questions. Thank you.

Dr Snape

26. Good morning ladies and gentlemen. My backgr ound is in crop genetics. I have extensive
experience of research in cereals and cereal biotec hnology and the handling of molecular analysis of
transgenic wheat, barley, rice and bananas. But my remit for the Panel has been fairly restricted and
my comments and conclusions are restricted only to the molecular characterization and the answers to
questions 12, 16, 18 and 25.
27. I should add that I found this a rather complex task given the amount and complexity of the
information that was presented. However, in my evidence I have tried to compile together all the
molecular information for each product to assess whether this is sufficient for the assessment of safety
and as Dr Healy alluded to, I have considered each product independently and all the information
independently for each product. In interpreting the information my main objective was to assess
whether a comprehensive characterization of the info rmation had been provided and also whether this
information that had been presented - the molecular in formation - had been correctly interpreted in its
submission. This was the basis of my conclusion s. My interpretation is based on a number of
technical issues concerning the size and copy number of the transgenic sequences, the organization of
those sequences, the organization of flanking and an y backbone sequences in th e transgenic plants.
This is the information which I tr ied to draw conclusions based on the scientific evidence to suggest
whether it is required for the safety assessment. I w ill conclude with those very brief remarks and I
will be happy to answer any questions on the mol ecular characterization of the products and my
interpretation.
Dr Snow

28. Thank you I am Alison Snow, Prof essor of Biology at Ohio State University. I am pleased to
be here and I could echo many of the comments th at have been made already. As you know my
answers refer primarily to environmental questions about these products and that is my training as an
ecologist. I have been involved in looking at the environmental effects of biotech products for many
years now.
29. One of the big challenges I think of doing this kind of work is taking evaluations from one
country and applying them to another when the envi ronments are very different, the crops are very
different, the weeds are different and also the way that people perceive environmental problems
differs among countries. In preparing my answers I looked particularly at what the EC had listed as
their concerns, and I am sure you are all aware of th is, they may be different than the other countries.
I found that to be very challenging and I was trying to take that into account.
30. We are mainly looking at problems that might affect weed problems, for example the effects
of the crops that might exacerbate a weed problem, effects on other organisms that we call non-target
organisms and effects that might change herbic ide and insecticide use in a way that could be
damaging to the environment. Those were the kinds of things that I was considering. In my answers I
stuck close to my area of expertise as much as po ssible. You will see that I was mainly addressing
questions that dealt with gene fl ow and gene flow and its conseque nces. One of my major points was
that if gene flow doesn't have any biological consequences I don't think you can consider it caused
environmental problems. From reading all the different responses I found that my answers were
understood and interpreted correctly and I would be ha ppy to clarify any of them later on in the day.
Thank you very much.

Dr Squire

31. Thank you. I endorse the comments from the other experts about the opportunity provided by
yourselves to be here. I wanted to not refer to any particular point made by or rather queried on my
answers but to explain how I have developed my appr oach to these subjects. Previously I had worked
on crops and environment about equally. I do not see th at we have to look at one against the other.
They are both part of the same thing because environm ent sustains the crops that feed us. I have done
this in several parts of the world, in Africa, fair ly extensively, and Asia; more recently in the UK and
parts of Europe. My view is coloured by my expe rience in these areas. Also I have worked on arable
land, grassland, woodland, a wide range of systems. Again, this experience colours my views.
32. This brings me to the point that I think has been brought up once or twice. That is: is there a
difference between natural ecosystems and highly ma naged agroecosystems? My view is that the
essential processes are the same in both. The way so il is formed, the way organisms that make the
soil, the way plants grow, the way plants sustai n the food web are essentially the same whatever the
system. Agroecosystems are different because they ar e highly disturbed but they are also very similar
to other forms of ecosystem. Now this brings me to my final point, which is to build on what
Professor Snow said. Compared to parts of Afri ca, where there are vast expanses of savannah or
certain types of woodland, some of the countri es in Europe are largely composed of arable
ecosystems. There is not much else left. What is le ft is also highly affected by man's activity. Is it
not the case throughout the European countries that in many of them arable land is their ecosystem?
We have to be responsive to that and consider that in this debate. That is all I have to say at this stage.
There have been several questions supporting and co ntending my answers but I can deal with those
during the day I hope. Thank you.
Chairman

33. Thank you Dr Squire. I would now on behalf of the Panel and the whole Members of the
Secretariat put on record my appreciation to all of you, to all of the six experts for the monumental
task you have been taking upon yourselves. Your contribution and your inputs are all the more
valuable as you have had to work under extreme ti me pressure - something academics are even more
loathe to than trade diplomats - and also the amount and order of presentation of the documentation
was such that your task was all the more difficult. Thank you very much for your work and presence
today. I would now like to give the parties a br ief opportunity to make gene ral introductory remarks
if they so wish in alphabetical orders. Argentina you have the floor.
Argentina

34. Thank you Mr Chairman. Argentina would like to take this opportunity to thank the Panel,
the experts and the Secretariat for the hard work in this case. We appreciate the opportunity to offer
further comments on the experts' replies. However, in light of the time constraints adhered to the
Panel in its letter dated 7 February 2005 at this juncture Argentina prefers to focus on the questions to
the experts. We have a number of questions we would like to pose to the experts Dr Andow and
Dr Squire which were provided to the Panel last M onday. We are ready to do it at a time and under
the conditions laid down in the Panel's letter dated yesterday. Thank you very much.
Canada

35. Thank you. Canada doesn't have a lengthy opening statement to make. Like Argentina, given
the limited amount of time available to us, we ar e anxious to get right into the questions for the
experts. However, before we do so we would like to take this opp ortunity to express our appreciation

to the experts for all the hard work in responding to the Panel's questions and for making themselves
available to assist the Panel and the parties with re spect to the issues raised in the replies to those
questions. Canada would also like to thank you Mr Chairman, the Panel and the Secretariat for all
their efforts over the last eight months. It is Ca nada's sincere hope that the meeting with the experts
will help the Panel sort through the scientific evid ence and other information and give it a clear view
of the relevance of this evidence and other info rmation to the legal arguments that have been
presented and will be presented in these proceedings.
36. As the Panel will note, Canada has distributed questions in writing this morning. Canada's
questions focus largely on the responses of the experts to the general questions. Canada considers that
many of the issues raised by these questions run through the questions found in the other three issue
areas. To the extent that we are able to address satisfactorily these issues during the discussion of the
general questions Canada does not intend to return to them during the discussion of the other issue
areas.
37. Also Canada wishes to note that these questions are not necessarily all of Canada's questions
nor will Canada necessarily ask all of these questions dur ing the meeting. In part that will depend on
the time available to us. It will also depend on th e direction the discussion takes. Canada reserves its
right to raise additional questions as the discussion m oves forward during the meeting. In particular
Canada may submit questions relati ng to product-specific applications in writing tomorrow morning.
Thank you.
United States

38. Mr Chairman, Members of the Panel, good morn ing. We would like to thank you and of
course the Secretariat for your ongoing hard work in this dispute. Given that today's session is
intended to allow for the Panel and the parties to hear from the experts and that the United States has
already submitted written comments on the experts' r esponses, we would just like to make two brief
comments.
39. First, on behalf of the United States, I would like to thank each of the experts for your
decision to accept the Panel's invitation to serve as experts and for the remarkable job you have done
to review all the materials and provide written responses in such a short time. We appreciate the input
you have provided. We look forward to the discussi ons during the following two days of meetings.
Second in our submission on Monday we explained th at we expected that most questions from the
United States would be in the form of brief fo llow-up questions depending on the experts' opening
statements and responses to other questions. Our submission on Monday also included a short list of
questions which for the sake of convenience we have attached to this statement. Finally we have
attached a second page with a small number of additional questions.
40. We have one procedural question. Will a transc ript of this session be typed up and circulated
at some point to the parties? I understand that has been done in other expert sessions.
Chairman
41. The answer is yes. Thank you United States. The EC has asked to make an introductory
remark here. You have the floor.

European Communities

42. I think a copy of our statement is being distributed now. There is also a copy of our questions
relating to the issues to be discussed today. Li ke Canada our questions on product-specific issues,
that is issue 1, are not yet formulated. They will be distributed tomorrow.
43. The EC welcomes this meeting and will be brie f. Our objective today is to discuss the issues
with the scientists and to benefit from their expertise. We need to say a few words about the role of
the experts, but first it is appropriate to recall the function of the Panel. As the Appellate Body made
clear in EC – Hormones, Article 11 of the DSU requires a Panel to make an objective assessment of
the matter before it including an objective assessment of the facts. That means in the view of the EC
that the Panel must take into account all the scien tific advice that has been placed before it by the
independent scientific experts it has appointed even if divergent. The Panel is not called upon to
prefer one scientific conclusion and disregard another. It is not the function of the Panel to attempt to
hand down once and for all a definitive statement on scientific issues surrounding GMOs. Rather the
views of the independent experts are relevant to ass ess the justification for time taken to process the
product applications and the provisional measures take n by the EC. In that regard it is of singular
importance to recall the words of the Appellate Body in paragraph 194 of the Hormones Case when it
stated and I quote: "The very existence of diverg ent views presented by qualified scientists who have
investigated the particular issue at hand may indicat e a state of scientific uncertainty". In the present
case the independent scientific experts have expressed divergent views and that plainly indicates that
there is considerable uncertainty that was even greater in the past. It is equally important to recall that
the Appellate Body in the same passage from Hormones made the fo llowing point: "Sometimes the
divergence may indicate a roughly equal balance of sc ientific opinions which may itself be a form of
scientific uncertainty". In most cases responsib le and representative governments tend to base their
legislative and administrative measures on mainstream scientific opinion. In other cases equally
responsible and representative governments may act in good faith on the basis of what at a given time
may be a divergent opinion coming from qualified and respected sources."
44. The purpose of the expert advice is to assist the Panel in understanding the scientific and
technical issues in particular so as to appreciate whether the requests made by competent authorities,
the objections raised by several EC member States in the context of the EC approval procedures, and
the continuing provisional concerns underlying th e safeguard measures adopted by some EC member
States have a sufficient scientific or technical basis. As we have just said the Panel does not need to
decide which of several competing interpretations of science is correct. It has to determine whether
the views were legitimately held and supported by scien ce. The EC further recalls that the role of the
experts is not to judge on the appropriateness of the EC regulatory requirements governing GMOs, as
the complainants in this dispute are not challengi ng the EC regulations. The experts can, however,
assist the Panel in ascertaining whether a given in formation request was necessary to meet the EC
requirements. Finally, it is not the responsibility of the experts to express a view, still less to decide
on questions, such as whether any delays were undue or whether any such delays support an
allegation that the EC was operating a moratorium.
45. I come now to talk about the advice. The EC would first like to reiterate its thanks to the
experts for the quality of their advice delivered in a remarkably short time.
Chairman

46. Excuse me, the US has a point of order.

United States

47. Mr Chairman we do not have copies of the EC statement. We were wondering if we could
get copies to follow along. Thank you.
Chairman
48. The same goes for Canada and Argentina?
European Communities
49. Apologies to the US. The EC would first like to reiterate its thanks to the experts for the
quality of their advice delivered in a remarkably short time. As you said, Chairman, it was a
monumental task. The EC has already made quite lengthy comments on this advice. This was
necessary in particular because it did not cover all the questions put by the Panel. For some questions,
the Panel received opinions from only one expert and there were instances where the EC felt that the
advice given to the Panel was based on a misunde rstanding of the question or was incomplete or
misleading in some other way. This made our comments longer than we would have hoped and we
apologize for this but hope that you have all been ab le to digest them. The experts' answers clearly
show that the over simplistic, generalized, black and white scientific debate as depicted by the
complainants is far from corresponding to reality . The Panel is now better equipped to assess under
the WTO Agreement the actions of the EC author ities during a period of complex scientific debates
and new developments. In order to do so when a pproaching the scientific issues that we will discuss
today and tomorrow the Panel should try to stand in the shoes of regulator in a time of scientific and
technological change and face with the clear di fferences of opinion among qualified and respected
scientists. The EC will not attempt to summarise, still less to add to, the views expressed in its
comments on the experts' answers to the Panel. It need only comment briefly on those of the
complainants. The EC would find a great deal to say about the flaws in the complainants comments
but we believe that our time could better be spent in other ways especially since there will be a further
opportunity to submit such comments. The EC wi ll limit itself to the time-being to some general
comments on differences of attitude between the comp lainants and the EC on the issues relating to
GMOs.
50. First on biodiversity, the EC would like to underline the striking misunderstanding of the
importance of farmland biodiversity between the comp lainants and the EC. On the one hand Canada
considers that the very purpose of agriculture is to reduce biodiversity. While on the other hand from
the EC's perspective agriculture is about the management of biodiversity and not its reduction.
51. It is therefore not surprising to see that the EC concerns about biodiversity are treated as
being entirely without merit by the complainants simply because they consider that farmland
biodiversity does not deserve protection. This di fference is in fact acknowledged by Dr Snow who
notes that the conservation of farmland biodiversity in Europe is a much bigger social and ecological
issue than in the US and Canada. It is instructive also to contrast the approaches of the complainants
to that of the EC when confronted with lack of evidence concerning a risk. For example, paragraph
03.01 of his advice, Dr Andow states that: "In answer to this question I will concentrate on Bt maize
and Bt cotton, yes there is some scientific evid ence to support the hypothesis that the widespread
cultivation of Bt crops adversely affect non-target organisms which may be exposed to such crops
under typical agricultural practice. However this evidence is insufficient to establish the hypothesis
that such adverse effects are expe cted to occur." The US takes this to be supportive of its case
because it assumes that it means th e product should be authorized. And if a problem arises risk
management can be used to mitigate and control it. The EC with its more cautious approach takes

Dr Andow's comment to support its view that the real potential risk resulting from the scientific
evidence of hazard needed to be studied before a specific product is authorized or any specific
management measure could be usefully designed. The US considers that in such cases it was
incumbent upon the EC to analyse the risk management options available to mitigate or avoid entirely
such effects and to make a decision on the application accordingly.
52. The EC would reply that regulators should ind eed analyse risk management options provided
that they have been sufficiently identified and de veloped either by the applicant company or other
persons. Indeed one of the problems that the EC h as faced over the past years, which in some cases is
still an issue of concern, has been the absence of appropriate risk management strategies. The experts
have confirmed that at present the situation is subs tantially different from the situation in 1998. The
EC has contributed through its financing for research to the current better knowledge on
environmental effects and management strategies. The complainants tend to react to uncertainty by
saying, "So what. Let's press on". The EC reacts by saying, "Let's take our time and try to reduce the
uncertainty".
53. When a new GMO is presented for authorizati on and scientific knowledge about the product
and its possible effects remains incomplete, re putable scientists are entitled to pose reasonable
questions aimed at gathering the information and evidence reasonably necessary to meet the concerns
of the legislator even if this takes some additi onal time and/or implies the use of some additional
resources. Let me be clear on one point. We are not speaking here about theoretical risks or residual
scientific uncertainty, but about a situation in whic h reputable scientists raise entirely valid questions
pointing to the existence of potential risks that in their views should be assessed. As is clear from the
files before you, the EC approach is to seek more evidence to establish whether or not there is a risk
inconsistent with the level of protection sought by the legislator, in order to make a definitive decision
on the basis of full information even if that takes mo re time. The complainants however consider that
such an absence of evidence should lead immediately to an authoriza tion. By insisting that their
approach is the only correct one the complainants are in effect trying to impose upon the EC their
chosen level of protection which reflects the complainants' specific circumstances and the
complainants' specific policy choices including thei r choices about the appropriate balance between
commercial interests and health and environmental issues.
54. That is not something that the complainants are entitled to do under the WTO Agreement.
Unlike the complainants, the EC does not choose to rush into actions that are ill considered and have
potentially irreversible consequences. The EC choo ses to take the time necessary to reach prudent
decisions which adequately reflect the concerns of the legislator. In the short history of GMOs we
have had limited occasions to explore in detail the effects of such organisms on ecosystems. Clearly
the situation regarding GMOs can hardly be compar ed with cases involving traditional products with
a long history of safe use. There is a lot of difference between the cases before you today and
disputes over issues like fire blight in apples. The EC is of the view that the potential of GMOs for
agricultural improvement among other things justif ies taking limited risks provided that sufficient ex
ante and ex post controls are put in place. That is why the EC has approved a number of GMOs and
GM food for marketing and use within the EC.
55. Other WTO Members may adopt more liberal or more restrictive approaches depending on
their priorities. That is their right. The EC does not challenge those other approaches and it would
have expected the complainants to abide by the same principle. In th e view of the EC the purpose of
expert advice is to shed light on all of the scientific and technical i ssues that have been raised by the
parties in support of their claims. This is especiall y true for scientific or technical issues that are
inextricably linked to legislative requirements in the EC. Requirements, let me stress again, that have
not been challenged by the complainants. The legal characterisation of any such scientific or

technical issues under WTO rules, for instance whet her it's an SPS or TBT issue is not a matter for
this meeting. It is a completely different matter and will surely be addressed next week. To give a
specific example, some experts, for example Dr Nutti and Dr Healy, assume that detection methods
are not a necessary component of risk assessment. It is nevertheless clear that such methods are
indispensable for risk management measures, as well as communication measures such as labelling
which are legislative requirements in the EC and which have not been challenged.
56. Mr Chairman, Members of the Panel, the EC is conscious that time like the environment is a
precious resource. They are both irrecoverable once lost so let us stop here and let us have more time
to devote to our discussion with the experts. Thank you for your attention.
Chairman

57. Thank you EC. I take it that part of your stat ement allow us to gain time for next week's
meeting with the parties. In view of the fact th at we are already behind schedule I note that the EC
prefers to devote the longer proportion of its time to those general comments. Without further ado I
would like to invite the complainants to ask questio ns to the experts on general issues. I will start
with Argentina. You have the floor.
Argentina
58. Thank you Mr Chairman. On the issue of the general questions we start with questions for
Dr Squire. We will refer to the document called "measures affecting the ap proval and marketing of
biotech products, notes on ecological and environmental standards" by Dr Squire. Referring to
paragraph 13 please comment on our observations wh ich were advanced as question 1 - Farm-Scale
Evaluation trials in the UK, does the expert agree with our comments? If not, why not?
59. The other questions to Dr Squire refer to hi s responses to questions 3-5. Referring to
response 3, potential for ecosystem effects of Bt maize on non-targe organisms: does the expert agree
with Argentina's statement? If not, why not? What scientific facts have already established that at all
molecular, atomic and physiological levels Bt toxins are highly specific to some insect orders?
60. In the same line, does the expert agree w ith Argentina's statement: "because of the
mechanism of action which starts by binding speci fic receptors in susceptible insects' mid-gut Bt
toxins are very unlikely to have harmful effects on other organisms"? If not, why not?
61. Referring to the title "mitigation", the expert say s, "However if Bt maize was found to harm
the infield biodiversity it should be feasible to rever se". Would the expert agree with this statement
insofar as there is no scientific evidence that Bt ma ize is harmful for the infield biodiversity? If not,
why not?
62. I continue with questions for Dr Andow. We will refer to document responses to questions
submitted by Dr Andow. To question 69 containing an explicit reference to SCI. Question 4, in
connection with response to paragraph 03-01, does th e expert agree that there is no solid evidence to
support the fact that the organism will actually in cur negative effects through exposure to Bt crops?
With reference to paragraph 03-03, please comment on Argentina's observations. Does the expert
agree with them? If not why not? In connection w ith paragraph 03-04, does the expert agree that
there is no confirmed hazard to earthworms which can be deduced from the scientific findings of EC
150?

63. With reference to paragraph 03-05 does the "po ssibility that unanticipated effects might be
identified" in any way refute the statement that there are no documented adverse effects of Bt maize?
Given the last sentence in the paragraph 03-11 in his response, does the expert agree with the
statement that there are no proven adverse effect s on non-target species in the US experience?
Referring to paragraph 03-12, does the expert agree w ith the statement that the toxin, given its widely
known form of action, cannot exert its characteristic toxic effect on mammals since it only can act on
certain insects?
64. Referring to paragraph 03-13, please explain in which way your assertion that "it is likely that
if the analysis is completed that there will be a documented risk". Is a conclusion of any scientific
finding mentioned by you in the preceding point? Ho w can it be recognized as a scientifically based
argument instead of an anticipated judgement? Do es the expert agree that there are no proven cases
of Bt maize?
65. Referring to his response to paragraph 06-02, c ould the expert please clarify the expression
"degree of release of the trait"?
66. With reference to paragraph 07-03 please comment on our observation advanced as
question 9. Next question, does the expert agree with them? If not why not?
67. In connection with your response in paragraph 07- 06, could it be said also that "the absence
of information does not imply the process of effects"? Would the expert agree with such a statement?
It is possible that evidence of su ch an effect had been looked for but not found. Therefore no report
with enough merit to be included in scientific literature has been issued.
68. Referring to the response to paragraph 07-12, does the expert agree with the argument that the
increase scale actually reinforced our argument in the sense that significant special scale of use effects
had still not been found?
Dr Squire

69. I think I need some clarification. Where you say "Referring to paragraph 13 in the document.
Please comment on our observations advanced as questi on 1", I am uncertain what question 1 refers
to. In the documentation here or the documentation sent by e-mail I don't seem to have a question 1.
Am I looking at the wrong thing?
Argentina
70. Shall I read for you the question 1? We are referring to paragraph 13 and the Farm-Scale
Evaluation trials in the UK.
Dr Squire
71. It wasn't given as question 1 in the document I have, but I understand now. I am sorry I still
don't have something called question 1.
Argentina
72. Question 1 refers to paragraph 13. Paragraph 13 refers to the Farm-Scale Evaluation trials in
the UK.

Dr Squire

73. It is one of the topics in that paragraph and there is an answer from yourself here with some
parts of it in bold.
Argentina
74. Let me clarify, when we say "advanced as ques tion 1", we refer to the question advanced on
February 14th. That is the original numeration. We had to make the new order because of the EC's
question. This is the new order.
Dr Squire
75. So you are referring to your comment "we be lieve these studies do not apply and quoting
them here is taken out of context"?
Argentina
76. What I am referring to is that the herbicide sp raying regime but not the genetic modification
is the root of the problem.
Dr Squire
77. Yes, it was the herbicide spraying that was generally considered to be the cause of the issue.
Argentina
78. So it's not dependent of the GM or non-GM nature of the crop. That is the first point. The
second point is that the results of the Farm-Scale Evaluation trials are likely to make it politically
impossible for the British Government to licence tr ansgenic crops. The political issue affects the
scientific question.
Dr Squire
79. That is an important point that you raised. We have to distinguish between the conduct of a
scientific experiment, which I must tell the Pane l that I was very much involved in, and the
presentation of the results of that experiment. The presentation of results was peer reviewed
excessively and published in a scientific journal of very high repute, with very measured, carefully
weighed results and conclusions.
80. It is impossible for those involved in that tria l to affect or strongly influence the way the
media or the government interpreted those experiments. So while I stand by the experiments, I cannot
be in any way responsible for the interpretation put over to the British people by the media. Whether
or not that is going to influence UK's acceptance of GM permanently is another matter. I suspect over
time it will fade. It is beyond science to do anything about it at the present time. Our results were
quite clear and measured. I don't know what science can do about certain newspapers and certain TV
channels. It may have influenced the way the public in the UK perceive GM but experimenters, I, can
do nothing about that.

Argentina

81. Yes I understand. But I am not quoting the media or magazines, I am quoting Nature. And in
these experiments one of the conductors of these expe riments, Dr Fairbank stressed that it is the
herbicide spraying regime not the genetic modifica tion that is the root of the problem. Herbicide
resistant crops are engineered to resist broad spectrum weed killers that remove almost all weeds from
a field. The results of the Farm-Scale Evaluation tr ials are expected from this spray regime of the
herbicides.
Dr Squire
82. I am not sure they were expected but the issue again goes to the root of how we value ecology
and food webs in managed systems. You have to put this in the context of where the UK puts its
weed control efforts. Weeds in the UK typically o ccupy 1 or 2 per cent of the total energy absorption
and nutrient uptake in the infield system.
83. We have already reduced them to a very sma ll fraction of the system, yet these weeds as we
call them have a dual function. They have an add itional function of supporting a very wide range of
organisms, typically ten times as many as the crop. The question that was put by the government was:
would bringing in herbicide tolerant crops that can be targeted at the last vestige of the weed flora
make a big difference to this last remaining bit of the food web? The answer was that in some cases it
would make a difference, positive or negative de pending on the existing regime. It was quite a
legitimate question to ask if you consider that a cr op field is more than simply a crop. The UK's
agricultural ecosystem has been here for 2,000 or 3,000 years and we wish to extend that for several
thousand years. If that is the case, then we have to accept that diversity in the food web is essential.
Given that, I don't see that there is anything wrong w ith the main conclusion of the experiment. What
the media or other commentators made of it is their business. I think the experiment is valid. You are
right in that the main effects appear to be through herbicide use and not the GM plant. But it is still
important to show that the effect was there at that time in the UK arable ecosystem. The effect is
valid. The result is valid and I think the government should have acted on it one way or the other.
Argentina

84. Do you think that the same conclusion would be found if instead the GM crop non biotech
crop would be used?
Dr Squire
85. I think the same conclusion would apply. It is the issue of managing the food web that is
important.
Argentina
86. I would like the Panel to take note that these same results would be obtained whether the GM
crop or not GM crop would be used in experiments.
Dr Squire
87. If there was a non-GM crop with broad spectru m herbicide capability and had the same kind
of effect then the same issues would arise.

Argentina

88. I would like this to be stressed.
Dr Squire
89. It has been stressed in our writings.
Chairman
90. These records are typed and will be written down. Dr Squire would you like to continue.
Dr Squire
91. That presumably covers your case in question 1, so I can move onto question 3 which refers
to my responses.
Chairman
92. Sorry Dr Squire, the US has a point of order.
United States
93. I just want to make sure we all have the documents in front of us. It will save time in the long
run. Does the Panel and Secretariat know exactly which document we are talking about? I apologize,
but I don't know which one we are working with here.
Chairman
94. As I understand it, Argentina has given two documents of questions addressed to both
Dr Squire and Dr Andow. Those are the two doc uments being discussed right now. I believe all
delegations have received those two documents.
United States
95. Right, but which document 1 refers to paragraph 13 of which document?
Argentina
96. We refer to our comments made to the expert responses. Each time we got the responses by
the experts we jut put our comments immediately after the response so it would be easier to read for
the experts. We believe everybody has got our comments. Our questions arise from our comments.
Dr Squire

97. The e-mail version of your comments which I read and was working to is slightly different
from this. Referring to response 3, I am not as competent on the detailed effects of Bt crops as
Dr Andow. He has developed this area of research in detail. Argentina is right to bring up the point
that the various effects of Bt toxins are highly speci fic. Indeed there are a number of different types
of Bt toxin that are specific. But, as has been mentioned elsewhere in the written evidence, even if the
toxins are specific to a particular insect or order or classification there are potentially a wide range of

organisms in that classification that might be aff ected by the toxin. There has been little detailed
information from the areas where Bt has been gr own widely about what those effects might be.
Largely because they haven't been look ed for. There are issues of speci ficity, i.e. that the toxin has a
narrow range of things it might attack but within th at range what it might attack has often not been
carefully defined. I agree partly with Argentina's statement but not entirely. I do believe that things
haven't been looked for and until they have been looked for in a proper and systematic way the
question remains open as to what Bt toxins might do. This leads on to 2a, in a way. Unlike broad
spectrum herbicides, Bt crops may have effects and these effects have not been thoroughly and
properly looked at. While there is specificity an d narrowness there is still depth within the regions
concerned. I think there is cause for doubt here. Point 3 referring to the title mitigation.
Argentina

98. May I make a comment? You were saying in other words that in every case that the
specificity was studied did one find that there is specificity?
Dr Squire
99. In practice impacts on wider things have rare ly been looked at. The main programme of
research in Europe on this issue, looking at the pot ential wider effects of Bt toxins in Bt maize for
example, has only very recently started to yield resu lts. Because there have been very few attempts
to look at any wider effects of Bt toxins in fields, the question at the present time cannot be answered.
Theoretically there should be a narrow range of sp ecificity but in reality we don't know whether that
is true in terms of the effects, for example, on soil organisms. There is uncertainty in that.
Argentina
100. In other words you are saying that we don't know yet something that can modify a decision
taken five years ago.
Dr Squire
101. We don't know yet. That is correct. I think that in Europe this project and one or two others
are looking at this. The scientific community will ge t clear results in the next year or two what the
signals are showing. It isn't my role to say whether we should wait for that. All I can say is that
within a year or two having kept very carefully abreast of that project I expect results to be
forthcoming. Whether or not they confirm your question I am not able to say.
Chairman

102. Sorry to interrupt this but we have a problem of time. I would ask Dr Squire to complete
Argentina's question in three more minutes. Then we will turn to Dr Andow for a very short reply.
Dr Squire
103. Again, question 3 very briefly in less than three minutes. Unless you look for effects where
Bt has been grown widely you cannot say that infield effects will not occur. There is no question that
effects on the infield biodiversity where Bt has been grown widely have not been looked for. I am not
saying that they will necessarily be found but they have n't really been looked for. I have to make
these cautionary comments. Thank you.

Chairman

104. Thank you Dr Squire. There is no need to repeat what you have written already because that
is on record. Dr Andow.
Dr Andow
105. There are a lot of questions here. With respect to question 3 in particular I would like to note
that your questions referred to my response to th e first part of question 3 from the Panel. I am
referring to the question from the Panel which is: "Is there any scientific evidence to support the
hypothesis that widespread cultivation of Bt crops adversely affects non-target organisms that may be
exposed to such crops under typical agricultural prac tice"? Before I get into the details of your
question I would like to just say a couple of things about how I viewed this question. In doing that I
may be able to explain more generally some of the apparent issues that you bring to this.
106. First the Panel asked: Is there any scientific evid ence? I took that to mean I am supposed to
look to see if scientific evidence exists. The ques tion is not asking me to weigh this evidence but
rather to identify this evidence. Some of your questions are related to how one might weigh this
evidence. I am not addressing that. I am simply pointing out what the evidence is if it exists. The
second point the question addresses relates to adve rse effects. Following the risk assessment
literature, I took that to be different from the question "is there a risk?" I did confuse the issue a bit in
my answer because I should have continued to refer to adverse effects rather than risk but since the
second part of the question does introduce the word risk I didn't want to address that in the first part of
the question as well.
107. To consider risk I would have to see evidence of some probability that the adverse effects
could occur given the exposure. That is why in a lot of my responses I confuse things by saying
things in highlight and bold and pa ragraph 03-02 that there is a possible hazard of adverse effects to
collembola. But I think I am quite clear in saying there is a potential risk to Chrysoperla carnea. But
given what I know about Chrysoperla carnea in maize I think the actual risk to Chrysoperla carnea
will be rather subtle. But the ev idence available does say that one h as to consider that as a potential
risk. That is how I viewed these questions. In connection to your questions 03-01 I would say that
this has to do with the distinction we are just making that one can find evidence for that adverse
effects are possible in the agricultural environment.
108. However, whether or not it translates into a risk is still an open question. In moving onto
paragraph 03-03, my writing is not entirely clear. I begin this paragraph by noting the 14 field studies
emphasizing that six of these used large plot sizes. My next sentence says that it is important to use
large plot sizes. What I meant was those six studies are better scientific studies because they had
large plot sizes. Then I went on to consider th ese various studies. I guess I could go through every
little detail here. I think that my general conclusion is that these studies don't enable an evaluation of
the risk to Chrysoperla carnea which is foreshadowing my comments and the second part of this
question. I can go into the detail. But my guess is that you really don't want to dispute that
conclusion?
Chairman

109. Argentina I am very sorry you do not have the floor right now. This is prime time for each
party. We have to allocate among the parties in an equal matter so please do not repeat statements.
Do not put on record what you have already put in record. Thank you. Dr Andow, please conclude.

Dr Andow

110. Your comments on my paragraph 03-04 note th at they are confusing with an approval
sentence followed by disapproval sentence. I must a pologize for this confusion. This was one of the
reasons I tried to highlight the points in bold that summarized paragraphs. The study in exhibit EC-
150 allows one to conclude there is a possible hazard to earthworms but that is only related to the fact
that the adults were 20 per cent smaller with Bt litte r than non-Bt litter at 200 days. This leads me to
conclude that there is insufficient evidence to conclude that this is a potential risk to earthworms.
Again I should have used the phrase "possible adve rse effect" and I have confused the answer by
using the term hazard.
111. Paragraph 05 refers to a paper showing that the Bt toxin can be exuded somehow from living
maize roots. I understand that you have confusion w ith this paragraph but again the summary is that
this paper simply documents that there is a potential for exposure and does not examine where there is
an adverse effect from such movement of the Bt toxin out of the roots. I would just like to leave it at
that unless you would like to follow up with questions on that point.
112. Paragraph 3-11 in some ways foreshadows one of your other questions related to the extent of
increased scale of use. This would be a comment of question 14 in response to my paragraph 07-12.
If Bt maize and the large scale plantings of Bt ma ize and Bt cotton were being examined for adverse
effects to non-target organisms, it would certainly be the case that information from such a monitoring
system would support your point of view that there are no proven adverse effects on non-target
species. In the absence of such a system what can be concluded is that any large effects which would
be evident without looking for them are not occurring . That doesn't preclude that there could be other
more subtle effects. I couldn't agree with your conclusion that there are no adverse effects based upon
this large scale use of Bt maize and Bt cotton not on ly in the US but other places in the world. To
narrow it down to proven adverse effects seems to me to miss the point of the original question which
is what relates to the existence of scientific evidence.
Chairman

113. Thank you Dr Andow. I am afraid we have to move onto Canada. The time is very limited.
We may come back to some of the questions raised by Argentina but I would now move onto Canada.
You have the floor.
Canada
114. Thank you Mr Chairman. I would just like to ask whether you would prefer us to ask one
question at a time or whether you would prefer us to ask all of the questions and wait for the experts
response.
Chairman
115. I think it is not necessary for you to read out your questions because the experts have been
given those questions.
Canada
116. First you will see from our questions that we distributed earlier today that the bulk of our
questions under General Questions re late to herbicide tolerant crops. Given time constraints we will
not deal with all of these questions at this point. We will save some of them for the product specific

or safeguard measures. Our questions are gr ouped under several themes. One relates to the
management of controlling volunteers or in-crop vol unteers. Another relates to the development of
weed resistance, gene flow persistence and finally persistence and evasiveness. My first question is
for Dr Snow and possibly Dr Squire and Dr Andow if he would like to respond.
117. Several experts have indicated that the introduction of HT crops derived through
biotechnology could make the control of oilseed rape volunteers a major problem. The EC has
suggested that the evidence of Dr Snow confirms that volunteers resistant to multiple herbicides prove
extremely difficult to manage. My first question fo r Dr Snow is: what methods, both chemical or
herbicide and non-chemical, are curre ntly used to control conventional oilseed rape volunteers in the
managed environment.
Dr Snow

118. Are you referring to Canada, the US, Europe or the whole world in your question?
Canada
119. Let's start with the whole world and then we 'll narrow it down from there. Or perhaps we
could just speak generally.
Dr Snow
120. Sorry I am being a little facetious. It is difficult to say in any one country what the best
method is, what is being used now, or what would be used in the future. It's obvious there are many
methods for controlling volunteers, including tilling or di fferent types of herbicides that are rotated.
These were addressed in my answers to the questions from the Panel. There are methods for
controlling volunteers that are effective at this time , that people have decided work. They come at a
cost because sometimes they involve using additiona l herbicides which may or may not be desirable
depending on which country you are talking about.
Canada

121. Would these methods of controlling herbicide tole rant oilseed crops that are derived through
biotechnology be any different from the methods of controlling herbicide tolerant oilseed rape that
had been developed through mutagenesis.
Dr Snow
122. With regard to the volunteers, I think the same methods could be used. The only difference is
that the herbicide tolerant volunteers that are transg enic. You have to think about which herbicides
we are talking about. Glyphosate is one of them. Many, many farmers want to use glyphosate on a
lot of different crops. If volunteers become resistant to glyphosate that limits the farmers' options.
There are some issues about how difficult they might be to control. Also the gene could spread
possibly more easily if it's a single transgene. It depends on the genetic basis of the trait how fast it
would spread to other plants and to weedy relatives. In general I would say the same principles apply
I am just giving you a few caveats here.

Canada

123. The ability to manage these volunteers would be dependent on the herbicide to which the
volunteers would be tolerant. What are your views in relation to the difference between controlling
volunteers using the immizolones - which I will call the immis - and controlling volunteers using
glufosinate ammonium. If the volunteers were tolerant to one of those herbicides as oppose to
glyphosate, would the issues be the same as between glufosinate ammonium and the immis?
Dr Snow

124. I think the issues would be the same.
Canada
125. Over 80 per cent of oilseed rape that is cultivat ed is composed of three herbicide tolerant
varieties: the glyphosate, glufosinate ammonium and the immis. Given the widespread use of oilseed
rape in Canada, the availability of alternative me thods for controlling oilseed rape volunteers and the
lack of reported problems: what is the scientific basis for concluding that the herbicide tolerant
oilseed rapes may prove extremely difficult to manage?
Dr Snow
126. Is the phrase, "the extremely difficult to manage", a quote from me or from the EC?
Canada
127. Sorry that is a quote from the EC.
Dr Snow

128. I think that is their opinion. I don't want to try to justify that. But I would like to mention is
that I have read a number of reports that do say that there are problems managing herbicide tolerant
volunteers. I cite several of them. One of them is Simard et al. in Weed Technology , a paper that
came out in 2002 and was submitted in 2001. By 20 01 this had become an issue and a topic sentence
of the abstract is relevant here. They say "the presence of volunteer canola is becoming a significant
agro-ecological concern given the large scale use of he rbicide tolerant varieties in some areas. They
don't distinguish between transgenic or non-transgenic. Two are transgenic and one is non-transgenic.
Herbicide tolerance is reported as a problem. This supports your statement that the immis may be as
much of a problem as the others but because glyphosat e is used so widely and is associated with the
transgenic crop, it is blamed for this problem.
Canada
129. You also say in an article by Linda Hall, w ho reviews the emergence of multiple resistance
herbicides. In that article she indicates that producers have not reported this because they are
controlling these multiple resistant herbicides or controlling canola HT volunteers using other
methods?

Dr Snow

130. That could be one explanation. That paper was published in 2000 so we don't know if she
would say the same thing in a similar paper now. Bu t I found it very difficult to nail down how big a
problem this is in Canada. I think you are suggesti ng Canada has been able to manage it; it is not
considered a problem. It could be different in different countries but people don't tend to highlight
that it is a problem in some of these publications. It may not be a large problem but it is hard to get to
the bottom of that.
Canada

131. I would like to move now to development of w eed resistance. Dr Andow, you say there is an
abundance of evidence that the rep eated use of a given biotech herbicide tolerant crop would likely
result in the evolution of resistance in weeds to this herbicide. I would like to ask you whether it is
true that there have been numerous reported cases of weeds resistant to the i mmis, the herbicide used
in conjunction with HT crops derived through mutagenesis.
Dr Andow
132. I didn't address that in my answer to my ques tions but I did note that Dr Snow addressed it.
Her answers to the questions indicated that there was such evidence.
Canada
133. Of resistance to the immis? [Dr Andow replies yes].
134. Are you aware of any reported cases of the evol ution of resistance in weeds to glufosinate
ammonium?
Dr Andow
135. Not to glufosinate ammonium. Certainly to glyphosate. I think one of the broader issues here
is that glyphosate is widely recognized as one of the safer herbicides that can be used in crops. This
has been one of the reasons why the glyphosate to lerant varieties have been widely accepted in
addition to their ease of use. Weed scientists, an d other scientist interested in the evolution of
resistance like myself, recognize that whenever there is su ch widespread use there is likely to be
resistance even if it has not been reported. Whethe r or not there are reports is not the main point in
terms of resistance risk. It is how much is bei ng used and how many weeds are being exposed. The
fact is, at least I understand in Australia, there ar e some reports beginning to occur of additional cases
of glyphosate resistance in weeds.
Canada
136. Now would this be through the use of HT crops or the use of glyphosate generally?
Dr Andow
137. This is HT crops in Australia.

