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Transcript of the Joint Meeting with Experts, held on 8 December 1999
Chairman
1. I would like to welcome the parties and the scientific experts to this meeting. My name is Michael Cartland and I am the Chairman of the Panel. The two other panelists are Ms. Claudia Orozco of the Permanent Mission of Colombia, and Mr. Kari Bergholm, formerly of the Finnish Ministry for Foreign Affairs. The secretary of the panel is Gretchen Stanton, assisted by Christiane Wolff. The panel is also assisted by Jeffrey Gertler and Joost Pauwelyn from the Legal Affairs Division. The expert advisers to the Panel are Dr. Br�ckner, Dr. McVicar and Dr. Wooldridge. 2. Let me start by informing you that this meeting is being recorded. Therefore, when you take the floor, please be sure to turn on your microphone by pressing the green button. A red light is visible on the microphone when it is on. Equally important, please turn off your microphone when you have finished speaking; this system only permits one microphone to be on at a time. 3. May I now invite the parties to introduce their delegations, beginning with Canada? (See attached lists). 4. The purpose of this meeting is to permit the experts to expand on their written responses to the Panel's questions, highlighting the main points, and to permit a full exchange of views between the experts, the parties and the Panel. 5. I would like to take this opportunity to thank the experts for having agreed to serve as advisers to the Panel, and for having responded within such a short period of time to the Panel's questions. As you know, we are operating under time constraints, we must produce reports within certain delays, and this puts considerable pressure not only on us but on you as well. 6. For your information, following today's meeting and meetings tomorrow and Friday with the parties and third parties to the dispute, the Panel must proceed to prepare its report. The first part of this report summarizes the facts and arguments raised in this case, and will be provided in draft form to the parties for their comments. One element of this first part of the report will be a compilation of the experts' written responses to the Panel's questions. You will be given the opportunity to make any necessary corrections to this summary of your responses. Subsequently, the Panel must circulate its final report to the parties. The Panel intends to include a transcript of today's meeting as an annex to the final report. 7. I must stress that the proceedings of this panel are confidential. Everything which is said in this room is subject to the WTO rules of dispute settlement and the Panel's working procedures. So it is confidential unless its release is permitted by the parties. When the Panel has concluded its work and a final report is circulated to all WTO Members, that report is normally considered to be a public document, including the summary of your responses to the Panel's questions and the transcript of this meeting. We expect that the final report will be circulated in early February 2000. 8. In respect of confidentiality, we note also that on 23 November 1999 Australia submitted information which it designated as confidential under Rule 19 of our Working Procedures. This information was provided to Australia by scientific reviewers of the 1999 Import Risk Analysis and constitutes the so-called List C "Papers from the Continuous Scientific Review Process Submitted to the Senate Enquiry". Pursuant to Rule 19, this information:
The parties and the experts can thus refer to this information. However, in our report, including the transcript of this meeting, this information shall not be disclosed. Note also that pursuant to Rule 20:
This obligation of returning List C information, designated by Australia as confidential, also applies to the experts.
9. In terms of this meeting, the Panel intends to proceed as follows: I will first give the experts the floor, one-by-one, to make any general introductory remarks which you believe appropriate. There is no need to repeat what is in your written responses, but I invite you to highlight your main points, the areas where you see the most important issues and points of contention. Should you wish to comment on any points made by another expert or by the parties in their rebuttals, you should feel free to do so. Please explain also whether any of the submissions you received after having given your written answers has changed your opinion or clarified certain doubts you expressed in your written answers.
10. At this time I would also ask for your responses to the additional questions you received when you came into the room. We will go through the questions to the experts one by one. (The parties will be asked to respond to these questions by Friday). 11. When this is concluded, Canada will be given the opportunity to raise any further questions and comment on the expert's views, and the experts will be given the opportunity to respond immediately. Should Australia wish to raise any follow-up questions directly linked to those raised by Canada, it will be given the opportunity to do so. 12. Following the responses from the experts, Australia will in turn be given the opportunity to raise any further questions and comment on the expert's views -- and Canada will be permitted to intervene to the extent that they have a directly-related follow-up question. 13. I should stress that the experts will be permitted to respond to each question as raised. However, it is not the purpose of this meeting to hear new evidence which the parties have not previously submitted. Similarly, we do not intend to have formal statements by the parties. Further arguments by the parties will be heard on Friday. 14. Subsequent to the interventions of the parties, the Panel may wish to raise some further questions or seek some additional clarification. Finally, I will give the experts an opportunity to take the floor again individually for any final statements you may wish to make, so that you may stress what views and conclusions you consider most important. 15. My last point is to request that you, experts and parties, try to be to the point in your responses, avoiding lengthy repetitions of what has already been submitted in written form. 16. With that introduction, I would first invite all of the participants to introduce themselves. And then I would suggest that we start with the opening comments of the experts: Dr. Br�ckner, Dr. McVicar, Dr. Wooldridge, in that order. Dr. Br�ckner 17. As you requested, I will not repeat the answers already given but I have prepared a short statement as a summary that I might go through. I think it is necessary to explain the rationale for the comments made and the terms of reference from which the comments were formulated. This is just a broad overview not going into specific issues, just to try and explain why these answers were given. 18. An import risk analysis is done for one primary purpose in my view and that is to enable the veterinary administration of the importing country to make either definite "yes" or "no" decisions to allow or refuse imports. If the answer is "yes" then the IRA must also be able to guide the administrator on the risk management practices to be implemented and to allow SPS measures to mitigate risk associated with the imported commodity. It is my view, and as explained in responses to questions 1 and 2 posed to the expert advisers, that irrespective of whether a quantitative or qualitative assessment was conducted the crucial consideration in respect of the product to be imported is the possible consequences in the event of disease establishment or spread. This is turn guides the decision on the risk management practices and the SPS measures to be applied. It is also common practice in international trade that risk mitigation is the responsibility of both the exporting and the importing country, but balanced in such a way that they do not impose a restriction on trade. 19. The methodology applied to the 1999 IRA follows a structural pathway, in my view, of reasoning and assessment in compliance with accepted and recommended international guidelines for a qualitative risk assessment. It succeeds, in my opinion, to spell out possible consequences and to establish the rational relationships between the risk management and the SPS measures decided upon and the foregoing hazard and identification and risk assessment criteria. It is, in my opinion, acceptable and scientifically justifiable, for example, not to fall into the trap of accepting the homogeneity but to evaluate the consequences of each disease individually and from that inference decide upon the measures to be applied. It can also not be taken for granted that if for a particular disease the probability of disease establishment - that is the release assessment plus the exposure assessment - is valued as "low" but the consequence assessment is "moderate" to "high", that the administrator should not consider the risk mitigation measures. One example is furunculosis where there is a difference in assessment factors in respect of wild ocean-caught Pacific salmon and other salmon. Another example is the rationale for the risk management factors given for IHNV. This rationale forms the basis for the disease-based risk assessment followed by Australia. Australia has for each example recognized this fact by making provision for this in the health certification requirements. That is, not requiring the same certification for A. salmonicida for wild ocean-caught salmonids versus other salmonids and also in respect of the certification requirements for ISA, and that is only for Atlantic salmonids. Recognition is also given to the fact where an exporting country for instance can give scientific verification of disease absence it will be evaluated on a case-by-case basis or be already reflected in the import requirements for a particular country. For example the acceptance of the more favourable disease status of New Zealand. 20. The expert panel was reminded more than once when the questions were given out to give comments but in view of the "1999 report in general". I perceived this request as a reminder not to concentrate on specific aspects related to specific diseases, but to judge the IRA as a total assessment and not to lose sight of the general trend throughout the report to verify the SPS measures eventually decided upon for the three commodities concerned. The other alternative would have been to insist on quantitative assessments for diseases where sufficient data exist, a qualitative assessment where such data is not available, and at the end come forth with a different set of SPS measures for each disease reflected in difference sets of health certifications. Such an approach would be in contradiction of the SPS Agreement and would result in a risk management approach that will be impossible to handle - both from a logistical and administrative point of view. 21. In conclusion, my approach in answering the questions was taken from this platform and also taking into consideration the framework within which the assessment was conducted - that is, excluding endemic diseases and concentrating on diseases exotic to Australia. From a veterinary administrative point of view it is also essential to focus on the rationale for addressing risk management, that is the findings of the release assessment and exposure assessment as well as the consequences of establishment or spread of an exotic disease. For this reason, it is in my view scientifically justified that the SPS measures eventually decided upon goes higher than the minimum requirement of evisceration proposed in the OIE Code in order to meet the ALOP of Australia. The only exception, as stated in my answers, is my failure to see scientific justification for the skin-on/skin-off requirements for "consumer-ready" products. I have read through the other documentation that was supplied after we submitted the answers to the questions, but I don't think we need to go into details of that. These remarks conclude my overall impressions. Dr. McVicar
