World Trade Organization

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World Trade



31 March 2008


Original: English


Report of the Panel


This addendum contains Annex G to the Report of the Panel to be found in document WT/DS321/R. The other annexes can be found in the following addenda:

– Annex A: Add.1

– Annex B: Add.2

– Annex C: Add.3

– Annex D: Add.4

– Annex E: Add.5

– Annex F: Add.6



27 September 2006, morning
1.Good morning. I would like to welcome the parties, the Panel's experts and representatives of international organizations to this joint meeting of the two Panels; the Panel on United States – Continued Suspension of Obligations in the EC Hormones Dispute, referred to as WT/DS320, and the Panel on Canada – Continued Suspension of Obligations in the EC Hormones Dispute, referred to as WT/DS321. The experts with us today are Dr. Boisseau, Professor Boobis, Dr. Cogliano, Professor De Brabander, Professor Guttenplan and Professor Sippell. We have representatives from the secretariats of the three international institutions: the Codex Alimentarius Commission, the Joint FAO/WHO Expert Committee on Food Additives, known as JECFA, and the International Agency for Research on Cancer, known as IARC. The representatives are Dr. Angelika Tritscher, WHO JECFA Secretary, and Dr. Annika Wennberg, FAO JECFA Secretary, Dr. Kazuaki Miyagishima, Codex Secretary, and Dr. Cogliano, one of the Panel six experts, who is also head of the IARC's Carcinogen Identification and Evaluation Group.

2.May I now invite the heads of delegations of each party to introduce themselves and the other members of their delegations. I would appreciate if you could submit the list of your delegations' members to the Panel secretary if you have not done this already. The European Communities first please.

European Communities

3.Good morning. My name is Theofanis Christoforou. I am Principal Legal Advisor of the European Commission in Brussels and I will be functioning as the head of delegation for these two days. If you agree each member of the delegation will introduce himself or herself.

4.Good morning. My name is Thomas Jürgensen – I work for the European Commission.

5.Good morning. My name is Sybilla Fries. I am from the Legal Service of the European Commission, now based in Geneva.

6.Good morning Chair. My name is Gudrun Gallhoff. I work for the European Commission Directorate General Health and Consumer Protection.

7.Good morning. Brian Marchant of the Commission, working for DG Trade.

8.Good morning. Lothar Ehring, European Commission, DG Trade.

9.Good morning. My name is Lars Berner and I am with the EC delegation here in Geneva.

10.Gentlemen, this was the delegation as such, the officials, lawyers and other advisors. Now we have a long list of experts with us and will also allow each one of them to present themselves, starting from Mr. Dan Sheehan.

11.Daniel Sheehan from Daniel M. Sheehan & Associates.

12.Annie Sasco from the University of Bordeaux, cancer epidemiologist.

13.Manfred Metzler, Professor of Food Chemistry, University of Karlsruhe, Germany.

14.Niels Skakkebaek, Medical Professor, Growth and Reproduction, Copenhagen University.

15.Henrik Leffers, Microbiologist, Growth and Reproduction, Copenhagen.

16.Professor François Andre from the National Veterinary School of Nantes, National Reference Laboratory for Hormones, Ministry of Agriculture.

17.Alain Paris from National Institute for Agronomic Research. I specialize in metabolism of steroids.

18.Professor Heinrich Meyer, Technical University of Munich. I am the Chair of biochemistry and physiology at the Technical University. Thank you.

19.I am Professor Frederik Vom Saal of the University of Columbia, Missouri in the United States.

20.With the delegation are also representatives of the member States of the European Community, and if you agree they will present themselves. Thank you.

21.Jukka Pesola, Counsellor, Permanent Commission of Finland.

22.I am Christian Forwick from the German Mission in Geneva.

23.I am Sebastian Keyserlingk from the German Ministry of Agriculture.

24.I am Anders Christiansen from the Danish Mission, Geneva.

25.Luca Burmeister, Danish Mission to Geneva.

26.Lukas Paul from the German Mission here in Geneva.

27.Cédric Pène from the French delegation in Geneva.

28.Blas Vicente, Spanish Mission in Geneva

29.Thank you. The United States please.

United States
30.Good morning Mr. Chairman, members of the Panel. My name is Jay Taylor with the US Trade Representative's Office. To my left is Dan Hunter with the US Trade Representative's Office here in Geneva. To my right is Dr. Adele Turzillo with the Food and Drug Administration. To Adele's right is Steve Wolfson with the Environmental Protection Agency. To his right is Kelly Stange with the Foreign Agricultural Service. To her right is George York with the US Trade Representative's Office here in Geneva. Across the table from George is Dr. Ralph Cooper with the Environmental Protection Agency. Next to Dr. Cooper is Rita Kishore with the US Department of Agriculture Food Safety and Inspection Service. Next to Rita is Dr. Richard Ellis, Consultant, formerly of the Food and Drug Administration. And next to Richard is Dr. Gregg Claycamp with the Food and Drug Administration. Thank you.