Canada

138. Is glufosinate ammonium used to the same extent as glyphosate in other areas?
Dr Andow
139. For a number of reasons, basically the spectrum of toxicity to weeds, glufosinate ammonium
has not gained as widespread acceptance as the glyphosate tolerant plants.
Canada
140. So would your concerns about glyphosate herbicid e tolerant crops be different than concerns
about glufosinate ammonium crops?
Dr Andow
141. I think that would depend on the crop. For example in maize as long as we have both
glufosinate ammonium resistance and glyphosate resi stance it is likely that the glyphosate resistance
would end up being used more. The resistance risk would be higher with glyphosate resistance crop
such as in soybean. But in other crops it may be th at the glufosinate ammonium would be a superior
product than the glyphosate. In which case it woul d be used more. The degree of use is what
determines the higher level of risk.
Canada

142. In terms of the loss of benefit of using th e alternative herbicides, you mentioned that
glyphosate is used in a number of different applications and therefore the introduction of glyphosate
tolerant crops may pose a problem. Would those same issues apply to the introduction of glufosinate
ammonium herbicide tolerant crops given that glufosinate ammonium is not used as extensively?
Dr Andow

143. Yes, I think that it depends on the crop.
Canada
144. I would just like to move onto gene flow. So me experts have indicat ed over the past five
years there has been some additional evidence that outcrossing amongst oilseed rape is more prevalent
than previously anticipated. First I would like to ask Dr Squire or Dr Snow: is the potential for
outcrossing also a concern for herbicide tolerant crops developed through mutagenesis? Then, in light
of this the new evidence of potentially broader outcr ossing in oilseed rape, are the experts aware of
any measures that have been taken in the EC to minimize the outcrossing of HT crops derived through
mutagenesis?
Dr Squire
145. The evidence in Europe of greater outcrossing has arisen because experiments have increased
the size of the donor crop in relation to the recipien t crop. I think detection techniques have improved
to some extent. Now we have a much better appreci ation that gene flow goes farther, with potentially
higher frequency and possibly to more species than was thought five or six years ago. But in principle
there is no difference between the process of gene flow unless there is a difference attached to the

GM-ness through the male fertility or male sterility of the donor itself or the recipient. As far as I can
see there is no essential difference in the mechanism other than that. Now, clearly outcrossing has
occurred in non-GM oilseed rape for a long time. There hasn't been that much herbicide tolerance
derived through mutagenesis in Europe so we don' t have the same kind of records in Europe. In
general Europe has not put in pl ace any consistent measures to mini mize crossing from new kinds of
oilseed rape, largely because these products are treated th e same as traditional varieties. So even if a
farmer over there gives his crop's genes to one over there, it is about the same. They can sell the
material.
146. There are exceptions to that. The exceptions co ncern oilseed rape destined for particular
markets - varieties for an industrial market for example containing different concentrations of some of
the oils. In those cases there are some measures put in place to do with the localization of those kinds
of fields and the non-harvest of any oilseed rape very, very close to the fields, but beyond that there is
not much information on the distance over which gen es might move from these industrial oils to other
fields. The actual criteria are quite lax - the per centage of industrial oil allowed in non-industrial
oilseed rape is relatively high. It is a few per ce nt. Gene flow will have occurred but nobody will
have bothered about it very much. That seems to be the case for Europe. Dr Snow do you want to
comment?
Dr Snow

147. The only thing I would add is that I really d on't know the answer to your question no. 9 about
whether the EC has taken measures to minimize outcrossing from non-transgenic crops. I suspect not,
but I don't really know for sure.
Dr Squire
148. It has not been a major issue. These kinds of crops have not been brought in a major way.
Chairman
149. A point of order. I suggest we have Canada until 12.20 then we will have the US until 12.40.
We will have the EC until 1pm, and after lunch from 3 to 3.30 when we will have follow-up questions
from the complainants for half an hour until 4pm. Then we will ask the Panel questions until 4.30.
After that we will see how it goes. Canada, please continue.
Canada
150. Thank you Mr Chairman. I will then move to some of the other questions. In terms of
question 7, would you agree that there is general sci entific consensus that there is no difference in the
types or kinds of risks posed by biotech HT crops compared with their non-biotech counterparts? I'll
direct that to Dr Squire, Dr Snow and Dr Andow.
Dr Squire
151. In general terms as regards ecological risk, the an swer is, with minor qualifications, there is
no difference. Generally I would agree with that.

Dr Snow

152. Yes, I always get uncomfortable when people group all HT biotech crops together and all
non-biotech. I think many people have said we should look at these case by case. For me it is very
difficult to group them all together and say the kinds of risk and the types of risk are the same.
153. I pointed out in my answer to the question th at came from the Panel that there are certain
characteristics of the biotech crops that cannot be found in the non-biotech crop. For example, a Bt
transgene is not available to intr oduce either through mutagenesis or breeding with a relative. These
are specific cases where I think the biotech crop is different from the non-biotech and the same thing
with the glyphosate resistant trait. But those are ch aracteristics of specific biotech crops. In terms of
generalizing, I don't think you could say there are major differences between these two large groups.
You have to look case by case and see whether it's attributable to being a biotech crop or not.
Canada
154. Ok, given this has there been any reported inci dence of glyphosate resistance that has been
developed through mutagenesis?
Dr Snow
155. I am not sure about that. There has been a single gene for a very valuable trait to biotech
companies. The reason why Monsanto has made so much money on this is they developed it first.
Your question is: could it be developed throug h mutagenesis? Several weed species have
spontaneously become resistant to this herbicide so there is a way that it can happen. Another
company was able to get it from bacteria through a process called directed evolution from bacteria.
They have the right to put it into a crop but I am not aware that it has been available to biotech
companies in any other way than through a transgene.
Canada

156. But if it did become available so that you had an oilseed rape herbicide crop that was resistant
to glyphosate, would that pose the same sort of eco logical issues or concerns as the biotech crop that
is resistant to glyphosate?
Dr Snow
157. If it is a single dominant gene, just like the transgene, I don't see any difference.
Canada
158. I have a question about genetic di versity. Dr Andow, you have indicated that gene flow from
a GM HT crop can reduce genetic diversity. Can you explain how the integration of a single gene
conferring herbicide tolerance then affects the genetic diversity of oilseed rape?
Dr Andow
159. It wouldn't be a single gene. There would be effects on genetic diversity through scale effects
similar to what Dr Squire was referring to. If a la rge amount of a particular genotype is planted then
the hybridization between the two means that all the hybrids have half of the genes of the one variety
and half of the other variety. If there is a lot of the one variety introduced then that puts pressure to

move more than just the one gene from that crop into the other varieties. In fact there is pressure to
move lots of genes. That is how the genetic divers ity is affected. It is the rapidity and scale of use
that influences the loss in genetic diversity.
Canada

160. Then would you agree that in the impact on biodiv ersity would be the same if there was a HT
crop developed through mutagenesis that had the same repeated use and scale elements?
Dr Andow
161. At this time there is no non-transgenic glypho sate tolerant crop, so it is still a hypothetical
question.
Canada
162. But your comment is if there is greater scale of us e this could have an impact. It's related to
how popular the crop becomes?
Dr Andow
163. Yes, it is related to scale and rapidity of use.
Canada
164. In terms of biodiversity I just have one comment. I would like to clarify a statement that was
made in the EC opening address. Dr Squire, would you agree that in fact agriculture by its very
nature has an impact on biodiversity. In fact th e purpose of agriculture is to reduce the range of
species within a managed environment so as to favour a particular cultivated species and to eliminate
those species which compete for soil nutrients, moisture, etc?
Dr Squire
165. I think this is a very important philosophical poi nt that will determine the future of mankind.
Because yes, but we have to channel resources thr ough single species for efficiency. We have been
doing that for a long time. But to work harder and harder to eliminate the last vestiges of biodiversity,
because it competes with crop production, will in fact end up destroying the system that sustains it.
We have to be very careful about this. The ma naged arable or agricultural environment may be
classed as being unnatural but you would have to class humans as unnatural as part of that system. If
humans are animals, and we are all to some extent natural, then the arable environment is another
example of a natural ecosystem. It's just that we control it to a degree. These systems might have
replaced a kind of forest or steppe vegetation with something else but that something else is not
ecologically non-diverse. It can contain a very larg e number of organisms - plan ts, and invertebrates.
It can be the main habitat for some kinds of organi sms, like certain types of beetles or spiders. We
have to live with this, make it work for us and not obliterate it. I think we should channel a lot of
resource into the crop but not everything.

Canada

166. Apart from the debate on GMHT crops and biotechnology are there instances in the context of
conventional agriculture where farmers are either en couraged or regulated to reduce the effectiveness
of weed control measures? To allow more weeds?
Dr Squire
167. I think it's a matter of balance, of where you are in the world, and of where you are in the
development of a cropping system.
168. In much of Europe, but not all of it, we ha ve largely succeeded in managing weeds. The
benefits of changing weed control over a factor of 1.5 are not very great. We are already there. There
are instances in parts of the UK where the food web is purposely stimulated. People were paid to let
fields lay fallow for some time. There are exam ples already in place where weed management is
encouraged rather than the total obliteration of the weed flora.
Chairman

169. Thank you. Canada your time is up.
United States

170. Yes I will take one of my 20 minutes to confer to reduce any duplication.
Chairman

171. United States, when you ask your questions please refer to the number of the question that
would be helpful.
United States
172. This is a follow-up question to Question 3 in the middle of the page. Can the regulator or the
scientist assess the e ffects of Bt toxins on non-target species without identifying all potentially
exposed non-target organisms? If you can do that, please describe how one might do that.
Dr Andow
173. There are many different procedures that can be used to assess non-target effects. The
different procedures have different data requirements and give different degrees of confidence in the
assessment. With pesticides, for example, one co mmon procedure is to use indicator species. A
relatively small number of indicator species are supposed to give some indication of possible
environmental effects. If you see adverse effects on those species it triggers additional environmental
testing. It takes a little bit of time to get there.
United States
174. This question, for Dr Andow, is from our second page of additional questions. It is on Bt
risks. Dr Andow had mentioned there could be s ubtle potential non-target risks. Could one design a
field study to address potential subtle non-target risks associated with Bt crops?

Dr Andow

175. I am going to treat it as a two-part question. There is the question related to subtle effects and
then there is the experimental design. To some extent getting at subtle effects requires a staged
process rather than a direct process be cause subtle effects are, by definition, hard to detect. What you
want to do is to determine what are likely ways in which such things could occur. You would do
some experiments to try to determine what possible mechanism could explain the effects. For
example, as I mentioned in my response to question 3, there is a possible risk to Chrysoperla carnea.
I predicted it would be a subtle effect. Us ing that as an example how would one go about
investigating that effect?
176. You could have started those experiments in 1999 to get at part of your answer. Since it is
known that any effects would result from what the Chrysoperla carnea feeds on I think the first study
would be to investigate in a field situation under what circumstances could Chrysoperla carnea
actually encounter the foods that could adversely aff ect it. The study would first define whether there
are circumstances where it would be able to encounter these foods in large quantities. That
experiment would not require any transgenic crop to do and could be done on a small scale because
you would focus on the feeding behaviour, rather than at the population biology and survival rates.
Through that process one can start to identify the c onditions under which that risk could actually be
manifested. Depending on what you find it would lead to the design of an experiment that could
detect the subtle effects. In contrast, if you just went out and planted a field and then counted
Chrysoperla carnea you may find that there are more Chrysoperla carnea or less Chrysoperla carnea
with Bt crops. Even if there were less Chrysoperla carnea with Bt crops that would not necessarily
let you say the reason for that Bt crops caused this effect. You have to get into the mechanism that
causes this effect. My feeling is that you can approach the mechanism first rather than later.
United States

177. Now I am going to question 1 which refers to the studies that were cited regarding Bt's
mechanism of toxicity and spectrum of activity. In light of subsequent studies that have called these
results into question, could you summarize the data, positive or negative, on the topic? Is there any
reason to believe this mechanism of toxicity an d spectrum of activity would vary across different
environments?
Dr Andow
178. Are you referring to the experiments associated with lacewings specifically? Because I
interpreted the question differently. Let me rephr ase what I understand the question is. A series of
studies looked at effects of Cry toxins on lacewings . The first studies that were published on this
were in 1998. Those were a series of two or three studies - two are quite prominent in my mind - that
suggested that when green lacewing larvae were fed ca terpillars that had eaten Bt crop that there were
higher mortality rates in these larvae. After these studies, a series of follow-up studies then confirmed
the first studies, but also suggested that when yo u feed green lacewing larvae mites fed on Bt crops
there were not higher mortality rates on Chrysoperla carnea despite the fact that the mites contained
the Cry toxin.
179. The final study, which I think both Canada and Argentina referred to, was an experiment in
which the investigators incorporated the Cry toxin in to the water that the lacewing larvae drink. Then
they exposed those lacewing larvae for a series of shor t periods in their life to this water. (Lacewing
larvae cannot live only on water so you have to feed them food at some point in order to get them to
grow. Otherwise you can't determine mortality rates and they will die.) They incorporated very high

concentrations of Cry toxins in water and they found no significant differences in mortality rates in
the larvae. The key conclusion of last experiment is that there is no evidence of acute toxicity of Cry
toxin to lacewings. It doesn't entirely contradict the first set of experiments in which lacewings were
given long-term exposure over their entire life. Whet her or not there is chronic effects on lacewing is
still a question.
180. To get back to the original question, it wouldn't have been predicted that the Cry toxins would
have any effect on lacewings, because the Cry toxin that was used, Cry1Ab, is one which had been
considered to be specific only to Lepidopterans (moths and butterflies). Given that lacewing are less
genetically related to Lepidopterans than fish are to humans, people thought that this Cry toxin should
only kill moths and butterflies. It was surprising that it had any effects at all on lacewings.
181. In my view that is probably one of the more significant issues. How can that happen? It
suggests that there might be other ways in which these proteins exert effects on insects. I think that is
still an unknown. There is unpublished evidence that the way that toxicity normally acts on
Lepidoptera is not how it acts in lacewings. That is unpublished information, but exactly how it acts
is still uncertain. Now the data h as been interpreted both ways. So me people say this proves that
there are no effects of Cry toxins on lacewings and others say there are still major effects. My
personal assessment has been that any effects are going to be subtle.
182. When I say any effects are going to be subtle I am not saying that there are going to be
effects. I am saying if there are going to be effects they will be subtle. That is in response to a point
that Argentina was raising earlier.
United States

183. Thank you. I think you may have answered this qu estion, but just to clarify. Is there a reason
to believe that the Bt toxin is likely to be th e source of the chronic concern that was potentially
identified in the original studies or is there a poten tial likelihood that the effects could be traceable to
the kind of food or the kind of prey that was available to the lacewings at the time?
Dr Andow
184. There is a lot of comment in the literature on this question. My assessment of what that
evidence suggests is that there could be food effects associated with this but it is probably not purely a
food effect because one of the experiments had an artif icial diet with and without Cry toxins in it.
The effects were seen in that circumstance and it is hard to explain why using food effects as the only
explanation. We should say that the data are not entirely consistent with each other, which means
there must be something else happening that we haven' t explained yet. So I am not willing to say that
I know the answer to that question. I think that something to do with food is possibly part of the
explanation but I am not yet prepared to believe that it is all of the explanation.
Chairman
185. Congratulations US. The EC has the floor.
European Communities
186. Thank you Chairman. By my calculations the complaining parties have spoken for 1 hour
and 20 minutes on general issues so the EC will exp ect to speak for the same length of time especially

since we also have to deal in our time with foll ow-up questions whereas the complaining parties will
get a short period of time later on for follow-up questions. Is that correct?
Chairman

187. I ask you to do your best and I note that we have not received your questions in writing.
European Communities
188. The questions in writing, or at least a draft of them, are available and will be distributed now.
I am told they have already been distributed, but if anyone does not have a copy we have some more.
The experts in particular should have a copy.
Chairman
189. Before you take the floor, EC, I would say this is not exactly a matter of minutes but I do take
in account that you have spoken longer than the othe r parties on the introductory statement. We will
try to stick to the 3.30 limit for your delegation.
European Communities
190. I agree it's not a question of minutes but a question of opportunity. Our first question relates
to question 1 and 2 from the Panel to the scientific ex perts. These questions related to the presence of
antibiotic resistance marker genes in genetically mo dified organisms - or some of them. Our first
question is therefore to Dr Nutti who commented on this. I will read out the question since you've not
had it so much time in advance.
191. We assume, Dr Nutti, you are aware now of the studies demonstrating transfer in vivo of plant
antibiotic resistance marker genes to bacteria by the group of scientists led by Simonet et al. published
between 2000 and 2004 which was mentioned in para graph 78 of our comments. We wanted to ask
you how you reconcile the results obtained in these studies with the view you expressed in your reply
to question 1 that, I quote, "to date there are no repor ts that markers genes and plant DNA transfer to
these cells".
Dr Nutti
192. When I answered that question I listed the literature that I was consulting at that time. I didn't
have the Simonet et al. I only received your comments last week so I will be happy to look at this. I
didn't have time to look at them.
European Communities
193. I hope you will have an opportunity to comp lete your answer taking into account those
studies. We can now move onto the next question. It will be delivered by Mr Flett.
194. I would like to ask a question about Bt toxin and non-target effects specifically to Dr Andow
and to Dr Squire. You already have some written questions from us on this matter, however in the
light of what has already been said this morning I would like to slightly reformulate those questions
and put them to you as one general question designed to get at what may be the essential point here.
The question is quite long but the sense of the question is sufficiently clear.

195. We recall in particular Dr Andow's comments this morning about the distinction between a
potential adverse effect and a possible risk. Dr Squire echoed this distinction on this issue of Bt toxin
and non-target organisms. This is the distinction between the first step when the scope of possible
further scientific enquiry is set and the second step when one considers whether or not the scientific
knowledge within that defined scope is sufficient for taking a view on whether or not there is a risk.
Now it seems to us that this may go to the heart of the difference between the parties on this point. It
seems to us that the complainants sometimes set this scope relatively narrowly whilst the EC
sometimes sets this scope more widely.
196. We would like to ask you Dr Andow and Dr Squire how, as scientists, you go about setting
this scope with particular reference to Bt toxi n and non-target organisms. How do you decide as
scientists what you need time to look at, what you need time to think about? How do you decide what
the relevant context might be? Do you, for ex ample, draw on your knowledge and experience in
relation to different crops, different regions, diffe rent natural or agroecosystems, and different
receiving environments? Do you believe that your approach to setting this scope, either narrowly or
widely, reflects conventional wisdom within the sci entific community? Are there divergent views on
this issue within the scientific community? Please fe el free in your answers if you find it helpful to
refer to the specific questions that we have already submitted in writing. Thank you.
Dr Andow

197. Thank you. When you say "set the scope", are you referring to the different possible ways of
investigating non-target effects? It is a little uncl ear what you are referring to when setting the scope.
Would you be so kind as to help me with that?
European Communities

198. We would like you to talk specifically on the ar eas in which you might think that more time
and resources could be spent by scientists analysing an ything relevant to the issue of the Bt toxin and
non-target organisms. If this scope is set in an extremely narrow way then you might, as the
complainants, look at the landscape with almost no helicopter vision and declare: "There is no
evidence of a problem". If, on the other hand, you have some reasonable degree of helicopter vision,
and you want to put the problem in context and look at a wider landscape, you might say: "I would
like to know a little bit more about this issue before I take a definitive view in relation to the specific
product application that is before me". I am tryi ng to get at this issue of how you set the scope of
possible relevant future enquiry as a scientist before you feel able to take a view on the absence or
presence of a possible risk. Is the question sufficiently clear?
Dr Andow

199. First of all, as a scientist, I am not a risk assessor. I am not in a position to make these
decisions as to when we have enough informati on. What I'll address instead follows from the US
question: how do you actually do these assessment s and are there ways in which you procede that
may require more scientific work and give you more information? Especially in the area of non-target
effects the challenge has been that there are so ma ny different species and so many different possible
ecosystem functions, biogeochemical cycles, ways in which nutrients are cycled through the
environment, etc., that could possibly be affected. It is simply not possible to study them all. Any
procedure has to figure out a way to focus. The one that I mentioned in my response to the US
question is focusing on a few indicator species under the presumption that they can tell you something
about the environments.

200. This has been an approach that has been used for toxic chemicals because the chemicals aren't
restricted to particular environments. In contr ast, most of the transgenic products are in the crop
environment. It may be possible to think about ho w to evaluate non-targets in a different way than
through indicator species because you have a particular environment of concern. Certainly for gene
flow it could go to other environments but the main environment is going to be the crop environment.
One can ask what kind of non-target effects would ther e be in that crop environment. In that sense
then there are other ways to focus things than trying to look at indicator species. One could select
species out of that environment for testing, for example.
201. I have also previously commented on how things have changed over the last ten years. This
relates to this question too and I'd like to amplif y it in this context. Since around 1998 there have
been non-target studies associated with transgenic crops focussing on actual things that could happen
in that agricultural environment ra ther than things that could happe n in some general environment.
For example, some of the Cry3 Bt toxins that are currently being assessed are supposed to kill beetles,
so the focus has been on other bee tles in that system. Rather than selecting any non-target species the
idea is to focus more on things that could actually ha ppen. In that respect a change is occurring, in
different degrees, in the way in which non-targ et risks are being assessed around the world. The
assessments are looking more at what could happen within that receiving environment. With this
approach you cannot use one indicator species applied to lots of different environments. It does mean
that you have to do more tests. It also means th at a test done in China on Bt cotton may not be the
same kind of test one would do in Spain on Bt cotton.
European Communities

202. I understand that what you need to look at may depend on what you're focusing on and this
has been changing during the period that we're looking at. I just wondered if Dr Squire might like to
also comment on the question.
Dr Squire
203. I agree in general with the sentiments. I thi nk scientists have to be aware of what makes a
soil, or an ecosystem work, and to be able to answ er a question or approach questions like the one on
Bt that was presented. There are numerous organi sms, bacteria, fungi, etc., that are absolutely
essential for the working of the system. By looking at the processes they mediate, for example the
transformations of compounds, we get a feel for what should be there and how it might be affected.
Quite a bit of that work is in place in various parts of the world. In the in stitute where I work there
are groups looking at those processes, not with Bt in mind. When the issue of Bt came up and some
of the first results in containers showing potenti al chronic or small cumulative effects came up, the
question was raised whether these effects would poten tially be different from something else that we
have experienced so far. Would they be importa nt and would they shift any of these organisms or
processes in a certain way that was beneficial or detrimental? Prior knowledge and awareness is
essential for the process. The question is: Is there any possibility that over long periods of time, over
larger areas of land these small effects might mu ltiply and cause some majo r effect on the essential
organisms and processes. In the case of Bt there are some legitimate queries. Because it exists
throughout the plant it might well have influences on parts of the system that other chemicals cannot
reach.
204. It is not catastrophic. The effects would be know n by now if they were catastrophic, but they
are potentially there. The next stage then is to see if we can predict those effects at that scale from
present knowledge. How could we scale up? What is the next feasible step to test whether these
potential effects on our known system are realized or not? That would need to be a gradual process.

At the present time that information isn't available or transferable to an European context from work
elsewhere. So there would be need, in this partic ular case, to consider these upscaling effects. You
would need to do field scale experiments for a few y ears in the first instance. My understanding is
that such experiments are in place in Europe. That is the way that I and colleagues would approach
this kind of problem.
European Communities

205. I think that brings us nicely to question 9 and your comments about transferability. Questions
9 and 10, again to Dr Andow. Could you indicate to us whether or not in your opinion there is a
consensus on the design and implementation of insect resistant management programmes in the US?
Are these designs directly applicable in Europe? And question 10: What factors in your opinion
might affect the efficacy of resistant management in Europe?
Dr Andow
206. Thank you. With respect to the design and impl ementation of insect resistant management in
the US there is a fairly strong consensus on some issues. For other issues there is still discussion
about how to design and implement the IRM.
207. There is quite strong consensus when the crop expresses what is referred to technically as a
"high dose". In those circumstances the consensus h as been that a structured refuge is a reasonable
approach to IRM. The refuge is specified as land which is usually about 20 per cent of the total land
area and within a certain distance, usually between a ha lf mile to a mile or so, of the crop. The area
where I am sure consensus will be reached over the ne xt few years is related to low-dose events. The
issue under discussion is what refuge size is needed for low dose events. Currently at the rate at
which they are being used in the US the idea has been to use the same refuge requirements (20%) and
then adjust them if necessary. Are these designs directly applicable to Europe? I would say, in
principle, yes. But the specifics of how one implements them in Europe are not as clear. For example
the implementation in the US is in part related to the legal authorities of the regulatory agency. My
understanding is that the legal authority, in this case EPA, is a little different from the legal authority
that is granted in the EU. It is very likely that the details of implementation will be different in the
two areas in terms of where liabilities lie. Those are legal issues. In the US the main point in terms of
the science is that each individual farmer is res ponsible for resistant management. Whether or not
Europe will decide to go in a similar direction or whether they will take a different perspective
because there are more small fields that will require communities to get together and cooperate is still
an open question. While those are not necessarily po ints of biological science, they would certainly
be important points in social science in terms of how one actually implements successful IRM.
208. I will go now to question 10 and the factors that will affect the efficacy of resistance
management in Europe. There are similar factors th at are going to affect the efficacy of resistance
management in the US. If the people that are supposed to implement it, actually are the ones to
implement it, then it will probabl y be efficacious. If they are unwilling to implement it then will not
be efficacious. That is one of the scientific issues that we have to deal with. Certainly it would be
better to have larger refuge in the US. Economic analysis of that question suggests that there would
be resistance on the part of US farmers to implement it. Then you get a lot more violations from what
you want which would affect the efficacy of r esistance management. Ag ain these issues are not
necessarily purely subjects of biological science. Th ey are issues of biological science entwined with
the economics of farmer behaviour that influence how the efficacy of resistance management works.

European Communities

209. To follow-up on some of the specific issues in the context of the community, is it your view
that there are divergent opinions in terms of how the scaling up might take place? How long it would
take? Second, also specifically on science, could you say a few words on what is and what is not a
high dose. Does it depend in your view of the target pest. For example, is the high dose the same for
all target pests in Europe for Bt maize, or is it different? In other words, does this depend on the
receiving environment?
Dr Andow

210. The scientific component of scaling up has to do with when the resistance management
should be implemented in order for it to be effectiv e. Most people agree that the earlier a particular
refuge strategy is implemented the more likely it is to be effective because people are used to it from
the beginning. But it is also possible to adapt mana gement as scaling up occurs. There are trade-offs
between the two that are recognized on scaling up. There are different preferences for how to
approach that.
211. In terms of high dose if you look at Bt maize, th e targets for Bt maize in Europe are what we
call in the US European corn borer. I think even in Europe they call it European corn borer. We
know that the toxicity spectrum is similar between European corn borers in US and Europe. In the
context of the Bt maize plants considered for Eur ope, the management strategies are likely to be high
dose in Europe. I have less to say on Sesamia because I cannot remember exactly what the toxicity
results are for Sesamia. Frequently that family has a lower toxicity spectrum. I do know that the
toxicity varies from life stage to life stage. The olde r life stages are fairly tolerant of the Bt crop,
unlike the European corn borer. We also get in to issues of timing. Whether or not there are
alternative posts they can switch from to becom es an issue in terms of design of resistance
management for that species. This would be a concern primarily in Spain and Greece.
Chairman

212. Thank you Dr Andow I suggest we now interrupt the EC's time on the questions to the
experts. Before we break for lunch I have two a nnouncements to make. The first is organizational.
We think that it might be difficult to finish issues 2 and 3 this afternoon. Given the fact that some of
the EC's experts will not be available tomorrow th e Panel is ready to sit an additional session this
evening from 6.30 to 8.30. That is under the assumpti ons that the experts are paid by the day and not
by the hour and that Argentina will accept that we w ill not have interpretation this evening. That is
not possible. The second announcement is that during the lunchtime this room is going to be locked.
This means you can leave everything you want in this room until we come back at 3pm and please be
here at 3pm Swiss time not Geneva time. This meeting is adjourned.
United States
213. Mr Chairman, we have been talking to our Gene va delegation who covers these things. It is
really not the norm for the defending party to have the same amount of time as the complaining
parties. In a very recent case in fact the EC argue d vigorously against the US having as much time as
the other eight parties in an Appellate Body context and the EC largely prevailed in its position. So it
is a little bit ironic for the EC to insist that that's the way it has to be. That said, we don't have
objections to EC asking questions. I just want you to be aware that it can't be considered the norm.
That's not the EC's position in other disputes.

Chairman

214. Thank you. Madame Fries you have the floor.
European Communities
215. Thank you Chairman. We have three questions on detection methods which we hope will not
take too much time to answer. Dr Nutti, I would like to ask you whether you agree that a detection or
identification method is required (1) to distinguish between authorized and non-authorized products
and (2) to assist in the withdrawal of authorized products in the unlikely event that hazards are
observed after authorization. Thank you.
Dr Nutti

216. Yes, I agree. When I answered in my written replies I pointed out that there were two kinds
of detection methods and that they are mostly used in the context of labelling requirements.
European Communities
217. Your response leads us onto the next question. Do you agree that DNA-based event specific
methods would consistently possess the ability to uniquely identify a product?
Dr Nutti
218. As I pointed out in my answer I am not an expert in detection methods. I tried to collect all
the information for this. I am not sure if DNA event-specific methods possess the ability to uniquely
identify a product, because you can have two events w ith the same trait. I would like to ask other
people with more experience in the field of molecular characterization to help on that. Maybe
Dr Healy could help me.
Chairman
219. Would you like Dr Healy to take the floor?
European Communities
220. Yes, I want someone to comment on it.
Dr Healy
221. Thank you. I was also going to go back to the first question on the detection methods because
the ability to distinguish between products is going to depend on the type of the detection method and
the type of product. For example if you have DNA or protein-based detection methods but your
product is a highly refined oil that does not have DNA or protein present, then the ability of the
detection method is limited. If the product has the DNA or protein in it and it can be extracted then
the detection methods have that ability to dist inguish between authorized and non-authorized
products.
222. In terms of the second question: do the DNA ba sed event-specific methods consistently
identify a product? If the methods are event-specific then they do have the ability to identify products

providing that the DNA is present in the product a nd the DNA can be extracted from the product.
Thank you.
European Communities

223. Thank you Dr Healy. May I also put the thir d question to you because it is connected to the
second. Would you agree that other DNA based or protein based methods would not always possess
the ability to uniquely identify a product?
Dr Healy

224. Certainly if the DNA based method is using DNA sequences or primers that are common to a
number of products then the ability to detect will not be unique. That is also true for the protein based
methods. For example, if your protein based methods relate to the detection of something like the Bt
protein and it is an antibody based method then of course your antibody is going to detect Bt
regardless of the product assuming that the protein is present and extractable.
European Communities

225. Thank you Dr Healy. I think we can move onto the questions on molecular characterization.
We would like to put this question to Dr Snape. Dr Snape, if there is not exact correspondence
between the description of the GM in the dossier and a complete sequence based characterization
could these effectively mean that the dossier does not describe the GM accurately?
Dr Snape

226. I was not specifically asked to comment on qu estion 9 because I will dealing with specific
products questions 12, 16, 18, and 25. I am happy to answer that question if the Chairman wishes me
to do so. Also in the question I wouldn't necessar ily use the word accurate in terms of describing
molecular characterization. I think a more appropria te word would be "complete" or "sufficient" in
terms of the molecular characterization. Molecu lar characterization is necessary because it indicates
the number and the complexity of the transgenic insertions. Therefore it is necessary to know the
complexity of the locus, the flanking transgen e sequences and also the presence of any backbone
sequences since this can determine target and non-target effects of the transgene.
European Communities

227. So Dr Snape, you objected to the use of the wo rd accurately and replaced it by a complete or
sufficient manner. If we replace it by this do you agree with the question?
Dr Snape
228. Yes, I think it has to be based on a product-by-product characterization. And are you
referring to oilseed rape Falcon in respect to this question?
European Communities
229. It's a general question.

Dr Snape

230. In a general question then yes. You have to ha ve a description that is complete and sufficient
to describe the target and non-target effects of the transgene.
European Communities
231. If the sequence does not correspond to the data in the dossier is the risk assessment valid in
your opinion?
Dr Snape
232. It depends on the type because we need to cons ider this on a case-by-case basis in terms of
the transgene and its non-target effects. The like lihood of any non-target effects of the transgene
could affect the safety assessment if it is not complete and sufficient.
European Communities
233. Thank you. Probably or maybe we will come back to this tomorrow in the product-specific
questions. Another question on molecular characteri zation: Is it possible that a detailed molecular
characterization could predict an unintended effect that would not be detected in the absence of
detailed sequence characterization?
Dr Snape
234. Yes, because unless you understand the complex ity of the locus you cannot predict its total
effects. For example if the locus is complex th en it is possible to have interspersed genomic
sequences which might have an effect which you couldn't predict from not knowing the sequence.
European Communities
235. Thank you. Since this was very clear and complete we might just skip to question 3.
Dr Andow, could you explain how this debate relates to unintended environmental effects.
Dr Andow
236. I think I described that fairly thoroughly in my response to question 9. Was there something
specific that you wanted to follow up on with respect to that?
European Communities
237. No we just wanted you to summarize or give in bullet points what can be the unintended
environmental effects.
Dr Andow
238. Again, I would refer you to the written record in the event that I leave something out here.
The characterization of the genotype is important because it allows prediction of phenotype. If we
have the information on genotype we can make pred ictions about what the expected phenotype is.
When we can predict the expected physical char acteristics of a product a number of things go from
unexpected to expected and this indicates what we should look for. We need to have good

descriptions of the phenotype in order to character ize exactly how the phenotype could be exposed to
the non-target species. That would be a non-target e ffect. With respect to resistance issues we need
to know enough information about the expression patte rns in order to determine how the organisms
that could become resistant to the transgene product would be subject to selection. Those are the two
major pieces relating to actual environmental effects.
European Communities

239. Thank you. The last question on molecular ch aracterization goes to Dr Healy. Could a
complete sequencing of the transformed and inserte d sequence have been done with application of
standard molecular techniques in 1995?
Dr Healy
240. The short answer is yes. Certainly by that stage the qualification would be around the rapidity
with which sequencing could be d one. By that stage we were starting to see automated sequencing
and the introduction of polymerase chain reaction. These types of techniques were starting to
accelerate the ability to sequence. But even without those techniques the sequences could have been
chained out and sequenced more traditionally.
European Communities
241. Dr Snape, would you agree with this?
Dr Snape
242. Yes, with the caveat that some of the tec hnology for getting at flanking sequences were not
available in 1995.
European Communities
243. Thank you Dr Snape, we would like to move to question 111. It is part of the general
questions. These are questions relating to approach es to safety assessment. We have a few questions
for Dr Nutti. In case of incomplete molecular ch aracterization could a whole food feeding study
provide assurance of no adverse unintended effects?
Dr Nutti
244. Usually one study complements the other. We need the molecular characterization and the
others. If one is incomplete you need to get the information through another means.
European Communities

245. Thank you Dr Nutti. Is targeted compositional analysis enough to completely preclude
unintended effects?
Dr Nutti
246. It depends. For instance under CODEX guidelines we have the compositional analysis for the
first step, but we never stop the analysis after onl y completing compositional analysis. We continue
with the 90 days study, with the protein study, the oral toxicity study, and at least one animal study.

European Communities

247. Thank you. Third question: Do you believe that feed safety, animal health, plant health and
environmental safety or other environmental impacts are fully covered by the approach that are in
paragraphs 128-133 of the US supplementary rebu ttal submission and that you supported in your
reply to question 111?
Dr Nutti
248. My reply to 111 was related to food and feed safe ty and not to ecological or other impacts. I
made that very clear in my answer.
European Communities
249. Thank you for confirming. Our last question is: are simulated gastric fluid studies for
purified proteins a true model for in vivo digestion given that Bt toxin has been detected in animal
faeces?
Dr Nutti
250. Again, we never use only one model. We would not rely only on the gastric fluid study. This
is one of the tests that you are going to use but it is not the only one. You need to have different tests.
European Communities
251. Thank you Dr Nutti,. We are going back to HT crop questions and I will hand over to my
colleague Mr Flett.
Mr Flett
252. We would like to ask Dr Squire our ques tion 11. What information do we have from
European or Japanese studies th at oilseed rape can be spilled and can become established along a
transport route? Could you tell us a little bit about that please?
Dr Squire
253. Yes, this happens visibly in many parts of Eu rope. There have been three major, almost
parallel, studies in Europe: in northern Germany, centr al France and in parts of Scotland. The results
of these studies mostly agree that spillage occurs frequently, that plants along roadsides and field
margins can become established and that they can pe rsist for several years. In many cases they may
disappear but grow back from buried seed. They ev entually die out but they keep being replenished
by new seed. To my knowledge the longest establishe d record of a population in one spot is about 10
or 12 years. They are becoming quite well established in some areas. These three studies, with
supporting work from Denmark and elsewhere in Germ any, confirm this phenomenon. They differ to
some extent from studies around motorways in the s outh of England which is a different environment
and probably not one that is as rele vant to agriculture. The interesting point is in how these three
studies differ. In particular the one in central France shows a much higher density of wayside, or
feral, populations than the one in Scotland. Th ere are uncertainties relating to why some persist
longer than others and why they persist at a differe nt density. They can exchange genes with crops.
They can also hold genes from crops for some time . But they are a fairly small pollen source
compared to the crops themselves.

Mr Flett

254. Thank you. Next we have a question for Dr Snow. Question 12. Could you tell us from your
experiences in Europe what do you think the impact of GM herbicide tolerant oilseed rape will have
on the management of conventional oilseed rape?
Dr Snow
255. Could you clarify what you mean when you say the management of conventional oilseed
rape? Are you referring to problems with labelling and thresholds or possibly weed problems?
Mr Flett
256. Thresholds and weeds.
Dr Snow
257. Both? If you are thinking about the thresholds that would be established in terms of labelling,
it would be very difficult to conti nue to grow conventional oilseed ra pe side by side with herbicide
tolerant rape because of all the gene flow issues that we have discussed with pollen movement and
seed movement and seeds persisting in the soil and the types of crop rotations that would be needed.
It makes it difficult to grow a non-GM crop in the sa me region. It could be grown in some other
region. That has to do with thresholds and labe lling. Otherwise the management of conventional
oilseed rape may not be that much affected by GM herbicide tolerant oilseed rape. I could imagine
that if the gene moved into a weedy relative th at would become a common problem where that
herbicide was used but it doesn't s eem like a large problem in the short term. That is why I was a
little confused about this question. Maybe Dr Squire could elaborate on that if you are ready for him?
Dr Squire
258. Yes. Our direct experience is fairly recent a nd it follows GM field trials in the UK. This
experience coupled with general know ledge of gene flow and persis tence in the environment would
indicate that growing conventional or non-GM in a field would be difficult if there was a need to keep
it to a threshold of 0.9 per cent because of the pers istence of volunteers. It is feasible under our
present calculations to grow it in separate fiel ds where one was always GM and the other non-GM
with reasonable aggregation in a region. Farmers w ould need to cooperate to concentrate GM in one
area and conventional in another. That is the curre nt thinking in the UK. The biggest defect is the
time effect that would make rotations impracticab le if you were growing GM and non-GM in the
same holding sequentially.
Mr Flett
259. Thank you. So I do understand from your answer that when it comes to controlling GM rape
and related weeds in a conventional oilseed rape e nvironment that that could well induce changes in
the herbicide regime previously operated in that environment. Is that understanding correct?
Dr Squire
260. It is possible, but the biggest effect would be that the farmer wouldn't be able to sell the
conventional rape under present regula tions if it contained GM above the threshold. It would depend
upon how the regulations developed. I suspect the desire to achieve that if it was essential to do so,

(i.e. a GM field going to non-GM) would mean probabl y more stringent controls for broadleaf weeds,
including the oilseed rape, than were implemented at present. But that is one of several possibilities.
Mr Flett

261. Thank you very much.
Mr White
262. Chairman, we are thinking of asking several follow-up questions on the basis of what was
said this morning, but I think they are not yet sufficien tly in a collate form. Perhaps it is better if we
can ask those questions later on and move on to issue one if you wish.
Chairman
263. You would have three more minutes. But now we will go to the complainants for short
follow-up questions taking a maximum 30 minutes altogether. Then the Panel will ask their questions
and we will see how time goes. Perhaps we can get you a small slot for follow-up as well. Would the
complainants like to ask follow-up questions in an y order from what was said this morning by the
experts and what was now said by the EC on general issues. Argentina you have the floor.
Argentina
264. Thank you. We had a time limitation this morn ing and also a misunderstanding on regarding
protocol. There are a couple of questions we woul d like to ask which we didn't have the opportunity
to ask this morning. Three of them are in our opi nion very important for the Panel. Three of them
refer to Dr Andow's response for th e translators. Our question 10 will refer to paragraph 03.13 in
Dr Andow's answer. It is question 7 in the original.
Chairman
265. Dr Andow you have the floor on the original question 7.
Dr Andow
266. To clarify is this the question with reference to paragraph 03.05.
Chairman
267. It is question 7, referring to paragraph 03.13.
Dr Andow

268. My argument is based on my close examination of many of the papers that were submitted in
the original materials and also resubmitted recently by Canada. There is a series of papers, perhaps
five or six, in the Proceedings of the National Academy of Sciences, USA on monarch butterflies.
There are also some recent papers in the last year in, I think, Environmental Entomology, by Dively et
al. and Anderson et al. In my examination of those papers I note there is an incomplete analysis of
event 176. The analyses of event MON 810 and Bt 11 will stand the test of scrutiny. Even if you add
an analysis of the variance asso ciated with the primary parameter estimates there is just not enough
exposure and enough toxicity associated with the polle n of those events to change that conclusion.