22. I thank the Panel for the invitation to participate in this exercise. I have found the issues involved to be highly complex and therefore very challenging. Having worked in the field of fish diseases for a full 30 years now both in primary research and, particularly during the last 15 years, in the use of statutory regulations control fish disease, I am only too well aware of the difficulties in achieving a definitive answer to many of the central questions associated with decision-making process. I hope that I will be able to assist the Panel in clarifying any points I have raised earlier in my written responses and to further assist today in additional areas where I have expertise. 23. The Panel should be aware that I have been closely involved in earlier aspects of the specific subject under discussion. I have been acting as advisor to the Quarantine and Inspection Service during the compilation of the 1999 risk assessment on salmonid and non-salmonid products and on ornamental fish. I drew the attention of the WTO to this before accepting the Special Service Agreement and it was indicated to me that there were no objections raised. I have also worked closely with Canadian scientists and regulators over the last few years. I don't consider this previous involvement in any way influences my impartiality in responding to questions raised by the Panel as my role with the IRA and with the Canadian scientists was purely on technical and scientific matters and not on any aspects of policy. I know both parties well and respect their views and their scientific expertise and therefore I am disappointed that a bilateral agreement could not have been reached prior to the dispute coming to this stage. 24. It seems to me that one of the major differences in this dispute is the extent to which quantitative data should be used in the decision-making processes. Right at the start I want to make clear I am not a risk assessment specialist or a theoretical modeller of fish disease. My background is as a practical scientist in the fish health field. My involvement with risk assessment in this area has been through research and epidemiological studies considering the origin and spread over a wide range of diseases in both wild and farmed fish, for instance pancreas disease, VHS and ISA, and particularly in the diagnosis and control of farmed fish diseases, and secondly in the development and modification of fish disease control regulations both in the UK and the EU. 25. Through my career I have been dealing with real-life situations where practical experiences, including the consequences of particular actions, have become apparent and have to be lived with afterwards. Wherever possible, my approach to the questions raised by the Panel has been to attempt to place my responses into real-life situations, either where I have personal experience or where there are sound data present in the scientific literature on fish diseases. I don't intend to review my written answers, but will just highlight some of what I consider to be the main issues, where disagreement still exists between the two parties and where it has been indicated uncertainty remains. 26. Historically, many of the decisions and practices and policies regarding fish disease prevention and control have been made with woefully incomplete numerical supportive data, and considerable emphasis has had to be placed on previous experiences on how a disease behaves under particular circumstances. However, although not formally recognized as such, all the main components of formal risk assessment have long been the basis of important aspects of both the application of practical fish health controls and also the formulation and use of legislation in this field. There is a progressively developing database for most important diseases and where good data become available, for instance survival of a pathogen under particular conditions, these are being used and are already or may become central to decision-making. 27. In this introductory statement there are three areas I wish to make specific comments on. These are where I consider there are practical constraints on quantitative and qualitative risk analysis; some reference to appropriate measures being used to reduce risk; and disease agents and variants of these as included in the risk assessment procedures. All my comments reflect areas of uncertainty in the science and where I would advocate caution in interpreting when the data can be used in decision-making. 28. First of all, the constraints. There are major dangers from attempting to over-simplify risk factors in fish disease patterns. Of course the ideal is to have direct evidence from real situations where true risk from disease can be measured in a fully quantified way. Unfortunately, most quantitative data on fish disease comes from aquarium or lab studies. The dangers associated with the use of such data as a basis for risk assessment is illustrated by the ease by which it is possible to break down natural barriers of host susceptibility under experimental conditions. This is reflected in international regulations where experimental studies cannot be used as evidence of host susceptibility. Similarly, data on survival pathogens quoted in the scientific literature are not normally refined and often reflect a maximum found under particular experimental circumstances or even simply how long the experiment lasted before it was terminated. 29. The second point I want to make in this area is that it is normally the case that a complex array of interacting components of the biotic and abiotic environment are determinant factors which may contribute to the establishment, severity and persistence of diseases in fish. I have actually participated in such detailed studies with disease in wild fish and confirm this statement from my own work. Because of this, and as a consequence of my practical experience in dealing with prevention and control of fish disease, I have a certain degree of reservation about the direct application of mathematical modelling systems in assessing risk in the field of fish disease. It is my view that unless models are securely based on field-tested data, there is a strong risk that assumptions being made may lead to seriously misleading conclusions. This is not to say that I do not consider there is a place for modelling risk assessment, particularly as a means of indicating where more data are required to allow us to move from a qualitative to a more quantitative assessment, which must always be our objective I think. And following on from this, it is of course true that the absence of the occurrence of an event after prolonged use of a certain practice, such as import of a product, is of considerable significance and I've indicated this in my written answer. However, again in this area a level of caution is necessary and there are two points of relevance that I wish to take up here, and probably I am slightly repeating what I have said in my written answer. The perception of risk is changed immediately by the first occurrence of a disease associated with an importation event. All too frequently scientists are seeking explanations for an event which has not been predicted, and that is very true in the field of fish disease. And the second point I want to make is for a risk assessment to hold good the conditions which led to the occurrence or the non-occurrence of an event must be the same. For example, the fact VHS has not occurred as a consequence of introducing herring, which may be infected, as bait is significant, but may have little relevance to the use of the same product in other circumstances, for instance in the extreme example as a source of food and in salmonid farms where the risk could be considered to be quite high. 30. If I go on to my second area then, this is the risk of reduction measures. Again, there are several aspects of this area where some caution is necessary. Its true that there has been no extensive or systematic studies conducted in practical situations on the actual consequences of each of the measures being introduced by Australia in reducing actual risk. Lab tests can show some viruses such as ISAV can survive for exceptionally long periods, many months, in sterile sea water, but practical experiences indicate survival in the field may be very short - actually only a matter of days. In this example there is dilemma as to which figure should be incorporated into a risk analysis. I would choose the practical side of it. Its also clear that a reduction in the level of viable pathogen in a product as a consequence of an introduced measure will not necessarily lead to precisely the same level of reduction in the final risk of disease exposure an establishment associated with product. Similarly, when it comes to assessment of risk of exposure and establishment, it is not always possible to make a direct comparison between the controls which may be necessary for the different diseases and Dr. Br�ckner has already referred to this. There are many variations in biological features which require they should be treated individually. It seems obvious that these problems in interpretations of the data currently available on occurrence of infection in product, and the survival and transmission potential of important pathogens is the crux of the dispute in the present case. Certainly this whole area needs to be addressed as soon as possible and quantitative data generated. Until such information is available, there are wide assumptions having to be made on both the need for and the effectiveness of any measures being introduced. It seems inevitable that differences of opinions will remain until more refined data are available. 31. To go on very briefly to the disease agents, and there are two areas here which I think warrant some comment from me, namely which diseases are specified and secondly how to deal with differences in the "types" within a disease name. Risk assessment and procedures which may be used to reduce a level of these risks to an appropriate level require identification of specified hazards associated with a particular product and that as far as I can see is in the SPS Agreement. For each product in this discussion it seems to me only to be relevant how controls are used for these specified diseases in the product in the same fish species or the same diseases in other products, for instance other salmonids, non-salmonids and ornamentals as we are talking about here. The fact that a country chooses to have more relaxed controls for other non-specified diseases, for instance in wild fish products, such as these which occur in pilchards or with indigenous diseases which have a restrictive distribution, it would seem to me to be of little relevance to discussion in salmonids. Similar comments I can make with respect to ornamental fish and to wild marine fish in the risk analysis. Each product and each disease warrant independent evaluation. I am possibly missing a point here, but if this is put into context of the potential for disease occurrence in the future I hope you will appreciate the perspective I am coming from. 32. It is a scientific concern that significant new disease conditions are continually being found and that international organizations such as OIE have to continually reassess their lists of notifiable and other significant diseases. By doing so they indicate justification for the possible imposition of trade controls which did not exist before. It is therefore inevitable that there is a significant risk that these diseases will have already been transferred with traded products prior to controls being implemented. 33. There is an increasing debate on the extent to which a precautionary approach should be followed, with organizations such as NASCO (the North Atlantic Salmon Conservation Organization) advocating care to avoid a levelling down to the lowest common denominator. However, its my understanding that trade restrictions should not be imposed on the basis of unspecified unknown risks as a precautionary measure. This is particularly relevant to the discussion on uneviscerated fish being fed to tuna, where whole fresh fish pose a risk from various known diseases and probably many unknown diseases. However, unless these are specified as being of concern to Australia after they have carried out their appropriate risk evaluation, it would appear that they have no relevance to this discussion. Also its true that as knowledge of fish disease is rapidly advancing, any new information should be continually incorporated in decision-making and risk assessment processes. Therefore it hardly needs to be said that the fact that a risk was assessed at a particular level some time previously, this may be of little relevance to current levels of risk now being assessed. 