31.Then I give the floor to Canada.


32.Thank you Mr. Chairman. I am Rambod Behboodi, First Secretary here at the Canadian Commission to the WTO. Counsel with me today who will argue this case are to my left Mr. Rob McDougall at the Trade Law Bureau, and to my right Mr. Kevin Thompson, also of the Trade Law Bureau of the Department of Foreign Affairs and International Trade. The rest of the members of the delegation, from the far left, there is Angela Webb who is the Paralegal, Dr. Don Grant who is adviser to the Government of Canada. Next to Mr. Thompson we have Dr. Jim MacNeil who is head of the Centre for Veterinary Drug Residues of the Canadian Food Inspection Agency. We also have Ms. Michele Cooper, First Secretary at the Canadian Mission and Mr. Vasken Khabayan, who is Second Secretary at the Canadian Mission, and across from me Mr. Evan Lewis of the Technical Barriers and Regulations Divisions of the Department of Foreign Affairs and International Trade, and Mr. Bill Bryson of the Department of Agriculture. Thank you.

33.Thank you. I would like to continue by introducing the members of the Panels. On my right is Ambassador William Ehlers, who is Ambassador of Uruguay to India. On my left is Madam Claudia Orozco, who is a former senior official of the Colombian Government and who is now working in Brussels as an independent consultant. And myself, Tae-yul Cho, serving as Chair of these Panels. I am Ambassador and Deputy Representative in the Korean Mission here in Geneva. The two Panels are composed of the same individuals and in agreement with the parties, we are holding a joint meeting with the experts consulted by the Panels.

34.I would also like to introduce the Secretariat officials who will be assisting the Panel: Mr. Yves Renouf, Legal Officer to the Panel; Ms Xuewei Feng, Secretary to the Panel, and Ms Gretchen Stanton, Ms Serra Ayral and Ms Christiane Wolff from the Agriculture and Commodities Division of the WTO Secretariat. Finally I would like to inform the parties of the presence of Mr. Walters Nsoh, Intern in the Agriculture Division and Ms Esther Katende, an intern with the WTO Legal Affairs Division.

35.As you all know, further to the parties' common request, the Panel has decided to hold this meeting with the experts open for observation by the public through a closed circuit TV broadcast. I would also welcome those who are observing this meeting from another room at this moment. I would like to remind the viewers who are observing this Panel meeting that tape-recording or filming during the Panel meetings by anyone other than the WTO Secretariat is not permitted. In order to ensure an orderly proceeding and as a courtesy to everyone, I also request everybody, including those participating in the Panel meeting and those observing the meeting of the Panel, to turn off their mobile phones during the whole meeting.

36.In addition I would like to underline that the parties may request that the public microphones be switched off when any confidential material or information is being discussed. Finally, if the meeting is adjourned or suspended, I will specify the time at which it will resume for the benefit of those in this room, but also for those viewing this hearing from CR II.

37.May I also remind you that the meetings of panels in the WTO are tape-recorded and that at today's meeting as well as the meeting of tomorrow, English/Spanish/French simultaneous interpretation will be provided in relation to the public broadcast of this hearing through closed circuit television into Room CR II at the request of the parties. 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 its extremely technical nature. I would also like to remind the experts and the parties that there are constraints and difficulties of interpretation and therefore technical language will be properly interpreted only if it is delivered at the reasonable pace. To the extent possible, any prepared notes or statements should be shared with the interpreters so as to facilitate their task and ensure accurate interpretation.

38.Turning to a brief history of the Panels' proceedings, I wish to recall that at its meeting of 17 February last year the Dispute Settlement Body decided in accordance with Article 6 of the Dispute Settlement Understanding to establish two Panels pursuant to requests of the European Communities. I further recall that the Panels held a joint first substantive meeting with the parties and third parties on 12 15 September 2005.

39.After its first substantive meeting, the Panel decided on 20 October last year to consult with experts who have specialized scientific expertise on the issue arising in this dispute. In consultation with the parties, the Panel adopted working procedures for its consultations with scientific and technical experts. These working procedures were communicated to the parties on 25 November 2005.

40.The Panel received suggestions from experts from three international organizations, namely, the Codex Alimentarius Commission, the Joint FAO/WHO Expert Committee on Food Additives, the IARC, and from the parties. Following consultations with the parties on the candidate experts, the Panel appointed, as I mentioned, Dr. Boisseau, Professor Boobis, Dr. Cogliano, Professor De Brabander, Professor Guttenplan and Professor Sippell to serve as scientific experts in this dispute.