But I do believe that if one were actually to carry through the calculations that are published in those
papers on event 176, and carry them out with respect to the new information (Dively et al and
Anderson et al. ), one would have a potential effect on mona rchs that would be significantly larger
than is claimed for MON 810 and Bt 11.
Argentina

269. In other words, you are not using the information established but you are anticipating research
results that would be obtained in the future?
Dr Andow
270. No. I am looking at the results that they pub lished in those studies. They simply did not
analyse the event 176 problem as thoroughly as they analysed the MON 810.
Argentina
271. Anyway, you have an opinion on that uncompleted study.
Dr Andow
272. Based on the data that they published in those pape rs, the analysis that they did was for the Bt
11 and Mon 810 events. They didn't carry through a si milar analysis on the event 176. They made a
similar conclusion for event 176 but if you look at the paper, the analysis of the event 176 is
incomplete. I am not using anticipatory information.
Argentina
273. I asked this question because I find in many of the questions, you often use expressions like
"may be exposed", "no solid evidence", "opens the po ssibility that", "a possible hazard". For instance
the conclusion points in 3.13 say "has been id entified as a potential risk, however, it cannot be
concluded that an actual non-target risk of Bt maiz e or Bt cotton has been fully characterized". You
first talk about possible hazards that have been iden tified, potential risks that are evident, and at the
end you say it cannot be concluded that an actual risk . I find it difficult to understand the logic of this
kind of statement.
Dr Andow
274. I will apologize for the lack of clarity here. I have probably confused things by introducing
the term hazard when the question was really associat ed with adverse effect. I think that the data
suggest that there are possible adverse effects identifie d. That is to say that there is some endpoint
that could be evaluated that would be considered to be adverse. When I say that potential risks are
evident I am referring particularly to the Chrysoperla study. I am also referring to my judgement
about event 176, that we just discussed, as potentia l non-target risks, rather than saying actual non-
target risks. I probably should have just said the risk has not been fully characterized. In other words,
the exact amount of exposure and the probability that the adverse effect would occur have not been
fully characterized for those two issues.
Argentina
275. Are you aware that 176 is phased out. Are you aware of that?

Dr Andow

276. It is phased out in the US because it no longer has a registration. My understanding is it is
still planted in Europe.
Argentina
277. Ok, going back to the questions. I am now refe rring to the response in 7.12 about the scale
situation. My question is the 14th question which was advanced as question 11.
Dr Andow
278. I believe I answered this question in response to Canada or the US this morning. To
summarize, any large-scale (magnitude) environmenta l impact due to the large scale use of these Bt
crops in part of the US and other parts of the worl d is very unlikely. However, unless we have some
way of looking for smaller scale (magnitude) effects we cannot make the same conclusion. I cannot
agree completely with your statement but I can agree with it in part.
Argentina
279. Next, we would like to look at number 13, whic h is question 10 in the advanced document.
When you say that the absence of information does not imply the absence of effect, as a scientist,
could you see the opposite statement - like the absence of information does not imply the presence of
effects?
Dr Andow
280. Certainly that would be true. Usually though the conclusion has been that there is no effect.
So I was guarding more against that mistake than the other. But yes you are right it would be also a
mistake if you have no evidence to assume there is an effect.
Argentina
281. Can I make a very quick remark on one of the questions to Dr Nutti. The EC said that there is
a phenomenon observed that HGT marker genes transfe rred from plants to bacteria. The papers that
were quoted were papers by Simonet et al. I would like to clarify to the Panel that these experiments
were made without treated bacteria prepared to eliminate the possibility of recombination. The strains
used were strains prepared especially to be recombinant for analogous DNA sequences coming from
the plant. If you do that, obviously you will find recombination because there is a forced
phenomenon. But I don't know of any other recent evid ence that gene transfer from plant to bacteria
occurs under natural conditions with natural bacteria.
Dr Nutti

282. As I said in response to EC questions, I didn't kn ow this paper. I didn't have the chance to
read it, so I cannot judge anything about that. In the papers I listed there was no evidence of the
transfer.
Chairman
283. US. You have 10 minutes. Sorry there is a point of order. EC?

European Communities

284. Just to put on record, Mr Chairman, that what Argentina said just then was not a question. It
was a comment. A scientific statement, a statemen t with which we disagree. We are sure we will
have an opportunity to explain the science at some other point in time. It was not something which is
coming from the expert but scientific opinion coming from Argentina. We are also in a position to
give you scientific opinions from our side and trust that we will have an opportunity to do so later on.
Chairman

285. The Argentine delegation did announce it as a co mment on a statement made this morning.
For more comments we will have ample time on Monday and Tuesday. US you have the floor.
United States
286. We have one follow-up question. We were all put in a difficult position on this question,
which refers to a paper that was included on a CD that I received on Monday or Tuesday. We
actually printed out over lunch two papers and took a quick look at them. Dr Flamm from the Food
and Drug Administration will have a follow-up question.
United States (Dr Flamm)

287. This is to Dr Nutti. We r ecognize that you have not had the chance to read the studies of
Simonet et al. on DNA transfer from transgenic plants to microbes in the soil, but we would like to
ask a follow-up question nevertheless. Given the ex isting widespread resistance in soil microbes to
the antibiotics at issue and their relatively limite d clinical utility, would studies showing potential
transfer of plant DNA to soil microbes in the enviro nment affect your conclusions in general answer
1?
Chairman
288. Dr Nutti before you answer this material was submitted after the time fixed for submission
and you have not had a chance to see. So you may or may not answer the question as you wish.
Dr Nutti
289. I was able to answer the question according to th e papers that I read. I cannot give any other
comment on that because I did not have the chance of reading this paper. The papers that I saw and
listed showed that there is not a possibility of this transfer.
United States

290. I just want to thank Dr Nutti. We've finished our follow-up questions for now. Thank you.
Canada
291. Thank you. We have several follow-up questi ons. One for Dr Squire in relation to EC
question No. 11. What information do we have fro m EC or Japanese studies that oilseed rape can be
spilled and established along transport routes? You indicated that there were three studies. Could you
clarify whether these studies involved the transporta tion of oilseed rape seeds from the field to the

processing plant or whether these studies involved the importation of seeds to processing facilities
located in port areas?
Dr Squire

292. It was very largely transportation within an agricultural region to grain silos or plants or
between farms: it is essentially transfer of a harv ested product from fields around the countryside. In
one case there was transfer to a port but that was transf er of harvested seed to a port area. These were
the three main studies I mentioned. The oilseed rape came mainly from recently harvested seed
within the country.
Canada
293. Yes, thank you. Second question in relation to EC question No. 12 to Dr Snow and
Dr Squire. This relates to the broader issue of coexistence and agronomic practice issues or changes
in the use of herbicides. If you could clarify whet her the impact is primarily an impact because of co-
existence issues or whether the impact relates to ch anges in agricultural practice because of a greater
incidence of weeds for instance.
Dr Snow
294. I think we could address each of those independently. There is definitely a threshold issue as
we both discussed. I think the confusion may be re lated to what are the other effects of introducing
herbicide tolerant canola into a region where you are growing conventional canola and how that might
affect the weeds. I had a hard time with that ques tion. If you start growing herbicide tolerant canola,
in a region that hadn't been using it, then the onl y impact would be that those herbicides would not
work on the volunteers that come up from that crop or on any related weeds that spread from that
crop. I am confused about what direct impact there would be on the local production of conventional
canola other than the threshold issues.
Dr Squire
295. I would support that. The main issue would be if a threshold of GM in non-GM was imposed
then that would be the most difficult thing to handl e. There would be a change in the way oilseed
rape was managed in those fields that grew GM but it would not be a massive change. It would be a
change in herbicide type and use, but it wouldn't be a massive change. The most difficult issue is
coexistence.
Canada

296. Yes, thank you. Just one last question to Dr Healy. This question follows up on the European
questions related to molecular characterization. The question is a variation of question 22 found in
Canada's list of questions. Would you agree that mol ecular characterization is one tool to inform the
risk assessment and that the risk assessment also c onsiders a wide range of other elements such as the
generation of agronomic data, nutrient, anti-nut rient and other compositional analysis, amino-
chemistry of the expressed protein, the nature of the expressed protein including any allergenicity and
toxicity issues? In light of all of the other elemen ts included in the risk assessment to what extent can
a risk assessment be considered to be an accura te and sufficient, to use Dr Snape's words,
characterization of the product?

Dr Healy

297. I would agree that molecular characterization is one tool that you would use in a risk
assessment or safety assessment. I am restricting my comments to the food context where I am more
familiar. The CODEX principles and guidelines docum ents clearly talk about incorporating a number
of elements into a safety assessment, including molecu lar characterization, analysis of the protein or
substances from the genes that have been introdu ced, and a compositional analysis. The extent to
which the molecular characterization becomes important is a little bit dependent upon what you might
find in that molecular characterization. It also is dependent upon the extent of the information
available from the other sources. I find it hard to be quantitative about it but it's certainly a judgement
about the quality of the studies undertaken from each of those steps and also the type of information
that is revealed from some of those steps.
Chairman

298. EC you have a point of order.
European Communities
299. Chairman, the EC is very pleased that Argen tina and the US are waking up to the scientific
evidence that we put on the record on 28 January when we referred to the studies by a group of
scientists led by Simonet. We referred to those studies as I said on 28 January and we were not aware
that only scientific literature and articles that are actually produced and copied to the Panel can be
taken into consideration as scientific evidence. We assume that at least in respect of published works
and unpublished works where the source is given, si mply a citation would be sufficient. So this
evidence has been on the table since 28 January. It is only now over lunch that the US has decided to
go and look it up. To get to my point of order, could you please c onfirm that it is only scientific
literature that has been submitted to the Panel in some form or another that can be taken into
consideration?
Chairman
300. On this very point do the other parties wish to make a comment? On the assumption that only
material submitted to the Panel in time is now before the Panel and the experts?
European Communities
301. It is not so much a question of time. To put the problem squarely on the table for you.
Argentina and US have not provided you with copies of the scientific literature to which they have
referred. Canada has done so and then made the obj ection that some of the literature to which we
were referring had not been provided as exhibits to the Panel. Some people say we have provided a
lot of information late but we consid er it to be voluntary provision of information to the Panel. If this
is inadmissible then so are all of the arguments of Argentina and US when they have not provided
copies of the literature to which they refer.
Chairman
302. This would be the Chair's understanding but I give the US the floor for comment.

United States

303. First of all, the 2004 study that we are talki ng about was unpublished. The issue is what's
before the experts and what the experts can be expect ed to look at. I don't th ink we expect, when an
expert cites a study, that the experts can provide a copy of that document. But the parties normally do
provide copies of their documents when they expect people to look at them. If the EC is missing
some document that they believe we have cited we will be happy to provide it.
Canada
304. Thank you Mr Chairman. Our concern is well-know n we expressed it in the letter. Certainly
we feel that at a minimum, if materials are to be taken into account by the experts, those materials
should be made available prior to the meeting. As for the larger question as to whether materials not
submitted as exhibits should be ta ken into account I think we would want to reserve on that for now.
Thank you.
United States
305. First of all let me say that we recognize that organizing and managing this meeting has posed
and will continue to pose a number of challenges to you and to the Panel. We want to thank you for
your efforts and assure you of our continuing support as this goes forward. I think there are two
separate questions. One is how the Panel should or ganize this meeting and take advantage of its
rights under Article 13 to obtain evidence it needs from experts. The question of how that is
organized and what information the experts have and whether it is on paper or not are entirely
separate questions from the question of what it is the Panel should take into account in writing its final
report. To the extent the EC is pressing that latter point I would suggest that that is not something we
should take time with today or tomorrow. Should they wish to press it again on Monday or Tuesday
we would be happy to revert to it then. Thank you.
Chairman

306. Whatever is in front of the experts in time for them to reasonably look at and upon which they
wish to comment, is before the Panel and is part of these proceedings for this expert hearings. As for
the question on what material is before the Panel without the experts we can revert to that on the
substantive meeting on Monday and Tuesday.
307. Now while I have the floor I would like to stra ighten out one thing with regard to this
question of time management. As you know all the questions were formulated with the consultation
and consent of all parties. To my knowledge there is not one of those for which now there is no time
for the experts to comment, which were at that time rejected for inclusio n in our questionnaire.
Secondly, the format for this two day meeting has been agreed also in consultation with the parties.
We have agreed on spending two days on this part of the process of the Panel work so we need to stay
on track. In other words, time limitations will continue to be applied by the Chair. We now move to
the next stage which is the Panel's questions. We have a number of follow-up questions. Point of
order only.
European Communities
308. Just to remind you Chairman, we said earlier on th at we were in the process of finalizing our
follow-up questions and it wouldn't take very long. Just before we leave the general issues we would
like to complete our questioning with some follow-up questions.

Chairman

309. Yes, and you will remember I said that you might get a chance after the Panel has its chance
so we will stick to that. The questions from the Pane l were given to the parties and to the experts this
morning. I will not read them out for purposes of saving time but I will ask the experts to try to
respond on the questions that were either asked to them specifically or to the experts in general. We
have three general issues addressed to anyone and th en we have some questions addressed to some of
the experts. Who would like to start on the ge neral issues questions and we take 30 minutes for the
whole two pages. Dr Snow?
Dr Snow
310. I will comment on biogeochemical cycle, what that is and how it might be relevant. The
biogeochemical cycle refers to the cycling of nutrients and carbon in any type of ecosystem including
a farmer's field. People are asking questions about whether the biotech crop might affect nutrients
that come out of the dead materials from the crop and are recycled into the soil. It could affect soil
fertility and things like that and or the rate at wh ich nutrients are cycled locally. Biogeochemical is
nutrients and carbon cycling in the form of organic matter and then coming back to their original
components in an ecosystem. People have been ask ing whether there is some GM product that would
interfere with this process and cause some bad conse quence that we need to know about. We haven't
really addressed it very much and I avoid it because I don't know of any problems that I could
identify. I have been hearing from a lot of people who study soil processes, but basically the variation
within agriculture in the way the so il is treated is so great and so extreme that the impact of a biotech
crop compared to a non-biotech crop would be insignificant. There are differences among crops and
agricultural practices but the effects of the biotech product would not be that great. People are asking
me these questions and that is my sense of the consensus, but it is outside my area of expertise.
Chairman

311. Who would like to come in on nptII that is question 2?
Dr Snape
312. NptII is a gene which confers resistance to the antibiotics kanamycin and neomycin. This is
used as a marker gene to select transformed cells and therefore to produce your genetically modified
plant.
Chairman
313. Who would like to answer the third question on the vector backbone?
Dr Snape
314. To introduce the target gene into the transforme d plant, it is necessary to put this DNA into a
piece of bacterial DNA, termed a plasmid, and the pl asmid is inserted into the cells. Sometimes the
vector backbone, that is sequences outside of the re gion that contains the transgene, are or can be
transferred into the genetically modified plant. Bo th of these issues relate to safety issues concerning
the use of antibiotic resistance genes present in the transformed plant.

Chairman

315. Unless any other expert disagrees I will ask Dr Snow to continue with the question 4.
Argentina?
Argentina
316. Two questions. For a backbone of plasmid or ba cteria to be expressed in a plant two very
stringent conditions should be met. One is that th e backbone should have an operating frame with an
appropriate promoter. The other one is that the governed usage of the backbone should be similar or
coincident with the plant's usage.
Chairman
317. Is there disagreement among our experts?
Dr Snape
318. No I think the issue is not so much about the expression in the plant but the possibilities that
these could be transferred to other bacteria in the soil or in the gut bacteria when these products are
eaten.
Chairman
319. We move to the next question. I see the EC wants to take the floor.
European Communities
320. Since Argentina is busy adding to the advice to the Panel in relation to the general issues we
also would have a follow-up comment or question on one of these issues which are probably more
convenient to take now.
321. Chairman, this is related to the biogeochemical cycles so we address it to Dr Snow. There is
new evidence that Bt crop decompose slower than conventional counterparts. I am referring to a
study that was published in soil biology and biochemistry in 2005 it is by Floris and Stotzky. Is that
kind of evidence relevant for biogeochemical cycling?
Chairman

322. Sorry, it is an unpublished study. I would not want to go into details about it.
Dr Andow
323. I don't mind saying that I don't think it's a big issue whether it decomposes more slowly or
not, because this is a reversible problem. If it turns out to be a big problem people could stop planting
that.
Chairman

324. Ok, we move to question 4. Who of the five experts would like to comment on Dr Snow's
comments?

Dr Squire

325. This is an outcome of some of the repeated requests for information and responses. What we
need for each of these issues is some indication of when we are almost there when is a reasonable
level of certainty achieved. This is often a two way issue. It requires consensus almost before a
product is discussed concerning what constitutes ade quate safety. I don't think on the environmental
side of things we have that agreement. We may ha ve it in other areas. I suspect that when we have
satisfied our need to know then we are there. Defi ning what we need to know is really quite difficult
to do.
Chairman

326. Question 5. Who would like to comment on Dr Andow's statement?
Dr Squire
327. The standard for what was an appropriate envi ronmental risk is not static. I think it has
evolved because we know more about the issues to do with GM cropping and wider issues. The
ecological environmental standards have certainly changed over that period. I would endorse his
statement.
Chairman
328. Thank you. I am being reminded we must turn off our microphones at the end of statements.
It reduces the quality for the interpreters. Dr Squire you have broken the ice on 4. Break the ice on
6 and 7.
Dr Andow
329. The unintended consequences that Dr Snow refe rs to are abnormal growth and development
which are typically evaluated during the agronomic evaluation of any crop. Such traits are unlikely to
have effects that are ecologically significant. As I pointed out in another answer, we begin with the
introduction of genetic variation and then seek to develop a variety with good agronomic
characteristics. This development of the good variet y will eliminate traits that are of poor agronomic
character. These issues Dr Snow is particularly referring to are ones that with poor agronomic
character. Those would be eliminated. Therefore I would agree with that statement.
Chairman

330. Thank you. Would you like to continue with question 7?
Dr Andow
331. This is where there may be a slight difference and this is where my points about the scale of
use coming into play. While I think I would agree with Dr Snow that it would be wrong to
characterize it as biotech versus non-biotech, certainly the scale of use of a crop would be very
important in determining whether or not there is influence on genetic diversity. In the cases that are in
front of us with respect to, say, the glyphosate resi stance trait itself, is quite advantageous to
production. So these crops have increased tremendous ly in scale of use. In the US perhaps their
production has increased faster than the production of any other agricultural technology.

Chairman

332. Thank you. Question 8 with three sub-questions. Who wants to have a go?
Dr Andow
333. I would say that it relates to my previous number five statement. I agree that absolutely safe
is not really the issue. However what is the benc hmark by which ecological safety can be judged? I
believe that that benchmark has been changing and that's what is making it so difficult In some
countries the benchmark has been changing, but ev aluations were continuing to be made. For
example in the US the benchmarks have been evol ving over the same period of time but the US has
been continuing to make decisions on products. Th at is partly because changes are being introduced
slowly over time. In contrast with respect to the benchmarks that we're referring to in the EU
regulations some of them have had to be worked out quite rapidly.
Chairman
334. Any other views. Replica from Dr Squire?
Dr Squire
335. What I was getting at here was that it is not impossible to envisage a set of criteria that
defines what a soil ought to do to keep it operating properly and what a complex food web ought to do
to keep it operating properly, including the production of crops. My point was that so far those
criteria have not been agreed upon and univer sally established. Even though people do make
decisions very often, it is not against independent criteria.
Chairman

336. Thank you. Dr Nutti
Dr Nutti
337. I would like to comment on Item B of the EC's statement which also applies to food safety
concerns. For food safety, we have the CODEX gui deline which is a generally accepted standard. It
is different for environmental issues. Maybe we need a step by step gu ideline, like the CODEX
guideline, for environmental assessments. Even when we have the statement that no product can be
assessed as absolutely safe, we could at least try to say "as safe as when we were going to the food
safety assessment".
Chairman
338. Question 9 about healthy population. Would you, Dr Andow care to respond?
Dr Andow
339. I would agree with Dr Squire's point that ther e are no reference objective criteria. However I
am not sure I completely agree with his point that it is possible to develop those objective criteria at
this time. I think there are some criteria that can be established, but the debates relating to what it
means to be able to sustain agricu lture into the future are still relatively unresolved. Part of those

objective criteria would have to include some reco gnition that these are not yet resolved and it's not
clear when they would be resolvable.
Chairman

340. Would you agree Dr Squire?
Dr Squire
341. Yes, in principle I would agree with that. It's a very complex issue. I would also say that we
could make progress in some areas, if the scientific establishment set its mind to it. But I accept the
point that there are some very complex issues that will be very hard to resolve.
Dr Snow

342. This question relates back to the previous one about what the benchmark would be for
ecological safety. By talking about sustainable agricu lture we are getting into the academic issues. If
we think back to what regulators are facing when they need a benchmark it is usually a reference
which reflects what is accepted within that country as being health y enough for the environment. It
could be related to what that is trying to attain in terms of environmental harms and benefits. It's
important to distinguish what is an academic goal and what is practical in the present or especially
1998-2003. What were people thinking at the time?
Chairman
343. Questions 10 and 11 go to all experts on a first-come-first-served basis.
Dr Healy
344. I was actually going to ask for clarification, because the term up-coming evidence is not a
term with which I am familiar and seek clarification from perhaps the EC about what they intended by
that term?
European Communities
345. Chairman the up-coming evidence was a ne w molecular characterization which was
submitted into the dossier.
Chairman
346. Dr Healy? If you are not familiar with this te rm then may be you don't want to answer this
one.
Dr Healy
347. What I understand from the response is that upcom ing evidence is in this case referred to new
information that was inserted into the dossier for consideration. In that case, if information is
included in the dossier then of course it should be taken into account in the overall assessment of the
product.

Chairman

348. We will move to question 11. Dr Nutti?
Dr Nutti
349. My answer is related to this case. I believe that first of all we need to have the risk
assessment of the product without the herbicide use. We have the levels of the herbicide determined
by the FAO joint committees. We don't need to asses s the herbicides together. We need first to
assess the GMO and the non-GMO and then maybe if we still have doubts then go further to assess
the safety with the herbicide. This is what I pointed out in my answers also.
Chairman
350. Thank you. That seems to cover the subject. The next question goes to Dr Snape.
Dr Snape
351. This goes back to the answer that I gave to qu estion 3, insofar as the backbone is there for the
introduction of the DNA into the plant. There is a possibility of the introduction of antibiotic genes
that are used in maintaining th e transgene in the bacteria. The environmental and health safety
assessments relate to the transfer of these genes to gut or soil bacteria and the general concerns of
antibiotic resistance genes.
Chairman
352. Dr Healy. Question 13?
Dr Healy
353. In responding to question 9 I included this caveat that I was talking about safety assessments.
The reason for making that caveat was that the product-specific questions related to safety
assessments and question 9 related to risk assessments. I did not know whether there was an
intentional difference in the use of those terms. A conventional risk assessment in relation to foods
would be considered to have four steps: identification of the hazard, characterization of the hazard, an
assessment of the exposure to the hazard and then ultimately a risk characterization. A safety
assessment is essentially a modified form of a hazard identification. It is asking whether there is a
hazard associated with this product. The CODEX doc ument, the principles for risk analysis of foods
derived from modern biotechnology, has a definition which says: a safety assessment is characterized
by an assessment of a whole food, or a component th ereof, relative to the appropriate conventional
counterpart (a) taking into account both intended a nd unintended effects, (b) identifying new or
altered hazards, (c) identifying chan ges relative to human health in key nutrients. The intent of a
safety assessment is to identify, if there are any hazards over and above what you would see in the
conventional counterpart. If you do find hazards, they would then be subjected to a conventional risk
assessment.
Chairman

354. Thank you Dr Healy. Our last question goes to Dr Nutti. It is a very long one on toxic
allergens.

Dr Nutti

355. We use the CODEX guideline for the conduct of food safety assessment of food derived from
common DNA plants as a reference. According to th is guideline, when we assess possible toxicity, it
is clear that we need to treat toxins and allergen s in different way. For the assessment of the possible
toxicity the new substances we are assessing can be proteins, fats, carbohydrates, vitamins and new
metabolites but they are new substances. This is why we have to have the assessment of possible
toxicity. The assessment of the allergenicity sh ould be done separately because it has a special
procedure. In addition the possible allergens are always proteins and so we are free to use different
methods. This is why the CODEX guidelines treat alle rgens differently from the toxins and also why
the EC SCF distinguishes between toxins and allergens.
Chairman

356. Thank you. This covers the Panel's questions to the experts. Thank you very much for giving
us your replies. I will now re-open the window on follow-up questions and this until 4.40. The EC
you have the floor.
European Communities
357. Thank you Chairman. We have just a few follo w-up questions. Since it is topical and related
to what we've been discussing just now I wanted to ask a question briefly to Dr Snape. In view of the
fact that backbone DNA can affect the transformed plant in many ways, for example, increasing the
probability of unintended recombination and the creation of undesired open reading frames, do you
not agree that the presence of backbone DNA in a tr ansgenic plant is undesirable and that a detailed
molecular characterization is needed to determine its presence or absence?
Dr Snape
358. I am not aware of what evidence you are quoting to say that it increases recombination or that
it affects recombination. Perhaps you can enlighten me on that?
European Communities
359. It is the fact that bacterial DNA present in the genome facilitate s the copying of that genome
by other bacteria, and its integration into the DNA of other bacteria.
Dr Snape
360. I still don't understand your question.
European Communities
361. I think, I am going to ask Dr Kleter to explai n to you, because I am sure he can do it much
better than I can.
Dr Kleter
362. As you correctly noted this pertains to horizontal gene transfer.

Dr Snape

363. Horizontal transfer refers to the fact that th e backbone will have antibiotic resistance genes. I
am not sure how you think that affects recombination within the transgenic plant.
Dr Kleter
364. It is recombination with other bacterial sequences.
Dr Snape
365. This means that it would occur when this was eaten or coming into association with soil
bacteria not affecting recombination between the pl ant DNA. That I can't comment upon. This refers
to an environmental issue rather th an a molecular characterization issu e about the transfer of bacteria
of genes between transgenic plants and bacteria. I am not competent to answer that.
European Communities
366. Are any of the experts competent to answer that question? If not, I will move quickly to the
next follow-up question which is in fact a follow- up question to Dr Andow in relation to clarify the
Panel's question No. 6. The question is about th e unintended effects arising from the creation of
transgenic plants. The question of the Panel spoke specifically about effects such as abnormal growth
or development. Can there be ot her unintended effects than those mentioned? That is other than
growth and development, for example, long-term environmental effects? Dr Andow?
Dr Andow
367. Thank you. In theory, the short answer is yes. With respect to the products that were at issue
here, any long-term or indirect or unintended effects of these products are hypothetical. The only way
we would know, whether anything like that woul d happen, would be because we were looking for
something in particular. It creates a bit of a quandary in terms of how one actually does it, because
you have to look for something particular and know wh at you are looking for. Whatever monitoring
system you have has got be match the harmful effect. With respect to how one might manage an
effect associated with decomposition rates, all we know right now is that there could be differences in
decomposition rates. We still have not made the link to what could be the adverse effect from that
difference in decomposition rate. Changes in deco mposition rates could be changing biogeochemical
cycle, but we still have to specify and figure out what is the adverse affect associated with that.
European Communities

368. I would like to pose my next question to Dr Andow and Dr Squire. This is in the context of
risk management strategies for non-target effects a nd HT crops: How can the fact that small farms,
meaning farms that have less than 10 hectares whic h are frequent in the EU, obviously effect risk
management strategies for Bt and Ht crops.
Dr Andow
369. The risk, as I have made it clear, as established for both Bt and HT crops is that adverse target
pests can involve resistance either to the Bt plant or to the herbicide. I would rather talk about risk
management of something that I believe to be an actual risk rather than something that is a
hypothetical risk. I'll focus specifically on the Bt crops, because I have thought considerably more

about this in a small farm context: I believe wh en you have large farms you can argue that you can
internalise the cost of risk management and have individual farmers be responsible for it. When you
have smaller farms it may be more difficult to get acceptance to do that. So one approach that has
been suggested is to organize local communities to be able to manage risks. In countries such as those
in Europe that would seem to be a potentially f easible approach, depending on the farm size. I am
thinking of farms that are as small as a few hectares per field. It does become more difficult to figure
out how to do this in such a way that it is acceptable to the farmers themselves.
Dr Squire

370. I agree with that opinion. There are two issues: the management of the ecological effects
over a region and the management of coexistence. Both would need agreement and cooperation
among the farmers involved. This would be an additional thing to achieve beyond what many
communities in Europe presently achieve. They wo uld need to actively manage their region among
themselves. The effects on biodiversity or food webs would be less because there would be inherent
diversity in small farms anyway. The greatest difficulty would be managing coexistence. For
example, if a small farm did not want to grow or market GM crops, or vice versa and if that farm had
neighbours who did grow GM crops then there w ould be difficulties. If those crops were open
pollinated and left seed residues, farmers would have to organize their joint machinery in a certain
way. They would have to organize the proximity of flowering crops. The smaller the farm and the
more heterogeneous the farming community, then the more difficult it would be to accommodate
coexistence. It hasn't been done in Europe yet on any big scale.
European Communities
371. We have a question for Dr Healy regarding in the context of detection methods. Before the
establishment of the community reference laboratory on 18 April 2004, did there exist any body or
infrastructure capable of organizing and completing a high quality collaborative trial validation of a
quantitative events specific detection method in less than 12 months?
Dr Healy

372. I am not a developer of detection methods, so I cannot answer that with any accuracy. I
would note that the joint European laboratories in ISPRA have been organizing collaborative, world
wide, ring trials over some period of time. I woul d not be able to comment on whether those ring
trials occurred within less than 12 months though.
European Communities
373. Another question to you Dr Healy, relating to the comments you made to the Canadian
follow-up question. How can you test the safety of the new protein as part of the complete safety
assessment if, as had often happened with GM plants, some new proteins had not been identified in
the molecular characterization?
Dr Healy

374. Again, there is a totality of information approach that can be taken and is clearly outlined in
the CODEX process, whereby you would look at the mo lecular characterization, the properties of the
protein that you intended to insert and then the compositional changes. Of course the protein analysis,
the middle step that I have just referred to talks about the protein that you intended to insert. What the
molecular characterization can give you is identification of open reading frames which you may not

have known were present. Detecting an open reading frame doesn't necessarily mean that a protein is
going to be made.
375. The impact of those open reading frames is then the next question. The ability to determine
the impact of those open reading frames on human health is quite problematic. Nonetheless, the
examination, particularly of the compositional info rmation, is very important in giving you an
indicator of unintended effects which may be biologically important.
Chairman

376. Thank you. Now, as you know, we had foreseen to break at six and resume at six thirty but
there are two reasons why I want to suggest a little cha nge. One is that we need five minutes to work
out the new time allocation for issues 2 and 3. The other one is that the cafeteria downstairs closes at
5.30. I suggest that we take a break until five o clock so that you can refresh yourselves and come
back here at five sharp so that we can continue but then we will work through until we finish the
agenda for today. Thank you. [Pause.]
Chairman

377. We have worked out a timeframe for the issue 2. The proposal is that we would give the
complainants half an hour, that means 10 minutes each starting with the US this time in reverse order
and then Canada and Argentina, followed by the EC with half an hour, followed by the complainants
or the EC at the later stage with another half an hou r. That would take us to 6.45 for issue 2. We
have interpretation until 6 pm. The Argentinean de legation has courageously agreed to do without
interpretation after that. So we start with issue 2 and I give the floor to the US.
United States
378. Thank you Mr Chairman. We have no initial que stions and any questions we will ask in
follow up. Thank you.
Chairman
379. Thank you. Canada?
Canada
380. Thank you Mr Chairman. We have a series of questions in relation to the Panel's questions 59
and 60 to the experts. This relates to the safe guard measure adopted by France in relation to MS1
RF1 and this can be found under issue 2 on page 5 of Canada's questions starting at question 26.
381. I would just like to preface these questions with a statement that here we are talking about a
crop that has been modified to be resistant to glufosinate ammonium and not one that has been
resistant to glyphosate. I apologize if we have gone ove r some of this material earlier in the day. Is
there a distinction between the methods for controll ing glufosinate ammonium tolerant oilseed rape
derived through transgenesis compared to oilseed rape that is tolerant to the immis in terms of
controlling crop volunteers in subsequent years. Suppose you plant canola one year and the next year
you plant something else, but you have canola volunt eers. In scenario (a) these canola volunteers are
tolerant to glufosinate ammonium. In scenario (b ) the canola volunteers are tolerant to one of the
immis. Do the management practices of controlling the volunteers differ?

Dr Snow

382. I don't think there would be a difference. All my other qualifications are in what I have
written which is on record, but I don't think there is a difference here between these two.
Canada
383. Would there be a difference if the comparison was between the glufosinate ammonium
herbicide tolerant crops and conventional oilseed rape, conventional meani ng non-herbicide tolerant
oilseed rape. For example, in the field you are plan ting oilseed rape one year and the next year you
decide to plant beet.
Dr Snow

384. If you wanted to use the same herbicide on the subsequent crop and the volunteers are
resistant to that herbicide then the volunteers would be more difficult to manage.
Canada
385. What is the likelihood that you would use gl ufosinate ammonium as a means of controlling
volunteers in subsequent years?
Dr Snow
386. It may be quite low at the present time.
Canada
387. Which would be in comparison to glyphosate where you might use glyphosate to control
these volunteers?
Dr Snow
388. Correct.
Canada
389. Dr Squire would you have anything to add?
Dr Squire
390. No, I would agree with that statement. With the proviso that there has been very little
experimental comparison in Europe on that issue.
Canada
391. Thank you. The next question is for Dr A ndow. At paragraph 59.05 of his answers of
comments on the Panel questions he states that there may be years when certain fields of GMHT
oilseed rape are not harvested at all and the en tire crop goes to seed since this happens occasionally
with non-transgenic oilseed rape. Subsequent problems with Brassica weeds may require exceptional
agricultural practices to bring the field under contro l. Such possibilities were not considered by the

SCP and France may be concerned about such scenarios . In light of the fact that there are other
available management measures to control oilseed rape volunteers or weeds could you clarify your
statement here?
Dr Andow

392. There are other management practices for contro lling these things, but the issue with respect
to, for the example of controlling GMHT oilseed rape, rather than directly controlling them, one could
make sure that the management systems were in place to ensure that they would actually be controlled
in the way that we would want it to be controlle d. In other words, there may be a requirement,
incentives, or a management system that would n eed to be in place in order to accomplish that
particular piece. It is not in place for the conventional practice.
Canada
393. Perhaps we can just build on this point. If the non-herbicide tolerant oilseed rape was planted
in a field and the farmer let that field go to seed but then in subsequent years decided to plant beet or
they needed to clear the field, there are several options that are available. You could spray glyphosate
as a preseason burn off, you could till or you could us e phenoxy. This would be used in conventional
practice. How would this differ if the oilseed rape was tolerant to glufosinate ammonium?
Dr Andow
394. The specific herbicide and perhaps the way th e equipment used may not be different, but
needing to make sure that the farmer actually followed the management practices would be a new
requirement.
Canada
395. What would make you expect that the farm er wouldn't anticipate then that the canola
volunteers would be tolerant to glufosinate ammonium and then just not use that herbicide, but use
something else like glyphosate or till. Isn't this something that farmers do all the time?.
Dr Andow
396. The reason I brought up the going to seed part was that there is a lot more seed that enters the
seed pool so then there is a longer term process that is involved in terms of the management.
Certainly a farmer may know that these seeds will be coming up, but depending on the crop that is
going in it may be difficult to control the oilseed ra pe. It could end up restricting the management
options. If they have to control the glufosinate ammonium oilseed rape for these purposes that may
come at a cost. Then the farmer will adjust by changing their management practices and it might not
result in the suppression of the particular GMHT oilseed rape in a way that prevents the movement of
the gene out to other areas.
Canada

397. If you are not using the glyphosate ammonium to clean the fields of weeds, why would this
matter?

Dr Andow

398. It's a question as to whether or not the oil seed rape would be sufficiently controlled.
Controlling it to reduce competition is one level, but controlling it sufficiently to minimize the
potential adverse environmental impacts associated with GMHT crops is likely entail a different
threshold of control. A farmer may be willing to tolerate more in their field, because they always
have dealt with volunteers and there is some level of tolerance of volunteers. They are not eliminating
all of them, they are eliminating enough to have economic control from the perspective of the
subsequent crop production.
Canada
399. And would your acceptance level of weeds within your field be the same regardless of
whether you are growing HT or glufosinate ammonium tolerant and regular canola?
Dr Andow
400. The farmer's acceptance level probably would be the same, but the point would be that with
the conventional weeds or the conventional volunteers the concern about gene flow from that field to
other fields is not an issue, whereas the gene flow from the GMHT fields may occur at densities lower
than the economic thresholds that merit the control by the herbicide. If there are many volunteers that
next year, meaning they are not back to some economically insignificant level, but are still at a high
population density, these other issues could arise.
Canada
401. When you say that there may be an issue with gene flow can you just explain why the
conventional farmer would not be worried about gene flow, whereas the GMHT farmer would be
worried about gene flow? Is this the coexistence issue?
Dr Andow
402. That is the one that most immediately comes to mind.
Canada
403. Thank you. Those are all of our questions for the safeguard measures issue no. 2.
Chairman
404. Thank you Canada and the experts. Argentina you have the floor.
Argentina
405. Concerning the second issue I will ask a few qu estions from our long questions. My first
question, number 16 in our questionnaire, refers to the paragraph 69.09 which was advanced as
question 13. It concerns Bt-176 maize in Austria. The question has to do with exposure to toxin in
the field as compared with spray or the presence of the Bt producing bacteria. Dr Andow?

Dr Andow

406. You want to know if the resistance risk in th is case with 176 is potentially higher or lower
than the resistance risk associated with another insecticide. I understood the Panel's question to mean:
is there any reason to believe that there is scientif ic evidence that would not permit it (the EC) to
undertake the appropriate assessment? And in consid ering that, I was not convinced that the relative
risk of resistance compared to any other insectic ide was necessarily relevant to answering that
particular question.
Argentina

407. So you don't agree with the report that was in your answer that "a Colorado potato beetle
population 100-fold resistant to a Cry3A- containing B. thuringiensis spray could not survive on
potato plants expressing the same protein"?
Dr Andow
408. One would have to say that European corn borers that express 60 to 74 resistance can't
survive on Bt maize either but that doesn't necessarily mean that ther e isn't anything that will become
resistant. For example, colleagues have found colonies of potato beetles that could survive on the
potato that you are referring to. We have not yet found any colonies of European corn borer that can
survive any of the transgenic Bt crops at this time. We do not yet have any evidence of resistance in
any European corn borer population that we have b een able to bring into the lab. Now we have
colonies with several hundred fold resistance in the laboratory and none of them can survive on the Bt
plants. It suggests that the amount of resistance that has to be in the insect is probably on the order of
a thousand fold or even higher levels before we can expect to see resistance.
Argentina

409. Were you talking about the special levels of the Bt toxin in the plant or the continuity of the
expression of the Bt toxin in the plant?
Dr Andow
410. I am not really referring to either. I am referring to the susceptibility in the target insect itself.
We measure the susceptibility in the target insect and conduct laboratory bioassay associated with the
toxin. Then we find how resistant it is. We put it on the transgenic plant and even those with quite
high levels of tolerance to toxin in the laboratory cannot survive on the plant.
Argentina
411. How does this compare with the chemical insecticides?
Dr Andow
412. I am not convinced that that comparison is relevant to this question.
Argentina
413. But what is the alternative under current agronomic practices?