34. And just finally I want to make a couple of comments on variants of the same disease. As I have just indicated, knowledge of these diseases are a rapidly developing area, although there are still many obvious inadequacies evident. In relation to the present discussion the ability to differentiate the diseases of concern from other closely related organisms is of particular relevance. At present, there is a gradation of knowledge apparent for the different diseases. I'll give a few examples here. From well studied bacterial agents such as Aeromonas salmonicida the differentiation of types, for instance between typical and atypical, is well understood and this is recognized in legislation. Similarly fish viruses also show considerable variations. IPN is a virus also relevant to this discussion. It is well know that there are several different serotypes of this well studied virus, each with different host-pathogen characteristics. However, only some of the known aqua birna viruses are differentiated by regulations. There is now increasing evidence that for some other fish viruses, the current internationally recognised diagnostic methods can not distinguish between different "sub-types". These can show markedly different biological characteristics, such as pathogenicity. For example, with the present level of knowledge it is not possible to separate "classic salmonid VHS" from possibly a wide range of marine rhabdoviruses and these are found in several different host fish species. In an attempt to resolve this problem, there are major research studies currently in progress to further refine diagnostic methods. Similar difficulties are beginning to emerge with other diseases and other viruses such as ISAV. 35. How can these difficulties be accommodated in risk assessment and that's why I ask. There are difficulties when international regulations cannot yet fully recognize such variations in disease types, yet science is beginning to point in a different direction. As a practical generalization, it is evident that the risk of a disease outbreak occurring is greatest when infection is transferred from the same or closely related fish species. This principal can be extrapolated to the risk associated with imported product and holds good when the "strain" of concern has limited host distribution. What disease the measures are trying to protect from may therefore strongly influence the decision-making in the risk assessment processes. I think that's all I want to say just now, thank you. Chairman 36. You express some regret that the parties had not arrived at a bilateral agreement before this. I would only comment that it is never too late, in fact. I have known cases where a bilateral agreement has come on the day when the panel was due to produce its report. So we live in hope. Thank you very much for that very substantive statement. Dr. Wooldridge, you have the floor. Dr. Wooldridge 37. Since I sent in my original report to you as you know we have received another considerable quantity of paperwork, but I was actually on holiday for the large proportion of that time, so I in fact only got to see the extra paperwork this week. Therefore I haven't studied it perhaps as well as ideally I would have liked to have done. However, in my opening statement I think I am going actually to address quite a number of the issues in question 34 that you have put: "what is my reply to the comments made by Australia on my written answers". So by the time I have finished this I think that question will basically, more or less, have been answered. 38. First of all I would just like to indicate my background, because I think it did say that I was coming to this from the point of view of a quantitative risk assessor. In fact, the relevant aspects of my background, among other things, are that I am a veterinary surgeon, qualified as an epidemiologist and have been working in the field of risk analysis now for a number of years in general, and that includes both quantitative and qualitative risk assessments. It also includes risk communication, hazard identification, and a little bit of risk management, so I think it is a bit narrow to suggest that I am only a quantitative risk assessor. 39. Looking at the questions that the panel set next, your question 2, I had quite a problem in answering because the question itself suggests bias because it already seems to assume that one might be looking in the direction that the report is not a proper risk assessment and that comes directly from the wording of the question. Now that worried me. I did conclude that, but I was worried that the Panel had already concluded that. I have to point out that I felt the question was worrying. The other issue about that question is the meaning of the word "proper" in this context. I spent quite a lot of time thinking about what "proper" means. Is a "proper risk assessment" proper because of the way it is set out or is a "proper risk assessment" proper because it comes to a conclusion with which one agrees, and is it necessary for a proper risk assessment to properly evaluate the risk? In the end I decided I wasn't entirely sure what, in fact, was required by the question. However, my answer I think gives the information you require, in that though I believe it to have been set out in the way in which a proper risk assessment would be set out, I do not believe for the reasons I have given that it actually fully assesses the risks. 40. The next point I wanted to make is that when I first looked at this risk assessment I did believe that it looked very good. It was full of relevant information and was well set out in general terms. But when I went through it in detail I did have some major concerns, which I have highlighted in my answers. They involved mainly the place of the exposure assessment in the risk assessment and the issue of subjectivity vis-�-vis the precision of the discrimination in the various levels of qualification. Now, picking that point up and looking at the Australians' comments on my comments, I would just like to say that with regard to the release assessment part, my criticisms were not, as it seems to be suggested in Australia's point 5, that I felt the release assessments were unclear per se, but that there was a risk of bias due to a perception issue due to the selected pieces of data actually included under the release assessment. I thought that was clear in my answer but I just want to re-emphasize that. 41. With regard to my worries about the exposure, I would like to say that in qualitative or quantitative terms a proportion of the total risk, and here we are talking about the risk of release, a proportion of that is always going to be less than the total risk. So if you have got a particular release assessment when it goes down different pathways, given that we expect that the majority of imported salmon for human consumption will be consumed by humans, the proportions going down the other pathways are bound by definition to be less than the total risk. If you are talking about a very small proportion, it is bound to be much less than the total release risks whatever they may be, and this holds true whether it is qualitative or quantitative. 42. With regard to my points about the subjectivity and the fine discrimination implied, and more than implied, in the risk assessment, there seemed to be a suggestion that I was suggesting that a quantified risk assessment was essential. Well, I am certainly not suggesting that, but what I am saying is that if one wishes to discriminate that finely then the only way to do it practically is by quantifying your points of discrimination. That is not the same thing as saying "I think the risk assessment has to be quantitative". I categorically do not think that it has to be. 43. I want just once again to emphasize the distinction between the assessed risk and the acceptable risk. I am very disappointed that I did not feel that the assessed risk here was proven to me in an appropriate and full fashion which I would like to have seen. However, I fully accept that any country is able to select the level of protection which it requires and it may be that if the things I would have liked to have seen taken account of in this risk assessment were actually taken account of in it, then it might be that I might have been convinced by the arguments. It wasn't that I believe that Australia necessarily got it wrong, but more that they didn't convince me that they had got it right. There are extra things I need to see in order to be able to make a decision one way or the other there. 44. My next point is that obviously both countries have been tasked to present all the experts opinions basically in a way which show their argument to best advantage. I accept that, so I realize that it is Australia's task to try and demonstrate that I in fact have come to the wrong conclusions. I accept that, and I'm not going to take it personally, of course. 45. It is the Panel's job, however, to decide whether the risk assessment fulfils what the World Trade Organization and the SPS Agreement require in terms of legal requirements. What I would like to say is that when I assess something like a risk assessment, I work on the basis of the highest standards that I can. So I'm assessing this risk assessment trying to look at it in terms of the best quality risk assessment that I would like to see. If the SPS Agreement does not require that risk assessments should be of the highest quality then I suggest there is a flaw in the SPS Agreement. Now, I don't actually think that's the case because the SPS Agreement or the OIE have been charged with the responsibility for setting risk assessment and risk analysis standards. With regard to this, there are various chapters in the various codes that the OIE have had drafted. There's one for fish risk assessment, fish risk analysis, which I have looked at. I believe it to be based very closely on the general Code for risk analysis which was produced in 1999, it was finally accepted in June-July 1999. Now there was a suggestion implicit in Australia's comments, I don't think it was actually explicitly said, but there was this implicit suggestion that I might not be totally au fait with the requirements of the OIE risk analysis code as per the 1999 chapter. In fact, I was one of the three people who wrote that, and every point that I wanted included in it was included in it and most of the points I didn't want include were not included. So I think it is true to say both that I'm pretty au fait with it, and that my way of viewing a risk assessment correlates pretty closely with its way of viewing a risk assessment. 46. I have got one final comment that I wanted to make in the opening statement that I had already decided that I needed to make. It is interesting that the same set of questions sent to three separate people, were actually interpreted in quite different ways by those three different people and that was a fairly short, fairly simple set of questions. So it does not surprise me that a document [the 1999 IRA] this size is interpreted in very different ways by different people. I think it just proves that this is an evolving and very difficult area, and so I would wish the Panel good luck. Chairman 47. Well on that note, perhaps we can now turn to the questions which we have circulated in writing at the beginning of this session. As I said in my introductory remarks, we do intend to go through these one by one. I think in the first case those that are addressed to all the experts, I'll just take them in the same alphabetical order that we have just had the three initial statements. So perhaps I can start by asking Dr. Br�ckner to respond to question number 25. Dr. Br�ckner 48. Thank you Mr. Chairman. I perceive this question as that, in view of the additional information that came out after we answered the questions, whether we have changed our views. I think I stated in my answer, especially in relation to questions 1 and 2, why I take that view so I maintain what I said originally. Dr. McVicar 49. Thank you Mr. Chairman, I take a very similar view to Dr. Br�ckner. As I've said in my opening statement, I have taken very much the practical aspects of this into consideration and to me it's the correct way forward in this particular case. Dr. Wooldridge 50. I think the reasons for my opinions I gave quite clearly in my answers to my questions and it's based on my wish to try and reach the highest standards of risk assessment that we possibly can. And I therefore don't think I've changed my view either. Dr. Br�ckner 51. Mr. Chairman, thank you. I'm not sure whether I understand part one of the question correctly, which says "whether Australia maintains any distinctions in levels of protection it considers to be appropriate in respect of different situations". Would that imply a change in the distinction in the level of protection? I don't follow it. Maybe one of the other experts could try. Chairman 52. � It's really referring to that. Dr. Br�ckner