41.In accordance with working procedures and after having considered the parties' comments, the Panel sent questions to the experts and international organizations on 13 April this year. The experts were requested to reply in writing by 12 June 2006, and these replies were communicated to the parties. Comments and counter-comments received from the parties and the expert replies were also provided to the experts in July.

42.The purpose of today's meeting is for the Panel to obtain further clarification of the scientific issues and to discuss the experts' written responses to the questions. The parties will also be given an opportunity to discuss the responses of the experts to the questions.

43.This two-day meeting will proceed in the following manner. Before proceeding with an examination of the specific scientific issues under consideration, the Panel will first give an opportunity to each expert and international organization representative to introduce themselves and make some brief introductory remarks, in particular in light of parties' written comments on their specific responses to these questions. But please bear in mind that these remarks should be kept as general as possible since we will subsequently discuss each issue in more detail.

44.Afterwards, the Panel intends to hold its discussions under five areas which are linked closely with the specific sections included in the written questions of the Panel to the experts. I will clarify the specific areas in a moment. For each of the five specific areas, I will open the floor to the parties to ask questions to the experts based on the written information and comments received thus far, addressed either to a specific expert or to the experts in general. The Panel would also pose some questions either at the beginning or following parties questions, depending on the issue. Once the question and answer process has been completed for one area, I will invite the experts and international organization representatives to make some concluding remarks, if they so wish, before moving on to next area. In addition to the four predetermined areas, we have also foreseen a fifth area to address any other issues not covered by any of the four areas.

45.Concerning the questions by the parties to the experts, the Panel will proceed as follows. Under each section, the Panel will first give the European Communities the floor to ask questions to the experts. Thereafter, the United States and Canada will be given an opportunity to ask their questions to the experts, including any follow-up questions to those posed by the European Communities. After that, the European Communities will be given the opportunity to pose any follow-up questions to those posed by the US and Canada. The Panel is mindful that these are officially two proceedings and it will make sure that parties are given ample opportunities to ask questions necessary for a clear understanding of the facts. However, the Panel notes that the scientific issues are similar in both cases and would strongly encourage the parties to avoid duplicating questions. Please all keep in mind that this meeting has been convened primarily to hear the views of the experts and that parties will have ample opportunities to express their views at our meeting next week.

46.Finally, once we have covered all the five specific sections, I would like to give each expert and international organization representatives an opportunity to make concluding remarks based on the discussions held by that time. I am not intending to invite parties to make any concluding remarks during this meeting since they will have the chance to discuss any relevant points further during the Panel's second substantive meeting with parties scheduled for next Monday and Tuesday.

47.I would like to underline that the Panel may ask follow-up questions at any time during the proceedings. Moreover, although the Panel or the parties may address a question to one or more specific experts, all experts should feel free to respond to specific questions if they so wish. In making any remarks, both parties and experts are requested to minimize redundancy with what they have already submitted to the Panel in writing. I would also like to remind you all that experts and international organization representatives are expected to answer scientific and technical questions; they must refrain from addressing any legal issues, such as questions of interpretation of the SPS Agreement.

48.I would also like to recall that the purpose of today's meeting is to take advantage of the experts' presence to allow the Panel to gain a better understanding of the scientific issues before us. The Panel's experts have been selected after extensive consultations. I would like to express the Panel's appreciation for their contributions and their presence today. I am confident that the parties will also make the best of their expertise during these two days.

49.Let me also clarify that the Secretariat staff will prepare a summary of all the information provided by the experts and international organizations in their written responses to the questions as well as a transcript of the information provided by the experts and international organization representatives in the meeting today and tomorrow. Each expert will be asked to review this summary and the transcript and to confirm its accuracy. These will be part of the Panel's reports on these disputes.

50.Last but not least, I would like to recall that we the Panel members do not have scientific expertise. Therefore I would like to ask the experts to bear this in mind in replying to questions and explain issues in layman's terms, providing information on underlying concepts as necessary. In order to get a clearer picture with respect to the six hormones at issue, I would also like to invite all those taking the floor to clarify which of the six hormones their question or reply applies to.

51.Now I would like to introduce the five areas that I referred to earlier. In order to facilitate a focussed discussion, the Panel would like to structure the meeting under four specific areas which relate to the Panel's original written questions: Area 1 relates to terms and definitions, which corresponds mainly to Section A of the Panel's written questions to experts; Area 2 is risk assessment techniques, which corresponds roughly to Section B of the Panel's questions and to some of the Panel's questions to international organizations; Area 3 is related to relevant scientific evidence, which corresponds roughly to Section D of the Panel's questions to experts; Area 4 relates to EC assessment of risks, corresponding roughly to Section C and some elements of Section D of the Panel's questions; and Area 5 is, as I mentioned, other – any follow-up questions that do not fit in the above categories.