Dr Andow

414. In the US, about 12 per cent of the maize is sp rayed with an insecticide for European corn
borers. Essentially current agricultural practices do not spray at all.
Argentina
415. My second question is number 19 referring to 69.11 point (b) and was advanced as
question 16. Did the committee address the issue of resistance as an environmental risk. My
contention is that if the committee addressed the environmental related issues like toxin presence
persistence in soil effects on agricultural prac tices they were really addressing the issue of
environmental effects.
Dr Andow
416. The committee considered some aspects of environmental risk but not the totality.
Argentina
417. I wonder if it is possible to consider all environmental effects, even effects that we don't know
about today.
Dr Andow
418. At the time I particularly referenced my comment to things that were known to be of concern
at the time the committee made their evaluation. Th ey did not consider the totality of environmental
risks that were known to be of concern at that time.
Argentina
419. Our next question is 21(a) referring to paragra ph 69.14, part 1 in your answer, and was also
advanced as our question 18(a). This question re fers to the new knowledge about transformation,
which you claim would be reason for the EC to postpone this issue. As science evolves continuously,
we can say that any decision could be postponed indefinitely because new knowledge will come out
and will require the revision of previous decisions.
Dr Andow
420. In comments on the experts from some of the othe r parties there is recognition that these were
possibilities that Austria could have made at that tim e but they did not make these points. They could
have made these points at that time but they did not make these points. Because the question was: is
there any information before the Panel that would indicate at that time that the evidence associated
with Austria was not sufficient for them to make a decision. Tthis was evidence in front of the Panel
that we received. It is information that was availabl e at that time. They could have used it, but they
didn't.
Argentina
421. Any evidence means evidence obtained after the decision of the committee?

Dr Andow

422. I took the timeframe to be at the time Austri a made their decision, which was February of
1997. Then there was another decision that was made in 2003, I believe. Those were the two
timeframes I was looking at.
Argentina
423. [blank from face 8]… modify whatever deci sion the committee has recommended to take.
Dr Andow
424. I don't think I can answer that specific question in terms of what the committee would do.
Argentina
425. Dr Andow I am asking this question to you.
Dr Andow
426. For event 176 the point is that there was some information that has become available.
Unfortunately this is not information before the Pa nel because event 176 is not one of the cases. But
sufficient information (for Event 176) has become available to say that: had Austria made the request
they could have gotten the information and they probably would have been satisfied with the
information on the molecular characterization. Fo r example with maize, because they said in the
initial reports that there were only so many insertio ns and had they done the additional work to fully
establish that, they would have been able to prove that there were only those many insertions and no
other silent ones. Then they would have been able to continue.
Argentina
427. So in your opinion, after the decision of the committee, any evidence on molecular
characterization would have required the revision of the decision.
Dr Andow
428. My point is summarized in 69.16, which is in 1997. I judged the information that was in front
of Austria to be insufficient, but by 2003 there remained some uncertainti es. They probably could
have had the information to make a decision by 2003, had they pursued those uncertainties.
Argentina
429. They didn't have the information in 1997?
Dr Andow
430. That is my point.

Argentina

431. The last question is 20 with reference to 69.12, which was submitted as advanced question 17.
It considers answers to the paragraph 69.06 and it concerns three points, the beta-lactamase (BLA)
gene, the Cry1Ab toxin, and if there is an environm ental risk for targeting insects with resistance that
would require resistance management measures. Was there evidence for point 1 to be disregarded as
a risk? Is there evidence of low or high probability of Bt entomotoxins to be toxic to other non-target
organisms. Since the development of resistance is an essential phenomenon in evolution - so it is
something that is expected to occur - it is also managed by the strategies like the high-dose/refugia
strategy. Did these three reasons support Austria's decision to ban commercialization of Bt event?
Dr Andow
432. In my response I did not consider point no. 1 about the BLA gene. I concentrated my
response to the points concerning non-target risks and the resistance for Cry1Ab toxin. My opinion is
that they didn't consider all of the non-target risks that were available, that were of concern at that
time. I will just refer you to my comments, because I think that they are clearer on these points than
anything I can say at this time.
Argentina
433. So resistance was known to be an environmen tal possibility. How can Austria raise this
point, when it is a natural evolutionary process and there are some means to avoid this risk?
Dr Andow
434. In terms of the resistance risk - and this is quoting then from the SCI scientific committee
document - the scientific committee did believe that resistance risks were not environmental risks.
They didn't consider it to be under their purview. Despite this they still made a recommendation that
resistance management should be considered. This is quite different from a recommendation based on
what they consider to be their remit on which they could have based a requirement for resistance
management.
Chairman
435. Last question from Argentina? Thank you. The EC.
European Communities
436. Thank you Mr Chairman. The first question is a slightly more general question. Then we
have briefly some more specific questions on th e safeguard measures picking up specific points in
relation to specific safeguard measures. The first question for Dr Snape and Dr Andow, although may
be Dr Squire would also like to comment, is about the issue of molecular characterization. We would
like to invite the experts to answer the following question: given the absence of a complete molecular
characterization in the periods preceding the adop tion of the Members' safeguard measures and the
consequent need for Member States with speci fic concerns to pose further questions, are you
supportive of today's generally more stringent requirements regarding molecular characterization?
437. We very much appreciated the experts' atten tion to placing their advice on these matters in
temporal contexts. We should not forget that we are looking at the science at that time. And also that

the experts have by and large taken care, notwithstanding the leading questions on occasion put by the
complainants, to limit themselves to scientific issues and not to legal issues which are for next week
Dr Snape

438. I wouldn't necessarily describe them as more stringe nt but I would make the point that I think
a complete characterization helps everyone in the risk assessment process of GM crops.
Characterization should take into account three levels of molecular characterization. The first is the
transgenic locus complexity, which refers to the intended effects of the transformation, in terms of the
copy number, in terms of the sequence and organiza tion of the transgene insertion. The second is the
information on flanking sequences, which can refer to unintended effects of the transformation. This
refers to gene disruption and unintended effects or proteins that might be expressed or might be absent
that could have unintended effects. The third is the presence of any possible backbone sequences
which again can influence the risk assessment process.
European Communities

439. I understand that you are supportive of the more current arrangements?
Dr Snape
440. I am believe that a complete characterizati on helps everyone in assessing what the transgenic
is doing.
European Communities
441. Thank you. I wonder if Dr Andow would also like to comment on that?
Dr Andow
442. Nothing more.
European Communities
443. Dr Squire, do you agree?
Dr Squire
444. In my written responses I commented that for so me ecological assessment you didn't need to
know in detail the full sequence. I don't want this to be misinterpreted. I agree with what Dr Snape
has said. But for certain kinds of ecological asse ssment, for example, the comparison of herbicide
tolerant crops with conventional, the design of th e experiment, the detailed running of it, the things
that you measure, the target organisms that you look at - all that can be done without detailed
knowledge of the entire transgene. Other aspects of characterization such as for example gene flow,
the kinds of segregants that are in the populations following gene flow, would need fuller
characterization. For a completely detailed knowle dge of what the transgene might be and do then
you would need sort of detail that Dr Snape has spoken about.

European Communities

445. Thank you. Our next question, number 24, rela tes specifically to the provisional measure put
in place by France in relation to MS1 RF1. It is just a question to Dr Snow at least in the first place.
You conclude in your advice to the Panel at page 21 that France had a valid reason to follow the
advice of its biomolecular engineering committee, of course at the time, to carry out more research to
supplement existing scientific know ledge and validate methods fo r managing the cultivation of
genetically modified oilseed rape. Now in your opinion and taking into account the specific climate
and agricultural structures in France: do you think that the estimated extent of gene flow and the need
for an agreed design for a monitoring programme we re areas that could reasonably have been the
subject of further research?
Dr Snow

446. Yes. I explained that in my written documents, but the reasons for my conclusion are that the
scientific committee on plants had identified concerns about the spread of herbicide resistance to
volunteer weeds and that they had underestimated the extent of gene flow. So back in 1998 one of the
quotes that I have in my document here about the ex tent of gene flow was that it was unlikely to
happen. Basically the hybrids that would be fo rmed would have low viability and the transgene
would not spread. That was back in 1998. Between 1998 and 2003 a lot more information was
coming out about where the genes would move and how rapidly. If France wanted to monitor this
process, you could argue that they had valid reas ons for getting more research because it was still
coming out at the time. This research included farm scale evaluations published in 2003 and an
article that I cite showing the extent of contamin ation of non-GM seed by GM seed. There are just a
lot of questions that France had at that time.
European Communities
447. Thank you. It would be correct, presumably, to say that in relation to the large populations of
Brassica Rapa in France as well as in other regions in the community; but at the time there was an
open question of what one would do in terms of ma nagement in the event that such plants became
HT?
Dr Snow
448. Yes. I agree.
European Communities
449. We move onto the next safeguard measure in relation to oilseed rape Topas 19/2. Here there
were provisional measures adopted by France and Greece. We wanted to clarify this point but I think
it has already been clarified by Dr Nutti that she did not intend to provide the Panel with advice in
relation to the environmental issues in relation to these two provisional measures.
Dr Nutti
450. When I was reading these questions, I looked for the food safety issues. When I answered on
question 63, I was looking at the documents about the food safety. I don't want to talk about
environmental issues, as this is not my expertise. I checked all the documents that were submitted to
the Panel. I may have misunderstood because I thought that I was supposed to check all the
documents, as well as the opinion of the scientific committee. This is why I checked the documents,

but I am not an expert on environmental issues. I stated that there were no reasons related specifically
to food safety.
European Communities

451. Thank you, Dr Nutti for that helpful clarification. I think that brings us to the next product
which is maize Bt 176. Here again there were some provisional measures adopted by Austria,
Germany and Luxembourg. The question is to Dr Andow. In your advice to the Panel on page 94
you conclude that when Austria adopted its safegua rd measures the evidence on risks to non-target
organisms was insufficient for the conduct of a full ri sk assessment at least for Austria. On this point
we take note of Dr Andow's observation that the questi on refers to the information before the Panel. I
think this is really touching on a legal issue which is for next week. For the time being Dr Andow has
correctly, in our view, offered scientific advice on the basis of the information that was essentially in
the public domain at a time when Austria for example adopted these measures as well as the other
Member States. And the question is: could you brie fly recap for us what considerations support your
conclusion regarding non-target organisms and Austria?
Dr Andow
452. Yes, I could recap. But in the interest of time I will simply refer again to my text and again
with some apologies to Argentina for not being clear on certain words. I would say my conclusions
would stand even if I were to respond fully to those comments.
European Communities
453. Thank you very much. I think we can move directly to question 31 since I think question 30
has already been the subject of some discussion this morning. This is in relation to maize T25 and the
provisional measures adopted by Austria and Italy a nd the question is to Dr Andow. Is it your view
that secondary ecological effects need to be assessed for each member state under regionally
appropriate conditions?
Dr Andow
454. This is certainly a difficult question from a scientif ic perspective. It is clear from one level
that one needs to identify and evaluate things under regionally appropriate conditions. But what is not
resolved scientifically is what is the appropriate re gion? For example in some work that I have done
associated with the Bt maize in Kenya we can id entify different cropping re gions within Kenya.
Some of the risks seem to be associated with these specific regions and others probably are specific
more to all of East Africa. I doubt that one could get it down to the individual cantons of Switzerland,
but there certainly is an issue associated with this. I would say that there is no consensus as to how
much regional specificity is needed. Even if you ge t down to all of North America it is still not clear
how much transfers from North America to Europe and how much is specific.
European Communities
455. Thank you. So if I understand your answer correctly it would be appropriate and even
unsurprising for an authority considering whether or not to go forward with a definitive decision on
authorization or whether provisionally to pose fu rther questions or look for conduct of further
research to take those kinds of issues into account , depending of course on the region for which that
authority was responsible.

Dr Andow

456. Yes. I raised issues associated with butterfli es and the Bt maize. There was a recent paper
that I referred to in which butterflies were of c onservation concern and identified as being associated
with maize. I believe it was in Hungary or some part of eastern Europe. When we are dealing with
issues of conversation concern there is likely to be some specificity because most species of
conservation concern don't have a very large geogra phic range. I bring that up merely to emphasize
that there were such issues I guess at the same time - what I didn't emphasize is that this issue comes
up around 1998. A logical approach would be to compile a list of all the known species of
conversation concern and start to do some research to determine which ones were associated with
maize and knowing that this sort of evaluation would be necessary.
European Communities
457. Thank you. I wonder if any of the experts disagree with Dr Andow's comments. Otherwise
we will move directly to our final question. In that case, our final question on the provisional
measures adopted by the Member States relates to maize MON809, where a provisional measure was
adopted by Italy. The question is to Dr Nutti in the first place: would you agree with the Italian
competent authority that the term substantial equivalence involves a significant degree of ambiguity
and as a scientist, do you think such ambiguity woul d have consequences for the conduct of a risk
assessment?
Dr Nutti

458. As I wrote in my written comments, I do not agree with the opinion of the Italian competent
authorities, because this was defi ned in the FAO, WHO expert co nsultations in 1996, 2000, 2001 and
Codex Alimentarius. You say that the consultati on talked about concerns about the substantial
equivalence. I would like to read a little bit of th is paragraph of the conclusions, if it is possible.
"The consultation was of the view that there were presently no alternative strategies that would
provide a better assurance of safety of genetically modified foods than their appropriate use of the
concept of the substantial equivale nce. Nevertheless it was agreed th at some aspects of the steps of
the status assessment process could be refined to keep abreast of developments in genetic
modification technology. The concept of the subs tantial equivalence was developed as a practical
modification technology approach to the safety assessmen t of genetically modified food. It should be
seen as a key step in the safety assess ment process although it is not a safety assessment in itself." So
I would like to emphasize that it's a tool. It is a ke y step, it is not the complete safety assessment. In
your comments you always pointed out that this consultation was not in agreement but, in fact, it was.
Chairman
459. Dr Nutti can you tell us at what step this pro cedure stands if it is a Codex document you are
referring to?
Dr Nutti
460. This is in the consultation phase and also in the Codex Commission. But the consultation was
earlier. When the EC refers to the consultations th ey only refer to a paper of Millstone that was
complaining about the substantial equivalent. They never refer to the conclusions of the
consultations. The conclusions of the consultations were also important, because we had discussed all
the papers that were presented for three days. The conclusions were that we needed to use the
substantial equivalence as a first step, and after that we should go to other tests that are needed.

European Communities

461. Thank you very much for that clarification. Of course we need to look at everything which
has been said, all of the information, even if it is di vergent. We just wanted to clarify the relationship
between some of the conclusions and some of the statements in the paragraphs leading to those
conclusions. We were particularly struck by the statement on page 64 of your advice to the Panel.
The first phrase of the penultimate paragraph where you say: "I do agree with the opinion of the
Italian competent authority regarding the ambiguity of the term substantial equivalence and we just
wanted to clarify."
Dr Nutti

462. I do not agree. If you look at the other comment s you see that I wrote in previous responses
that I do not agree.. May be in this one I forgot to add the "not". But I do not agree.
European Communities
463. That is important. So we may understand that as a typographical error and we should have
the word not. It should read "I do not agree" rather than "I agree".
Dr Nutti
464. English is not my first language and I checked the answers a lot before sending but sometimes
I did have some typos.
Chairman
465. Do I take it the EC has come to the end of its questions and follow-up questions?
European Communities
466. Mr Chairman we have certainly finished for the time being our questions and I suspect that
we may have exhausted our follow- up questions. But I would just like to have a few moments as the
proceedings progress to consult with my colleagues in order to make sure that is indeed the case. But
I don't want to stop the proceedings progressing in the meantime.
Chairman
467. While we wait for your answer on the eventual follow-up questions I will now go back to the
complainants to see whether they have follow-up ques tions. Then you will get another chance. So I
turn to the complainants for the po ssibility to ask follow-up questions on issue 2 and to the experts.
Canada?
Canada
468. I'd first like to clarify with Dr Andow your discussion regarding secondary ecological effects
and the necessity to create an inventory of poten tially affected species. Are you referring to the
possible effects on these very species as a result of Bt maize?

Dr Andow

469. In the context of my previous answer with respect to Bt maize, yes.
Canada
470. The maize T25, which is the maize that was s ubject to the Austrian safeguard measure, was
actually a maize that was tolerant to glufosinate am monium and not to Bt. So in that way I wonder
whether that affects your response?
Dr Andow
471. Yes it would. I think the question, as it was posed to me, it was listed by the EC under maize
T25. I did not understand their question to be restrict ed to maize T25. That is why I expanded in that
way. I would have to consult again with my an swers particularly for maize T25 before I could
provide you with a response.
Canada
472. That's fine. I have a question for Dr Healy. Is it possible to do a molecular characterization
for a product that had been derived through either mu tagenesis or any other form of plant breeding?
My second question is: is it not true that molecula r characterization or the requirement to provide
molecular characterization is in part a function of th e fact that this information can be generated, and
that as technology progresses, the extent to whic h the detail that is required in a molecular
characterization, will likely increase?
Dr Healy
473. Can I just ask that you repeat the first question?
Canada
474. Is it possible to do a molecular characterizati on for products that had been developed through
mutagenesis or any other form of plant breeding?
Dr Healy
475. It may be possible in certain circumstances, partic ularly for the trait that has been looked at.
If the gene for the trait has been identified, then it will be possible. What it probably will not be
possible to do is a molecular analysis of the whole genome and of course when you're doing
mutagenesis, you're going to have random DNA breaka ges or other changes to the DNA at a range of
sites. This contrasts to the situation with GM where you are often able to identify those and any
additional sites or the sites for insertion. This type of specific identification is not necessarily possible
with mutagenesis. To summarize, it would be possi ble to do part of the molecular characterization
but it may not be possible to do a whole molecular characterization.
Dr Snape

476. Could I supplement in fact that some of the he rbicide resistance genes, for example some of
the immis resistance genes generated by mutagenesis, have been in fact sequenced. The nature of the

changes have been demonstrated. So it is possibl e. It is happening where you have a major mutant
gene that is cloned and sequenced and the changes described.
Dr Healy

477. The second question then which relates to whether other requirements for molecular
characterization increase as the capab ility increases. I think that's probably true. Certainly the
changes in the technology have been highly significant over the last decade, over the last five to eight
years. So that sequencing ability has improved certa inly in terms of the speed and a whole range of
other techniques have come into play. The re quirements have increased as the technology has
changed and one is able to get a much more complete characterization of the molecular
characterization of genes and of the surrounding regions then previously was possible.
478. Sometimes there is a difficulty in interpreti ng what those changes mean in a biological
context. Sometimes you can see what's happened at the molecular level but the understanding the
impact of any changes at that molecular level in te rms of its biological impact and in terms of health
impact is less developed.
Canada

479. If one was concerned about the possible health effects of a plant that has been developed
through mutagenesis, given the fact that it's not possible in some cases to do a complete molecular
characterization, would it nonetheless still be possible to conduct a risk assessment on that particular
food?
Dr Healy
480. Yes indeed. I guess we have the evidence th at many of our crops have been developed
through mutagenesis type techniques, have been su ccessfully released into the environment and have
successfully entered our food supply.
Canada
481. Just one last question for Dr Snow. You have indicated that France had concerns regarding
gene flow to Brassica rapa. Why would the gene flow to Brassica rapa matter if the trait or the gene
conferring tolerance to the herbicide is conferring to lerance to a herbicide that is not used in the
control of Brassica rapa weeds? Here we talking about glufosinate ammonium. If glufosinate
ammonium is not used to control Brassica rapa weeds, why would there be a concern about the
transfer of this gene to weedy Brassica rapa?
Dr Snow
482. In framing my answer I was looking exactly through what France's concerns. I don't know if
that was even one of the major concerns. It isn't mentioned but they speak of contamination and then
in EC 161 attachment 4 they talk about, I am quoting from my page 23,: "the main undesirable
effects of this herbicide tolerant oilseed rape would be agronomic and commercial". They namely
want more research on gene flow. You are asking wh at are the consequences of gene flow and why
would they be worried about Brassica rapa? I don't know enough about the frequency of Brassica
rapa in France and whether there is a concern that it might increase in frequency the more glufosinate
ammonium is used, and whether this would be an a dvantage to a weed that is maybe minor right now.

I don't know enough about the current and future herbic ide use in France to be able to answer your
question.
Canada

483. Thank you.
Chairman

484. I'll go back to the EC.
European Communities
485. We have one follow-up question. We have been listening to discussion of molecular
characterization. I think it is uncontroversial th at the technology was developing very rapidly even
accelerating at the time. If you find yourself operating in an area where you need to look at dozens of
different complex areas, so that you need different ex perts for different fields, and you know that the
science is developing very rapidly or even accelerati ng in one or more of those areas, are there any of
the experts here, who think that it would be inappropria te or irrelevant for an authorizing authority to
take that circumstance into account when consid ering whether or not the time was right for a
definitive yes or no on authorization. From a purely scientific point of view, is it relevant as a
scientist, if you find yourself in that kind of environment? Would anybody disagree with the
proposition that it was appropriate to take the fact that the science was dynamic into account? I
suppose not, but I'll put the question. Thank you.
Chairman

486. I am not sure these are questions for scientists, but if anyone wishes to go on the ice you are
free.
Argentina
487. May I? Thank you Mr Chairman. I would say the progress of science is such that if we
consider everything that may be known in the fu ture as a reason to disbelieve current science, we
would be paralyzed. If we were revising all th is information every two months, we would be
paralyzed by the progress of science. In this situatio n, progress, the very thing that science is for, is
used as a justification not to move forward. I don' t think we can justify not taking a decision in order
to wait for something new to appear that could support or not support any decision that we might have
taken today. It's a philosophical question. I don't think I will agree with that.
Chairman
488. I will not qualify the question anymore, but I suggest we wait for Monday until we continue
this particular discussion. The Panel has one follo w up question on its own. Basically to Dr Squire
and Dr Andow. In terms of the EC's questions on the need for complete molecular characterization in
order to fully analyse transgenes, when was this need for comp lete molecular characterization
identified and when was the necessary technology av ailable to undertake this complete molecular
characterization for the specific products at issue?

Dr Squire

489. The answer is difficult to give. Dr Snape w ould be better (or Dr Healy) to answer the
question precisely when because knowledge has increased so rapidly on this particular topic. The
question of whether it is essential is a rea lly complex question. Without full molecular
characterization a lot can still be done in the way of assessing and developing experiments on
ecological and environmental risk. You can still do a lot if you know something. And again, you will
probably be able to get a better assessment the more you know. As an example, one very interesting
aspect of some of the herbicide-tolerant varieties is the range of progeny that you get, because they
are constructed from a number of different source s. If you take something like the glufosinate
ammonium oilseed rape, you get nine different typ es of progeny from crossing, because of various
number of copies and combinations of male sterility and male fertility which come out. Now, if you
did not know that, and did not know what was behi nd it, you would not be able to formulate very
clear hypotheses about that particular issue. But you could still look at the issue of the effect of
herbicide-tolerance on the ecosystem. The more yo u know about molecular characterization the more
you can do to assess the benefits and potential harms of the product. My answer can't be definitive. I
will defer to others on the issue of when it became available.
Chairman
490. Dr Andow, then Dr Snape.
Dr Andow
491. I will address it primarily from the context of the environmental risk. In that area I would say
that in 1992 it was technically feasible to sequence a transgene in a plant. However, it was difficult to
do. In my role as Advisor to the USDA Secretary of Agriculture I heard multiple testimonies saying
that "while it was technically feasible it was not practically feasible to implement in a regulatory
context in 1992". By the year 2000 I was invol ved in a committee with the National Research
Council at which point the discussion was more about whether, since it was technically feasible, it
should be a regulatory requirement. Improvements in technical capacity affected how we were
viewing environmental risks, and that in turn affected the regulatory context.
Chairman

492. Thank you. Dr Snape?
Dr Snape
493. I think it's been technically possible for some ti me, since before 2000, to look at the stability
and the inheritance and the sequence of a transgene insertion in a crop plant. In terms of flanking
sequences, I think, the technology is still developi ng. That is possible but it's still a developing
technology.
Chairman

494. Do I see Argentina with a follow up question?

Argentina

495. I would agree with Dr Snape, when he says that molecular characterization is something that
is evolving very rapidly. It may not be availa ble in a practical way in 1992, like Dr Andow was
saying. But in Argentina molecular characterization has been a regulatory requirement since 1998. In
1991, when we developed the first regulatory system for GMOs in Argentina, we asked about the
complete genetic authorization of the insert. A fe w years afterwards, we were requiring the complete
sequence, and also the flanking sequences. We require the applicant to analyse the nucleotide
sequence against the amino acid sequences of databanks of toxins and allergens. I think that this
technology has been available from at least from 1995 or 1996. I would imagine that any developer
of GM crops would be doing this molecular character ization very early in the development of the GM
crop. Because if he happens to find any sequence wh ich has some homology with toxins or allergens,
I don't think he would spend more money going ahead with the development. If they find any
homology, a complete sequence characterization from the beginning would be necessary.
Chairman

496. Thank you, Argentina. I believe this brings us now to the end of issue number two. I suggest
we break for five minutes and then we start with issue number three. [Pause]
497. Complainants will have a maximum of 30 minut es to ask questions, followed by an equal
maximum amount of time for the EC, followed by an equal maximum of 30 minutes of follow up
question from the complainants. Who, from the complainants, would like to start? Canada?
Canada
498. Thank you, Mr Chairman. My first question is for Dr Andow. I am now reading from page
six of Canada's questions under issue three, a nd its paragraph 30. Under question 102. Is
mutagenesis also a process to introduce genetic variation?
Dr Andow
499. The answer is, yes.
Canada
500. I wonder if you could just briefly describe what mutagenesis is, or the techniques involved in
mutagenesis.
Dr Andow
501. There are lots of different techniques to do this , but the overall idea is to use a technique to
introduce a mutation in the genome, in this case of the plant.
Canada
502. Through the use of either chemical mutagens or gamma rays or x-rays. Is it true that you
have a series of seeds, you shoot them with gamma rays or x-rays and then you plant them to
determine whether or not the seeds have either surv ived or display or present the phenotype that you
are looking for? Is that a rough description of the process.

Dr Andow

503. I will grant you that rough description, yes.
Canada
504. Rather unscientific, I know.
Dr Andow
505. It's a good rough description of the process. It is not always seeds. It is not always how you
actually do the screening. Of course it's quite complicated.
Canada
506. You indicate that insertional mutagenesis is another outcome of transgenesis that is new to
breeding. And then you later state – at paragr aph 102.11 of your report – that the magnitude of
insertional mutagenesis, introduced by transgenesis, is higher than th at introduced by recombination
of adapted material. Perhaps you could describe what adapted material is.
Dr Andow
507. By adapted material I mean ma terial that has already been selected for use for agronomic
purposes.
Canada
508. When you say that the magnitude of inserti onal mutagenesis is higher than that of
recombination of adapted material, are you implying then that insertional mutagenesis can occur with
the recombination of adapted material? Corn, for example.
Dr Andow
509. We are increasingly more aware of the complexity of normal recombination. So, I guess, I
would have to say, yes, it is possible.
Canada
510. So it is possible. If it is possible then, how can insertional mutagenesis, as an outcome of
transgenesis, be considered a new risk, if it is possible with the recombination of adapted material.
Dr Andow
511. I knew you were heading there.
Canada
512. Sorry, I was trying to be a little bit more oblique.

Dr Andow

513. You are implying that it is inappropriate to say th at the whole idea is absolutely new. But I
would say that the frequency of insertional mutagen esis would be higher, which is newly considered
for transgenesis.
Canada
514. You state that the magnitude of open readi ng frames (ORFs) introduced by transgenesis may
be higher than deliberate or spontaneous mutation in cell culture, although this is not certain. Is there
any scientific evidence to suggest that the magn itude of open reading frames is any greater for
transgenesis than for mutagenesis.
Dr Andow
515. That, I am not prepared to say one way or the other.
Canada
516. So, you are not aware of any scientific evidence, or, the scientific evidence is inconclusive or
there are no studies, or..?
Dr Andow
517. I would say I am not able to answer your question.
Canada
518. Okay. I wonder if one of the other experts would be able to answer that question.
Dr Snape
519. I am sorry, I don't understand what is meant by magnitude of open reading frame. I don't
know that that refers to anything I am familiar with.
Dr Andow
520. I was referring to the rate of induction.
Canada
521. I could rephrase the question as: is there scientific evidence to suggest that the likelihood or
possibility of open reading frames is any greater for transgenesis than for mutagenesis? Dr Snape?
Dr Snape
522. It depends on the type of mutagenesis, because mutagenesis isn't one type of process. It
depends on the mutagene that you use. If you use x-rays or gamma rays you tend to induce deletions,
which tend to be knock-outs in terms of gene f unction. Whereas, if you use chemical mutagenesis
you generally tend to create base substitutions an d therefore you create novel proteins by base-
substitution and changes in amino acid sequence.

Canada

523. Then how does that effect then the likelihood or possibility of open reading frames?
Dr Snape
524. Transgenesis would be form of mutagenesis similar to deletion mutagenesis, because it
generally tends to be knocking out the function of a pr otein rather than creating a new type of protein,
depending on the type of construct you put in, a nd whether it is a promoter-less construct or a
promoter on its own that will actually stimulate the expression of a gene that's possibly silent.
Canada
525. Would the likelihood be the same?
Dr Snape
526. It is difficult to say because it's comparing apples and pears.
Canada
527. Now I think we a getting to metaphors we can all understand. Is the possibility of having a
gene silenced or disrupted any greater or any less in the context of mutagenesis.
Dr Snape
528. That would depend on the construct that is used for the insertional mutagenesis.
Canada
529. But it is possible that there are some forms of mutagenesis that may lead to a greater
likelihood of open reading frames.
Dr Snape
530. I can't comment. I don't have the data for that.
Canada
531. I'll move on to the next question. This is for Dr Healy or Dr Snape orDr Andow. Is it true
that all eukaryotic cells, that is cells that ha ve a nucleus, possess non-transcribed putative ORFs?
These cells contain nucleotide sequences which appear to be ORFs but are not transcribed in the
messenger RNA. That's the first question.
Dr Snape
532. Yes.

Canada

533. Thank you. Is it also true that eukaryotic cells routinely produce transitory and unstable
messenger RNA that is not translated into a protein.
Dr Snape
534. Yes.
Canada
535. From a safety perspective, would you agree that the important issue is not so much the
presence of an open reading frame but whether these are transcribed and translated into a protein -
whether they affect the phenotype?
Dr Snape
536. They don't necessarily have to be transcribed into a protein to have a regulatory effect on the
genome.
Canada
537. Could you elaborate on that? Would you agree from a safety perspective that the important
issue is not so much the presence of the open reading frame but the effect that that open reading frame
has, either in the production of a protein or the regulation of the plant metabolism.
Dr Snape
538. Yes, whether a gene works or doesn't work would affect whether or not it has an effect.
Canada
539. Dr Andow, you state that unanticipated effects could arise from a transgene by any of the
following mechanisms, and you state that there is a whole series of possible sources of unanticipated
effects. I won't read. If any of these unanticipated effects result in a serious disruption to the plants
metabolism, would they be expected to present themselves in the phenotype, for example in
agronomic performance, or in compositional analysis. This question relates to unanticipated effects
that result in the serious disruption of the plants metabolism.
Dr Andow
540. I'm going to back up, since you did ask if I had a response to 33. Relating to that last part, it
may be not just related to the expression genetically. Really it has to do with whether or not the open
reading frame would result in any particular risk. One doesn't necessarily have to go to the trouble of
showing that it is expressed. You could just say "let 's presume it's expressed". We know that if it's
expressed it will have this type of protein structure and that kind of protein structure doesn't have any
allergenicity risk or any other food safety risk th at we can think of. Then we can avoid the whole
problem of determining whether or not there is e xpression of that gene worth examining, and do the
risk assessment directly from that information. It is important to realize that we don't have to go
through all those other steps necessarily. In some cases, it would be necessary. That's why I have

listed it as one possible source, because from a risk assessment perspective one doesn't necessarily
need all the molecular information.
541. Then again, you have limited the question to "serio us disruptions". It would have to be said
that such serious disruptions– if you define serious disruptions as ones that affected plant growth and
development - would be the kinds of serious disrupt ions that would be screened out in the selection
process. That's not to say that all changes that would occur, due to any of the effects, would be
serious disruptions.
Chairman

542. Argentina, you have the floor.
Argentina
543. Thank you, Mr Chairman. I have only three qu estions. The first one is to Dr Andow and
Dr Snow. It refers to Dr Squire's statement. Do they agree with Dr Squire's statement on question no.
103, when Dr Squire says "there is no reason to s uppose that biotech crops confer different degrees of
genetic impurity compared with crops produced from, say, induced mutagenesis"?
Dr Snow
544. Yes, I am going to go first, while he looks something up. Dr Squire, could you remind me
what you meant by impurity.
Dr Squire
545. Yes, there are about 20 lines there. In 103 what I was saying was that many crops have
impurities in them: we can ignore these in some cases, and in others we can ma nage them. I cite the
issue of high erucic (?) oilseed rape, for example. The potential of the crop to convey an impurity
isn't the same for all varieties. It differs dependi ng on a number of issues in its physiology and gene
flow. What I am saying is that the ability to confer impurity should not be affected by the GM-ness of
the plant, but it would be caused by other characteri stics. The only caveat is that, if a conventional
type of variety was contained with in another type, it might not be considered an impurity, whereas a
GM one might. It's the physiology of conferring that impurity that need not be different, depending
on the way the crop was developed.
Dr Snow
546. So you are referring to the uniformity of the seed source. If it is impure it includes other
seeds of unwanted types.
Dr Squire
547. Yes. The seed source and the seed yield. The seed that goes into the field and the seed that
comes out of the field.

Dr Snow

548. I would agree with that. We are talking about contamination and whether you are any more
likely to get contamination from a GM crop compared to a non-GM crop. Contamination is related to
gene flow, which is the same for all genes, no matter what kind of crop they come from.
Dr Andow
549. If the question is restricted to the issue of, say, th e rate of gene flow then yes, we will have to
agree that there is no difference. Except as you poin ted out earlier, if the GM crop has been modified
to have altered pollen viability or reproductive rates, then that certainly could affect it. The other
thing that I think you are raising here is related whether you have different goals associated with the
levels of contamination, which may change the si gnificance of that level of contamination. Seed
purity standards may be different in one case than another.
Argentina
550. Thank you for your answers. I would like, though, to say that I don't agree with impurity or
contamination wording. I would rather talk about advantageous presence, which is a better idea to
convey to the Panel, because of the pejorative value of the word "contamination".
551. My second question is to Dr Andow and Dr Squire , and refers to a statement by Dr Snow.
Dr Snow's statement was that another way to answer this question is to focus on the characteristics of
biotech products - the phenotypes - rather than th e male presence of transgene. This is more
appropriate if the goal is to avoid direct or indir ect harms to human, plants or animal health, or the
environment. This is Dr Snow's response to ques tion 103 . I would ask Dr Andow and Dr Squire if
they agree, or if they have observations to this statement?
Dr Squire
552. In the context of that original question, y es I agree, the issue is of contamination or
adventitious presence, or whatever, there's the pres ence and the effect, they have to be looked at
differently. Something might have a presence but no real effect. In the case of some GM crops, in
Europe, for example, that might be the case. The presence isn't wanted, even though there's no effect
of that GM in the yield known. In other case s, the presence may well be divorced from the actual
effect. I think you have to look at both or con centrate on one depending on the circumstances. In
relation to the overall question, in which Dr Snow talks about presence and effect, I agree, but maybe
qualify it with the fact that the concentration on presence and phenotype or effect might differ with
the particular question or particular circumstances.
Dr Andow

553. I would agree with Dr Squire and also add that , as I point out in my answer to question 103,
scale issues can also influence some of these concerns.
Argentina
554. This is to all experts. Does anyone have any information on experiments done with to
compare the turn-on of genes by micro array tec hniques, for instance, comparing GM crops versus
crops obtained by breeding?

Chairman

555. Can I ask the experts to indicate in their reply wh ether this material if before them, has been
given to them?
Argentina
556. No. It has not been given to them. It's a completely new question.
Chairman
557. Yes, I understand, but the experts should tell us whether the experiment, they are going to
refer to, has been on the table of this proceeding.
Argentina
558. I don't think so.
Dr Snape
559. I know of unpublished information but I don't know of any published information on either
using micro arrays or Massively Parallel Sequencing or SAGE techniques to look at and compare GM
with non-GM. There is unpublished information of a project in the UK from the Food Standards
Agency. It will be in the public domain hopefully later this year.
Chairman

560. Dr Snow.
Dr Snow
561. If you're wondering why this question is being asked, I think the reason is you're asking if
there might be more unanticipated effects from one type of breeding than another. The way you
would detect these is this new method called micro arrays. It's a way of getting at unanticipated
effects, but we don't have any good data on that . Several review committees like the National
Research Council have requested that more studies like that be done so we could answer that question.
We don't have any good answers.
Argentina

562. Thank you.
Chairman
563. I see six minutes to the credit of complainants, maybe Canada wants to have one more
question.

Canada

564. One question to all the experts: is there any reason to believe that the unanticipated effects
that could be produced through mutagenesis are any more likely than the unanticipated effects
produced through transgenesis or RDNA technology?
Dr Snape
565. I'm not aware of any data on this and so I'll ha ve to present an opinion. My view is that
transgenesis is introducing completely foreign DNA into the genome, whereas mutagenesis is not
introducing foreign DNA into the genome. It is either disrupting the DNA that's already there, or it's
creating base substitutions, which might occur natu rally in the process of evolution anyway. And
therefore I think that the processes are not directly comparable.
Canada
566. Would any of the other experts like to comment?
Dr Healy
567. I would agree that in transgenesis you may be introducing DNA from another organism.
That's not true in all cases, of course. In some cases you may be silencing a gene. In some cases you
may be transferring a gene from a different variety of a particular crop into another variety. It's not
always the case that you would be introducing no vel DNA. When you're thinking about whether
you're introducing novel DNA, another aspect that has to come into the consideration is the level of
similarity between genes across sp ecies. We know quite a lot about that now, with the various
sequencing projects. In my mind it's not as simple as saying it's from a different species. That's not
always the case and in some cases, certainly, the ge nes may be similar even if they are from different
species. It was certainly one of the concerns in the early days. We are starting now to get some
empirical experience with these kinds of changes. Some of those concerns were the basis for
proceeding slowly at the beginning. I might add th at the familiarity and empirical experience is the
basis for some of the approaches adopted with co nventional crops as well. There is an increasing
degree of familiarity at least in a subset of changes that have occurred within various crops.
Chairman
568. Thank you. Dr Nutti.
Dr Nutti
569. In Brazil the problem that we have is that crops that are obtained by mutagenesis are not
submitted to any food safety assessment at all. You can have rice that was bred from mutagenesis and
then it goes to the market without being submitted to any toxicological or any allergenicity testing.
When I answered these questions, on the perspective of food safety, my concern was that I think all
the new products should be assessed step-by-step and not only once.
Chairman
570. Thank you. One minute for Canada. Dr Andow ...