53. Is it mainly in relation to the pilchard issue?
Chairman
54. Yes, and consistency.
Dr. Br�ckner
55. Mr. Chairman, in the comments from Canada they did supply the paper, I think
by Whittington, in relation to this issue and in Australia's comment they also
made further comments on that. Australia still maintains the view that given the
fact that it's endemic in Australia they don't need any further levels of
protection in connection of that. I indicated in my answer that I reserve
comment on that because we had the general comments in the report that was not
very elaborate in terms of pilchards, we had the scientific paper and then we
had a rebuttal on that. So I am very hesitant to give a definite opinion on
that. But the stance taken by Australia in terms of the endemic situation of
pilchards in their view, I supported that in lack of further evidence.
Dr. McVicar
56. Thank you Mr. Chairman. I had the same difficulty as Dr. Br�ckner had in
understanding what was going on here in the underlying situations, essentially
the same problem. Thank you for your clarification. As I said in my opening
statement, the science of fish diseases is very, very rapidly developing and we
are continually faced with new issues, new developments and the herpes virus in
the pilchards in Australia was one such example. I think it is anything but
clarified yet what the significance of this or the origin of this actually is. I
find it very, very similar to the situation we are actually dealing with in
Scotland at the moment regarding the ISA virus, where we don't know the origins
of it and the possibility that it maybe imported, it maybe from a natural
source, in which case is it endemic or is it not endemic? These are exactly the
questions we are wrestling with at the moment. As I also said in my opening
statement, control measures to reduce risk have got to be based on demonstrable
and proven cases and not on possible cases. I find this situation too unclear as
yet to actually say that this disease is coming in from the outside, in which
case you would wish to possibly introduce control measures. Thank you Mr.
Chairman.
Dr. Wooldridge
57. I am not, as you know, a fish disease expert and therefore this potential
disease of pilchards and the question as to whether it was endemic or exotic was
something I had not considered before. So I was reliant entirely on the
information I could obtain from the papers, and it seemed to me that there was
grave doubt about which source it had come from and whether indeed it was
endemic or exotic. Given that, I did think the way it was dealt with was not the
way I would have chosen to deal with it if I was trying to do a risk assessment
and therefore rather odd. I don't think that anything that has been said so far
or that I have read since I wrote my report has actually changed my opinion on
that.
Chairman
58. Thank you very much. We'll now go on to question number 27, which refers to
question 29 to the parties. I just wonder whether we now actually need this
question in view of the answers we've just had. You probably have basically
covered it in what you have just said. Let's go on to number 28 in that case.
Dr. Br�ckner
59. Chairman, yes I think it relates probably to the previous one. I think the
issue here is whether the difference in the protection set for salmon and
pilchards are scientifically justifiable. In the comments that we had afterwards
from Canada and then from Australia, I tried also to set my mind at ease in this
whole issue. In the end, I think the reasons given by Australia for the
difference are, in my view, acceptable for the reason that they follow a logical
pathway to come to that conclusion. I heard what Dr. Wooldridge said and maybe
otherwise in quantitative terms it could have be challenged, but in view of what
we have and the structured way of reasoning for this issue, I think it is
justified.
Canada (Mr. Kronby)
60. If I may, just to clarify, the question refers to Canada's rebuttal
statement. It's in fact paragraph 37 in Canada's responses to the questions to
the parties.
Dr. McVicar
61. Thank you Mr. Chairman. My confusion was on the rebuttal because I had made
comments on the rebuttal statement from Canada not on the original. As I said in
my written statement, I believe a distinction can be made where a product is
used in different circumstances, and in different situations. The use of whole uneviscerated pilchards for use as bait and feed, in the environment it's being
used currently, with long experience, would indicate low level of risk in that
environment. That is an accepted statement I think that most people would go
with. Circumstances will change if disease appears as a direct consequence of
that, as I have also indicated. Therefore, the level of protection necessary on
that product used in these circumstances may be different from the use of that
product in different circumstances. For instance, and I use the example in my
opening statement, if you use that as feed directly into a salmon � And I feel
very strongly that that is the situation here. There is a different level of
risk. Hopefully any risk assessment will take in this final step in the chain,
not just what infection is present, not just survival through, not just the
release, but also the exposure at the final end point: availability of
susceptible hosts, etc., dilution factors. I mentioned all of these factors in
my earlier statement.
Dr. Wooldridge
62. I think I have covered this in my answer to your original question 10 and I
cannot see that I can add anything.
Chairman
63. Let's go onto the next question. The next two are in fact addressed to Drs. Br�ckner and McVicar. So we will start with 29, for Dr. Br�ckner. No we have
dealt with that. 30.
Dr. Br�ckner
64. As far as question 30 is concerned I would not like to comment because I am
not an expert on the trade issue of fish internationally, whether it is
processed or chilled or so on. So I think it would be unfair for me to comment
on that question.
Dr. McVicar
65. Most trade throughout the world in fish product, specifically if we take salmonids first, is in the gutted product. Not exclusively, there is a market
certainly within Europe for whole ungutted product and for the sort of reasons
that you can indicate freshness, etc. There is clearly a market for that which
is protected and is a niche market. However, it is true that most of the trade
is an eviscerated form, and looking at the OIE recommendations, this is
recognized as a way of significantly reducing risk from diseases which are
usually associated with blood and blood-rich products. So yes, I would agree
that most of the trade is in this. The further removal of heads and gills and
any part which is not going to be eaten or not cooked, will reduce risk. I think
that goes by virtue of the fact that you are removing tissue which is not going
to be disposed of and I can appreciate that. However this, as far as I am aware,
has not been quantified or properly evaluated, and a level of protection gained
by assessing such a process is not at all clear. Looking at the form of frozen
fillets, frozen as indicated in my direct response, particularly with herring,
does reduce the level of activity present and viability of any pathogen that may
be present. So again there is a possibility of a further reduction at this
level.