52.In their replies, the experts may want to refer to various documents, including the parties' submissions and exhibits. These documents are either filed in the binders placed in the cupboard over there, or in the CD-Roms. The CD-Roms can be opened and viewed in the laptop computers near your seats. The Secretariat staff are ready to help you locate these documents if necessary.

53.Unless there are any comments or questions we can now proceed to hear the experts' brief introductory remarks. I will first give experts the floor in an alphabetic order, starting with Dr. Boisseau, which will be followed by the representatives of the international organizations. Dr. Boisseau, you have the floor.

Dr. Boisseau
54.Thank you, Mr. Chairman. Let me begin by apologizing for my voice – I caught a cold some time ago and I am afraid that my voice is not very clear, but I shall do my best to make myself understood. So, my name is Jacques Boisseau, and I withdrew from professional life four years ago. Before that, I directed the National Agency for Veterinary Medicinal Products (ANMAV) in France for 20 years. I was a member of the European Union's Committee for Veterinary Medicinal Products for 14 years and headed it for six years when it was still in Brussels. For 13 years I participated in all of the meetings of the JECFA, and had the honour to chair four of them and to be Vice-Chairman five times. Finally, for about 15 years I headed the French delegation to the Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF). So, I specified in my curriculum vitae that in the above capacities, I had not done any scientific work on hormones, and that consequently, I had not published anything on the subject. I suppose that I have the honour to be part of this panel of experts thanks to my experience in assessing the safety of residues of veterinary drugs in food. I would like at this point to make three remarks that could be of help to the discussions that will be taking place over these two days.

55.The first comment is as follows: the experts have been given 64 precise questions, to which they were asked to provide precise answers. Consequently, I think that any comments on the replies of the experts, or criticism thereof, should focus on the replies in relation to the questions asked and not in relation to the questions that were not asked. Secondly, I think it is important that we should all have a common understanding of the risk analysis procedure. In other words, we should clarify together, and in agreement with each other, what pertains to the risk assessment procedure as opposed to the risk management procedure. We should be able, as well, to reach a common understanding of what a hazard is, and what a risk is. Finally, we should be able to adopt a common approach to what a qualitative risk assessment, is as opposed to what we might call a quantitative risk assessment. Finally – since I had meant to be brief – I think that we must clarify together the specificities of conducting a risk analysis for an endogenous substance as opposed to a risk analysis for xenobiotic substances. There we are, Mr. Chairman, thank you very much.

56.Thank you. Professor Boobis, please.

Dr. Boobis
57.Thank you Mr. Chairman. My name is Alan Boobis. I am currently a professor of biochemical pharmacology at Imperial College London where I am also a director of the Department of Health Toxicology Unit. I originally trained in pharmacology at the University of Glasgow, but since 1976 have been involved in studies of xenobiotic metabolism of foreign compounds and in toxicology, particularly mechanisms of carcinogenesis of dietary contaminants. For the last 15 years I have played a role in national, regional and international advisory committees, as an independent member of a number of committees advising on the safety of chemicals, both pesticides, veterinary drugs and consumer products. I have published over 200 papers in peer reviewed journals, including a small number on issues of hormone research. I currently have two PhD students and a post-doctorate research fellow working on aspects of oestrogen toxicity.

58.I have very few comments to make specifically about the issue at hand today because I hold myself ready to expand upon my responses to the questions. I would just make one general comment at this time which is that in risk assessment it is important to recognize that it is not possible to establish safety with absolute certainty. Safety is a concept which is related to the probability of harm, and this is the reason that we use terms like "no appreciable risk". In risk assessment we don't have a concept of zero risk, because in strict scientific terms of risk assessment, risk is considered as a probability – the probability of harm based on the hazard of the compound and the specific conditions of exposure to the agent under consideration. Thank you.

59.Thank you. Dr. Cogliano, please.

Dr. Cogliano
60.Thank you, Mr. Chairman, members of the Panel. My name is Vincent Cogliano. I am the Head of the IARC Monographs Programme at the International Agency for Research on Cancer in Lyon, France. The IARC monographs are a system of expert scientific reviews where we convene international working groups of scientific experts to evaluate the potential carcinogenicity of a variety of agents. They started out looking at chemical agents but since then have evolved to look at occupational exposures, chemical mixtures, lifestyle factors, physical and biological agents. Over the 35 year history of the Monographs Programme we have looked at over 900 agents and identified approximately 400 as potentially carcinogenic to humans, including 100 agents which are considered to be known to cause cancer in humans.

61.I am here perhaps in a double role; partially in my role at the International Agency for Research on Cancer but also as a member of the expert committee. Before coming to IARC I worked for nearly 20 years at the United States Environmental Protection Agency in Washington, DC where I was part of the Office of Research and Development assessing the health hazards of chemicals found in the environment. I am not going to make at this time any particular statements about risk assessment or risk but I do stand ready to assist the Panel in any way I can in answering any questions that come up today. Thank you.

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