Dr Andow

571. I agree with that perspective. First Dr Snap e suggested that because a lot of mutagenesis is
introducing variation in a plant that has probably already been tried. It's not clear that that's true
because there is a significant amount of genetic vari ation in any organism. If you start to calculate
how many different individuals you'd have to evaluate to actually try them all, often times it ends up
that the number of genotypes that you'd have is more than the number of atoms in the universe. It's
really not possible to evaluate all possible genotypes. Part of my answer was emphasizing that there
is a scale issue here. For a crop like maize, mutagene sis is simply not used that much in conventional
plant breeding, whereas the transgenic techniques are used quite a bit.
Chairman
572. Thank you. I believe we now go to the EC for their questions on issue number 3.
European Communities
573. The scientific issues have been fully clarified. They were made clear in a general way earlier
on. We don't think it's necessary to ask those questi ons and we'd much prefer to use the time to go
away and properly prepare for tomorrow's meeting which we think will be very important.
Chairman

574. I open the floor for follow-up questions from the co mplainant's side, if there is a wish, since
we have not exhausted fully our allocated time. W ould anyone like to come back? This is not the
case. EC wants to come back.
European Communities

575. Just to say that since we don't ask any questions and the Panel hasn't asked any questions, we
thought that would mean that they're couldn't be any follow-up questions.
Chairman
576. I take note of your statement. Canada to one point.
Canada
577. Just two small follow-up questions. One related to the use of the term "contamination". Is
there any scientific justification for why the mi xture of biotech herbicide tolerant seeds with
conventional seeds is referred to as contamination while the admixture of HT seeds derived through
other forms of breeding, is not? Is contamination he re being used in a scientific manner or is it being
used more in a colloquial manner?
Chairman
578. Dr Squire.

Dr Squire

579. It's used variously in the UK. Adventitious presence, impurity, contamination. I get the
impression that people are not too politically correct. They use it generally. They would use it to
mean the unwanted presence of one thing in anothe r, whatever it was and however it got there and
whatever its type was. We don't use it as an emotiv e term or an anti-biotech term. I would say that
high oleic oilseed rape in non-high oleic oilseed ra pe, was contamination or impurity or adventitious
presence. It's not colloquial. It's a correct and usef ul description, if the party buying the oilseed rape,
or selling it, doesn't want that particular thing in its product. Sometimes those who have perhaps most
to lose on this, try and make us not use such wo rds as impurity and contamination in their right
context.
Dr Andow
580. The term arises a lot in seed purity standards.
Chairman

581. Ladies and Gentlemen, as you know we have reserved one full day of tomorrow for the
remaining issue, number 1, as well as probably so me wind-up questions which may be necessary to
make full use of the experts presence tomorrow.
582. There are some points I wish to raise in this context so you may reflect over them this
evening. The first is that one of the experts, th at's Dr Snape, will only be with us in the morning
session.
583. Secondly, the Panel is not quite sure to which cases the questions from the Parties are
referring. It would help us to get some informa tion from the Parties on this account. We ask you to
send an email by 9am tomorrow morning, to indicate where according to the EC chronology you
would have questions. We will th en group those questions togeth er according to the cases identified
for further discussion with the Panel's experts, taking into account that priority will have to be given
to molecular characterization. The procedure tomo rrow might be a little bit different from today in
the sense that we would go by the cases where all of the Parties have indicated that they will have
questions. And at 10 'o' clock when we convene we will then give you the order of proceeding as we
see fit in this context, given these circumstances. Of course, it goes without saying that we will seek
to ensure equivalent time for both sides. We also would like you in your mail to indicate any products
where the questions may be in particular be addressed to Dr Snape.
584. Is the request from the Panel clear to the Parties? Argentina.
Argentina
585. Just to get a clarification. I believe we al ready circulated questions for the meeting for
tomorrow and in our paper there is a reference to a specific product. This covers the request of the
Panel in the sense that our allocated questions relate d to the specific products. Do we need to send an
email repeating that?

Chairman

586. We have noted your written questions on the ta ble. In case you have additional questions on
the basis of today's discussion you should then come back with a mail. If we do not hear from
Argentina that means we know which questions you will raise and in which cases they are located.
587. Other clarifications required?
European Communities

588. Chairman, you're only talking about the questions for tomorrow, not the existing questions, of
course. You'd like each of them to indicate the produ ct to which it relates and the scientist to whom it
is addressed?
Chairman

589. Actually we don't even need the precise formula tion of the question. Wed' like to know to in
which cases, relating to EC chronologies, you have questions, and which of those you would want to
ask specifically to Dr Snape.
590. If there are no other questions, I would like to close the meeting by thanking you for your
endurance, especially also our cherished and valued experts. I ask you, in order to make full use of
the Panel's time and the interpretation time, to be in your seats tomorrow by 10am. Thank you. The
meeting is interrupted. [Pause]
Chairman

591. As envisaged yesterday, we will start with issue number 1- which are all product-specific
questions. Then, if necessary, the available remain ing time can be used for discussing further any of
the issues addressed yesterday. Finally, we 'll move to closing remarks by the experts.
592. I would also like to remind the parties that Dr Snape, as announced, will only be available in
the morning session. According to our feedback and our own questions, there is only one question
addressed to Dr Snape which is further down the chronol ogy line – that's 94. Therefore, I suggest we
take the issues according to the EC chronology, starti ng with 62. Then, briefly before 1.00 o'clock, if
we haven't got there by then, we will take item 94 which has a question addressed to Dr Snape. This
will allow us not to jump back and forth from one cas e to the next and make full use of the presence
of Dr Snape at the same time.
593. For each issue or group of applications we would first have the convening parties in
alphabetical order and give them time for their questions to the experts. Then the EC will be given an
approximately equal period of time for their questio ns to the experts, per subject, and including any
follow up question to the complaining parties' ti me. I do not at this time propose to make any
allocations by minutes or hours but if we take more time than available today then I may have to
revert to a more clockwise attribution like we did yest erday. So, for the time being, let's see if we can
do without strictly timing everybody's interventions.
594. The Panel will also have questions and will a ddress them on its own, also within each group
of questions of cases. In this context, I wish to remind the parties that they should limit themselves
during this meeting to ask questions of the Panel's experts. Should the parties have any comments on
the experts' replies, those comments should be ma de in the context of the second substantive meeting

starting next Monday. We do not propose to have comments and discussions between parties in this
meeting today.
595. Finally, the experts themselves are requested to answer the questions from parties and the
Panel and should refrain from offering any view on the legal implications before the Panel, including,
for example, whether any delays that might have occurred were due or undue within the meaning of
the SPS Agreement. So, without further ado, I suggest we start with the case no. 62. Unless you have
questions on the procedure? No? Argentina, you have the floor.
Argentina

596. Mr Chairman – just a clarification. May we have a chance when we address a particular
product to get the name of the product. This wi ll help my delegation, because we prepare the
questions by making reference to the expert and th e problem. I presume 62 should be a question to
Dr Snape. We don't have questions to Dr Snape, but it would help very much if, at the moment, when
you trigger a particular exercise, we have a chance to have in our mind the product.
Chairman
597. That's okay. The EC?
European Communities
598. Thank you Mr Chairman. If I understood you correctly while shuffling my papers, you said
that you would take questions to Dr Snape first. You didn't?
Chairman
599. No, the idea is to go in chronological order and before we get to one o'clock we will see that
all questions to Dr Snape have been put forward. On our line, on the feedback you gave to us, there is
only one which goes after 74 and that is in 94. So, we will see how time goes. Before one o'clock we
may come to 94 or we will have to come to the question addressed to Dr Snape in case 94.
European Communities
600. Just to be clear Mr Chairman. There is also EC 62 and EC 74.
Chairman
601. To make it very clear, we have questions to Dr Snape. According to our information these are
62, 63, 74 and 94. Those are the ones announced and that seems to allow us to go in chronological
order without having to jump back and forth in order to take the presence of Dr Snape into account.
Chairman
602. On 62 we have questions from the EC but I will first turn to the complainants to see whether
they have questions on case 62. Nobody? EC you ha ve the floor. You have questions to Dr Healy
and Dr Snow?

European Communities

603. Our first question on oilseed rape Falcon is to Dr Snow. In your reply to question 11, you
indicated that the widespread adoption of glufosinate tolerate oilseed rape could have implications on
biodiversity in farmland habitats. Would this, in your view, justify the requests for more information
(as made by the Italian competent authority) and would a rigorous post event monitoring (as requested
by the German competent authority) provide that information?
Dr Snow
604. I would say, yes. This is one of the issues th at I pointed out. That early on, there was no
information about possible effects on farmland biodi versity. Would monitoring be enough to answer
your questions? It will certainly be a step in the ri ght direction if that's a concern to the German and
the Italian competent authorities. I think that this is a valid concern, and the question is – how do you
answer these difficult scientific questions?
European Communities
605. Thanks. So we understand that these questions were actually justified.
Dr Snow
606. I think so. Yes.
European Communities
607. Thank you very much. I move on to a question to Dr Snape, that relates also to oilseed rape
Falcon, but to Question 12 from the Panel. You conc lude in your answer, that for a formal accurate
characterisation to satisfy all regulatory require ments, the experts would suggest that more
information is still required. Dr Healy, on th e other hand, concludes that additional molecular
characterisation requested by the lead CA is unlikely to affect the conclusions of the safety assessment
and was not necessary to ensure that the conclusi ons of the safety assessment were valid. We would
very much welcome your comments.
Dr Snape

608. My analysis of the documentation showed that th ere are two loci in this particular product.
One locus had been sequenced and well characteris ed. The other locus which was a complex locus –
EE2 – which had not been fully sequenced. I suggest that the sequence of that locus is required for a
full safety assessment.
European Communities
609. I think this concludes our questions on 62.
Chairman
610. Then I come to the Panel question on Falcon G7 GS40 and the first question is to Dr Snape.
The first one to Dr Snape. Further to your reply to Question 12 on bio oilseed rape, you indicated that
there was a need for a study on the progeny of the bi otech plants. When was the technology to do this
type of study commercially available? And b) You indicated that you examined the information

requested relative to the EFSA-Q-2003/005 guidance document produced by the scientific panel on
GMO's. When was this guidance document adopted? Please explain how this document is relevant to
the request from Germany in April 2002.
Dr Snape

611. The technology for studying the inheritance and stability of transgenic loci has been around
for a long time. It's one of the first analysis that would be done with a transgenic plant. The guidance
that I used is the 2003 guidance document. It is rele vant to the request from Germany, in so far as the
totality of the information required for the full characterisation is summarized in that document, which
I think would have been good practice.
Chairman
612. Dr Snape. I think we want to have the exact date of that document. Otherwise I will ask the
Communities.
Dr Snape
613. I don't have the exact date.
Chairman
614. Communities – do you have the date?
European Communities
615. We will look for it and give it to you in a second.
Chairman
616. Then I will turn to Dr Healy with a questi on. What is the significance for the safety
assessment of this product, after the subsequent identification of additional DNS fragments in Round-
Up Ready soybeans?
Dr Healy
617. The Round-Up Ready Soybean example, provid es an interesting example in a different
product, where the molecular characterisation whic h is carried out using the southern blotting
techniques do not necessarily give you all the inform ation that a sequence analysis would give you.
But it also is an interesting example in that it demons trates that despite the fact that there is additional
sequence present, it does not affect the safety or the safety assessment of the product because the
other elements of the safety assessment provide that additional assurance. So, it's quite analogous to
the situation that we find with the Falcon product.
Chairman
618. Last question from the Panel to Dr Healy and Dr Snape. Could you please explain why you
have different views regarding the necessity of the additional information on molecular
characterisation requested by Germany?

Dr Healy

619. Can I just clarify that that is the request in Attachment 106. It's the attachment that's
referenced in the actual questions. Yes. I think this relates to the approach that I took. As I said in
my introductory remarks yesterday I examined th e molecular characterisation information in the
context of the other elements of the information that were available for the safety assessment. In this
particular case, there was a reasonable amount of molecular characterisation. There was a
characterisation at the protein level as well as at the compositional level. Taking account of the
totality of the information and the method of transf ormation, in my judgement, additional information
which was around the DNA sequence for the inserts as well as the junction regions, was unlikely to
have an impact on the safety assessment.
Chairman

620. Dr Snape.
Dr Snape
621. In my view, when you have complex transg enic loci, it is necessary to have sequence
information to understand the inherence and the stability of that transg enic locus. Therefore, I thought
that sequence information was required for the safety assessment.
Chairman
622. Thank you. Follow-up questions from Canada?
Canada
623. Yes, we have a follow-up question for Dr Snow. Can you indicate whether or not the
widespread adoption of any herbicide tolerate oilsee d rape could have implicat ions on biodiversity in
farmland habitats?
Dr Snow
624. In other words: Does it matter if it's transgenic or not?
Canada
625. Yes.
Dr Snow
626. No. It doesn't matter if it's transgenic or not in that context. It just matters if there is a very
effective gene for herbicide resistance and herbicide is used and has greater effect on the weed flora,
as people have hypothesised might be the case. Then there could be an effect on farmland diversity
regardless of the source of the gene, whether it was a transgene or not.
Chairman

627. Thank you. I believe we can go to Case 63. Th at's biohybrid oilseed rape. The EC has a
point on 62.

European Communities

628. We would like to reply to your question on the da te. If your allow me, I will give the floor to
one of our experts who is one of the authors of that document.
European Communities (Mr Sweet)

629. Thank you, Mr Chairman. This is just to confirm that the EFSA guidance – that's the
European Food Safety Authority guidance document on the risk assessment of genetically modified
plants and food and feed – was adopted on 24 Se ptember 2004. That was after the date in your
Question 15b to Dr Snape.
Chairman
630. Thank you. That's helpful. The US on 62.
United States
631. A question to Dr Snow. I wanted to clarify your response to the first EC question. It talks
about whether this additional information is requi red and there is a parenthetical in the question
related to a request from the Italian competent author ity. Were you, Dr Snow, opining on whether or
not, in fact, the Italian authority asked for that inform ation? Or, was that sort of an assumption of the
question?
Dr Snow
632. Actually, I would like to see that information ag ain. I was trying to look it up just now
because I don't recall the exact wording of it. I avoide d the answer, since I haven't seen it recently. If
anyone could show it to me recently, I could answer the question better.
Chairman
633. We will ask the US to provide it or to see in the laptop...In the meantime the EC would like to
clarify?
European Communities
634. Chairman, if you would like I can read out the Italian request in Attachment 10 referring to
the conclusion of the last meeting of the Regulat ory Committee of the EC. "Italy would be very
pleased to receive from the notifier more information concerning the assessment of the effect of the
genic product on the biogeochemical cycles and on the food chain, and on the spreading of the gene
due to the possibility of crossing between the PGM and wild species". We are referring to the last bit
of the sentence.
Dr Snow
635. The part that is relevant to the farmland divers ity issue is the reference to the food chain.
They are asking for more information about food ch ains which refers to: whether the weeds are being
controlled to such an extent that there is no longe r a food supply for some of the endangered farmland
birds.

Chairman

636. Is there any question to Dr Snow, or to an expert, left? EC still on 62?
European Communities
637. Our answer on the EFTA guidelines was in part mi ssing. It is true the document is from 2004
but it is based on a previous consolidated guidance. It actually only consolidated good practices that
were there from well before the date of its adoption. Therefore, we concur definitely with what your
expert said that this document is relevant also for your request from 2002, insofar as it was only a
consolidation of good practices in the field.
European Communities (Mr Sweet)
638. Previous to that, the guidance was coming from th e EU Scientific Committee on Plants. That
committee terminated in 2003 with the formati on of EFSA, and the Committee that took over the
regulation of GMO's and risk assessment was the EFSA GMO Panel. They took up the guidance
document produced by the Scientific Committee on Plants and reissued it in September 2004.
Chairman
639. Can I ask Dr Snape if you are aware of any major changes having taken place between the
good practice and the consolidated good practice.
Dr Snape
640. No.
Chairman
641. Thank you. Canada?
Canada
642. My question is to Dr Andow. This is in relation to your comments concerning the Italian
request at EC 63 Attachment 95. You stated in paragraph 1013 of your report that "while a request
for additional clear assessment of the possible effects on the environment can be readily justified,
such a request itself must be clear and specific". In your view, was this request clear and specific?
Dr Andow
643. The reason I said that is because the request was simply for – as it quotes here – concerning
the assessment of the effect of the genic product on biogeochemicals and on food chain. It is three
things. The request on biogeochemical cycles is just two words and gives very little guidance as to
how to think about that request. The short answer to your question is yes.
Chairman
644. This takes us to the end of 62. On 63 we have question from Canada, the EC and from the
Panel. I do see the EC wants to have the floor.

European Communities

645. One follow up question to Dr Snow. But you woul d concur that gene flow to wild relative is
a valid concern for Europe and the competent authorities?
Dr Snow
646. Yes, they also mentioned gene flow.
European Communities
647. Can we therefore conclude that although a bit formulated in generic terms, the request from
the Italian authority contained concerns that can be shared by the experts?
Chairman
648. I am not sure that that is a scientific question.
European Communities
649. It is in a sense that although formulated in ge neral terms it contains scientific concerns. I
think the experts can reply, if they wish.
Chairman
650. Dr Snow. Do you wish to reply?
Dr Snow
651. I agree that it is vague and not very specific but it's a valid point that was raised. These food
chain effects were just coming. The Scientific Committee on Plant did not iodentify that this might
become an issue and it later did. This is an example of developing science and questions during the
time that these products were being put forward.
Chairman
652. On the same point, Dr Andow.
Dr Andow
653. To elaborate. The other part of the reason for my concern about this particular request is the
timing. It is in 2000. It's before the promulgation of the 2001 regulation. This is the test period and it
would seem that it is appropriate to give some guidance in trying to implement the test, when you are
working through a test period.
Chairman

654. Thank you. We take note.

European Communities

655. I guess that is not a scientific comment but a regulatory comment.
Chairman
656. We take note. Canada we have floor on 63.
Canada
657. My first question is to Dr Nutti. The questio n is 15, which is paragraph 3 on page 1 of
Canada's questions. Dr Nutti, you state in your re port that, "the low levels of PAT protein and the
weight of evidence available concerning the safety l eads the Committee to conclude that there is no
significant risk to humans or livestock following the ingestion of the gene product". You then
conclude that you agree with the overall SEP's asse ssment. The Europeans criticize your assessment
in the following terms: "The experts speak of we ight of evidence available elsewhere concerning
safety. However, the evidence is misleading. No references are provided". They later state
"however, when researching for the weight of evid ence, one finds more often than not, that this
evidence is actually meagre, unpublished, informal, containing grey literature or notification, a
notifier documentation". That is at paragraph 328 of the European comments. I would just like to
read to you a statement by the Scientific Committ ee on Plants. Their opinion issued in May 1998 -
found in EC63 Attachment 54 - on the bottom of page 4 the scientific committee states "low levels of
PAT protein and the weight of evidence available elsewhere concerning the safety of PAT leads the
Committee to conclude that there is no significant risk to humans or livestocks following the ingestion
of the gene product. Is the weight of eviden ce that you were referring to "meagre, unpublished,
informal and contained in grey literature"?
Dr Nutti

658. No. I have checked all the information that wa s here and also the references that were on
files. Also, the codex. That was my basis for evaluating this.
Canada
659. So, the weight of evidence that you are relying on in part, is that the same weight of evidence
that was relied on by the European Scientific Committee on Plants?
Dr Nutti
660. Yes. I used all the documents that were presen ted by the Scientific Committee. Then I made
it very clear that I was in agreement with the Eu ropean Scientific Committee. I used the same
material that was given to them.
Canada

661. My next question to Dr Nutti is in relation to po tential allergenicity and toxicity of the rival
nuclease of MS8/RF3. Considering that these rival nucleases are only expressed in the anthers – that
is the male flowering parts of the plant – and onl y for a short period of time, and that humans do not
eat the anthers or the flowers, and that even if they are expressed elsewhere in the plant there is
extremely little protein in the oil consumed by humans, what would be your conclusion about the risks
to human health of these enzymes?

Dr Nutti

662. My conclusion was that there was a very low possibility for a problem for humans. All the
questions related to human health and human were goi ng to ingest the oil and not the flower. So, in
this case, my conclusion was the same as the Comm ittee's: that there was no problem for human
health.
Chairman
663. Canada satisfied? Other complainants? That's not the case. The EC.
European Communities
664. Dr Nutti. A follow up question. Are you aware th at this application was not about food and,
therefore, did not concern human health as you assessed. But it was about feed and, therefore, it
concerned animal health. Are you aware that anim als are fed a protein-rich by-product of oilseed
processing and that this is called cake?
Dr Nutti

665. When I assessed the documentation, I was looking for human health. If this is supposed to go
for cake, then you have to look at the proteins and it is a different evaluation.
European Communities
666. Thank you very much. You also briefly t ouched in your answer on issues related to
molecular characterisation. Would you agree that molecular characterisation is important for animal
feed safety?
Dr Nutti
667. As I mentioned yesterday, we need to have an integrated approach. We need the molecular
characterisation to help in the overall characterisation. There will be times that we need the molecular
characterisation. In all my answers I pointed out that the Codex put the molecular characterisation as
the first step to be done.
European Communities
668. One point you make on this is that although de tection methods were commercially available,
the detection method that is at stake here had not been validated. What it means that a method has not
been validated? What is the implication?
Dr Nutti
669. To my knowledge, after you develop a method you need to validate it. To validate the
method, is to take steps to ensure that the method can be duplicated in different labs. Sometimes you
have a method which is not validated. The method can be validated through inter-laboratorium, or
you can submit it to the Codex CCMS in order to have it recognized. In this case, I looked at all the
information and, my understanding was that the me thod was available. But the method had not been
validated. Validated in my understanding is that the method should be internationally recognized and
used in different labs. For the same method then, different labs will have the same answers.

European Communities

670. Can we therefore conclude that the further re quest by the lead competent authorities on this
issue of animal feed and molecular characterisation was therefore valid?
Dr Nutti
671. It was not clear for me. Maybe if you could read again the question from the competent
authority, because I thought they were assessing for ri sks to humans. Maybe this is the difference on
our understanding. I don't have the question fr om the authority in front of me now, but my
understanding when I was doing all of this, was that it was related to human health. As you can see
when Canada asked this there was a lot of stress on human health risks associat ed with oil. Was the
request specific for animal feeding?
European Communities
672. I will look for it and we will revert to you.
Dr Nutti
673. Maybe you could take the SCP, because as far as I could remember, they emphasized human
health. Humans and not feed.
European Communities
674. The problem is that the authorization was request ed for animal feed, so the whole analysis of
this product was done in that context. What is im portant for us is that to your knowledge it was not
invalid to have these concerns with regard to oil seed rape when fed to anim als, because this was the
end use that this product was going to fulfil once on the market.
Dr Nutti
675. We need to pay attention to whether or not the feed contains the proteins. Therefore to the
whole composition. Because in the oil, proteins are not included.
European Communities
676. So it was not invalid, in fact, for animal feed?
Dr Nutti
677. It was not invalid but the question for me is that this product was for humans. Maybe, we
should check this.
Chairman
678. I think we will go on and refrain from furt her comments on validity or non-validity of
applications in terms of regulators. Canada, on this point.

Canada

679. If I could be of some assistance. In the opini on of the Scientific Committee on Plants -issued
in May 1999- it was asked whether or not, for the purposes used, does the product cause any adverse
effects on human health and the environment. The Committee at the time did indicate that they were
looking at both the risks to humans or livestock following the ingestion of the gene product.
European Communities
680. I think this confirms our point of checking th e document. The questions are not qualified for
human health or animal health. The issue here is that the legislation under which this product was
requested authorization, concerned only animal feed. If it had been food it would have been under the
novel food regulations and not under the environmen t legislation. So, although the SCP was looking
also at these other effects on humans because it was a wider concern, the scope of this product
authorization was animal feed. For the same product there have often been, in fact, two notifications.
One under the environment directive and another u nder the novel food regulations. You have the
same product dealt with twice in this case. So, EC -63 and the application that was called C/BE/9601
referred to animal feed.
Canada
681. In any event, Dr Nutti, considering that protein is only expressed in the anthers – that is the
flower of the canola – and not in the oilseed, and th at the oilseed is processed, would this have an
effect on the safety of the seeds for livestock?
Dr Nutti
682. No it does not. If it is in the flower, it will not be on the seed. But I wonder if whether in the
processing you could have a contamination. This would be the only problem. But the proteins are not
supposed to be in the seed, because they are only in the anthers. There is a very limited possibility
they are going to import the seed and the seed will not have the protein.
United States
683. We have a little trouble procedurally with questio ns that start with new facts and then ask
experts to comment on new facts. First, we have new facts about what "cake is". My people who
know "cake" say cake only has seeds and not anthers. The SCP opinion clearly says the proposed use
is for food, feed and industrial uses. It says food and feed, both. The SCP says food and Dr Nutti
answers on human health. I don't know what good it is to present new facts and then try to ask
additional questions that way.
Chairman

684. I am not sure whether these are new facts or old facts. So I will not stop this discussion.
Unless we need a definition for the term of cake. But I think this is almost common knowledge.
Dr Nutti
685. I am a food engineer; I know the term very well. The cake would not have the flower,
because the cake is supposed to have only the seed.

Chairman

686. That is quite clear. Yesterday we decided that contamination and adventitious presence was
synonymous. For the purposes of this hearing.
European Communities
687. Can I give the floor to one of our experts to try to clarify what is in th is cake that can be of
damage.
Chairman
688. Actually, I would like to have only questions to our experts.
European Communities
689. Yes. It will be in the form of a question.
Chairman
690. Please try.
European Communities
691. It is stated here that the PAT protein would onl y be expressed in flowers, correct? Given that
the crop is glufosinate tolerant, it should be at least expressed in the green part s. Because otherwise it
would simply die after application. So, do you agree that it would also be expressed outside the
flower.
Dr Nutti

692. I don't agree.
Chairman
693. EC, one more question.
European Communities
694. Yes. But before, you agreed that the animals ar e fed a protein which is rich in by-products of
oilseed processing.
Dr Nutti
695. When I gave my answer to you, I tried to cl arify that all my answers were focused on human
feed concerns. If it was about animals we would have to check the protein. But in this case, if the
protein is the same that was analysed for the seed, there is no difference. The problem is that it was
analysed, and the small difference is on the flowers. That is not going to go in the seed or in the cake.

Chairman

696. I think we should move on. OK, the Panel is sa tisfied with the questi on and answers to this
point. The EC had another question, I believe, to Dr Healy? EC you have the floor. Canada, on this
one?
Canada
697. We had several other questions in relations to MS8/RF3. I was wondering if we were going
to go through the complainants and have an oppor tunity to address the questions to the experts on
MS8/RF3 before the Europeans, or whether we will have some opportunity afterwards.
Chairman
698. Canada, you can continue with your questions to the experts.
Canada
699. My question is to Dr Andow. This is questi on number one or the question in paragraph one.
You indicate that the SCP did not consider that cont amination of conventional varieties was an injury
to plants in your report in paragra ph 1401. This is in relation to th e determination of whether or not
MS8/RF3 could constitute a pest. Can you confir m whether you are referring to the adventitious
presence of biotech seeds in non-biotech seeds or some other form of injury to plants?
Dr Andow
700. I agree with what Dr Snow has written in her dete rmination of the pest status here. I simply
looked at the information associated with what th e SCP actually said and used that information in
trying to make this determination. But the short an swer to your first question is yes, and that should
be clear from my answer to question 6, which is the more general answer.
Canada
701. So, either a question to Dr Snow or Dr Andow . Is the economic harm that potentially arises
from the loss of an ability to sell a product as GM-fr ee an injury to plant life or health within the
meaning of ISPM No. 11?
Dr Snow

702. I was not interpreting this in terms of economic harm to farmers but more as the creation of a
weed that is more difficult to control. I was very literally looking at the wording - which I quoted -
about what are the possible definitions of weeds. That 's very early on in question 6, lets just turn to
that page-. Definition of a pest. Indirectly affec ting plants, such as weeds or invasive plants. Annex
three mentions animos with increased potential to spread due to "pesticide resistance including
herbicides", so that was what I was basing my answer on.
Chairman
703. OK, thank you.

Dr Andow

704. I came to slightly different perspective b ased on the same reading, although I wasn't
considering the weed side of it. As I read in the SCP, they determined that there wasn't going to be
higher survival or out-crossing. So the weed issue, according to the SCP was not an issue. Then I
turned to the issue of contamination. Here there is some issue as to whether or not the contamination
certainly could have the effect of the farmer not being able to sell the seed. It could also have the
effect of the farmer not being able to use the seed. It could also have the effect of the farmer believing
that those seeds are no good. In other words, those seeds are in the farmer's perspective "harmed". I
did not make a determination as to whether any of those were applicable. But I did not want to simply
say that it could or could not be a pest, because that point had not been clarified.
Canada
705. I would like to move on to question 19. Dr Snow, can you elaborate on what data, requested
by the competent Belgian authorities, seemed unnecessary in their October 2003 request?
Dr Snow
706. This is a bit similar to that previous one we were talking about, where the words were
biogeochemicals, cycles and food chains. Only here there is more. The co mpetent authority asked
about effects on "farmland diversity (macro fauna, weed flora and microbial soil ecosystem, food web
integrity, trophic structure, population dynamics of key species, life cycles, etc.,)". By having that
etcetera it seems all encompassing. When I first read it I thought that they were asking for everything
and that it was really vague. Although it seems to ask for too much unnecessary information, what I
really think they were getting at is this question about ecological effects of intensive herbicide use on
food chains. Because it seems all-encompassing, it's a difficult one to respond to.
707. If you think about what regulators are faced with, there is a certain amount they need to know.
There are some things that would be nice to know and there are other questions that may or may not
be possible to know. There are things that scientists just may not be able to answer. So, the second
paragraph of the next part of my answer goes into how difficult it is to prove that there is going to be
no effect on farmland biodiversity. This is a ph ilosophical question. Can scientists answer this
question? The Farm-Scale Evaluations are an attempt to begin to answer that question and I think we
should talk about that more. I know you have questions for Dr Squire about what is the value of those
Farm-Scale Evaluations. I am assuming the intent is to ask a serious valid questions about farmland
biodiversity.
Canada

708. Would you agree that in addition to being a theo retical concern, it is also a very practical
issue, in that a notifier has to respond and provide information?
Dr Snow
709. Yes, and I think maybe an alternative would be to say – if you can't provide this information
we won't approve the product. You know, if it is not possible to answer the question. There may be
concerns that are strong enough to not approve the product. It is really difficult for me as a scientist to
know how to evaluate this.

Canada

710. If it is impossible to know the answer to these question then you just shouldn't approve the
products. Would that also apply to any other herbicide tolerant crop?
Dr Snow
711. Regardless of whether it is transgenic?
Canada
712. Yes.
Dr Snow
713. Yes, it would. I am not saying because it's impossible to answer that it's now worth looking
at. That's why I wrote in my context all the exampl es of publications that have actually shed light on
important questions, even if they don't answer the re gulators' question. I think it's very important to
look at these questions.
Canada
714. My next question is for Dr Squire. You indicat ed that there is a need for a standard or a
comparator to evaluate the effects of biotech de rived crops. Recognising the importance of ensuring
sustainable agriculture and recognising that all agri cultural practices have some degree of detrimental
impact on biodiversity, would an appropriate sta ndard or comparator be the effects of typical
agricultural practices?
Dr Squire
715. Interesting question. Since the bronze and iron ages in Europe, humans have been balancing
cereal-based rotations with weeds. Weeds are still here. I think they always will be. I think there is a
philosophical point here. You could argue that humans have replaced one form of habitat or
biodiversity with another. They have created th eir own habitat in which to grow crops and that
habitat is an essential part of the future of humans on the planet. Now, in some parts of the world,
that habitat is potentially sustainable and could be used as a comparator. In other parts of the world
there is a general agreement that the typical practic e is not a good comparator. In the most intense
European agriculture I, and many others, think cu rrent practice is not a good comparator. There is
general widespread opinion that the use of seven, ei ght or nine chemical applications per year to a
crop is not sustainable. So the answer is, it depends on what your typical practice is. Current intense
practice, as carried out in parts of Europe, is not a good comparator.
Canada
716. So, has the type of information then request ed by the Belgian competent authority in EC
Exhibit 63/At.149 been required, in relation to any ot her of the forms of conventional agriculture that
you have just mentioned?

Dr Squire

717. In general, no. There has been little appreciation -as I indicated in my notes- of the
developments in intensive agriculture during the last fi fty years. I think the point I made also is that,
relying on what I would consider the bad practice in the past, or bad approaches in the past, doesn't
mean to say that you can justify the continuation of those for any particular reason. It just happens
that the impending introduction of GM cropping into Europe, has coincided with a number of large-
scale experiments and changes in philosophy and approach.
Canada

718. Is the same sort of scrutiny - in terms of the impact on this particular agronomic practice on
biodiversity - being applied to some of these bad agricultural practices that you have just referred to?
Dr Squire
719. No. I think there are some examples. I think Europe is slow to learn, and I think that in some
instances we are not applying the same sort of rigour to our understanding of different types of things.
It doesn't mean to say that we shouldn't be applying a certain level of rigour in this case. I take the
example of the use of glyphosate as a herbicide in parts of Europe, its rise in the last ten years, and the
balance of minimum tillage and deep ploughing for example. Both these occurrences will have large
effects on the future and they are taking place without adequate understanding.
Canada
720. As you may know, in the UK, in order to register a new herbicide, the regulations require that
the herbicide must control, I believe it is about 95 per cent of weeds. So considering the concerns
evaluated in the Farm-Scale Evaluation - that is th at the adoption of some GMHT crops could affect
biodiversity by being too effective at controlling weed s-, is this not inconsistent with current policies
regarding herbicides where the efficacy of the herb icide is, in fact, a precondition to the approval of
the use of that herbicide.
Dr Squire
721. In this instance it is not inconsistent. If yo u consider that typical primary production above
ground – that's the production of plant matter in fields in Europe – is around ten tons per hectare, as a
general order of magnitude figure. Current estimates suggest that the weed flora is of the order of one
per cent of this. It could rise well above that, but in well-managed fields it is around one per cent of
that primary production. Since the iron age we ha ve reduced the weeds down to around one per cent,
typically. A control of around 95 per cent is well belo w the level that is curr ently exercised. That
level is a result of long-term repeated use of a range of herbicides. Now, what the Farm-Scale
Evaluations were saying regarding those two crops that were found to decrease weeds further was that
the effects appear to be - at this stage for those br eak crops - in excess of what was required to control
adequately the weeds for yield. It was over the top. If there is to be a balance between sustaining the
food web, the soil organisms, the predators that are beneficial to agriculture, then we don't want to go
over the top. We need to find a balance.
722. My own understanding of the agronomy and economics of herbicide use was founded by
detailed study of two large-scale, long-term experime nts in the 1990's in the UK. These are referred
to by acronyms TALISMAN, and SCARAB. They are both government funded. They showed that
cutting herbicide use by half from the present intense use gave a moderate increase in the weed flora

and a net improvement in gross margins. There wa s no detriment to yield worth speaking of and the
benefits came through less use of herbicide. So, in the UK and in parts of Europe where agriculture is
intensely managed, there is no additional benefit fi nancially in squeezing the last bit of effort into
reducing the weed flora at the expense of biodiversity.
Canada

723. In terms of other forms of agricultural practice that you mentioned, some of the bad practices,
would you consider that there is a justification or a reason for imposing a much higher level of
scrutiny on the introduction of this particular ag ricultural practice, the HT cropping, with other
agricultural practices?
Dr Squire
724. I think it is incumbent upon us to scrutinize those other practices with the same rigour that we
are scrutinizing, for example, herbicide-tolerant GM crops in advanced agriculture in Europe. I don't
think the option to reduce the rigour of scrutiny of GMHT crops is the way to go. I think we need to
be consistent. I agree, we are inconsistent at the present time. But the consistency should be upwards
towards appreciation of the ecological aspects of agriculture.
Canada

725. For instance, Dr Squire, in your report you indicate that large-scale autumn-sown cropping in
some parts of Europe was not scrutinized with the same rigour. Would your assessment on the impact
of farmland biodiversity of not leaving a field to fallow would be in comparison to HT cropping?
Dr Squire

726. I would say it is at least the same order. Autumn-sown cropping has b een used for centuries
but it rose to predominance in the 1970's in the UK a nd some other parts of Europe. There have been
few systematic and detailed records of the effect of that very major change. It also occurred with a
very big change and continuous change in the range and type of herbicides used with that cropping. It
is at least as big as any potential effects of GMHT cropping. But again, that in itself, is past. I believe
that we should have monitored and regulated that change as appears to be the case for GMHT
cropping.
Canada

727. Would you agree that the ability to use zero-till systems with broad spectrum HT crops, as
opposed to the more conventional practice of soil in corporated herbicides, be a more sustainable
agricultural practice?
Dr Squire

728. Again, it is difficult to generalise. It depends where you are in the world. It is certainly a
potential option in the UK and some people are going towa rds this practice. It is certainly an option.
The uncertainty in the soils of the UK is whet her zero-till for longish periods would itself cause
problems for farmers and for soils. Surprisingly in Europe there is little detailed information on the
effects of zero-till. Experiments are now starting, in cluding some that we are looking at ourselves.
It's a possibility but it hasn't been demonstrated.

Canada

729. My next question is for Dr Snape. We have passed out -for the Panel's convenience, as well
as the experts' convenience- EC - 63, Attachment 105, and these are the Minutes of the Belgian
Biosafety Council Scientific Committee transgenic pl ants. It's the meeting of 7 February 2002. I
would like to direct Dr Snape's attention to the back page- at the bottom it's marked 41 under the
heading Discussion 1.9.2. It's the second paragraph. The experts had a monumental task. There was
an incredible amount of information, as you indicated in your cover letter, Dr Snape. This report or
this assessment that had been done by the Belgian Biosafety Council- who admittedly had the file for
about five years now.
730. The Minutes read as follows (and I would like to read the full paragraph, if I may):
"Mr Delouse presented new molecular data submitted by the company. In general, he
concluded that the experiments carried out by the notifier were well done and that
exact but vague conclusions were made. As a scientist he felt that more could be
done. One of the figures suggested a linka ge but it was not demonstrated and not
claimed, meaning their conclusions were co rrect. In fact, they proved, as requested
by the guideline on molecular characterisation of transgenic plants, that the flanking
regions were plant material but not the li nkage. It was suggested that either the
pictures in figures one would be adapted, or that the results supporting this figure
would be added to the document. Next to this some mismatches were found. These
data will not have an impact on the risk assessment knowing rearrangements occur
frequently."
731. Given the conclusion of the Belgium Biosafety Council in February 2002, again bearing in
mind that they have had the file for five years, and obviously you are at a bit of a disadvantage
because you had this information over your Christm as break, that additional molecular data will not
have an impact on the risk assessment knowing rearrangements occur frequently. And given the
totality of the information submitted in the dossier, including the 1998 opinion of the European
Scientific Committee on Plants that stated: Ba sed on phenotypic and molecular techniques, it is
shown that the genes are stable and follow standa rd mendelian inheritance. And given as well the
statement of the Biosafety Council that the documen ts related to molecular characterisation are well
documented and experiments and results are of a high quality, was the request for additional
information in Attachment 107 necessary in order to enable the risk regulat ors to conduct a risk
assessment?
Dr Snape

732. Thank you for that and thank you for the additional document. My assessment of this product
with the two components MS8/RF3 is that this is th e most complete molecular characterisation that I
have seen in the evidence that I was asked to look at. I found that the ev idence for the molecular
characterisation of MS was complete and that there was adequate information to provide a safety
assessment. I had some queries of my own about the inheritance and stability information for RF3
but, again, I concluded overall that the molecular ch aracterisation of this was sufficient for a safety
assessment. In the document that pr esented to me (what you have just read through) I find it difficult
to understand the saying that "information. were we ll done and that exact but vague conclusions were
made". I don't understand how those are compatible . I also don't understand how these data will not
have an impact on risk assessment knowing rea rrangements occur frequently, and I am not sure,
without of course discussing it with them, exactly what sort of rearrangement that they are
considering. In conclusion, I think that the in formation on this product is comprehensive and to a

high standard. I wouldn't say that the additional information was n ecessary in order to conduct the
risk assessment.
Canada

733. I missed that last part.
Dr Snape
734. I wouldn't say that additional information w as necessary in order to conduct the risk
assessment.
Canada
735. So the information was not necessary in order to conduct.
Dr Snape
736. Yes, the information was sufficient, in my view.
Canada
737. We have no more questions on MS8/RF3. Thank you very much.
Chairman
738. Thank you. This goes over now to the EC.
European Communities
739. One final point. Do I understand you correctly, therefore, that with regard to agricultural
practices the small structure agriculture of Belgium justified the concerns that its lead competent
authority expressed with regard to its request of 2003.
Dr Squire
740. Could you clarify slightly, please, with regard to what explicitly.
European Communities

741. All of the discussion was generated by the revi ew of these requests for further information
that the Belgian competent authority addressed to the notifier on farmland diversity (macro-fauna,
weed flora and microbial soil ecosystem). So, do I understand correctly from your answer that given
the fact that in Europe, unlike in other parts of th e world, the agricultural system is structured on a
small-scale basis, and that that is very true for Belgium, their concerns, as expressed in that request,
were valid.
Dr Squire
742. Yes. I would say in general that they had a valid case for concern, given some of the
uncertainties in this issue.