Chairman
66. Does that cover whole fish as well? You mentioned fillets.
Dr. McVicar
67. Yes, getting on to whole fish for human consumption. It is unusual for whole
fish, apart from pilchards, small herring, white bait, etc., to be traded for
human consumption in that the digestive enzymes present in the viscera are
liable to lead to degradation of the product and it is only quite rare in fact
that the whole product is actually traded for human consumption.
Chairman
68. But the whole fish, eviscerated?
Dr. McVicar
69. Eviscerated is quite often traded. It is a normal method of trading, for
instance for farmed salmonids throughout the world from Europe.
Chairman
70. So the concern is with the viscera rather than with the skin.
Dr. McVicar
71. That is correct.
Chairman
72. If there is nothing further on that one, can we go onto the next question,
number 31, to Dr. Br�ckner?
Dr. Br�ckner
73. Thank you. I agree with Canada that I probably interpreted that as whether
stricter measures than the current ones could be applied. But whether they are
stricter or more lenient, it is not an easy question of just "yes" or "no". If
one proposed more lenient sanitary measures, then they would once again need to
be evaluated against the outcome of the measures. So, yes, it would be possible,
but then it would imply the proposal of less stringent measures and an
evaluation in terms of the consequence. So whether it goes one way, or the other
way one has to reassess in terms of the whole process again, especially in terms
of the risk management and the consequence factors. I think what has been done
in the IRA is that they have followed this approach, in general, to establish
the relationship between the proposed measures and the ALOP. So if I say "yes",
then I need to have evidence in terms of the total process again.
Chairman
74. � Question 32, which is addressed to Dr. McVicar.
Dr. McVicar
75. Just to aid those people who don't have the actual question in front of
them, I shall summarize it. Fish used for purposes of fish-feed (bait) is
obviously more likely to introduce disease agents into the aquatic environment
than product for human consumption. The conclusion cited that risk of such
imports introducing exotic disease capable of producing large fish kills are
either low or doesn't exist. Canada made a submission, paragraph 115 of their
statement, that the absence of disease from billions of tonnes of dead
eviscerated fish is even stronger evidence that the risk from such product is
negligibly small. I think I have already partly answered this, and have
certainly repeated something that was already said in my written statement. But
it depends on where you are using this. If your tuna farm is beside a salmon
farm, then the salmon farm may be at risk from any disease agents that can cross
between the species. So it is putting the salmon at risk if you are growing the
salmon in the same area as you are feeding or using this as bait.
Chairman
76. Is that in reality a real possibility?
Dr. McVicar
77. I can't say what the situation is in Australia, but certainly in Britain,
because of the risk of carcasses produced in secondary processing of salmon
products, for instance from Norway being used as lobster bait, we have brought
in regulations and codes of practice to prevent that from occurring. There is a
serious risk of that material then transferring across. There is a similar risk,
with the caveat that less of the diseases (because it is a different species)
will transfer from pilchards or herring being used as bait or feed into salmonids. They will pose a risk to the same species or related species.
Chairman
78. Am I not correct in this particular case that the geographical separation is
very great?
Dr. McVicar
79. I understand that is the case.
Chairman
80. So therefore the situation that you are envisaging is unlikely to have
arisen.
Dr. McVicar
81. Indeed so. In fact within the country we are now looking at legislation to
prevent secondary processing taking the same line, i.e. release of material from
carcasses and from heads into their environment in the vicinity of important
producing areas.
Chairman
82. If we have got nothing further on that one, perhaps we could now go on to
question 33 to Dr. Wooldridge. I think actually you have probably covered 33 and
34. 35 is rather curiously drafted again because it refers us to a question
("does Canada agree") - I guest that is not part of the question you are being
asked. Do you have any views on the IRA 1999 meeting OIE standards?
Dr. Wooldridge
83. Yes, I do believe I have answered question 34 already. I am not sure about
question 33. I would just like to pick up on that, if you let me, because I
think the question suggests that my original answer has been misinterpreted. I
think my paragraph 10.2 actually covers the first sentence there or the
first-half of point 33. The second-half of point 33 - I think I am reading this
correctly - is asking if my opinions have changed on whether there is a
scientific justification for the difference in quarantine measures. I didn't say
that there wasn't. What I intended to say was that it has not been proven to me
that there is, which is not quite the same. So I have a problem with the wording
there. I am not sure whether I have just clarified it or made it greyer.
84. Going on to question 35, I am sorry, but again, I think I have answered that
in questions 1 and 2 in the sense that it all revolves around what is the
meaning of the word "proper". The things that are required are all in there. I
do not believe they have been utilized completely appropriately. Consequently my
interpretation of what is required from the OIE chapter which I co-wrote is that
it doesn't fulfil those requirements. However, the information required to do
that is there, I believe. I hope that clarifies it. Come back to me if I need to
go on with it more.
Chairman
85. We will reflect on that. We might have something further to say. For the
moment I think that is fine. I think what we can usefully do now is go on to the
next stage, which is to offer the floor to Canada for any questions or comments
that Canada may have on the experts' views. I said earlier the experts will have
the opportunity to respond immediately and Australia would also have the
opportunity to put any directly related questions.
Canada
86. If I may ask that we have a short break so that I can consult with my own
experts and that we can digest what we have heard a little bit and maybe try to
decide whether we do have questions and if so how best to formulate them to get
clear answers.
Chairman
87. Fifteen minutes - until half past. Thank you.
Chairman
88. Perhaps we can resume after that little break. I take it that Canada is now
ready to put its questions and comments. You have the floor.
Canada
89. Thank you Mr. Chairman. I think after discussing this among ourselves we can
keep this short and simple. Canada has really just one question, and it is a
question directed to Dr. McVicar. I understand you to say that in the case of
bait fish, the fish to which bait are fed, that is the species, will
significantly affect risk. I am leaving aside for the purposes of this question
other factors such as volume or location because I understand your comments
earlier about dilution, depending on the environment into which bait fish is
deposited. Generally the fish to which the bait is fed will significantly affect
risk. Thus if pilchards are fed to salmon, for example, as bait or feed, risk
would be higher than if it is fed to tuna. Would you agree then that if
pilchards are used as recreational bait fish, such as for salmonids, that would
pose a more signficant risk than if they were fed to tuna?
Dr. McVicar
90. Yes, I think there is possibly some misunderstanding that has crept in here.
Pilchards fed to pilchards will be higher risk. Salmon fed to salmon will be
higher risk. Pilchards fed to salmon will be lower risk, but significant only if
it is shown that the same agent, or even strain of agent, is present in the
pilchards which will cause disease - as opposed to infection - in the salmon.
And tuna fed to tuna will be higher risk, because the agent that is carried by
the tuna being fed to the farmed fish will clearly be from the same species. So
crossing the species barrier, although not impossible, in general terms will
provide a lower level of risk; both by not carrying the same range of agents
capable of infecting the receiving fish, and also by carrying different strains.
This is very clearly illustrated by the presence of different virus strains in
many different fish species of marine fish in European waters which, although
they may show substantially different biological characteristics, such as in
their pathogenicity to different types of fish, may not be distinguishable by
current techniques. It is clear that the rhabdovirus, which is identified as VHS
in the OIE Code, although pathogenic when fed to turbot - another of our marine
species - shows very low pathogenicity and low infectivity when the same species
is fed to salmonids. The rainbow trout VHS fed to turbot is at low
pathogenicity, low infectivity. They are all recognized as VHS, but these are
clearly different strains. Does that answer your question?
Australia
91. I would just like to thank all the experts for their further comments and
clarifications. We have just got a couple of questions for each of the experts
and one which I will address to all three. Also just one point. I just wondered
whether there is any possibility, if the experts have written versions of their
statements, whether we could get copies of those.
Chairman
92. Yes, I did raise the possibility in my introductory remarks that the experts
may wish to confirm in writing what they have said, or elaborate a bit. I wasn't
actually requiring them to do so, but if anything does come in writing within
the next two days that is either a confirmation or an elaboration of what has
been said, then we will certainly see that that is circulated to both parties.
Australia
93. Just a question which I would like to address to each of the three experts
to begin with, if I could, and it relates to the question of the herpes virus
and pilchards. I just draw attention of the experts to paragraph 119 of
Australia's rebuttal statement or submission and also section 6 of Australia's
comments on Dr. Wooldridge's answers to the earlier questions. I will just read
briefly paragraph 119. It just states that the herpes virus is highly
host-specific to pilchards and wild ocean fish and is not associated with salmonids. It is endemic to all marine waters of Australia where the species is
found and also appears unique to Australia-New Zealand marine waters. The cause
of the sporadic disease outbreaks is yet to be established. There is no
suggestion that the disease was introduced from imports. What I would like to
ask the experts is that are any of them aware of any evidence that this
statement, in particular that the herpes virus is endemic to all marine waters
of Australia, is not correct?
Dr. Br�ckner
94. I think I have answered the question earlier - suffice it what has been said
for lack of further evidence.
Dr. McVicar
95. I think I also answered that question earlier on. The evidence either way is
actually very slim at the moment, but until such a point in time as we have
evidence that it has been introduced there will be no justification in taking
measures against it.
Dr. Wooldridge
96. I am not a fish expert and I am not au fait with all the evidence on fish
diseases and particularly including this disease. As I said earlier, I was going
on what was in the papers and I thought that I had already answered that
question in my answer to number 19.
Australia
97. Just to clarify - our point is that this disease is now endemic to
Australia. Is there any evidence to suggest that that is not the case of which
the experts are aware?
Dr. Br�ckner
98. I have got no evidence to prove the contrary at this stage.
Dr. McVicar
99. I repeat the same answer - no, there is no evidence to the contrary.
Dr. Wooldridge
100. I have no evidence of that at all.
Australia
101. A couple of questions that I will put to Dr. Br�ckner. We understand that
you have been involved in OIE work for the last few years. Is it your
understanding that the 1999 OIE Animal Health Code chapter on import risk
analysis gave substantially less emphasis to a quantitative approach to risk
assessment than the 1997 version?
Dr. Br�ckner
102. I have not got the Code with me. Dr. Wooldridge was also involved in that.
I think what is more clear now than in 1997 is that it is explicitly said that a
qualitative risk assessment is also acceptable, when previously it was not that
explicitly stated.
Australia
103. Secondly, do you consider that the scientific advisors engaged by AQIS in
the 1999 risk analysis are representative of international expertise in the
field of risk assessment in aquatic animal disease, including the management of
aquatic diseases.
Dr. Br�ckner
104. Yes, two of those names are familiar to me so I would agree with that
statement.
Australia
105. Just a couple of questions or points on your answers to questions 7 and 8.
In your response to the Panel you advised, and I quote, that "no scientific
justification could be found in the 1999 risk analysis for the measures relating
to consumer-ready salmon product and for product that is not in this form to be
processed in approved premises", although these issues were discussed on page
201 of the import risk analysis. You would be aware that in this rebuttal
submission, particularly in its comments on responses to Dr. Wooldridge's
comments, paragraphs 24 and 61, and the following of our comments on Dr.
Wooldridge's, Australia explained the reason for the measures that relate to
consumer-ready product with reference to three key factors, and they were that
consumer-ready product is less likely to be commercially processed than other
forms of product, for commercial reasons, and that this reduces the risk because
processing plants generate waste at a higher concentration and volume than do
households. Secondly, the commercial processing of consumer-ready product may
occur, for example smoking of skinless fillets of salmon, however this would not
be expected to generate a significant amount of waste material. Thirdly,
premises processing imported product must have appropriate systems for disposal
of solid and liquid waste, because this will reduce the likelihood of exposure
of domestic fish to disease agents present in such material. Do you agree that
these factors justify Australia distinguishing between consumer-ready product
and other product in terms of the associated-quarantine risk? And if so, do you
consider that Australia's measures represent a valid approach to risk
management?
Dr. Br�ckner
106. This is a tricky one because I try to evaluate this from the veterinary
administrator's side of view, and I have read the reasons given, in terms
especially of the waste and the possibility of pathogens finding that pathway. I
would accept the arguments, but not very confidently. The opinion was that there
was much emphasis placed on the perception of the people in the trade on this,
rather than a quantitative way of expressing that. I know there were studies
done and figures given in terms of the waste and the possibility of finding that
in that pathway. In the lack of any counter scientific arguments, I could not
disagree with you, but I am not confident to say yes.
Australia
107. In relation to questions 15 and 17, you advise the Panel that you could not
find convincing evidence for Australia's further restrictions on size and
processing of salmons, but not for other finfish. You are aware that in the 1999
risk analysis Australia identifies four salmon diseases - IHN, ISA, Aeromonas
salmonicida and Renibacterium salmoninarum - in relation to which the
consequences of establishment in Australia would have moderate or more serious
consequences. Depending on the types/stage of infection, these agents can occur
in the flesh and skin of salmon. You will also be aware that, as explained in
the risk analysis, non-salmonids finfish are not generally considered to be
significant hosts of these four diseases. There is a negligible likelihood of
such fish being infected with IHNV, ISAV or R. salmoninarum. For A. salmonicida ,
it is a negligible likelihood of infection, except in farmed marine fish closely
associated with infected salmon. Accordingly there was no reason to impose the
consumer-ready further processing measures on non-salmonids finfish generally.
However, additional controls including measures that pertain to product form,
the presentation, processing and certification were imposed on farmed,
non-salmonids marine finfish in recognition of the greater likelihood of
infection of A. salmonicida in these fish. In light of this explanation, do you
believe that there is adequate justification for the different measures which
Australia has chosen to apply?
Dr. Br�ckner
108. In the last sentence I said that I felt unconvinced of evidence at that
stage, but in the comments received afterwards and the comments from Australia,
I am happy with those replies given.
Australia
109. In relation to your answer to question 16, you state that it is reasonable
to ask why Australia does not apply the same measures on salmon imports,
specifically in relation to the consumer-ready further processing measure, as
New Zealand, considering the similar disease status of the two countries. In its
response to the Panel's questions, Australia has noted that the measures applied
by the two countries are, in fact, very similar. There are some differences
which reflect differences in the assessed quarantine risk as between the two
countries. These differences in assessed risk in turn reflect differences in the salmonid health status, exposure pathways, the nature of the domestic salmonids
industries, and the appropriate level of protection of New Zealand and Australia
as documented in Chapters 4 and 5 of the 1999 risk analysis. Do you agree that
such differences in key parameters relevant to the assessment of risk and the
management of risk would readily justify the relatively small variations between
the Australian and New Zealand approaches to control quarantine risk in imported
salmon product?
Dr. Br�ckner
110. In my opening summary remarks I did refer to this, because at that stage I
could reasonably ask why Australia did not apply the same measures. But in the
documentation that came afterwards you included that risk assessment of New
Zealand and you also gave further evidence in terms of this.
Australia
111. Some questions for Dr. McVicar if we could.
Canada
112. If I could just get some clarification from Dr. Br�ckner on the question
before this last one, on the justification for the consumer-ready requirements.
Do I understand it, Dr. Br�ckner, that you have changed your views, your
answers?
Dr. Br�ckner
113. I have not changed my view. I said that in view of me countering it with
scientific evidence, I have to agree with our Australian colleague. But I said I
do it with hesitance, because my gut feelings do not agree with the difference
between the 450 grams and not, and the skin-on, skin-off issue. I have got no
scientific evidence to counter it.
Australia
114. The first question is in relation to Dr. McVicar's answers to question 7.
In your response to the Panel on this question, you advised that the removal of
skin from Canadian salmon would be unlikely to significantly contribute to risk
reduction. However, in your response to question 20 you advised, and I quote,
"there would not appear to be a major disease risk associated with salmonid
skin, but balanced against this is the greatly increased risk that this
inedible, low-value material may be disposed of in an unsafe manner prior to
cooking". These issues were discussed on page 201 of the import risk analysis.
You would be aware that in its rebuttal submission, particularly in its comments
on responses by Dr. Wooldridge, Australia explained the reason for the measures
that relate to consumer-ready salmon product with reference to the three key
factors that I had mentioned before. Do you agree that these factors justify
Australia distinguishing between consumer-ready product and other product in
terms of the associated-quarantine risk, and if so, do you consider that
Australia's measures represent a valid approach to risk management?
Dr. McVicar
115. Yes, as a disease person I recognize that there are certain pathogens which
do occur on the surface of fish skin - Aeromonas for instance; ISA is another
example - and have a preponderance on these areas But taking into account the
level of removal of these by appropriate washing and handling, packaging,
general processing, etc. the likelihood of significant numbers being still
present when the product is exported is actually quite small - these are quite
aggressive environments. It is a route of spread and I would, for the agents I
have mentioned, in particular, consider that the risk is very small. This was
recognized in the European Union regulations requiring only gutting from
ISA-infected areas, as an example.