European Communities

743. On another point, because you mentioned that Eu rope is not fast to learn. Aren't you aware
that – maybe not in the UK but in continental Europe –an enormous amount of money is spent on
assessing changing agricultural practices to fund la rge scale projects to increase and maintain
farmland biodiversity.
Dr Squire
744. Yes, I think things are improving. In some pa rts of Europe there are serious considerations
given to this broad approach to the future. But, Eu rope hasn't been quick to learn in the last twenty-
five years. So, compared to, say, the early 1990's, the attitude to sustainable agriculture has improved
immeasurably in Europe – and it differs between c ountries. Some are advanced in this respect.
Denmark, for example. Others are less so – but things are improving.
European Communities
745. Thanks a lot. We have no follow up questions, thank you.
Chairman
746. Thank you. This leaves the Panel with just one question. Since you have been given the text
of our questions I will not read it out again. It is question 19 and goes to Dr Squire.
Dr Squire
747. I think in this instance the argument had co me to a position where the request was that
information be given on large-scale processes. Gi ven that knowledge could only be imported from
other parts of the world with a great uncertainty, th e only way to answer this kind of question was to
do large-scale experiments. Generally, this is not the way that the development of agriculture has
proceeded. If things start to go wrong after the event then good monitoring should detect that. I
would say looking back over the past one hundred y ears in the UK, for example, few developments
have gone this way, i.e., that there was a request for large-scale data before ge neral release. At this
time there were, in practice, some large-scale experime nts either starting or about to start. So, given
the uncertainties it was legitimate to ask what the large-scale effects would be. This is where the
impasse comes because the country says "give me the evidence" and ever yone knows the evidence
isn't there. I can't say anymore than that. It isn' t usual to do this. But given the concerns in this
instance it was done. There was no precedent. It's a very difficult situation.
Chairman
748. You are saying there is no precedent in cases wher e before there were such question in regard
to non-transgenic on crops.
Dr Squire
749. There have rarely been such questions asked in relation to non-transgenic organisms at the
time of their potential introduction into agro-ecosystems. The questions haven't been asked before.

Chairman

750. Thank you. I think that that is clear. Any more follow up on 63? The EC?
European Communities
751. To follow up on your answer Dr Squire. Do yo u think it was either appropriate or reasonable
that this information was requested?
Dr Squire
752. In the case of this particular product, it was r easonable to understand the potential risks. How
that is done is another matter, but it was reasonable for the country to ask in this instance. That isn't a
blanket sort of statement that I would make for all GM crops or any kind of crop. But in this
particular instance I would say it is a reasonable request. As an example, if you go back to the
introduction of different pesticides, they were tested for their toxic properties on different organisms -
often in a laboratory, often in small trials. And then they were deployed quite widely in the field. If
there proved to be effects that were consequent on that, then those chemicals might, or would be,
withdrawn. But there was no clamour in advance for testing of these chemicals at the field scale, over
long periods of time before they were introduced. This is where the difference lies in this case. There
was a request for large-scale testing of ecological effects before the produc t was introduced. Given
the uncertainties that have been expressed both to do with gene flow, impacts on biodiversity and
persistence, I think these concerns are reasonable.
European Communities

753. Thank you very much Dr Squire. Am I permitted another question, Mr Chairman?
Chairman
754. A scientific question, yes.
European Communities
755. Dr Squire. We have heard a lot about comparisons, perhaps between the experiences in North
America and the problems confronting Europe. What would you say are the essential different
elements in Europe which have caused the concer n amongst the Europeans, in particular amongst the
Belgians, in relation to herbicide-tolerant oilseed ra pe? Bear in mind Europe is a milder climate and
we are talking about winter oilseed rape with a hi gher yield. We are talking about different farming
systems and we are also talking about the use of a herbicide which is widely used in fruit production
in many parts of Europe.
Dr Squire

756. The salient issues have to do with the land scape, the size and arrangement of fields, the
degree of transfer between fields that exists and also the desire of growers, or farmers, to maintain
some control or integrity over those fields. The sm aller scale and the need to restrict, as far as
possible, unwanted movement between units of manage ment is one aspect of it. The arable landscape
is fragmented and fairly heterogeneous. The second aspect is that increasingly large numbers of
people in Europe regard the arable ecosystem as bei ng of value to them. This particularly applies to
land-locked countries without mountain ranges or larg e forests. One can understand that people wish

to see organisms, often in the form of birds and mammals and visible invertebrates, in these
ecosystems. The evidence for this is the massive rise in the past twenty or thirty years of nature
conservation in these countries. I would say these were the two main issues that distinguished large
scale production where it occurred from the very small, heterogeneous intimate landscapes of parts of
Europe. Not all Europe but parts of Europe.
Chairman

757. Thank you. You have already extensively co mmented on this question in your responses to
our questions. I will allow Canada a small question, but not to repeat what Dr Squire has written
already.
Canada
758. Dr Squire, you mentioned that pesticide regulation. First of all, are you aware that the
Belgian pesticide regulatory authorities have alrea dy authorized glufosinate ammonium which is the
herbicide to which MS8/RF3 is tolerant, for use with genetically modified herbicide tolerant oilseed
rape? And in light of the fact that the pesticide authorities have already auth orized the pesticide for
this particular use, does it not seem a bit inconsis tent that you wouldn't authorize the product – or the
seed – because of the potential impacts on biodiversit y, when actually the application of the herbicide
and the use of the herbicide has al ready been authorized for that u se. And if there was a concern,
wouldn't the concern be with the use of the herb icide and the solution would be to modify the
conditions under which the herbicide could be used?
European Communities
759. We object to the question as not being scientific, it has to do with our regulatory system. If
the Canada has a problem with the way we deal with herbicide regulations and what we authorize and
how we authorize products, they should bring a case on that basis.
Chairman
760. I would like to hear Dr Squire on this one.
Dr Squire
761. Thank you. It's not just to do with the herbicid e in a small country that wants to keep its units
of land management discrete. There are issues of movement of genes by pollen and by seed and the
ecological impact of GMHT crops. The only la rge scale study has been in the UK – Farm-Scale
Evaluations and literally one or two other trials. The issue is not the use of the herbicide per se in this
case, it's the way it can be used with a crop to get at certain aspects of that crop's weed flora that can't
be accessed by the herbicide used alone in other circumst ances. It's a particular use, the timing of the
herbicide application, that was found to be impor tant in the biggest large scale study - Farm-Scale
Evaluations. That may not answer your question, bu t whatever the use of the herbicide there are still
issues perceived or otherwise of the movement of a tr ansgenic organism out of the field in which it is
grown. It isn't just the use of the herbicide, it's the way the herbicide can be used to target certain
organisms where it couldn't be used in the absence of a GMHT crop.

Chairman

762. Thank you. The floor is still open on 63. If th ere are no more requests for the floor we will
pass to the next case which is 64, Round-up fodder be et. And here we have questions only from the
Panel, but I will first ask if the complainants or the EC have impromptu questions on this particular
case. This does not seem to be the case so the Panel will ask its question. It's our question no. 20 and
it goes to Dr Nutti and Dr Andow (the first one). Dr Nutti …
Dr Nutti
763. I'd like to clarify that my answer was rela ted to food safety. When I was checked the
information of the SCP in the request, the request was about molecular characterization. I would like
to rephrase my answer explaining that regarding concerns about food safety there was no need for
more information. This is why there is a diffe rence. Because I focused on the food safety and I was
checking all the information according to the codex guideline. Thank you.
Chairman
764. Thank you Dr Nutti. Dr Andow …
Dr Andow
765. I'm going to say almost the direct complement to that. Even though I did, in my answers to
questions 21 through 23 include an indication of th e clause "human health" in my answers, that was
more hypothetical than a necessity, and my focus was more on the environment.
Chairman
766. Thank you. Question 21 goes to Dr Nutti again.
Dr Nutti
767. They presented all the information regarding th e substantial equivalence. That one was
comparable. But my conclusion on this question is not with regard to the backbone, because this is not
my field. My conclusion was with regard to the fo od safety assessment. I did not understand, if your
question is also asking about the Italian CA, or it 's only the Dutch? The Dutch CA's question was
about molecular characterization so my answer is not related to that. My answer is related to the food
safety assessment. And in this case, the notifier has presented all the information necessary for the
food safety assessment and the SCP and the Danish authority had agreed with the conclusion.
Chairman
768. It's on Italy.
Dr Nutti
769. It's because their question is about the biogeoche mical cycle and this is not related to food
safety. This an ecological question.

Chairman

770. Question 22 to Dr Andow.
Dr Andow
771. The documents and chronologies were a little conf using, I hope I got them right. But what I
understand is that the Dutch competent authority firs t made a request for information on the backbone
information. The notifier then provided information in two different ways. Then, after that, the UK
CA made an almost identical request which the notifier then simply said that they had already
provided the information. So that must have been that the UK CA didn't realize that the information
had been provided, but that information was necess ary, even though it was already provided, so the
request was not necessary but the information was. Th e request by the Italian CA then was to – and
this is what wasn't clear – is if the Italian CA was disputing the response of the notifier, because the
Italian CA was requesting information that essen tially the notifier had al ready provided. So I
understood that request, then, to be unnecessary beca use the information had already been provided,
and I suppose it's a little bit puzzling there …
Chairman
772. Time wise, these informations were on the ta ble, on the record, when the next Italian
commission …
Dr Andow
773. My understanding – and, please correct me, someone should correct me if I'm wrong – is that
the information that the notifier provided was available at the time the Italian CA made the request.
Chairman
774. Thank you.
775. This is all for the Panel. Would any of the Parties wish to have a follow-up question on 64?
776. EC …
European Communities
777. Chairman, could we have a break for 5 minutes while we discuss whether we have any further
questions? Would that be possible?
Chairman
778. I'd prefer to go on to the next case, but if there are no questions for Dr Snape we will revert to
this one later today. OK? So we have an open point on 64, possibly. And we turn now to 66.
779. EC has a follow-up right now. Please do.

European Communities

780. Thank you, Mr Chairman. This is a question to Dr Nutti. Do you agree that the use of sugar
beet pulp for animal feed justifies a risk assessment for animal feed of Roundup Ready sugar beet?
Dr Nutti
781. I think that that justifies the risk assessment for animal feed, but that you have to take into
account what was the assessment th at has been done before and ch eck if there is a necessity of
complementary analysis. But in my case, I would look at what has been done for the composition and
everything, and then look if there is anything else needed. Thank you.
Chairman
782. Thank you. Do I take it the EC has finished or do you want to have a mental reserve on 64?
We do go to 66 now, and here we have questions from Argentina and from the Panel, both addressed
to Mr Squire. It is on RC 1545 cotton.
783. Argentina you have the floor.
Argentina
784. Thank you, Mr Chairman. As you know we ha ve these three questions and if you allow us,
we are going to request Prof. Burachik to put forwar d our questions and perhaps we are going to have
some follow-up in light of the developments.
Chairman
785. Thank you.
Argentina (Prof. Burachik)
786. Thank you, Mr Chairman. We have a few ques tions for Dr Squire regarding the glyphosate
tolerant cotton. First question is, if the expert ag rees that the original gene transfer from the GM crop
to bacteria is a very unlikely phenomenon, and if it is or if it is not, then why it is, or is not, a very
unlikely phenomenon?
787. I think that this subject was touched yesterday at some time and it was the idea in the floor
that original gene transfer from plant to bacter ia was a very unlikely phenomenon, but I would like
very much for Dr Squire to elaborate on this in this particular case of glyphosate tolerant cotton.
Dr Squire

788. I think I should like to qualify some terminology. "Likelihood". "Likely", as opposed to
"frequency", because some things are likely to happen but they would do so under extremely low
frequency, so it would be a time-dependent issue. Bacteria are known to be fairly free with their
genomes, they do take in and give out their genomes to other organisms. It is likely that they will take
in genomes or bits of them from plants. Whether this occurs over evolutionary time or over arable
time scales of the lifetime of crops and crop species is uncertain, and I know that several studies are
underway in Europe to look at the exchange of genes between plants and bacteria. I'm perhaps not the
most qualified person to give definitive informati on on these recent studies, but I would say that in

general I agree with the tone of this question that , even though such exchanges will happen, they will
do so under very low frequency.
Argentina (Prof. Burachik)

789. Thank you, Dr Squire. I think actually there are some experiments done in 1995 which were
addressed to find this frequency and it's 10/-17 in one particular case, in one study. So I agree with
you that it's a very low frequency.
790. You say in your answer to this question that there is now widespread perception that
antibiotic resistance should not be introduced thr ough GMHT products, and I would like Dr Squire to
clarify this question as to where these perceptions are coming from – scientists? from risk managers?
or regulatory agencies? companies? or the me dia? Yesterday you made some comments about the
media, so I would like you to elaborate on this case wh at is the origin of the perception that antibiotic
resistance genes should not be introduced into the GM crops?
Dr Squire
791. From a number of sources now I think, scientists, risk managers, government regulators,
would prefer … I've just realized that there is a possible misunderstanding here, in this respect. I was
referring to perhaps the unintentional introduction of these products, or their introduction as a result of
selection during the transgenic process, not through an intentional introduction. I was talking about
antibiotic resistance being in a GM product that wa s intended for an entirely different purpose. I'll
answer the question in relation to that.
792. There is a desire amongst scientists doing this kind of work and regulators and others, to have
the GM construct as clean as possible, to have as little extra in there that isn't doing the job that it was
intended for. It is partly to satisfy maybe non-scientific concerns, that these products are doing
something else. But I think from what Dr Snape h as said, and from other more knowledgeable stances
than myself, that we can only truly evaluate a tr ansgenic product if what is in it is only the essential
bits and that nothing else is in there that might cau se issues or difficulties. I'd like to suggest that
others on the Panel comment on that. I'll give one particular example. That is during our work on the
ecological effects of GMHT crops in the UK, part of the genetic line was found to contain antibiotic
resistance. It was there because it hadn't been clean ed out by the company pr oviding the seed. Now
my stance on this, for example, was that it was in such low frequency that it had no ecological impact
by itself, but it cast doubt in the minds of activist groups and the media on the validity of our
measurements. To us it was an entirely unwan ted intrusion into a perfectly good scientific
experiment. So there are those aspects as well as th e potential genetic, or the kind of interrelations
that were discussed yesterday.
Argentina (Prof. Burachik)
793. I would like to have a few minutes to examine the question.
Chairman
794. In the meantime the EC has asked for the floor. We can use the time, perhaps.

European Communities

795. Thank you, Chairman. At the invitation of Argentina, Dr Squire just commented on the
likelihood of horizontal gene transfer, distingui shing between likelihood and frequency -an entirely
valid point- and he qualified his remarks by saying that he's not the best expert on the Panel to
respond to this issue, about whether this horizontal gene transfer can take place on an arable time
scale, as he put it, or not. But just in order to put his advice in context, please, could I ask Dr Squire if
he has looked at the articles, the literature that we put on the record, the studies by Simonet et al., and
in particular a paper by Kay and others, and which shows, in our view, the transfer, this horizontal
gene transfer taking place. Just a question about whether he's read the study or not, please.
Dr Squire

796. I don't feel familiar enough with this work or competent enough to comment at this time
without further detailed study of my own of this particular issue in these papers.
Chairman
797. Thank you. Argentina.
Argentina
798. Yes, in reference to the question that just w as in the floor, you said just a few minutes before
that you're not familiar with the Simonet work... Would you consider a homology-facilitated
unintended combination between genes of plants and bacteria to be a natural phenomenon?
Dr Squire
799. There are examples of that that are natural …
800. Sorry, as far as I understand it, there are examples of that that are natural, but I would have to
qualify that very considerably. This is an extr emely complicated issue and without further detailed
study of these papers and the issue in general I do not want to lead myself into making hasty remarks
or drawing conclusions that I may regret.
Argentina (Prof. Burachik)
801. Thank you very much. And I appreciate what you're saying …
802. I go on to the second question then. The third question. Coming back to the perception issue,
would you qualify the weight of the perception issue versus the scientific evidence, in terms of which
one will override the other one?
Chairman
803. Dr Squire, the Chair is not very comfortable with perception questions, but you may wish to
respond.

Dr Squire

804. If we are, as scientists, conducting experiments that are very much in the public eye, that will
be scrutinized by scientists and by people who have a vested interest, then it's essential that the plant
or invertebrate material that we use is as pure as possi ble in terms of its genetic construct. So even if
there is no major demonstrable scientific effect of a particular impurity -in this case antibiotic
resistance- it is still better to be safe, and to ensu re that no unwanted impurity lies within the material
we are looking at. It isn't just a perception, it is for scientific rigour in comparing one thing with
another. I still think there are others who could comment on the scientific issues of the presence of
the potential influence of antibiotic resistance ge nes in transgenic organisms where they're not
intended to be there.
Chairman

805. Thank you, Argentina
Argentina (Prof. Burachik)
806. Thank you, Dr Squire. Thank you, Mr Chairman.
Chairman
807. Argentina, you have further questions? Your third question …
Argentina
808. No further questions, thank you.
Chairman
809. Thank you. Let's go to the Panel and then follo w-up by the Parties. On 66 the Panel has one
question also to Dr Squire. Would you care to respond?
Dr Squire
810. Yes, yes I saw this and quaked. It's like telling a man that he's condemned to death and
letting him choose the method of his going.
811. I have been frustrated, I must say, in my deliber ations on these issues, by the lack of criteria
or a comparator, in many instances, and I have t hought, whose responsibility s hould it be to provide
that? It isn't a scientific question, in our sense, and the answer I would give wouldn't be a scientific
answer. I suggest it's up to both parties, but as I say, I'd rather not choose the method of my dispatch
from this world.
812. So I prefer not to answer a non-scientific question, with respect to the Panel.
Chairman
813. That was clear.

814. This concludes the Panel's question on 66. I open the floor for follow-up questions from
Parties.
815. This is not the case, then we move on to case 70. And in 70 we have questions from Canada
and from the EC to Dr Nutti and Dr Squire. It's on GT73.
816. Canada you have the floor.
Canada

817. Thank you, Mr Chairman. Canada has a ques tion for Dr Andow, regarding his comments on
the Panel's questions.
Chairman
818. You do not to read it out if you don't want to modify it …
Canada
819. All right. I understand Dr Andow has a copy of our questions.
Chairman
820. Yes, he does.
Canada
821. So should I just read out the question as opposed to …
Chairman
822. No. Only if you want to reformulate it.
Canada
823. OK. Well, if I could just ask Dr Andow to r espond to questions 11, 12 and 13, please. Thank
you.
Dr Andow
824. So question 11, I'd like to say that I will res pond to the part associated with the environment
but not to the part associated to adverse effects on human health. So if you would delete that from the
question I would appreciate that …I had formulated an answer about half an hour ago and I'm now in
the process of reconstructing that. I'm sorry to take your time. OK. So I would say in all three, the
issues, if we leave the references to human health. And I answer them in association to the question
of the monitoring system proposed. I'm understandi ng you're asking about my rationale for why I
believed there is a scientific justification, and mayb e I'll start with that …To summarize this issue, it's
certainly true that the original competent author ity, and the EFSA concluded that there were no
identifiable risks to the environment. And I go into th is in detail. My reading of Austria is that they
suggested that there was a concern that they did not feel was addressed. OK. Italy raised a concern as
well. I conditioned my answer to Italy on whether or not this actually had been covered some place

else, and I couldn't find whether it had been covered so me place else, so I simply said that I expected
that it would then be covered some place else, but w ithout knowing that I was unable to eliminate that
for sure. The UK. The general perspective here, the UK is asking that monitoring can be used to
verify the conclusions of a risk assessment, in th is case that there are no environmental risks. And
this is a position that the NRC Panel in 2002 also pointed out, that monitoring can be very helpful
because by doing that – and I don't elaborate on this in my answer –one can confirm that the risk
assessment process itself is doing a good job, and it gives greater confidence in the risk assessment
process. So I understood that that was the overall function of the UK. I think I may be missing one
… but those are basically the overall rationales for my conclusion, that there are scientific
justifications for having a monitoring plan.
Canada

825. OK, thank you Dr Andow. Are you suggesting that that justifies having a monitoring plan?
Or it justifies why the EFSA conclusion would not be something that you agreed with, that the
proposed monitoring plan was sufficient?
Dr Andow
826. Again I apologize for the delay. I didn't see that aspect in the original questions, and so my
conclusions on the sufficiency of the monitoring plan are related to the specific issues raised by those
countries, and then what I did was I used the general criteria that I developed for, that I proposed for
what is a sufficient monitoring plan. I can't remember to which question that answer was in, but it's in
my response to one of these questions. I applied t hose criteria to that monitoring plan and that's
detailed here, and I point out that there are certain points that the proposed monitoring plan do not
meet the needs expressed by those countries.
Canada
827. Thank you, Dr Andow.
Dr Andow
828. Thank you.
Canada
829. We have a question for Dr Snow, if she would care to comment.
Dr Snow
830. Yes, I see your question. I don't think I answered this in my responses, did I?
831. You don't have a reply from me in writing?
832. But is this another case of importing for processing only, and in that case my answer would
be similar to my other answers having to do w ith import and processing where I didn't understand the
need for environmental impact studies if seed spillage is going to be very, very limited and there is
going to be plans for minimizing seed spillage. But I' d rather wait until we get to those questions,
since I didn't reply specifically to this one.

Canada

833. Thank you.
Chairman
834. Any other complainant on GT73? This is not the case. The EC on GT73 please.
European Communities
835. Yes, thanks. I will leave the floor to Dr Sweet.
Dr Sweet
836. Thank you, Mr Chairman. I'd like to move on to our question no. 12, since this is also on the
subject of post-marketing monitoring. I'd like, just slightly, to rephrase that question, but still direct to
Dr Squire and perhaps Dr Snow would like to comment. But following on from Canada's questions to
Dr Andow, on the post-marketing monitoring, referri ng to the comments yesterday on feral oilseed
rape derived from seed spillage that Dr Squire ma de, and considering especially that we're talking
here about glyphosate tolerance and glyphosate is wide ly used on farmland in Europe and also along
roads and railways, would you consider it reasonable for a competent authority to request a post-
marketing monitoring plan in this instance?
Canada

837. Is that not our question with respect to regulation?
European Communities
838. The question is about whether it was not unreaso nable to request a monitoring plan, and I
think that's a scientific question. Canada has be en asking so many questions about regulatory policy
that I find it rather strange they should be raising an objection on this question, which is a scientific
question.
European Communities
839. And also, Mr Chairman, it's following on direc tly from Canada's questions on monitoring
plans to Dr Andow. Dr Squire, would you like me to repeat the question? It's no. 12 on the EC list. I
had slightly rephrased it because we'd already ente red a discussion on post-marketing monitoring, but
bearing in mind your comments yesterday on spillage , and the fact that we are particularly looking
here at a glyphosate tolerant oilseed rape, and gly phosate is widely used on farmland and roads and
railways in the EC, is it not unreasonable to expect the competent authority to request a monitoring
plan in this instance?
Chairman
840. Dr Squire will you reply to the scientific part of the question?

Dr Squire

841. Yes. There's no question in the way that gl yphosate is applied. The frequency and extent
over which it is now applied. And that GM plan ts of this type would become part of feral
populations, so it would seem reasonable to me to request a plan to assess that post-marketing, yes.
Chairman
842. Canada …
Canada
843. Thank you, Dr Squire. Would your answer be a ny different if the application related simply
to importing processing where the seeds were being moved into a port and then from a port to a
nearby facility, as opposed to cultivation?
Dr Squire

844. It would depend upon the layout and the infr astructure involved and the quality of the
vehicles that transported the material- their leakiness in particular. There would be issues of distance,
tortuosity of road network, and so on. Clearly, if it could be ascertained that there was absolutely
minimum spillage because the vehicles were entirely contained – sorry, that the seed inside them was
entirely contained – and that transport was simply from port to plant, along well defined roads – then I
would say that there was much less need or call for that. The importance or the need for doing this
would depend upon this range of factors and I think that they are uncertain at the present time. The
need is not great as it would be if the product was for growing and harvest in the country.
Canada
845. I'm not sure if Dr Squire could read a passage from the EFSA opin ion, where it discusses
these issues, that might allow him to provide a more complete answer. Is it possible to do that?
Chairman

846. Dr Squire, you're aware of that opinion?
Dr Squire
847. I'm happy to re-read the passage. I don't have it with me.
Chairman
848. We'll take a break on this one, and we'll stay within the GT 73 case and move back to the EC.
European Communities
849. Yes, just a follow-up to that question directly to Dr Squire. I was wondering if Dr Snow
would also like to comment, bearing in mind we're talking about glyphosate tolerant oilseed rape.

Dr Snow

850. I have the same general opinion as Dr Squire, that it all depends on how effectively spillage
can be controlled, and that glyphosate is the type of herbicide that is used so widely that that gene, if it
does escape into small populations, might spread. So th ere may be some concerns about the spread of
glyphosate resistance that I didn't address in any of my comments. But it's hard to answer the
question because we don't really know much about how these seeds are transported. When I read
these questions, my thought was, if they're just goi ng straight to processing, the amount of spillage
would be very, very small, but I don't know enough about how that works.
European Communities
851. Thank you, Dr Snow.
Chairman
852. Dr Squire, have you had the chance to look at this opinion?
Dr Squire
853. Sorry. I haven't got the paper with me.
Chairman
854. OK. It will be given to you right now. In the meantime I have a layman's question to,
actually any of the experts. Is every herbicide also a pesticide?
855. Dr Snow.
Dr Snow
856. I think so, in general usage, yes.
Chairman
857. That's quite enough, thank you. Maybe Dr Squire needs more time, but then we have still
open the floor on GT73. From the EC perhaps another question. Not to Dr Squire.
European Communities

858. We can move on to Dr Nutti, then. And as you saw in our comments to your replies, we
actually identified in the applicants own experi ments a number of reported abnormalities in the
animals fed with GT73, and they admitted a shortc oming in the design of these experiments. So we
were wondering whether, given these shortcom ings, and these facts, you would consider it
unreasonable for a competent authority to request additional data or to repeat these feeding studies?
Dr Nutti
859. You see, when I checked these studies, I checked the feeding studies with rainbow trout,
quail, broilers and lamb, and I could not find di fferences. If I could see the case, I could answer,
because of course if there are differences …???

860. … It was also the conclusion that the SCP has arrived at. So if we could see what are these
abnormalities because I didn't find them when I checked it. So if maybe at lunchtime I could see
these studies. Then I could answer, because as you can see my answer shows the SCP they didn't find
the difference. If I could see the things I would be happy to check it.
European Communities

861. Sure. They are contained in our attachment t oo, so we will print it out for you and we will
show it to you, and I refer to the rat studies, rat feeding studies.
Chairman
862. EC. More questions on GT73 to other experts?
European Communities
863. No more questions on GT73, thanks.
Chairman
864. Dr Squire, have you had the chance to look at the opinion?
Dr Squire
865. Yes. This describes the methods that are likel y to be used to transport imported … rapeseed,
to crushing plants, and the fact that the people doing that work, operators, are trained to avoid or
minimize spillage. It comes down to the leakiness of the vehicle and the distance over which things
travel. It's common knowledge in a number of Eu ropean countries that oilseed rape likes dockland
areas and ports. They occur there as a result of spillage during unloadi ng and storage. Now clearly if
the distance between the point of dockland (?) storage and the plant is short, if the vehicles concerned
are leak-proof, and if people are very careful, then this risk is minimal. I accept that. Those would
have to be conditions for the risk to be absolutely minimal. If the distance was long and the vehicles
were leaky then feral populations of the imported s eed would generate and pe rsist along roadsides.
Under the terms of this paragraph it would seem … If these conditions, as applied here, were applied
very rigorously, then I would say that the risk was minimal. There may well be no need for a post-
marketing plan, but I do not know personally whet her the vehicles used in these instances would be
leak-free, regarding seed. And that is something which is outside my knowledge at this stage.
Chairman

866. Any other expert on this question? No. Is Ca nada satisfied with the answer? Thank you.
The United States on this point. You raised your flag.
United States

867. As soon as you've done with this point …

Chairman

868. We are done with this particular point. We 're still in GT73 for follow-up questions by the
Parties. Any party I take this opportunity to give you an advance warning, after this point we'll move
to case 94.
869. Follow-up questions on GT73, the United States you have the floor.
United States
870. I just wanted clarification. The EC was going to provide a document with an attachment and
I just want to make sure that we all know where to find it. I presume it's b een submitted before I just
want clarification as to where it is so we can also look at it over lunch. If the EC wouldn't mind...
Chairman
871. EC, which attachment is it?
European Communities
872. We are talking about CD-ROM No. 1, exhibit EC 70, attachment 02, in Adobe PDF file.
United States
873. A little slower please, sorry.
European Communities
874. It was on our CD-ROM 1, it concerns exhibit EC 70, it is its attachment 02, and it's an Adobe
PDF file of 77,691 Kb.
Chairman
875. European Communities, do you have a follow-up question on GT73? This is not the case. So
with the open mandate for Dr Nutti's lunch break, we will close GT73. I see no objections from the
floor. So, as a test to your flexibility we now go to case 94. The reason being that this is the only
open question to Dr Snape. The only one on record, th at is. And we'll take the whole case in one, so
as to finish it before the lunch break. On 94 we have questions – recorded questions – from the EC
and from the Panel, to Drs Andow, Nutti and Snape. We 'll start with the complainants to ask them if
they have any additional unrecorded questions on M onsanto 8-10. This does not seem to be the case
for the time being. I'll give the floor to the EC on this particular case. EC, you have the floor.
European Communities

876. Thank you, Chairman. So our first question would go to Dr Nutti, and this is about
compositional analysis of hybrid GM. In your reply to question 44, you referred to different
approaches that can be used to perform comparis ons, based on the compositional analysis on a hybrid
GM. All we would like to know from you is whether the approach chosen by the competent authority
is one of these different approaches that you are referring to?

Dr Nutti

877. Can I check my answers here and answer you back?
Chairman
878. EC, try someone else?
European Communities
879. Sure. Do you want me to ask another question, in the meantime?
Chairman
880. Yes, please.
European Communities
881. Right, Dr Andow, can we ask you what you mean by alternative techniques, that the
competent authority would have to address concerns about additional DNA fragments? Thank you.
Dr Andow
882. Yes. This is elaborated in 44.10-some, but I gu ess the main point here is that if you have a
transformation and there is a possibility that there are many insertions going on, they could be on any
of the number of chromosomes and anywhere on a pa rticular chromosome. You really only want to
retain one of them. So one way to try to deal w ith that is you try to find them all molecularly, and
characterize them all, which is the approach that has been proposed in th e package here. But a
different way to do it is to try to eliminate them. Wi th an inbreeding plant such as soybean it's hard to
eliminate them, because when it inbreeds, all of the genes are retained any time there's inbreeding. So
it's like a brother/sister mating, you get that going on … But with an out breeding plant like maize it's
very easy to get rid of a lot of other genes, because you use a technique called recurrent back-
crossing. So you have your plant that has all the vari ous, the hypothetical transgenes all in it, and you
have your variety that you'd like to get the transgene of interest in, you cross them, and then you
evaluate the progeny and you only take the ones that have the transgene of interest. You keep doing
that, and if you do that for several generations you're going to get rid of all the other transgenes that
are on all the other chromosomes. So then you just have to deal with one chromosome. And maize
chromosomes are long enough, that most of that is going to get crossed out through recombination
during that process. So depending on how many ge nerations you do this, you can limit the area you
have to be concerned about to a relatively small part of the chromosome, and th en you can test in that
one area rather than having to do the whole thing. You can be even more efficient if you used
molecular markers to help you to screen the plants that you want.
Chairman

883. I'm sure that was very clear to Mrs Fries. Dr Nutti are you ready to answer question 16?
Dr Nutti

884. Yes, OK.

European Communities

885. Excuse me, Dr Nutti, could we have a second to make sure we've fully understood what
Dr Andow just said? Thank you. Chairman, may I attempt to ask hopefully a simple follow-up
question? Yes, to Dr Andow. This is just to make sure that the method you're proposing would deal
with the problem of multiple insertions. And only with that problem. So am I correct in saying that it
would not deal with the other possible unintended defects? And only molecular characterization
would? Thank you.
Dr Andow

886. As I've indicated, unanticipated – I call them unanticipated effects – would come about from a
number of different sources, some of which can be dealt with molecular characterization, some of
which can't be. So in general the point … the breed ing scheme that I suggested is not going to deal
with all of them. It will certainly deal with any of the multiple insertions that could be possible, but
there is still the one insertion that you're interested in, and that would need to be characterized.
European Communities
887. Thank you, that would be enough. Dr Nutti, can I now turn to you?
Dr Nutti
888. In my answer, when I stated that my understa nding is that there are different approaches, I
could say there are two different a pproaches that I underline that can be used when GM traits have
been combined by traditional breeding (stacked). And I would like first, before answering you, to
point out that when we were in the Codex- discu ssing the guidelines-, we didn't address this issue
because there was not an agreement if a stacked is a GM or not. There were different views and
different opinions because it is obtained by a traditio nal breeding of two GM. So when I am talking
about two different approaches, this is not in the guidelines because some countries have one
approach and some other countries have another way of viewing it. It's not written in the guidelines.
So one is that the comparison of the new hybrid sh ould be done with the GM parental lines, and this
GM parental lines should have been compared with the conventional counterpart. Another is that the
new hybrid should be compared with this non-transgenic parental lines. My understanding is that the
request from Europe was according to the second appro ach. But I would like to point out that this is
not in any guideline that you should go in this way or in another way. I mean, you have to analyse
what are the possibilities. Thank you.
European Communities

889. Thank you. Just to make sure, that means that the approach chosen by the competent
authority is a valid one. It's not in a guideline, I understood that much, but it's a scientifically
legitimate one.
Dr Nutti

890. There is not … Yes, because both ones can be done … also the competent authority could
have analysed the other one because there is no doc ument saying that you should go in this way or
other way. So if there was not in that way it coul d have analysed the first option. For instance, in
Brazil when we have to do that, we try to analyse the information that is available and then try to

discuss if it's possible or not possible. I am not say ing that this is wrong. I am saying that there are
different ways to analyse and they submitted it in one way. That can be analysed in that way.
European Communities

891. Thank you. Chairman, our last question would go to Dr Snape. So within the process of
stacking two independent GMOs, DNA sequences may be partially lost, rearranged, etc., This may,
for instance, alter the gene copy number or gene expression profiles in the stack as compared to the
parental lines. In turn this may explain the differe nce observed in protein content. Do you agree with
the Dutch authority that detailed molecular charact erization and DNA sequence analysis of the stack
are therefore elements needed to carry out an adequate risk assessment?
Dr Snape
892. Thank you. I have not read the information/ dossier on this particular product so I cannot
comment on the quality and quantity of the molecular information supplied. My understanding is that
I presume that when you mean two independent GMOs, you mean two independent transgenes, you
don't stack genetically modified organisms, you stack transgenes into one genetically modified
organism. My understanding would be that there ar e different ways of stacking transgenes. You can,
first of all, take them from individual products and backcross them into a single individual where they
would be in the homozygous stable inherited state. The other is, if you were creating a maize hybrid,
is to put a different transgene into each, or the sa me transgene into each half of the hybrid into two
separate inbreds, and then you would put those toge ther in the heterozygous state within a single
hybrid, which I presume is what's happened with the product we're talking about.
893. Yes. Thank you. My opinion would be that, if the individual inbred lines that the molecular
characterization had been carried out to show that the transgenes were stable and stably inherited, then
I don't see any reason why they should be instab ilities introduced just because they're in the
heterozygous state. So I'm not sure what info rmation these phrases, that DNA sequences may be
partially lost or rearranged, is based on, unless th e transgenes are the same, in which case there are
opportunities for them to recombine or that, if there are homologous sequences between the
transgenes then there may be opportunities for them to recombine.
894. If the transgenes are separate and there is no homology between them, I see no reason why
they should recombine or why there should be any problems of stability, or why it would be necessary
to resequence. If they do recombine because th ey have homologous sequences, or there is the
opportunity for homologous sequences, then this could lead to a situation in which there would be a
rearrangement in the transgene structure. Therefor e it might be a necessity to reanalyse the molecular
characterization of the recombined transgenes.
European Communities

895. Thank you, Dr Snape.
Chairman

896. Does that conclude the EC's interest in MON 810 for that state? It does …The Panel has two
questions on this case. They are questions 31 and 32 . And they go to both Dr Andow and Dr Nutti.
Whoever wishes to take the floor first, is invited to do so … Dr Andow.

Dr Andow

897. I'll go ahead. I'm not sure I'm going to answer your questions directly. I'm going to say
simply why I can to my view, and then put the burden on my colleague Dr Nutti to explain the
difference …So first of all my response is not give n in the context of Dr Nutti's responses are given,
of food safety in terms of the codex issue. I'm l ooking at it from an experimental design perspective.
And there is a certain uncertainty, for me, what are the main questions that are being addressed? So
you have a non-transformed plant maize, you have the transformed maize, and then you have the
transformed maize with glyphosate applied. And so if you want to know what the effect of the
transformation is, on the food content, you'd probabl y want to compare the non-transformed one with
the transformed one, without the herbicide. In the ev ent that the herbicide could have an effect. The
experiment that they conducted was essentially the non-transformed variety and the transformed
variety with the herbicide. So, I concluded that th ey couldn't really determine that the differences
were associated with the transformation. Now the thing about that, is that you could argue that any
difference that occurs between those two are going to be the sum with the interaction between the
herbicide and the transformation. So if you don't see any difference between them, then maybe there's
no difference in either. But it's also possible that they cancel each other. That's why we wouldn't
consider it an effective experimental design for is olating one factor. Now whether or not that was
essential to isolate that factor, I couldn't determine fro m the information. But if the question was that
you want to determine that the transgene had no effe ct on food, then I felt that the experiment didn't
really conclusively address that question.
Dr Nutti

898. In my answer, I was looking at the food composition and usually the main thing is to compare
the GM with the non-GM, because usually you have the information about the herbicide being done
before, when the herbicide is approved. So when we try to look at this, you have to have the
comparison with the GM or the non-GM. There are cases that further information has been requested,
as was in this case, and then you can check that th ere was no difference. Because if the herbicide was
being used according to the level that was established, it would be no different, so this is why I answer
in this way.
Chairman
899. Thank you. 32?
Dr Andow
900. I have to say I can't find the notifiers response in exhibit 90, in the case 94.
Chairman
901. We're having a look. In the meantime I will ask the EC to take the floor.
European Communities
902. Chairman, we would like to ask a follow-up question on your question 31 to Dr Nutti.
903. Thank you, Mr Chairman. Dr Nutti, the Codex Alimentarius guidelines, mention among
others things with regard to the design of fi eld studies for compositional analysis that herbicide

treatment should be taken into account. Do you agre e with the Codex Alimentarius paragraph on this
issue?
Dr Nutti

904. Can I point out what is the paragraph we are citing? If it's in the GM or in the pesticide
analysis?
European Communities
905. In the guidelines on foods derived from GM crops.
Dr Nutti
906. Can I just check it?
European Communities
907. Yes, it's in paragraph 44, in the fourth and fifth line, where it says "in some cases a further
comparison with the recommended DNA plant grow n under its expected agronomic conditions may
need to be considered, for example, application of an herbicide".
Dr Nutti
908. Yes, but I think this is why we are using the word "may", so you have to check if it's
considered or not. So we can check the opportunity to see. So maybe consider …
European Communities
909. Thank you very much for your answer.
Chairman
910. It looks like on 32 we need some more time. The United States has asked for the floor.
United States
911. It's a follow-up to Dr Nutti, unless she's working on 32. OK. This goes to …We were talking
about the different approaches for crosses and the EC asked you a question about it, and you spoke
about the different approaches in the discussion on C odex. In your answer you wrote "in conclusion,
my understanding, is that the information submitted by the applicant was sufficient to ensure the
validity of the safety assessment". That was your conclusion. Does your discussion with the EC
about the different approaches change that conclusion?
Dr Nutti
912. No. My discussion didn't change that conclusion. I just agreed that they can go in another
way to try to check but the conclusion, I think, will be the same, because the information is the same.