116. Balanced against this, and as indicated in my answer to question 20, is
recognition that parts of a fish which are not consumed, which are considered to
be of low value, such as fish skin, are liable to be disposed of in an unsafe
manner. Really, to accommodate the low level of risk, I can understand why
somebody may wish to do that. But if the risk is so low in the first place, then
this is what led to my response to question 7 - that it is unlikely to make a
significant contribution. If the level of risk is very low in the first place,
the removal of the skin to further reduce that will make very little difference.
Australia
117. Yes, in follow-up to an answer from an earlier question - question 30 from
the Panel - the Chairman appeared to draw a conclusion from your response that
skin was "not a problem in the sense of disease risk". I just wonder, Dr. McVicar, whether you could clarify that the Chairman's comment on evisceration
and the form of fish traded relates to commercial practice and not to the issue
of disease risk.
Chairman
118. Let me just comment first, please. I was not drawing a conclusion, I was
merely trying to clarify what I understood Dr. McVicar to have been saying, so
my remark was merely for clarification. It wasn't to indicate that we have any
thinking at all on that.
Australia
119. It seemed to us that the response to that question seemed to lose a bit of
clarity; whether Dr. McVicar was relating to the commercial practice of how
products are traded, or to the issue of disease risks.
Dr. McVicar
120. Yes Mr. Chairman, you specifically asked what I considered were the main
routes of trade in product, and that is what I responded to, not to the disease
issue, since it is my understanding of the trade in product, rather than the
disease.
Australia
121. Finally, just two questions, if I could, to Dr. Wooldridge. You have
commented on what you perceive is the subjectivity of Australia's qualitative
risk assessment. How would you avoid the problem of subjectivity if sufficient
data are not available to permit a quantitative risk assessment to be conducted?
Dr. Wooldridge
122. It is impossible to avoid subjectivity in a qualitative risk assessment.
Australia
123. Just as a follow-up - are you saying that subjectivity is not an element of
a quantitative assessment?
Dr. Wooldridge
124. No, that is not what I am saying, but it is easier to reduce it.
Australia
125. Finally, how would you ensure that quantitative data, which may be scarce,
are properly representative, given that they may be obtained under conditions
that are not representative of a field situation.
Dr. Wooldridge
126. Any risk assessment should use the best information currently available, so
I think what you are saying is how do you work out what is the best information
available. My answer to that is that you need to get together the experts who
know about the particular subject, and in essence ask them which is the most
appropriate and best data available. That of course leaves you with a number of
additional questions, for example, who are the most appropriate experts to ask;
how do you illicit the information with a minimum of bias; if there are
contradictory opinions, how do you correlate those into one risk assessment;
even if the opinions tend to be similar, but are not precisely the same, how do
you correlate those into one risk assessment. These are all very important
methodological issues which are all currently the subject of a lot of
methodological research. However, the simplest answer I can give today, without
going into an awful lot of detail, is that I believe that these can be done
using distributions and stochastic modelling.
Kari Bergholm (Panel member)
127. This is a follow-up question just to Dr. Wooldridge, just to get better
educated on this complex issue. Would it be possible to use such a risk
assessment with parts that are quantitative and parts are qualitative, a
combination of qualitative and quantitative, or should it be throughout
qualitative or throughout quantitative? If a risk assessment is basically
qualitative, would it improve the probability that it is correct if those parts
that could be made quantitative where the data is available - would that be
possible, or should assessment be throughout qualitative or throughout
quantitative?
Dr. Wooldridge
128. I think that whenever there is quantitative data available, it should be
recorded as part of the information gathering exercise and used wherever
possible and appropriate. And I do think in a complex risk assessment it is
possible, if it is a very long pathway, to actually cut it up into pieces, some
of which you may be able to get a quantitative answer to, and other parts of
which you may not. And to take this as an example, I do not know precisely what
data is available, though I would go back to my point from the original Panel
and say that in my experience there is always more data available when you look
for it than you thought there was when you start. However, it might be possible
that one could do a quantitative release assessment, for example, and a
qualitative exposure assessment. As soon as you have any part of the chain being
qualitative, it precludes you being able to undertake a complete quantitative
risk assessment. But certainly I would strongly advise that if someone wishes to
clarify the issues, then they quantify as much as possible.
Australia
129. Mr. Chair, just one further follow up question to Dr. Wooldridge. In the
1999 risk assessment we did use qualitative data when it was available, and ran
that past experts to see whether that data was relevant and whether it could be
improved or enhanced etc. Does Dr. Wooldridge consider that that is part of this
reasonable approach?
Dr. Wooldridge
130. That sounds very reasonable, yes.
Chairman
131. I take it that we have now come to the end of questions and comments from
the parties. I don't think the Panel has any further questions at this stage
unless my colleagues do. I am going to ask the legal adviser to put the question
on the Panel's behalf.
Joost Pauwelyn
132. It seems that everyone agrees that there should be a consumer-ready
requirement or something; but what about the specific definition given in
Australia's measure, the 450 grams and the skin-off/skin-on? If you compare that
specific definition to, for example, the definition given by New Zealand to just
require consumer packaging. How would you compare these two definitions, or do
you think that the New Zealand definition would meet the same level of
protection?
Canada
133. Yes, if I may Mr. Chairman, I am not sure it can fairly be characterized
that everyone agrees that there should be some form of consumer-ready packaging.
I'm not even sure it can be agreed among the experts, assuming they agree
something.
Australia
134. Mr. Chairman, the question I think is very similar to, in fact I think
question 32, which we will respond to on Friday.
Chairman
135. But it is addressed to the experts, so we will take it.
Dr. Bruckner
136. As I said, I still feel very uneasy with this whole issue. One could, for
instance, ask Australia what is the possibility of people getting the
consumer-ready product of 450 grams with skin-on requesting that the skin be
removed, if they prefer it that way. What I am trying to say is the possibility
of even skin being disposed in waste of what is perceived a safe consumer-ready
product, is that a factor or not. So it is coming back to the question that has
been asked here, in terms of the comparison of New Zealand. I told Australia
that, in view of me countering their scientific arguments, I can't oppose that,
but I still feel uncomfortable with the decision.
Dr. Wooldridge
137. I'm not quite sure that I'm fully au fait with what the question is asking,
but I would like to say I have no problem with the idea of bringing in this
issue of consumer-ready products. I think it is relevant to consider this and
any other issue which might be appropriate when doing a risk assessment. I think
I actually understood what Australia was getting at and why they were doing it,
in that it might well be the case that a consumer-ready product is treated
differently to a non-consumer-ready product. I was unhappy that there was no
evidence that convinced me that that was in fact the case. And I actually think
that the people from whom evidence of that might be available did not appear to
have been consulted. Unless I missed it somewhere in the rather large amount of
paperwork. But I wasn't convinced by those parts which I studied closely.
Kari Bergholm
138. May I have a follow up question, because I still think that something is
missing here, at least for my understanding. There is still missing, for my
understanding, some elements here. If we accept that the requirement of
consumer-ready packages is justified, what is the justification to put the limit
of 450 grams? Is there a scientific justification to put the limit of 450 grams,
instead of 1 kilograme, or 200 grams, or from where comes this 450 grams? Does
that limit reduce the risk in a significant way? Then I have a comment to Dr.
McVicar, when you said that skin is a low level product that is discharged. In
my country, some skin is considered as a special delicacy. So if a product is
without skin, it is a low-level product in my country, so the markets are
different. Tastes are different. But going back to my question, it is really
what is the scientific justification for this 450 grams result? We already have
your answer as to what is the significance of skin or no-skin, but for this 450
grams, that is still �
Chairman
139. This is for the experts. Dr. McVicar?
Dr. McVicar
140. Can I respond to that? As I said in my written response to the questions, I
cannot see a cut-in point or a cut-out point at 450 grams which would justify
that particular aspect from a disease point of view. Diseases which are present
through the life of the fish will be as present beyond the 450 grams as they
were under, and may manifest themselves under stress conditions at any point
during the life of a fish, if they are persisting in a low-level state so they
can reproduce. As I said, and I speculated, maybe wrongly, possibly because of
my involvement in the risk analysis with Australia, possibly justifiably, that I
could see that some logic that this would be a consumer-ready product in a size
which would be consumed and directly cooked, that that was an assumption, which
I think Australia should respond to.