Chairman

913. The floor is still open on 94.
914. The EC has the floor.
European Communities
915. Chairman if I may comment on this. May I? I can put it in the form of a question.
Chairman
916. You must!
European Communities
917. My understanding of what Dr Nutti said is that there are two different approaches, and my
assumption is – and maybe Dr Nutti wants to confirm – that these two differe nt approaches are based
on differing views as to what is necessary and how you want to go about doing it. And my
understanding is that you're saying that the appr oach chosen by the competent authority is valid
because that's from their point of view what is necessary. We're not contesting that from the point of
view from the applicant who has chosen the other ap proach, it would be equally valid from their point
of view, but we're talking about two different approaches here which are equally valid, right?
Dr Nutti
918. I will try to make myself clear again. There is no guideline saying that you go in this way or
that way. So in my personal opinion you can go in either way. The applicant has chosen one way.
And in my view the way the applicant chose has prov en that the product is OK. But if you choose the
other way, you can, because there is no guideline sayi ng that you have to go in this way or the other
way. But in this case the applicant will be able to show to you that his information is also valid and
the way that he has chosen can prove that the product is safe. So this is what I'm trying to say. I don't
think that you were not …
European Communities
919. Can I still follow-up? Could it be possible that if , on top of the first approach chosen and the
data submitted in line with the first approach , you request the second approach, there could be a
different outcome?
Dr Nutti
920. I don't think so.
European Communities
921. You don't think so?
Dr Nutti
922. Yes. But I didn't see the other way, so this is …

923. I'd like to make it clear that we don't have any guidelines saying you should go in this way.
So you can try to go in one way and reach one conclusion.
European Communities

924. Thank you. I think that's all.
Chairman
925. Dr Nutti, can I clarify this review?
926. Does it mean the applicant was not given the information on which way to choose, no
instructions, no … he was not?
Dr Nutti
927. As far as I know, there is not an information saying when you have a stack, you have to go on
this way … You try to go on the way that you can or that when you believe that you are going to
prove … When you have a stack, you have a cros s, a conventional cross of 2 GM, so how are you
going to compare? Are you going to compare thes e two with the one that they are derived from,
which are GMs? But in this case you say, oh, but you need to compare also with the non-GM, that
was before. This is one way. And the other way is to prove that the first alteration was done and then
the second was done. So there are two ways but nor the Codex or anybody has said you have to go in
this way or the other way. This is what I was trying to say in my answer.
Chairman

928. And both ways are likely but not necessarily leading to the same result. That's what you were
saying in answer to the questions from the EC.
Dr Nutti
929. Yes. The way that I analyse it, the results confir m that they are safe. My personal opinion is
that the other way would lead to the same conclusion, but they didn't have this information, so …
And nowadays we don't have these established becau se for a lot of countries involved, they don't
believe that staked should be treated exactly as a GM because it was a conventional breeding. So this
is why we never reach an agreement.
Chairman
930. Thank you. Dr Andow would you be ready to reply to question 32, or Dr Nutti for that
matter? OK,we have to wait a little more. Thank you, Dr Andow.
Dr Andow
931. The answer to the question, according to th e chronology the notifier did not provide a
response until February 2002. In terms of whet her the additional information would require
19 months to gather and provide, part of that depe nds on how the notifier decided to respond. They
provided considerable information in their response. My response was concerned primarily with the
glyphosate treatment. And in reading their response, the response to that part of the question would

not have required 19 months to gather. However, I do note that there is extensive experimental results
on a broiler study and I would have to defer to Dr Nutti for an opinion on that.
Dr Nutti

932. Usually the broiler study is 48 days, but here they have carried also other studies because they
have carried the 90 days study and other studies. Th ey have a 13 week feeding with rats. Sometimes
you need to grow the grain, to prepare in order to fe ed exactly with the experiment. So, if they need to
have the grain that they need to multiply, it would take more time, so this might be possible that it
would take the time necessary.
Chairman
933. Thank you Dr Nutti. Now I believe this takes us to the end of 94 and also in that case to the
end of the morning session. We will here say goodby e to Dr Snape, with our sincere thanks for his
contribution, they were very valuable, and we will resume at 3 'o' clock sharp. Thank you. [Pause]
934. Before we start on Case 74 I would like to ask Dr Nutti if her lunch break has been
successful. You are still looking at it. Would the EC care to come back on 64? There is no more
point in 64. So that case is also closed, thank you. So, with an open point in 70, I now turn to Case
74 which is BT Corn and I have questions from the EC and from the Panel, but I will again ask first
the Complainants on 74 whether they have any qu estions which have not been notified to the
Secretariat. No for Canada, no for US, no for Argentina. EC has the floor on 74 please.
European Communities

935. Thank you Mr Chairman. We have a questi on for Dr Healy. We would like to know,
Dr Healy whether, in light of your reply yest erday to Question 21 and recalling the submission of
2000, you would agree that it would have been feas ible for the notifier to provide sequence-based
information about the transformed and integrated se quence as part of the molecular characterization,
rather than only the southern blot information as it was submitted.
Dr Healy
936. I'll preface my comments by saying that this is not one of the dossiers that I have reviewed, so
I can only answer in a general way. Looking at Question 21 from yesterday, it was about whether the
complete sequencing of the transformed and inser ted sequences could have been done with the
application of standard molecular techniques in 1995. You have just asked, would it have been
feasible for the notifier to provide sequence-based information? I would expect that it would have
been feasible for that information to have been provided.
European Communities
Thank you very much.
Chairman
937. No more questions from the EC? That is catch ing me by surprise. I have, from the Panel,
one question to Dr Nutti and one to Dr Andow. Dr Nutti could you answer Question 24 please.

Dr Nutti

938. I was unable to reply to Question 32, because it was related to molecular characterization. I
was unable to answer Question 33, since, as I explain in my answer, the information was very difficult
to handle. The request for the information was not provided in a straightforward way, so it could not
be analysed completely. I did not find the relevant data. This is why I could not give the information.
Chairman
939. Dr Nutti, do you refer to the documentation provided by the notifier?
Dr Nutti

940. By the notifier. The notifier did not give the straight information unlike the other files that I
worked with. This is why I stated – it was not the Panel's fault, it was the notifier's.
Chairman
941. Thank you, that is clear.
Dr Nutti
942. Thank you.
Chairman
943. Dr Andow.
Dr Andow
944. Thank you Chair. Because of the nature of th e product, I would have to assume that the
information was somehow related either to a food or a feed issue, which is not my strength. That is
why in my answer, I indicated that I could imagine so me reasons, but I couldn't really be sure that any
of them were valid. The only things that I could even start to imagine had to do with establishing
substantial equivalence. What is puzzling here, is that in the other cases there weren't requests for
specific geographic locations in terms of establishing substantial equivalence. I was not entirely sure
about what the purpose of these requests could be, except to ensure representation in the sample.
Chairman
945. Thank you. This concludes the Panel's questions . Are there any follow-up questions to the
experts, or perhaps a clarification from some party on behalf of the notifier? The EC has asked for the
floor.
European Communities
946. I have some difficulties with these studies. I would like to understand better, because we tried
to highlight in our comments what we thought was the reasoning. I'll go back to page 74. What we
think is relevant here, is that this application for maize was for import and processing. Therefore the
compositional analysis had to be done with regard to the geographical location of the growing of the
plant. The problem here is that the notifier submitted field trials that were done either in France, or in

Italy, which being EU countries, would not be relevant because the plant would not be grown there, or
Chile, which was not usually an exporter of maize into Europe. Could Dr Andow please explain what
the problem is with asking for this kind of additiona l studies, in a situation where the analysis has to
be done with regard to the imported product, plant, and the compositional analysis relates to where the
plant is actually grown. The soil composition, the environment, or the habitat for pests.
Dr Andow

947. As I detail my answer, it is surprising that th e notifier said that they were going to submit
information from France and Italy about maize th at was going to be imported into the European
Communities. And so I agree on that point. I gu ess what I couldn't find when I was going through
the files is a clear statement as to why the request wa s made. That is what led to my last comment in
my answer, and probably stimulated the question from the Panel. My response to that was essentially
similar to what I think you just said. But again, I have to say that it is not my area of expertise.
European Communities
948. Thank you very much
Chairman
949. Dr Nutti.
Dr Nutti
950. There was a lot of attachments in that file whic h had the title but did not include the annexes.
So, for instance, in my case I tried, and was unable to see attachment 36. I didn't have the information
that was in the annex. It can't be known what the purpose of the studies that they are referring to is.
Chairman
951. Thank you, Dr Nutti. Can I ask you, in terms of risks for feed use or food safety, what is the
potential impact on safety from the place where it is grown?
Dr Nutti
952. When we design an experiment, for instance in Br azil, we try to grow the crops in three or
four different places in order to have different hab itat stresses and submit the product to variation. In
these cases, it is important to have the informati on not only for one place, but for different regions
with different stresses. That is why in the Codex we say that relevant differences should be taken into
account. For instance, when we design a project with beans, we develop a few trials in five different
regions of Brazil in order to have different inform ation from different soil and different stresses. We
cannot rely on only one or two, or only one that is the places where we will be growing. You have to
have variation.
Chairman
953. I understand that this could affect environmen tal impact, but how then does this bean from
different regions in Brazil have different effects on feed safety?

Dr Nutti

954. Sometimes it is not only the environmental impact . The soil can have an effect on the mineral
composition.
Chairman
955. And that has different impact on the feed or food safety – not quality, but safety?
Dr Nutti

956. More on the quality. For the s ubstantial equivalence we need to see if there will be any
difference, so this is the first step. If there is a difference you have to pay more attention. This is why
you have to grow the plants in different places.
Chairman
957. And it could be that one of those five regions in Brazil produces a bean which is unsafe?
Dr Nutti
958. You cannot give an answer about safety, based only on one issue. For safety evaluations you
have to conduct many studies and compare all the results. You cannot give an answer about the safety
of the product, based only on one result.
Chairman
959. Right, but it could be that the safety is differently affected in different regions?
Dr Nutti
960. It could be that you have a different result, and then you have to conduct other studies. And
then you have to compare the results. I cannot affi rm that, for instance, if the iron amount varies
from one place to the other that this will have an im pact on the safety of the product. But attention
has to be paid, because there is a variation. Maybe the rat fed on a plant grown in one area will not
gain the same weight as a rat fed on the same plant gr own in a different area. I have to pay attention
to this type of indicator.
Chairman
961. Thank you. Canada, on this point.
Canada
962. This isn't really our product, but I do have a question, because I am a little confused by the
answer. This seems to suggest that food, no matter how it is produced, if it comes from different parts
of the world, would have to be tested at least th e first time that it is imported, given that there are
changes in composition. Is that really the case, is that what the EU or other countries do? It doesn't
sound to me like it's a GM issue per se, it's simply an issue of food importation.

Chairman

963. Dr Nutti, perhaps you can clarify? Dr Nutti?
Dr Nutti
964. Just to clarify Canada, I think the question for th is is that, when you prepare a trial to submit
for comparison that you need initially to have diff erent growing locations. But in my opinion you
don't need that the second or third time you submit a tr ial. You need to grow the plant in different
places to have different stresses, in order to have a variation.
Canada

965. Thank you. I was simply asking is this a GM issue or is it a food issue? Thank you.
Dr Nutti
966. No, we are supposed to do this when we have a GM product, because it is a food issue. But
you have to have information for both the non-GM and the GM products. Because, with regard to the
information on the non-GM, you also have to have da ta from different places, to capture the a natural
variation.
Canada
967. I'm sorry, just to be clear. There is a natura l variation whether the food is produced through
transgenesis or otherwise?
Dr Nutti
968. Or otherwise, of course.
Canada
969. Thank you.
Chairman
970. Does that conclude questions on 74? United States.
United States
971. We'll have to consult. Please put one of your special holds on this and go on. Thank you.
Chairman
972. 74 on hold. We move to 75, Bt corn again. And there are two questions from the Panel. One
question to two experts. That is Question 26. Could one of you respond, or both.

Dr Nutti

973. My answer on 36 was with regard to the protein. On my understanding the protein used on
the toxicological and allergenicity tests was obtai ned in a heterologous system and not from other
maize. hen I read the question it seemed to me that the person who was asking had understood that
the protein was obtained in another maize variety. Then the notifier explained that the evaluation had
indicated it was not the bacteria that provided the protein. Maybe the reason for the misunderstanding
resides in the fact that the same protein is expr essed in two maizes, and they had these two numbers.
his was very difficult to analyse. It is a lot of in formation. The important thing was that the studies
were carried out with protein derived from recomb inant micro-organisms that were proven to be the
same.
Dr Andow

974. I would say that I agree entirely with that analysis. But the reason I concluded that the
question was necessary was because the CA at th at time was under the understanding that it was
something different. They had to ask the question in order to clarify that it was or was not. Once they
got their clarification, that was the information necessary to proceed.
Chairman
975. Thank you. Any follow-up questions on 75? From the Complainants? The EC?
European Communities
976. Chairman, I would like to ask Dr Nutti whet her you saw our comments. We are under the
impression that actually the misunderstanding is of a different nature, in the sense that you base your
reply on information provided by the applicant ex post actually, following the request from the
competent authority. Do you want to take a look at this? It is in 444. We are claiming that you are
basing yourself on attachment No.1 EC-75 and that th e data contained in this attachment is actually
data that was provided in 2002. (This may be our mistake.) The request made by the competent
authority dates from 2001. We can clarify this: probably attachment 1 is an updated SNIF or
something. That misunderstanding might have come about this way.
Dr Nutti
977. I did not check exactly the date, I was checking the technical information. The information
that was there, maybe it was 2002, proved that it was the protein that was necessary. So I can go back
and check this.
European Communities
978. Well, Chairman, if you want, I have the attachme nt 1 in front of me, and indeed the top date
given in this letter is 14 February 2002.
Chairman
979. Any more flags on 75? This is not the case, so we move to 76 and Case 603. Round-up
Ready Corn and Cotton. Here we have questions from the EC, from Argentina and from the Panel. o
I would suggest we start with Argentina, that's NK 603 Maize to Dr Squire. Argentina, you have the
floor.

Argentina

980. Thank you Mr Chairman, just allow me to make a clarification. The nature of the questions
of the debate which took place yesterday and this mo rning, in our perspective, satisfy our related
questions. We prefer to reserve our right to ma ke a follow-up questions if necessary after the
exchanges of questions that you or the Community may put, thank you.
Chairman
981. Other Complainants' questions? Not the case. The EC please.
European Communities
982. Chairman, we are on EC 76, right? I don't think we have a question on this one, thank you.
Chairman
983. I was given to understand that you did have qu estion to Dr Nutti on food use of NK603.
EC96.
European Communities
984. On food use – that is EC96. So we would come back to that later.
Chairman
985. 96 is not on my list, and it concerns the same product, right?
European Communities
986. But it concerns food use, so it's under a different regulation.
Chairman
987. Yes, I'd rather have it now, so that it won't be forgotten.
European Communities
988. In our document that we submitted this morning, this is in paragraph 20, it is a question to
Dr Nutti on Question 53 of the Panel. Yesterday you replied to our question on Question 111 of the
Panel that food studies and molecular characte rization are complementary. Would you agree,
therefore, that whole food studies can provide assu rance regarding the safety of the second protein
that was identified in the further molecular characterization.
Dr Nutti
989. If in this case there was a second protein, I would agree. When I was looking, I was not
aware of a second protein. But if there is a second protein in the molecular characterization, I would
agree with the test.

European Communities

990. Thank you, perfect. There was a second protein.
Chairman

991. Ok, so here we go with the Panel's question. Question 27 to Dr Andow, please.
Dr Andow
992. It does look like I am reversing my opinion be tween 37 and 38. But my opinion 37 is based
on what I read by the lead CA. The questions that the lead CA posed in 2001 were all prefaced by the
remark that I put in here - "although this is for no tification, it is not for cultivation". We know that
cultivation is going to come up soon, and so we are going to ask these questions in that eventuality. It
seems to me that it is a not necessary for a notifier to answer questions, any questions related to a
future event. I point out that it is true that these questions will need to be answered in the future.
Then the CA makes a point specifically about accide ntal dissemination and germination. I could not
see exactly how these points had been covered by the notifier previously. I felt that it wouldn't be
difficult to cover them, but since they had not b een covered, it would be necessary to have that
information.
Chairman
993. Thank you. Dr Squire on Point 28.
Dr Squire
994. Maize and soybean and thousands of subtropical and tropical plants exist in Europe. Often
they exist around points of entry, where foodstuffs are imported, around plants for the processing of
those foodstuffs and sometimes around restaurants and other places where the food might be put into
refuse. Maize is one of those plants. It exists widely, but not in any great density in these locations.
Where it is cold - this is a generalization - toward s the north of Europe, it doesn't really last beyond
the season it emerges in. Now, it is less cold toward s the south, and there is the possibility that this
kind of seed, the seed resulting from spillage or from refuse might persist for more than one season.
The level of problem here is much less than that of crops that shed their seed in fields and persist over
many years. It is a minor problem, but it seemed to me that because it was fa irly widespread in the
case of maize that the CA was making a reasonable request about this issue.
Chairman

995. Any follow-up questions on Dossier 76? Argentina you have the floor.
Argentina
996. Thank you Mr Chairman. Argentina would like to go back to Question 53 on the so-called
second protein in NK603. Argentina would like to point out that the second protein was the same
protein, CP4EPSPS which was introduced purposely, as two copies. The second copy was mutated in
one single nucleotide, so this second protein was act ually the same protein with one permutation.
This so-called second protein was analysed by protei n structure activity, toxicity, allergenicity, using
bioinformatics approaches, invitro digestion pr ocedures and studies on experimental animals and
animal field trials. These analyses indicated that this NK603 so-called second protein is absolutely

similar. It has the same biological effects that the non-mutated NK603 CP4EPSPS protein. There is
no second protein. It is the same protein, but th e second one has a permutation which didn't alter any
of the products. Did Dr Nutti examined or analyse the statement in our 25 page 2, fourth paragraph
and if, so what does she think about that?
Chairman

997. Can you give the text to Dr Nutti? Thank you. Argentina you want to quote the text so
everybody can have a look at it? Just give us the number of the Exhibit.
Argentina
998. It's Exhibit EC76, Attachment 70, which we submitted as Argentina 25. It's the same exhibit
that we provided to Dr Nutti just now.
Chairman
999. Does that allow everybody to look up the text? United States?
United States
1000. I apologize, the EC Exhibit number we are working on now is which?
Chairman

1001. I understand we are talking of EC-76 Attachment 70, also submitted as Argentina 25. So now
Argentina must repeat the question, not the statem ent, thank you. And which particular question are
you referring to. Which product, Sir?
Argentina
1002. The question for Dr Nutti is, if in view of what the Exhibit shows, she is of the opinion that
the second protein, being substantially equivalent to the first protein, can be dealt with as the same
protein for food purposes. Page 2, paragraph 4.
Dr Nutti
1003. I read page 2 and paragraph 4. I would like to go back to the question that the EC asked me,
because you are referring to the same point. I don't know the number of the question. Could you
please inform me what the product was and what was the question? They were asking for additional
feeding studies. If I don't see the question I don't know which additional feeding studies.
Chairman

1004. Help from the EC?
European Communities
1005. We are talking about Question 53 of the Panel. I put a question to you just ten minutes ago
about its NK603 food use, and I was referring to ou r paragraph 444 in our submission. It is in our

paragraph 20 and this was going back to what you said yesterday in the context of Question 111 of the
Panel.
Dr Nutti

1006. When I answered this question, I said that the applicant has provided in the dossier all the
information usually requested for food safety asse ssment, for toxicological assessment, he presented
the studies for CP4EPSPS protein digestion in animal gastric and intestinal systems, acute gastric
studies in mice, homology to known toxins, and allergens, and exposure to human diet. It was also
confirmed that the GM maize was equivalent in composition and nutrition to the conventional
counterpart. Therefore in my opinion there was no need for requesting a semi-chronic toxicity study.
1007. Yesterday you asked me if I had a doubt in the molecular characterization and if I agreed with
another feeding study. I said yes, I agree, because if the molecular characterization raises any doubt,
it should be taken into account. Today when you asked me about a second protein, I thought if in fact
there is a second protein, for me this raises a doubt. But when you look here in the analysis of the
scientific panel of the European Union in this para graph, there is no doubt. The analysis shows that
the protein is equivalent. This is not a second protei n, it's almost the same. As a result of the genetic
modification the product contains two slightly different proteins expressed from two copies,
CP4EPSPS. The proteins differ from each other in one amino acid, and analysis of this change
indicated no apparent changes in CP4EPSPS protein activ ity, toxicity or allergenicity. In this case a
second study is not necessary. There is one point that we need to pay attention to, that is a case by
case evaluation is needed. I cannot answer these questi ons generally. I would like to go back to the
product and to the question, because it is fair to analyse it this way.
European Communities

1008. Thank you Dr Nutti. I realise that it is difficult if people start throwing documents at you in
the middle of the meeting and expect you to provide expert reply on the spot. I would just like to
point out that the document referred to by Argen tina is the EFSA opinion of the year 2003. We are
talking about a request for additiona l information for the year 2001. That is all I would like to say,
thank you.
Chairman
1009. Thank you. Does this clarification take us to the end of dossier 76? That seems to be the
case. I then move to 85 and read that this is Monsan to Upgraded Corn again. Here I have a question.
United States, is this on 76 or 75?
United States
1010. We think it is on 76 but are not exactly sure where we are.
Chairman
1011. I'll put you on hold then. Does anybody from the Complainants have a question to the experts
on 85? No, then I give the floor to the EC for your question to Dr Nutti.

European Communities

1012. Thank you Chairman, this should be a straightfo rward one. We are talking about EC85, that
is the Monsanto Roundup Ready Corn GA21. That was the Question 40 of the Panel to which you
replied. The question is simply whether you agr ee that animal feed might differ from foods from the
same crop. I think we talked about this today already, as well as that the animals consuming the crops
can differ widely in physiology, intake digestion et c. We would like to know whether you think that
such differences exist, and whether that affects the risk assessment.
Dr Nutti
1013. There are differences that exist and usually we start the risk assessment with a 90-day study
with rats. Then you also go to 48-day study with boiler chicken study because this gives you a better
answer with less time. Then, depending on these firs t two, and also the acute toxicity study, you
analyse whether you should continue with different studies. The person who is conducting the safety
assessment should take into account the first results and then look for the need to go to the next ones.
European Communities

1014. May I follow up on this? Could additional studies include studies on target animals, because
my understanding is that boiler chicken is not necessar ily the target animal of the feed used, but
ruminants.
Dr Nutti
1015. There were some cases which asked for more test s on target animals. If you go back to the
Codex, you see that the Codex is very clear that if none of these tests show any difference, going to
the target animals will not always be necessary. Y ou have already an indication that there will be no
differences. The Codex is very clear that add itional animal testing is not necessary when the
composition is comparable. Only if you see differences for instance in the fatty acids and the profiles,
then you should go for additional testing. But if you don't see differences, it is questionable if you
need to go further.
European Communities

1016. Thank you. We all agree that Codex is on food, and we are talking about feed safety here.
Chairman
1017. Ok, here is a question from Mr Kumar
Mr Kumar
1018. I wanted to address a simple question to Dr Nutti. If something is safe for human beings can
it ever be unsafe for animals?
Dr Nutti
1019. I don't believe so.

Dr Kumar

1020. So there is no practical evidence of anything which has been declared safe for human beings
being possibly or potentially unsafe for animals?
Dr Nutti
1021. I cannot remember, because I have to think about specific papers. In general, as far as my
knowledge goes and based on everything I have been d ealing with, I don't see any practical evidence.
This answer is limited in the scope of this product, and not in the scope of different products.
Chairman
1022. I have ticked off 85. EC you have the floor.
European Communities

1023. What Mr Kumar asked is interesting. There is a lot of brainstorming going on around this
table because we all would know of immediate exam ples of things humans can eat, and animals can't
eat and the other way round. As far as I understand, there are parts of a plant which a human would
never eat, and animals eat, so there are certain test s which simply do not provide the data you would
need on animal safety. Second it see ms that there are certain things we eat, that you could not feed to
an animal without killing the animals, such as s ugar in excessive amounts to cows. Everyone around
the table can eat excessive amounts of sugars, but appa rently that is not very good for ruminants, right
Dr Nutti?
Dr Nutti
1024. When I gave my answer I tried to state very clear ly that it was in the scope of this product.
The question was if this maize grain is good for a humans, whether it is going to be bad for an animal.
That was the question, and my answer was in the scope of this product.
Chairman
1025. We have a follow-up question to Dr Kumar's ques tion. Would you say Dr Nutti, that this is
both the case with regard to potential adverse eff ects on animal health and with potential adverse
effects to humans from consuming the meat of those animals? You said that this product is basically
safe, if it is safe for humans, it is also safe for animals. Would that apply both with regard to potential
adverse effects on animal health like you said, but also with potential adverse effects to humans who
consume the meat of those animals?
Dr Nutti
1026. I have addressed this issue in one of my answ ers, when you asked about the potential effects
of the GM products in milk, meat or products thereof. In my answer I even cited a bibliography of the
studies that have been done with these products. Up to now with the products that are not different in
composition there is no difference in the meat, in the eggs, or in the milk. Maybe in the future when
we have products that will be different in the fa tty acid composition, we will have differences on the
composition of the product, but with these products that are on the market now we don't have
differences in the composition of the meat. For in stance if a cow was GM fed with one of these
products that were not different in the composition, the studies that have been published up to now

show no difference in the composition of the milk or the meat. EC in its comments to my question
and my answer, gave the example of the high-oleic soybean. I don't believe that anyone will feed a
cat or a pig or a chicken with a high-oleic soybean because it has been used for capsules. It has a
different concentration in the fatty acids than the pro ducts that are being used for feeding the animals.
Thank you.
Chairman

1027. Thank you. The EC.
European Communities
1028. One last point on the issue of GA21 maize a nd how animals and humans eat that product.
Assuming that, this is indeed only about kernels an d I am told that humans eat only some grams of
maize kernels per day if at all, whereas cows can eat between 5 and 10 kilos of maize kernels. The
intake might be substantially different which might have an effect on how it affects the being eating it.
Dr Nutti
1029. The question that was before me was from the Panel. I don't think I need to answer it.
Chairman
1030. Thank you.
European Communities
1031. What was before you and what was put to you from Mr Kumar was to know whether the food
safety assessment on this product could be transferre d without any hesitation to the issue of feed
safety. The point I am trying to make is that it cannot be transferred without any hesitation because
the intake is different and that might make a difference in how it affects safety.
Dr Nutti

1032. I pointed out several times that the compositi on matters. This is a key issue. If the
composition is the same, we can go further. While you are talking about kernels or the grains, I was
talking about the grain and the composition of the gr ain. The way we are going back and forth with
the different products is misleading.
Chairman
1033. Here is a contribution from the Chair. When we wanted to supply raw milk cheese from
Switzerland to Australia, the health authorities to ok a long time to assess the risks to humans, and
when they finally got through, the veterinary authorities wanted to have a check on their own, because
possibly our Gruyère could contaminate Australian cows. That case was even tually also solved.
Anyhow there seemed to be differences in at least, in some parts of the world, on intake by humans
and by animals of the same product.

Dr Healy

1034. I think that this is an interesting example, but that comes to different pathogens that would be
associated with the product. Some pathogens ma y affect animal health and some pathogens may
affect human health.
Chairman
1035. We have no more questions on 85 now. We go to 87. The Panel has one question on this
case. It goes to Dr Nutti and Dr Squire.
Dr Squire

1036. I'm not certain that I can comment competently on the food safety risk in this case, and would
defer to Dr Nutti. I think my interest in this qu estion was on the plants that might survive. I would
say that I am not competent to respond to this one.
Dr Nutti
1037. As far as I can remember, this was a case in which the lead CA asked for at least two seasons,
because usually when you make the comparison, you need to have information from more than one
growing season for a particular product. If you need two seasons the applicants has to grow each two
times, extract and then analyze both seasons. He could not have done that with only one season. I do
not remember if they had presented two seasons at one time. When I answered this, what I was
looking at in the papers was the notification that the additional information regarding the data of the
composition of high-oleic soybeans lectin content and composition data was from at least two
seasons.
Chairman

1038. The question is whether this could have been a ll asked at the same time. If you see that the
request came in December 1998, in January 1999 and in October 1999.
Dr Nutti
1039. Yes, it could be done at the same time. If you look at the information and you see only one
season you ask for the other ones. It is not necessary to do it in different times.
Chairman
1040. Dr Squire is of the same opinion?
Dr Squire
1041. From what I have just heard, I would agree with you.
Chairman
1042. Thank you. Any follow-up questions from the floor on Dossier 87? EC.

European Communities

1043. A hold on this one please, Chairman.
Chairman
1044. Meanwhile we move to 88. Monsanto Sugar Beet. The EC has a question to Dr Nutti.
European Communities
1045. This is a question on EC-88, that's Monsanto Syngenta Round up Ready Sugar Beet. It is a
question on allergenicity. I would like to know whet her you agree that small amounts of allergenic
proteins might be enough to cause an allergic reaction?
Dr Nutti
1046. Yes I agree.
European Communities
1047. Thank you. So your statement in your reply th at allergens do occur at higher levels than one
per cent, does not preclude the risk of allergic reac tions to small amounts of proteins - smaller than
one per cent?
Dr Nutti

1048. This is different. The protein that can cause th e problem is in a very small amount. What I
was saying here was that food allergens are generally abundant in food, usually greater than one per
cent of the protein. This is a statement that ever ybody who deals with allergenicity knows. I am not
saying that you need one per cent to cause an allergy, I am saying that the food allergens usually have
more than one per cent of the protein.
European Communities
1049. May we follow up on this. Dr Nutti, Given your answer to the previous question, would you
agree that if a cross-reactive protei n were present in a plant at low leve ls, this could, in theory, illicit
an allergic reaction?
Dr Nutti
1050. Under allergenicity, we need to follow all the steps that are recommended for allergenicity, in
the Codex guidelines. You cannot just pick one exam ple, you need to go with the entire analysis and
then see if it will probably cause a reaction or not. We cannot rely only on one data point. You have
a step by step procedure in the Annex that you fo llow one step at a time. If there is a doubt at a
certain step, then you go to the next step, and to th e next step. I would not answer based only on one
set because we need to analyse all the points.
European Communities
1051. Just for clarification, calling a protein cross-re active implied that other parameters had also
been confirmed, but thank you for your answer.

Chairman

1052. Thank you. Any more questions on 88? Othe rwise Dr Nutti can close her microphone, and
give her a break for some moments. We are going on to 89 and here the Panel has a question to
Dr Healy. Question 30.
Dr Healy
1053. There are a number of documents in the dossier th at relate to this question, but the dossier
does not appear to be complete. As far as I can work out the history associated with the development
of this detection methodology, the company involve d had been developing a detection method. Then
there was either a need or a requirement - and I am not sure which - to undertake some sort of
validation process. It seemed to be in conjunction w ith the joint research laboratories. In undertaking
that joint work, using the method that had been developed by the company, some technical difficulties
were identified. The joint laboratories then proposed to the company that they could further develop a
method, which the joint laboratories themselves had been developing under a research project. It was
that method that was ultimately developed. A lot of that history is available in the dossier through
email correspondence.
1054. There are two substantive documents that talk about the technical difficulties. The first set of
difficulties seemed to relate to the amount a nd the quality of the DNA that the company had
developed, that would form the basis of the method. Certainly one of the documents shows that the
different laboratories were detecting different amounts of DNA which seems to be a bit odd, but
nonetheless that's what seemed to be happening. The quality of the DNA seemed to be an issue as
well. In the Dossier there is a technical report th at comes from the joint laboratory where they have
tried to use the DNA provided by th e company to do what has been called a pre-validation test. It is
to see whether the method is sufficiently robust to m ove forward into a validation test. The document
in the Dossier that comes from the joint European laboratory - who undertook this pre-validation test -
and the document identifies or states that the repr oducibility and the repeatability of the method was
not sufficiently good to move to the validation stage. This is particularly so at low concentrations.
Now this is quite possible because we are talking about very small amounts of DNA. Starting DNA
usually is used in very small volumes. The qualit y of the DNA needs to be very good and it can be
very difficult to establish the right parameters to make the method work very well.
1055. I am unable to go the last step in the Pane l's question and make a judgement myself about
whether those problems that were identified in the doc ument are really sufficient to explain the delay.
I think you need to be very specialised in method development and the optimization parameters that
are described in the document to really make that ju dgement call. I certainly don't think that I am. A
range of problems were identified. If indeed so meone who was competent to make the judgement
calls said that the DNA fell outside the parameters, then they would be of sufficient magnitude to
slow down the development of the method.
Chairman

1056. Thank you Dr Healy. Do the parties have views, questions on this particular Dossier follow-
up? This does not seem to be the case. 94 we have dealt with this morning. We come to Dossier
101. There we have questions from the EC and fro m the Panel to Doctors Andow and Squire. Would
the Complainants like to start with something we ha ve not announced before. This is not the case.
The EC has the floor.

European Communities

1057. Thank you Chairman, I am just trying to make sure that we dealt with Bayer Liberty Link
soybean, that would be EC-93. We would have a question on that, it relates to Question 50 of the
Panel. It's in our paragraph 19 of our document.
Chairman
1058. So why don't you start with 93.
European Communities
1059. This relates to Bayer Liberty Link soybean. Some herbicides such as glufosinate and
glyphosate inhibit enzymes that are important in pl ant metabolism. Do you agree, Dr Nutti, that the
effect of herbicide treatment on the composition of herbicide-resistant GM crops should be tested?
Dr Nutti
1060. Yes, I agree, but I don't want this to be confused with my statement, that for the GM we need
to compare the GM and the non-GM. Usually the he rbicide has its own evaluation. I would like to
make this very clear in order to put two answers together.
European Communities
1061. Can I follow up on this? This may be a regulat ory question. Still, I think it should be on
record. Do you think, Dr Nutti, that when yo u assess the herbicide you assess the composition of the
GM crop that the herbicide is used on? You are making a distinction here between the assessment of
the herbicide treatment and the assessment of the GMO as such. My question to you is when you
assess the herbicide treatment, and I understand you to be assuming that this takes place elsewhere in
the safety assessment of the herbicide, do you think in that in the safety assessment one looks at the
composition of the GMO in question that is going to be treated with the herbicide?
Dr Nutti
1062. I didn't get your question. In my understanding, when you are going to access the GM, even
if this GM is going to be treated with the herb icide, you compare the GM with the non-GM. Further
treatment with the herbicide can be discussed and can be looked on a case by case basis. For instance,
this was the approach in the files that I examined. You can have one herbicide that has already been
approved by the Codex, the limit has been establishe d, and if the doses that have been recommended
are inside this limit, sometimes you don't need to have this further evaluation. There are cases in
which the third trial and a third experiment are done. Then you compare with the treated GM. Of
course you cannot have the control with the treatme nt because the control will die. There are cases
where you do that and there are cases where you don' t do that. This morning when we talked about
this, the term used in Codex was 'may' – you ma y evaluate. You have to look on a case-by-case
basis. I was trying to explain that the herbicide h as been assessed in a different way. The first thing
you do when you are looking for the comparison is to compare the GM and the non-GM. Then if you
still have doubts, then you go with further studies.

European Communities

1063. Thank you Mr Chairman. I think there is some misunderstanding here. What the EC's
question is trying to point at, is whether the herbic ide applied to the GM plant might have an impact
on the compositional analysis of compounds expressed by the plant or the plant compounds and the
nutritional quality of the plant. How would you assess that, if you don't test the plant sprayed with the
herbicide?
Chairman
1064. Before you reply, Dr Nutti, the United States has a point of order.
United States
1065. Is it possible that we are discussing Question 49 of the Panel, because I am a little lost.
European Communities

1066. I was under the impression that we are discussing Question 50, so this would be the request
for additional information regarding nutritiona l composition by Belgium. That should be EC93
attachment 23.
United States
1067. I just didn't see anything in 50 related to what we are talking about here. Maybe my questions
are numbered differently.
Chairman
1068. Dr Nutti. You have the floor to reply to the EC's question.
Dr Nutti
1069. I am just pointing out that she thought that it w as related to Question 50 of the Panel, and it is
not. We are discussing another thing. Because question 50 is about nutritional composition.
European Communities
1070. Can I clarify this is on Question 19 of the European Communities?
Chairman
1071. Let me try to phrase that question. Here is the question. Is the only concern with the
herbicide a question of potential effects of residues or can the herbicide use affect the composition of
the GM plant itself?
Dr Nutti
1072. If I expect the herbicide to change the GM plan t, I would expect the herbicide to change the
non-GM plant also. This is what I was trying to say. If this herbicide has been approved, and you
have to look at the residues, I am not expecting the herbicide to have differences in the GM plant.

Chairman

1073. Thank you. EC.
European Communities
1074. Can I first clarify where this request -for additional experiments on GM treated with herbicide
-is, for the benefit of the US. Also to correct the mistake we must have made, because indeed it is not
Question 50. We are referring to Question 49, and we are talking about the Italian request. We are all
agreed, and I apologize.
European Communities (Dr Hilbeck)
1075. Yes there might be effects of the herbicide on the GM plant that changes the compositional
nutritional quality of that plant, and it is clear that if you apply the herbicide to the control plant, the
control plant dies. In order to see whether th ere are changes in a compositional analysis and
nutritional quality of the plant, you have to use th e control unsprayed and you have to use a sprayed
GM plant. That gives you the valid comparisons. We were asking whether you agree with that.
Dr Nutti
1076. Can you give an example that this difference had occurred?
European Communities
1077. No, not offhand. But I know it exists.
Chairman
1078. EC.
European Communities
1079. Chairman. We are not asking about whether in retrospect the effect occurred or not, but
whether the effect is conceivable and is it therefor e valid to ask the question. Perhaps this is the
question to Dr Nutti. It is theoretically possi ble in our view that the herbicide changes the
composition of the plant and the fact that you cannot compare it with the non-herbicide tolerant plant,
because non-herbicide tolerant plant can never exist af ter the herbicide has been applied to it. My
question to Dr Nutti: is it conceivable that the app lication of these herbicides to herbicide-tolerant
plants would change their composition?
Dr Nutti
1080. The fact that Codex kept the word 'may', was exactly related to this discussion, because there
were opinions on both sides. The word 'may' in th e guideline is exactly to give space for discussion
and to see if it can be done or not. I will not say that it will never be done. I think that it should be
studied so to see whether it should be done or not. That is why, as I said this morning, in the
guideline the word 'may' is used and not 'shall'.

European Communities

1081. Thank you.
Chairman

1082. Any follow-up on 93? Otherwise I will ask the EC to move onto 101. EC you have the floor.
Dr Nutti
1083. I still need to answer 70. EC-70.
European Communities
1084. I am afraid we are not through yet with the issue of herbicide treatment. This time the
question is in the context of a hybrid. I persona lly, don't know whether that makes the discussion any
different. I don't think so. Our question goes to Dr Andow to give Dr Nutti a break. You were
saying Dr Andow, regarding the fact that you were re ferring that there is a legitimate scientific debate
as to whether all three sets of data from non-tr eated, control and GM crops as well as herbicide-
treated GM crops are necessary for a conclusion on safet y. That's what we have been discussing for
the last 20 minutes. Would you agree that the Code x guideline paragraph 44 supports the view in that
scientific debate that calls for all three treatments?
Dr Andow
1085. First I would like to preface my remark by tha nking Dr Nutti for clarifying the answer to my
question. I don't know what Codex guideline paragra ph 44 says. But as Dr Nutti explained, there is a
debate that is embodied within the Codex guideline a bout the three treatments. I agree that there is a
debate. Because of that there are several perspectives a scientist could take on this. Therefore
depending on which perspective y ou take, you could justify different approaches towards what you
need.
European Communities

1086. Thank you.
Chairman
1087. EC is finished with 101. The Panel has its last question on 101, and would like to ask
Dr Squire our Question 33. You have the floor sir.
Dr Squire
1088. The Panel is quite correct in drawing attention to this temporal anomaly in my answer. Of
course the Codex guideline which I take to be – CA C/GL45-2003 - did not have any relevance to the
answer in 2001. What I was drawing attention to, and this seemed to me to be the case throughout a
number of the requests, was that th e kind of requests put by the EC were quite compatible with what
turned out to be within the guidelines in 2003. Wh ere the other countries appeared to claim that the
requests were too rigorous or too stringent, two years later guidelines appeared that were very
stringent indeed. I accept that there is a temporal anomaly in my response.

Chairman

1089. Thank you Dr Squire. I would like to call for. EC, another question on 101?
European Communities
1090. We would like to ask Dr Nutti to explain how these Codex guidelines came about, especially
when the process started because, as Dr Squire point s out, this is a debate that has been going on for
over a few years. The Codex guidelines reflect the ultimate result of that debate. Perhaps Dr Nutti
could briefly tell the story of these guidelines and when discussions started on the Codex.
Dr Nutti

1091. It was over four years. We discussed the guide lines in 2000, 2001 2002, and 2003. By 2003
everything was approved. I just don't remember if the first meeting was 1999 or 2000. The
Commission asked us to start working on them in 1998.
European Communities
1092. I'd just like to point out that it was under discu ssion in the Codex at the time the request was
made.
Chairman
1093. Other questions on 101? This does not seem to be the case. This brings us to the end of the
questions in order. I will now return to the mental marks put on questions on dossier 74 by the US, 76
by the US and 87 by the EC. I will start with Dr Nutti who had a chance now to look at dossier 70
and give us an answer.
Dr Nutti
1094. I looked at the dossier and didn't change my answer. In my answer I had pointed out that
there were studies on different types of animals including, rat, trout, quail and lamb. The EC
emphasized that the abnormality was found in the rat studies. There were three rat studies. The first
and the second ones raised some doubts. In the thir d rat feeding study they concluded that the body
weight gained, food consumption, a nd liver and kidney weights were not different. I do not change
my statement.
Chairman

1095. These were laboratory studies?
Dr Nutti
Yes.
Chairman
1096. US on this one? Or anybody else? So 70 is closed, 74 ...

European Communities

1097. Dr Nutti have you realized though that I gave you several attachments? The issue is
chronologically in the first attachment, you only had a summary of these studies. Attachment two
was the request for additional information from Ju ly 1998. The requests of the lead CA, the
Netherlands in this case, attachment eight and thirteen are dated November 98 and August 99
respectively. The document which you looked at wh ich gives the full analysis - which the lead CA
hadn't seen then- is attachment 90 of our chronol ogy and is only dated 5 of August 2003. The
question is: based only on that first summary and gi ven the flaws in the first two studies, wasn't the
lead CA entitled to ask to have the full report to look into them?
Dr Nutti
1098. No, if it was only the summary it was OK. Because looking at the full report the information
is here.
European Communities
1099. Thanks a lot. So your answer is positive.
Chairman
1100. United States.
United States
1101. This question is for Dr Nutti. We are returnin g to the issue of comparisons of compositional
data from multiple locations. Is the purpose of c onducting multiple trials in different locations to
determine whether the range of nutrients found in th e new product falls within the natural variation of
those nutrients for the crop?
Dr Nutti
1102. Yes, absolutely. Because we need to look to see if there is a variation if this is due to the
stress of the place that the product was being grown. We need to see if the variation falls within in the
natural variation.
United States
1103. Would comparisons of compositional data from co rn grown in three countries with a range of
climatic conditions provide the kind of comparative stress data that you described?
Dr Nutti
1104. Yes, and I think I pointed this out in my answer when I answered it in writing.
United States
1105. Are you aware of any evidence in which Bt co rn or any other corn has had a change in
composition that could affect food or food safety based on the location of where it was grown?

Dr Nutti

1106. Not on food safety. I don't know publications. There might be a difference in the mineral
composition of these things. So, maybe it could have to do with the quality.
Chairman
1107. Anybody else on 74? The EC.
European Communities
1108. Dr Nutti, my understanding is the requirement is fo r trials at a number of locations. Is it your
understanding that the reason for this is to look at the stability of expression of the gene over a range
of different environments and seasons?
Dr Nutti
1109. The expression of the genes has to be confirme d before you go for a food trial. You cannot
go to a food trial with a product for which the expr ession of the gene is not confirmed. You go for
two seasons, at least two seasons, to confirm your results. For instance in the group that I am
conducting studies with we only go to the food trials after the fifth year. You first have to confirm the
expression of the gene. The food trial is for the expression of the gene.
European Communities

1110. My question was on the uniformity and the cons istency of the expression of the gene under a
range of different environments and the different se asons. Surely this is the reason why we ask for
data from a number of years and a number of locatio ns, to ensure that stability of expression of the
gene under those conditions.
Dr Nutti
1111. Usually when you design an experiment you look for different places and at least two
seasons. You cannot have only one information
European Communities
1112. We also have a follow-up on 87.
Chairman
1113. That concludes the discussions on 74 I believe. The US wanted to raise a question on the next
dossier which is 76.
United States
1114. This question is for Dr Andow and Dr Snow. Could you tell us whether you are aware of any
evidence to suggest that hybrid corn can establish itself as a weed?

Dr Snow

1115. I haven't really studied hybrid corn or volunteer hybrid corn so I don't know. I think
Dr Squire was mentioning in Southern Europe ther e is the potential for volunteer. I don't know if you
would call it a weed. I doubt it.
Dr Andow
1116. As you know the definition of a weed is a plant th at a person doesn't want to have and a lot of
farmers believe that the volunteer corn plants are weed s. But I don't think that is really what you are
trying to get at. You would like to know wh ether it can actually escape and become weedy and
afterwards establish feral populations. I think that outside of Central America I haven't heard those
kinds of reports related to weediness. My points were not necessarily aimed at weediness however.
Chairman
1117. Anybody else on 76? This is not the case. So, the final open dossier is 87, with the
possibility for the EC to come back.
European Communities
1118. Chairman, I would like to come back to Dr S quire and Dr Nutti. Your question was whether
the competent authority could have asked all these requests for additional information at the same
time and Dr Squire and Dr Nutti replied yes. I woul d like to know from both of them what they base
themselves on because my understanding is the followi ng: The first request was made in December,
7 December I think. It is a lengthy document, seven pages, explaining what it is that was missing.
Then there is an e- mail exchange between the a pplicant and the competent authority. The competent
authority explained in more detail what the options for the applicant were related to providing that
additional data. Then there is a second letter, in January, barely a month afterwards, in which the
competent authority does nothing but confirm that they have put this request for additional
information to the applicant. There is nothing new in that letter. It is repeating the essential points of
the first letter. Then, there is the second request of October 1999 which is indeed a new request for
additional information but which is based on the info rmation that has been provided in the meantime.
So, I would like to know why you say that the compet ent authority could have asked all of this in the
first letter. Thank you.
Chairman

1119. Dr Squire?
Dr Nutti
1120. Do you know how many dossiers we read for you since October?
Dr Squire
1121. I'd like two hours to reread that dossier before I answer this question if that's possible. I'm
prepared to do it this evening, but you better get up very early tomorrow to get my answer.

Dr Nutti

1122. My point is that you need at least two seasons. If the person that was looking at the document
and saw that there was only one study this would be one of the first things to say. "There is only one
we need at least two for comparison." We had to read all the dossiers in less than two months.
European Communities
1123. I realize that this was a lot of documents to read. I also realize that the point you just made is
what you said in your reply. It is not what the question the Panel asked you about in its question of
today which has a potential negative consequence fo r us, which is whether the competent authority
could have asked all of this earlier. My point was to put on record that there is a reason as to why the
sequence of letters was such. I note here that bot h experts actually cannot co nfirm that the requests
for information could have been made in a different sequence. If this is subject to verification this
might make perfect sense.
Chairman
1124. Before you answer Dr Nutti, I would like to cl arify that the applicant provided the answers to
the first one or two questions in July 1999 and the further request were handed back three months
later. Would you like to respond Dr Nutti to the EC's question?
Dr Nutti
1125. I really don't know what you are asking.
Chairman
1126. I think the answer has been given
European Communities
1127. This is a comment more to the Panel than to you Dr Nutti. We are talking about a delay of
three months until a request was made in October, instead of what looks lik e a large amount of time
for a competent authority to send out letters one af ter the other asking whatever questions came to
their minds. This is simply not the situation. I don't think Dr Nutti needs to follow up on that. It is
clear by now that they have not looked at this particular question you have in mind.
Chairman
1128. We take note. I believe this takes us to the end of the questions on product-specific questions,
issue one. On our agenda is still the possibility for a ll of the parties to come back with any questions
referring to the subjects we discussed yesterday. Th at is both open general questions and both issues
two and three. And the Panel, w ill on its own have two additional ques tions to the experts as well.
Before we do so I suggest we take a break, especially for the mental health of our experts, and resume
in fifteen minutes. That is ten past five. [Pause]
1129. We have forty-five minutes of the paid presence of our experts and the unpaid presence of the
Panel. I would now suggest the parties start wi th their questions arising from the discussions
yesterday or possibly such questions which could not be put forward because of the time allocation

which was very strict yesterday. I do repeat th at we do not wish to hear comments, but scientific
questions only. So this being said I'll turn to the complainants in any order. Canada.
Canada

1130. Thank you Mr Chairman, my first question is for all of the experts and it relates to an exhibit
that Canada filed on Thursday in response to the Panel's instructions. It is exhibit CDA-195. I
provided you a copy of the front page as well as a copy of page 64. I appreciate that there's a
considerable amount of information that you've ha d to absorb over the last number of months. I
would certainly appreciate the fact that you may not have had an opportunity between last Thursday
and now to review the additional information that was submitted by Canada. I would like you to look
at the graph on page 2. First, if I could ask if an y of the experts are aware or have been involved in
the safety of genetically engineered foods appro aches to assessing unintended health effects by the
Institute of Medicine and the National Research C ouncil. And if they then would feel comfortable
commenting on this. If you are not aware of this study and do not feel comfortable in answering this
question I certainly understand.
1131. The graph here shows the relative likelihood of unintended genetic effects associated with
various methods of plant genetic modification. Ac cording to the description, it says the grey tails
indicate the committee's conclusions about the rela tive degree of the range of possible unintended
changes. The dark bars indicate the relative degree of genetic disruption for each method. As you
can see on the left hand y axis, there is a ranking of all of the various forms of genetic modification -if
you will- and along the x axis, the horizontal axis ther e's a scale from less likely to more likely. This
graph illustrates or attempts to estimate the varying degree of unintended effects associated with
various forms of genetic modification. I am using that in a generic sense. My question to the experts
is whether or not you think this represents a generally accurate view as to the likelihood of unintended
consequences or unintended genetic changes of these various forms of genetic modification.
Dr Andow

1132. First, as you probably know, I'm a member of the NRC Committee on Agricultural Bio-
technology Health and the Environment. That standing committee essentially developed the
parameters of the study, so I am familiar with th e fact of how the study was commissioned and what
the overall scope of the project was supposed to be. I have to admit though, that I am not entirely
familiar with all of the contents of the study. I woul d like to clarify first, what exactly the y axis is.
You were using a number of different words, you settled on one. I noticed that it must be either in the
text or someplace else exactly what they used and it does make a difference as to how to interpret this
figure.
Canada
1133. You are referring to the x axis? If we look at it this way there is a horizontal axis and a
vertical axis. It says "Figure 3.1 the relative likelih ood of unintended genetic effects associated with
various methods of plant genetic modification". The grey tails indicate the committee's conclusions
about the relative degree of the range of potential unintended changes. The dark bars indicate the
relative degree of genetic disruption for each method. I'll read the whole description. It is unlikely
that all methods of genetic engineering, genetic modification or conventional breeding will have equal
probability of resulting in unintended changes. Therefore it is the final product of a given
modification rather than the modification method or process that is more likely to result in unintended
adverse effect. My apologies for not providing a copy of the entire section.

Dr Andow

1134. Thank you. So the x axis then - if you hold the book sideways- is relative likelihood of
unintended genetic effects. And for the benefit of the Panel the bars that are refer to transgenic plants
would be the -if we hold the book like this- the second bar from the right, the third bar from the right
and the fourth bar from the right and the fourth bar from the left. Those are the transgenic bars. The
bar that Canada has been talking about quite a bit is the bar furthest to the right.
Chairman
1135. Is that clear to everybody? It is.
Dr Squire
1136. I'd like to request a point of clarification on th is late, incomplete and confusing submission.
I'd like to ask Canada to define what a genetic effect is in this context. Is it a change in the genome, a
change in the phenotype or a change in the impact of that plant on other things? Is it a change in the
impact of the plant on ecology? It is very diffi cult to interpret this, as I say, incomplete and late
submission unless you know what the definition of the axis is. Otherwise I think we are wasting our
time.
Canada
1137. The changes are translocations, breakages, delu sions, cross-linkages, insertions any kind of
unintended effect that arises from the process of plant breeding or genetic modification. There are
series of unintended effects that are possible. This graph attempts to illustrate a lot of the technical
evidence and comments that we have been hearing and to put it down in a synthesized form, putting
biotechnology in the context of other plant breeding mechanisms.
Dr Andow

1138. So let me try to clarify once more then, that what we are talking about is changes to the
genome. We are not talking about changes to the phenotype or any other thing like that. We are
talking about changes to the genome. I'd also like to elaborate, that for those who may not be aware,
the NRC process in putting together these reports is usually comprised of a panel of about ten to
fifteen independent scientists. The vast major ity of these scientists are from the United States
although a few Canadians serve on these panels. I don't know about this one. And the product is
considered to be a consensus product of all those scientists. The scientists are usually selected from a
broad range of backgrounds, in order to get go od representation of opin ions and to make the
conclusions as broad as possible. Saying that, I do no t believe I am in a position to argue against this
graph without considerable analysis of it.
Canada
1139. Would any of the other experts like to comment?
Dr Snow
1140. I did look at this when the book came out. The picture is a representation of a consensus
viewpoint. If you hold it so the writing is right side up, most effects come from mutation breeding.
This argues the point that Dr Healy made yesterday: that maybe that type of breeding should be

looked at more carefully for unintended health eff ects and maybe even environmental effects. The
next four categories all involve common methods used in genetic engineering. I don't really see it as a
strong argument for why this is so safe -if that is what you are trying to say.
Canada

1141. No. We are not trying to say that it is safe at all. I am just asking whether or not you think it
is an accurate reflection of the range and likelihood of unintended effects or changes as a result of
modern plant breeding techniques.
Dr Snow

1142. I'm not really qualified to evaluate the accuracy of it.
Dr Andow
1143. For the benefit of the Panel though, the clarification that it's about changes to the genome is
quite important, because in many plants there is a lo t of DNA that is not functional. A lot of these
changes would occur in non-functional parts. Th at compresses everything down proportionally. I'm
still not willing to dispute the shape of the graph but it is important to realize the translation from
unintended genetic changes to adverse effects is quite substantial.
Dr Nutti
1144. I would not comment on the graph. Yesterday I made the point that I would like to have the
food safety evaluation for products of mutagenesis done in this same step by step way that we do for
genetically modified.
Dr Healy
1145. I also noticed with interest when this ca me out and when it was circulated around again
earlier this week. I've not looked at the literature in a systematic way that would allow me to
comment on the accuracy. I certainly would concur with the earlier comments though, that there is
lots of DNA in plants and other organisms th at does not translate into functional products.
Nonetheless this is a fairly interesting shape of the curve.
Chairman
1146. I suggest we take turns, starting with the Un ited States, taking questions from each party in
turn until we more or less finished with it. United States.
United States
1147. I don't have a follow-up question. I'd just like to reserve a couple of minutes at the end for
each of the delegations to have a chance to thank the experts
Chairman
1148. Well thanks by all means. For comments, we have time on Monday. Argentina, questions for
the experts.

Argentina

1149. We don't have follow-up questions Mr Chairman.
Chairman
1150. The EC? One question.
European Communities
1151. Chairman we are inclined to sympathize with Dr Squire that we risk wasting our time by
asking lots of further questions. We could ask lots of questions. We could also read out to you the
recommendation number four from the paper which is in front of you but we are not going to. We can
do that later on and so we don't have any questions.
Canada
1152. Canada has no further questions.
Chairman

1153. The Panel will ask one question then. We have a follow-up question to our first questions
from yesterday and it goes to Dr Snow and Dr Squi re. With respect to the biogeochemical cycle,
would any impact that the release of GM plants might have on this cycle be of concern because it
affects the health of micro flora and or micro fauna in the soil, or because it effects the health of plants
in the soil or above the ground? Is this impact one directional, in the sense that it would lead to a
deterioration in the ecosystem, or would it simply r esult in a change in the ecosystem which might be
beneficial in some respects and harmful in others?
Dr Snow

1154. Just to remind you about biogeochemical cycles -t hat's referring to decomposition of plants
and other organisms that release nutrients and orga nic matter back into the soil. If the GM plant
affected that it could have an effect on the micro fl ora micro fauna in the soil and that could affect the
health of plants, or soil fertility and the soil health . The question is, could any of these products that
we are considering be of concern and require more st udies. None of us are specialists in this area but
I know that a lot of questions have been raised and studied. I can't think of any that would be
irreversible or of larger magnitude than the normal variation within agriculture. There could be many
changes, they could be beneficial or negative as you po inted out. They could be neutral. People have
detected the effects of DNA on soil micro organisms, but they have not detected major differences in
function with the possible exception of slightly slower decomposition rates from Bt corn.
Dr Andow
1155. I'd like to clarify that there is not one biogeoc hemical cycle. They are called biogeochemical
cycles because they typically are oriented around a pa rticular chemical element. For any element that
you can see on the periodic table almost all of them go through biotic systems. We consider the way
that they move through the biosphere to be th e biogeochemical cycle. Of course sometimes we
consider water as a separate element even though it is not technically an element. These elements go
through all different kinds of ecosystems. The car bon cycle is one that has been quite receiving a lot
of attention because of its connection to global clim ate change for example. Decomposition of course

is part of the global carbon cycle. That is one of the reasons why some people have had concerns, not
necessarily only about GM plants, but in terms of decomposition in agriculture more generally. (I did
not see in the materials a direct link between the eval uation of GM plants regarding this issue. From
the point of view of the ecologist that would be something to be thinking about.) Whether or not there
is an important effect is another question. It is mo re than just the health of the micro flora and micro
fauna and more than just the health of the plants and the soil itself.
1156. I would simply agree with Dr Snow that the effects on the biogeochemical cycles may either
be positive or negative. If the decomposition rate is reduced, then that means more carbon is retained
in the soil and less carbon is released in the atmo sphere. The soil can become a sink for global
carbon. In that sense the decomposition rates, if they are slowed down in GM crops could actually be
a benefit to the eco-system. Of course if they are faster, it could possibly be a benefit. But it could
also possibly have a negative effect on the enviro nment. Of course the understanding of the soil
micro flora and micro fauna in relation to soil hea lth is much more complicated than I can go into
here. I probably couldn't give you quite so simp le an example without getting into many more
technical details about the ecology of the soil.
Chairman

1157. Thank you. Dr Squire
Dr Squire
1158. To build on those two responses briefly, I agr ee it could go both ways with this. Agriculture
affects or has affected the biogeochemical cycle, the carbon or the nitrogen cycle. It can affect it very
easily by exposing soil to very high temperature through sunlight in the tropics or very heavy rain.
You can erode the amount of carbon held in dead matter and in some GM bacteria very rapidly. You
can get rid of it. You can prevent the cycle from oc curring. This is most in evidence in areas where
the encroachment of deserts takes place. Fortunately in much of Europe that is not happening yet.
Let's use the carbon cycle as an example. There are large amounts of carbon in European soils
generally, and this is added to ever y year and taken from every year in different ways. The shifts in
carbon going into different parts of that cycle are of the order of about 1 per cent a year. You can
bring about fairly small shifts in the timing of events in the carbon cycle and the amounts of things
going into it. But they are very small. Because of the mass of carbon in there, it is difficult in Europe
to shift it quickly. Repeated effects can accumulate but it will take time in a system like Europe, with
generally not too hot temperatures and not too inten se rainfall. But it can happen. I think that GM
can take it either way depending on the nature of the GM . It will be a slow process in this part of the
world. Ten years would probably give you a 1 per cen t or less change in some of the main elements
of that cycle within arable systems as an order of magnitude approximation.
Chairman

1159. Thank you. Dr Andow.
Dr Andow
1160. If the chair would allow me to tell an ecology story to illustrate the point. There has been
concerns about earthworms and how earthworms are a ffected by GM plants for example. You asked
would a change in earthworms in some ecosystems create benefits in some places and adverse effects
in other places? Let's suppose the earthworms are k illed by a GM plant. We can say that in the
Northern deciduous forests of North America th ere are no earthworms. Because there are no

earthworms the understory soil is very soft and many of the herbaceous plants that live in the forest
are growing in that soft duff layer. About halfway up Minnesota we have had an earthworm invasion.
The earthworms come in and eat up all the duff. Then the duff shrinks down and most of the
herbaceous layer is killed. We believe that the en tire process of regeneration of those forests will be
changed from now into the future because of the earthworms. So in this case it probably wouldn't be
a bad thing if the earthworms were killed. However in many agri cultural ecosystems the agricultural
soils are so hard that the earthworms loosen up th e soil. Unlike in a forest where you have a huge
duff layer and very soft soils, in the agricultural soils you have very little or no duff and very hard
soils. The earthworms are beneficial in that situation because they loosen that soil.
Chairman

1161. Thank you I think that is a sufficient answer to our question number 1. I will turn to Canada
for our next question to the experts.
Canada
1162. Thank you Mr Chairman. This is a question for the food experts or the food safety experts.
In your opinion or to your knowledge, in cases wher e no new risks have been identified during a pre-
market food safety assessment how would post-mark et monitoring of human health effects be
designed and conducted? Thank you.
Chairman
1163. Is this a scientific question Canada?
Canada
1164. I believe so Mr Chairman.
Chairman
1165. Would someone care to respond?
Dr Nutti
1166. From the food safety perspective, given that I didn't comment on any question about post-
monitoring that was here. Even in the Codex consultations we thought this might happen in the future
but nobody knew how to do it. In the Codex discussion there was an acknowledgement that it could
happen but we never discussed how. So, I don't feel competent to say how to do the post-marketing
as far as food safety is concerned. Furthermore, I understood that the questions were dealing with
environmental issues and I did not cover these issues.
Chairman

1167. Thank you. Dr Andow
Dr Andow
1168. Although I am not a food scientist, I would li ke to respond from a more general perspective
about monitoring for unintended effects. Becaus e you don't have an end point, you can't be

monitoring for anything specifically. Instead it seems that the monitoring system has to be set up so
that you can trace back information should something be detected later. For the environmental side,
what has been recommended in one of the NRC report s is that you want to monitor how much of the
crop is planted in different parts of the country so that then if an environmental effect is found, you
can use epidemiological tools to try to associat e the environmental effect with the previous
distribution of the crop plant. I think a similar sort of approach could be used in any other kind of
setting, where instead of thinking about an endpoint that you are monitoring you are trying to monitor
in order to allow you to extract information from the monitoring system later.
Chairman

1169. Canada any more questions?
Canada
1170. No thanks that's all.
Chairman

1171. There is one more question from the Panel. It goes as a follow-up question to our question 14
of yesterday to Dr Nutti. If I understood your reply of yesterday correctly, you are essentially saying
that it made sense for Codex and the EC SCF to dis tinguish between toxins and allergens. Because a
toxin can be a protein a fat or a carbohydrate whereas an allergen could only be a protein. If that is
so, does this mean that instead of referring to to xins on one hand and allergens on the other hand,
Codex and the EC SCF could also have referred to allergens and ot her toxins. What I mean, is,
scientifically speaking, are allergens a sub-category of toxins or are they in a completely separate
category?
Dr Nutti

1172. I think that, in this case they are a sub-categor y because they are proteins. The allergens are
always protein. But we still need to go with a complete evaluation of the allergens.
Chairman
1173. Any differing opinions from any of the other e xperts? This is not the case. Any follow-up
questions. Dr Andow.
Dr Andow
1174. So then are you saying that a toxin is defined purely on its protein, fat or carbohydrate?
Dr Nutti
1175. No. Yesterday I said more. I talked about th e new metabolites. The new substances can be
conversion of components of the plant such as prot eins, fats, carbohydrates, vitamins which are novel
in the context of the recombinant DNA plant. Ne w substances might also include new metabolites
resulting from the activity of enzymes generated by the expression of the new introduced DNA. The
Chair is wondering if allergens are toxins. Allergens are always proteins, so why should they be listed
separately if in a general view you can put these proteins inside the big group of toxins?

Dr Andow

1176. I didn't mean to restrict it. Can we define allergens on the basis of their chemical class
essentially or do we define them on other bases?
Dr Nutti
1177. As far as my knowledge goes, most of the alle rgens are proteins in the cases that we are
looking at in this year.
Chairman
1178. Thank you Dr Nutti and Dr Andow, you appreciate that our questions are loaded. I'm sure the
parties know what we are referring to. United States, you have the floor.
United States

1179. Thank you Chair for giving just this brief moment. We know that the experts have a
terrifically hard job and we really thank you. We hope that you have enjoyed the time here with our
coffee bars and numbered paragraphs and we've alwa ys enjoyed listening to you . You were always
very clear and kept it interesting. We enjoyed being in your world for a couple of days.
Chairman

1180. Canada you have the floor.
Canada
1181. Canada wants to reiterate the US statement. I already thanked the experts for all their hard
work and effort when we began this session. After these two days I would also like to express
Canada's deep appreciation for their patience. So thank you very much.
Chairman

1182. Thank you. Argentina
Argentina
1183. Thank you Mr Chairman. I would like to thank th e experts, particularly for their patience and
the attention they gave to the questions that were put forward in the name of Argentina.
Chairman
1184. European Communities
European Communities
1185. Chairman if you would allow us we would just co me back to the issue of allergens and make
one clarification. Is that agreeable? Sorry it took us a time to figure it out. In the meantime everyone
has already thanked the experts...

Chairman

1186. EC your very last chance on allergens.
European Communities
1187. We want to make sure Dr Nutti that you are re ferring to the issue of allergenicity in the
context of food safety, because my understanding is that there can be broader allergenicity issues. In
other words that you can have allergic reactions to compounds that are not proteins, such as nickel
and certain metals for example.
Dr Nutti
1188. I was referring to GMOs. If you go to the Codex, when you go to the annex "Assessment of
possible allergenicity", you see all newly expressed proteins produced by GMOs. As far as GMOs are
concerned when you go to look for allergens you are l ooking for the proteins. This was my answer. I
was not thinking of nickel or zinc or these other things. I think the question was in the context of this.
European Communities
1189. Thank you Dr Nutti
Chairman
1190. The EC has the floor again.
European Communities
1191. Chairman, we wanted to thank the experts, because we do appreciate they have done a
monumental task and they have, at least for us, el ucidated the facts. We would like to thank them
very much for the seriousness with which they have approached their work. Thank you.
Chairman
1192. Now we have reached the end of our deliberations. I will give the floor first to the experts for
their concluding remarks and then it will be the privil ege of the Chair to conclude the meeting. I will
start in the alphabetical order. Dr Andow
Dr Andow
1193. I would like to thank the Panel for providing me this opportunity to address you on these
issues. I'd like to thank the various delegations for their interesting questions. I would like to say that
I found the Canadian questions particularly interesting and many of them were quite useful in terms of
clarifying important points that were left ambiguous in my answers.
1194. I would just like to say a few words to the Pane l though. Perhaps at risk of oversimplification
I wanted to contrast the environment versus the fo od/feed issue. In general, the issues related to
products derived from mutagenesis are not entirely clear . With the food/feed side there is generally a
presumption that the presently consumed food is safe. The debates that we are hearing are more about
how to do the comparison between the GM and curren tly considered safe food and while at the same
time balancing the efficiency of the evaluation with the sensitivity. Whereas with the environment,

the presumption that the current production systems ar e safe to the environment is no longer granted.
Indeed the current varieties produced by conventiona l methods are no longer all presumed to be safe.
This is a point that was taken up in NRC 2002 Report, in particular. There has been an evolution of
concerns associated with agricultural production, th at stems over a period of about fifty years. To
some extent GM crops are swept up in this broade r movement of the evolution of concerns of new
agricultural technologies that has been changing over a longer time period. Furthermore, because of
their prominence they are getting a lot of attention on this point.
1195. What that means, then, is that a lot of the comparisons are ceteris paribus type comparisons
(all other things being equal). Th e problem is with environmental i ssues often all other things are not
equal and it is all these qualifications that then b ecome important. Dr Squire says there is not a good
comparator. One of the reasons is that environmental issues are not as cut and dried because all things
aren't equal. It takes time to figure out what is a proper comparison. In addition, because of this
change in approach to agricultural technologies that GM crops are swept up in, there is also a change
in what is considered a good comparison. This is part of the issue that we are dealing with here,
which makes it more complicated than the food/feed issu e. I think you have realized that many of the
responses to the food/feed issues could refer to the Codex guidelines and proceed from there. And
those Codex guidelines are a way of comparing the GM crop with other foods. No parallel guidelines
exist for environmental concerns.
1196. I'd like to turn to both the safeguard measures and product-specific issues. Since much of the
discussion was on GMHT - genetically modified herbic ide tolerant plants - I'd like to say that the
scientific issue associated with these are made complicated by the regulatory issues. In particular, one
of the issue that gets caught up in this is the r esistance in the weeds, because technically and narrowly
speaking the weeds become resistant because they've been exposed to the herbicide, not because they
have been exposed to the GMHT plant. Some regula tions make that distinction. However, it is also
clear that the reason you use the GMHT plant is so that you can use the herb icide. It seems from a
scientific perspective that the issues like the resistance in weeds are a sc ientific issue to be considered
with respect to GMHT plants.
1197. There is also a question as to whether or not su ch risks or weeds are hypothetical. My answer
to this is based on a view of how, biologists associat ed with pest control, have viewed the resistance
problem over about the last 50 years. What we have seen is that resistance problems have emerged
first in many species of insects. Then they emerged in many species of fungi and then they emerged
in weeds resistant to the herbicides. Part of the reason is that the take off of the use of herbicides
occurred later. There has been a delay in terms of when these issues have arisen within the three
different pest control areas and what's happened on the insect side is that for each new insecticide
product that came out, the entomologists thought that insects couldn't evolve resistance to "this one"
(the new insecticide). By the 1980's the entomol ogists gave up on that argument, because every time
they said it they were proved wrong. There has been a major change in entomology dating from some
time in the 1980's. There is a similar change going on in the weed science community at this time
with respect to concerns about resistance. One of th e factors that seems to be driving it is the concern
over glyphosate. Because, as I said earlier, gly phosate is one of the compounds that has lower
environmental effects compared to many other herbicid es, so there is a concern about losing it. At
one point in the past one could have said that these are hypothetical concerns. But now no longer.
There is a lag in the way that th ese disciplines have developed so th at some disciplines recognize this
more generally than other disciplines.
1198. Finally, I took note that all of the parties looked very carefully at my comments, and I must
congratulate them. I'm glad that they discovered so many ambiguities in what I said. I'd also like to
acknowledge that many of the points in those comment s were not addressed here. I would like to tell

the Panel that I did look at them. Generally I don't ag ree with the re-interpretations. If there is a need
to, I would be pleased to have the opportunity to clarify any of those issues that may come up in the
future. Thank you
Dr Healy

1199. I talked a little bit in my opening comments about the approach I had taken to think about and
answer the questions on the molecular characterizati on and the role of the molecular characterization
in the safety assessment. There are several points that I would like to reiterate and a couple to add on
the basis of the discussion that has happened over the l ast couple of days. The first is to perhaps re-
emphasize the importance of a case-by-case approach involving the careful consideration of the
available scientific information as well as the impact of any data or any informa tion that is missing.
In thinking about the scientific information, I gave consideration to both the quantity, as well as the
quality, of that information and in particular to think about whether the available information gave
any indicators of safety concerns and whether the missing information was likely to find an indicator
of safety concerns. I was conscious to put it in th e context of the other available information because
I am of the view that there is not one scientific technique that will give you the definitive answer
about the safety of the food. Generally we are talk ing about whole foods and we need to look at the
properties of the foods from a number of perspectives. Looking at a whole food, is a very different
situation from looking at a single chemical, such as a contaminant.
1200. I also wanted to pick up on the discussion on th e scientific completeness of some of the
dossiers compared to the information that might be necessary for a safety assessment. In reviewing
the molecular characterization information in the dossi er, I tried to make this distinction. From the
perspective of a scientist this is not always easy b ecause more data is always better from the scientific
point of view. But, from that perspective of scien tific completeness of the information it is certainly
clear that not all the information that scientifi cally you'd want to see in the dossier was actually
present. In fact in some places I was surprised that some informati on was either not supplied or not
requested. That tended to be at the simpler end of the molecular biological tools that were available.
But the questions that I was asked by the Panel to address related to the safety assessment. I tried to
think about the relevance of the available, and of the missing, information in terms of the safety
assessment. The information is only useful if it is going to help you with the safety assessment.
1201. One of the other points that's been discussed over the last couple of days is the extent of the
change in the molecular biological technology over th e past decade or so. The molecular biological
tools that are available today are very different than those that were available ten to fifteen years ago.
I guess this applies particularly to the ability to obtain information like the sequence information, the
information about whether the genes are transcr ibed into messenger RNA, to analyse flanking
sequences and so forth. Many of these techniques today are quite standard. However, again in the
context of understanding the impact on safety, it is very important that one is able to relate the
molecular information back to an impact on human health. When you are looking for differences
between GM and non GM lines you really taking the first step, because differences are not necessarily
bad. They may be neutral, even beneficial and they may have adverse consequences. The molecular
information is only going to be useful for a safety assessment if you can, in some way, link that
information back to biological impact and then ultimately a health impact.
1202. I want to reiterate the weight of evidence approach. I had been thinking about an analogy that
I might be able to use to express this very simply . There is a saying in the English language, which I
hope will translate appropriately: "If it looks like a duck, walks like a duck a nd quacks like a duck, it
probably is a duck". It may be a goose it may be a pi geon, it is possible that it is something else. You
can gather all sorts of other in formation to strengthen the probability that you are right in your

conclusion, but in the end it is probably still a duck. That statement summarizes this weight of
evidence concept.
1203. The final point I want to make relates to th e detection methods. The rapid changes in the
molecular biological tools have also had a tremendous impact on the types of detection methods that
are available today. We have very sophisticated DNA-based detection methods that were simply not
available in say the mid-1990's. The rate of deve lopment of these techniques really accelerated in the
late 1990's kind of around 1998 and 1999 and into th e early 2000's. The tremendous advantage that
these powerful techniques bring is the increased specif icity, but it is also very important to recognize
that such techniques are not useful in all situations, particularly in relation to complex foods or highly
processed foods. We need to keep in mind the use to which the techniques are going to be put.
1204. I'd like to thank the Panel for asking me to be pa rt of this process. I'd like to thank the Panel
and the countries for a stimulating and thought provoking discussion over the last couple of days.
Chairman

1205. Thank you. Before I ask Dr Nutti, I must inform you that the interpreters are going to leave
within a few minutes. They have accepted to do some overtime for us. So I would like to express my
thanks to them. I'm sure you will agree that the voc abulary in this case had been extremely difficult -
and sometimes even confusing- for normal WTO proceed ing. My very special thanks on behalf of all
of us and I am sure also on behalf of the Ar gentinean delegation for your services. Dr Nutti would
you like to take the floor.
Dr Nutti
1206. First I would like to thank the Panel for the opportu nity of being an expert in this Panel. I
think it was a unique opportunity. Of course from the beginning when I knew that I would comment
on the food safety issues, I knew that there was a lot of work to be done and that in for most cases I
would have to go into the food safety. On the other hand, I was lucky because we have the Codex
guidelines, the FAO/WHO consultations and also the OECD consensus documents. In this respect the
analysis of food safety is a bit more organized than that for the environmental issues. That helped me
a lot in my work. I would like to thank the parties for the questions. I particularly hope that these two
days have given the parties the opportunity to consid er how seriously I had taken my task as an expert
to the Panel. I would also like to thank the other experts for being so supportive in all this time.
Thank you very much.
Dr Snow

1207. I would like to echo all of my colleagues co mments about how much we have learned from
this process and how satisfying it is to be part of it. Coming from the United States and being more
familiar with that system and learning about what is happening in Europe, it is almost like learning
about another planet. I have tried in my answers to take the perspective of the EC in terms of what
their goals are for the environment and what their values are in terms of preserving bio-diversity.
These are not necessarily my views, but I was trying to get into the mindset of what their concerns
are. I also was looking at the complexity of the regulations that were evolving as I examined these
documents from 1998-2003, including the new direct ive and the demand for monitoring and labelling
issues. That was very interesting and very challe nging. I'm still unsure how to use the scientific
information about gene flow in terms of coexiste nce issues and labelling. We've talked a little bit
about how many surprises there have been in terms of genes getting out, moving around, and
persisting, especially in oilseed rape. Even though I don't consider a transgene to be a contaminant in

any way some of the science could be relevant there. I'm really gratified that we have been through
this whole process. I stand by my position in my answers, some of which have been clarified. I think
on average people understood what I was saying and I appreciate having a voice in this. Thank you
very much.
Dr Squire

1208. I've enjoyed the mental sparring. What struck me about the whole issue of having to think
about these issues from the ecological view point, w as how much has been learned through research
over the past five or six years in particular: our knowledge - of detecti ng genes, of understanding
their movement, of the pollination issue - has increased immeasurably in the last five or six years.
This enables us to answer some of the questions that are being posed now. They were of course
introduced several years ago. We couldn't have had this debate five or six years ago. It wouldn't have
been possible to the level that we have now, not just in gene flow but in other areas as well. The same
is not yet true about the ecological impacts and shifts that we have been discussing. Those of us in
this area would appreciate something like a kind of C odex guidelines for soils and fields. They aren't
there yet, but they are very urgently required. I hope international science funding will help generate
those.
1209. We have been dealing with fairly small chang es, compared to, for example, bioterrorism or
nuclear winter or heat and cold or severe drought. The changes we are talking about are fairly small
but they are small sequential changes which ultimatel y might have large effects, good or bad. They
are not catastrophic changes in the ec osystem. There is one exception. This is where there is some
regulatory threshold applied which pr events or allows a farmer to market a crop. In this case small
changes can have a devastating effect on the farmer in question because he or she might have a crop
that they intend to sell and they find that for no reaso n of their own that they can't sell it. The issue of
co-existence is of a different order of magnitude than the ecological effects that we have been looking
at as well
1210. While we had a difficult job, I've felt strongly that we have benefited from being here. I think
all my colleagues here will agree that the three of you have a far harder job in the weeks and months
to make decisions on these very complex issues. I am sure my colleagues wish you well in coming to
those conclusions.
Chairman

1211. For your information the Panel does not intend to at this point in time to ask additional
questions of the experts in writing. But in the light of the meetings next week we would reserve the
right to do so. However, if we do so we would give you immediate advance notice so as to allow you
to manage your time as best you can. There is a po ssibility that we may want to have your advice in
writing one more time. But this is not yet decided.
1212. This brings me to the end of the meeting. I have first of all to place on record our thanks to
the experts. I want to repeat my appreciation wh ich I expressed yesterday morning. You have been
working under three types of pressure, one of time, one from the amount and the quality of the
material and one from the sensitive political character of this case. My appreciation since yesterday
has increased even when I have been able to benefit from your contributions and performance, and
this of course is very useful for us. Be sure that all the parties will make full use of your
contributions, whether or not they did advocate rec ourse to experts and expert hearings and be also
sure that the Panel will do its best to put all of this in the right perspective in our report to the Dispute
Settlement Body. Incidentally, we have for the fi rst time in WTO/GATT history a gender equality in

expert hearings. Ladies are even in a majority th is afternoon. There is however a bias in language
and this may not be without mere coincidence. I a ppreciate that Dr Nutti is, at least, trying to redress
that balance in our favour.
1213. Next week's meeting will start as indicated on Monda y, at 15.00 hours. It will be in Room E.
The subjects we intend to raise have been given to you already, by a letter dated 7 February. I will
repeat them here for your ease of reference. The Panel intends to give the parties an opportunity to
offer comments on first of all the meeting with the experts
1214. This brings me to the end of my concluding remarks. Unless there are any other further
questions from the floor I would like to adjourn this meeting. Thank you very much.