141. The second point about skin, if I could just briefly mention it. I am aware
that skin, for instance in Iceland, is a very valuable leather product and is
treated as such as well, so it is not exclusively low value, and I accept your
comments of my ignorance about the Finnish habits as well.
Chairman
142. No doubt Australia will wish to come back to that point when we get to the
meeting on Friday but do you wish to �
Kari Bergholm
143. But I would like to hear the opinion of the other experts on my question,
if they have any.
Dr. Wooldridge
144. Yes, my understanding was that the 450 grams was the size of the portion,
not the actual size of the fish. Consequently it may be, though it is to me not
obvious from the information we have been given, but it may be that there is
somewhere some evidence that that is a typical size which a consumer would cook
in one go, or treat in one way that is different to another. Now, I didn't find
that evidence, but that isn't to say that it doesn't exist. I think if it does
exist, well it's a shame it isn't shown in there, but my understanding is that
this is not a case of the amount of infectious agent potentially present in the
portion size, but that it is a case of what the exposure pathway following on
from different portion sizes might be. So the fact that the bacterial or parasitalogical or viral load is not affected by the portion size, except as far
as a unit load is concerned, but that it is an exposure pathway problem; that
Australians are saying, as far as I understand it, that if you have a portion
that somebody will cook in a kitchen as is, they are going to treat bits and
pieces of it in a different way, so the exposure pathways will be different.
Chairman
145. I'm not sure that I gave Dr. Br�ckner the opportunity to respond.
Dr. Br�ckner
146. My perception is the same as that of Dr. Wooldridge. I think in the
Australian 1999 IRA there was an annex of a letter from one of the traders, and
I have the same idea that it is also the size being preferred by the trade.
Australia
147. If I could just clarify the points, basically I think we are in close
agreement with what Dr. Wooldridge and Dr. Br�ckner have said, that I think it
comes down to perhaps two elements. One is the definition, if you like, and that
was a commercial matter based very heavily on advice that we got on consumer
behaviour and the likelihood that that is the amount of product that the
consumer would cook and eat themselves. The second element then is the factual
basis for the measure and that gets to those three facts that I mentioned, that
that sort of portion would be likely to be consumed by a householder in its
entirety. And if it was processed, then again the waste would be minimal. I
think that perhaps gets to one of the points that Dr. Br�ckner raised earlier.
And then the third element that there is resort for the further processing in
certified premises.
Chairman
148. Can I just clarify that the concern then is about waste disposal, not from
domestic consumption but from commercial large-scale consumption?
Australia
149. The disposal is certainly in commercial processing, the disposal there is
the greatest concern. These other elements, that the consumer-ready size is 450
grams, limits then the wastage in those other areas. So I think it is those
three factors together that lead us to the position.
Chairman
150. Do you want to add anything further or �
Australia
151. Just to put into the record, if I could Mr. Chairman, that it is in fact
paragraph 68 through 71 of our comments on Dr. Wooldridge's comments that I
think do go to this question of the definition of consumer-ready product. But we
will come back to this certainly on Friday.
Canada
152. Thank you, Mr. Chairman. I think you just asked the question that I was
going to be seeking clarification of. Having read page 201 of the 1999 Report to
which Australia referred, it was my impression as well that the concern that the
consumer-ready requirement was trying to address was commercial processing, and
having read the exposure pathway assessments throughout the 1999 Report, that
was also my impression, because of the conclusions drawn regarding other
pathways. I think I will just return to that on Friday rather than pursuing it
here.
Chairman
153. Well, it does seem that we have in that case exhausted the process this
afternoon. I will give the experts the opportunity of making any final closing
remarks that they feel that they wish to make, to summarise what they have said,
or to highlight any particular points which they think are important, and make
it as long or as short as you wish. Dr. Br�ckner.
Dr. Br�ckner
154. I don't think I've got anything to add to what has been said, but I think
in retrospect, when we look at this dispute in later years, and I think Dr.
Wooldridge will agree with me, I can't recall any previous incident where an
issue in terms of the SPS Agreement, questioning the relevance of a qualitative
versus a quantitative and the place of that in future decision-making, has been
debated so intensively. Maybe it is good that it came to the fore. That's just
that. I hope this dispute gets settled and good luck.
Chairman
155. Thank you very much.
Dr. McVicar
156. Thank you, Mr. Chairman. I have written down just a few comments earlier on
just what I feel would summarize my position as I see it. I won't repeat my
earlier statements, quite obviously, but it is evident to me that as a practical
scientist there will always be scope for disagreement on what is considered to
be an appropriate level of protection. I really equate that with what I would
call a precautionary approach, as opposed to a less precautionary approach, and
if you look at this at the extremes, I think you can see where I am coming from.
If you take the one extreme of precautionary approach you do nothing until
you've proved the negative. That's impossible and not permitted under trade
rules. Or the opposite extreme, you allow everything until you get a positive
consequence, in which case it is too late by that time. It is an obvious
statement that the stances, and what has been deemed appropriate measures;
clearly different approaches are being taken by the two parties here. From a
scientific point of view, the differences evident in the hazard identification
and risk assessment sections of the 1999 documents are not major, and probably
do not significantly influence the conclusions arising from that. But as the
scientists appear to be in general agreement, it is in the translation of the
science into policy that, it seems to me anyway, the disagreement then appears.
157. I've heard criticism that more quantitative analysis was not carried out,
and firstly I don't think this is required, and I think we have covered that
point already. And, secondly, even a full quantitative analysis might resolve
differences in view about whether a particular measure is warranted or not, or
might not in fact resolve differences. An example, from a different view
completely, and it's a serious example: the risk of an individual being struck
by lightning can be quite accurately measured, but this doesn't stop people
partaking in outdoor activities. A much lower level of risk can be calculated
from BSE, but this was sufficient to actually have beef banned from the UK
throughout the world. So, it is down to perception of risk, and perception in
the individual, and it becomes a cultural and political aspect thereafter, which
is void of science. I am not advocating a uniform numerical kick-in point for
imposition of risk reduction measures. That clearly is impossible. I have no
answer on the question how to define what is an acceptable level of risk and, as
I have said earlier on, a negotiated agreement seems to be the only sensible
route to take on this.
158. I have been amazed at the amount of effort and paper this exercise has
generated, and in the time available it has been difficult for me to seek out
and remain on top of the issues. Particularly in the latter stage, I have had an
advantage over some of my other colleagues and experts here, in that I was
familiar with the Australian risk assessment documents while they were being
developed. I have considered all of the risk assessments produced by Australia
in relation to SPS and OIE requirements and have been satisfied that they meet
the criteria for qualitative assessment. As a fish disease scientist who has
also been dealing with legislation, I could follow the logic as presented by
Australia in the hazard identification risk assessment sections of each of the
risk assessments. Inevitably for such a major piece of work, which has been
produced in a very short time, there are areas which could be improved, but I
have not detected problems which I believe could affect the main conclusions.
When it comes to the risk management sections, I have less to say as a
scientist, for obvious reasons. But it is disappointing that so little
information is available on the contribution of each of the risk reduction
measures, (i.e. their efficacy) in achieving a reduction in risk to meet
Australia's ALOP. The requirement to remove skin is an example, and we have
spoken about this earlier on today. I don't mean this as a criticism of
Australia's IRAs as such, but as more a plea for more real research done in an
area of science on a worldwide basis. The lack of good data on which to base
decisions is a thread running through the whole of this discussion we have had.
The question facing the Panel is what to do in the interim period, while this
information is actually being generated.
Chairman
159. Thank you. Dr. Wooldridge.
Dr. Wooldridge
160. One of the big issues, I would agree, that seems to have been discussed in
the written and the spoken submissions, is the issue of qualitative versus
quantitative risk assessments. I believe that attempting to quantify risk
assessments clarifies issues greatly. It clarifies a number of issues. It
certainly points up where you do not have adequate data, and provided you are
thorough enough in collecting the data that is currently thought to be the best,
it can give you a good guideline as to the kind of levels of probability that a
risk might be posing. Having said that, I agree there is no requirement to
undertake a quantitative risk assessment. However, there are two big worries
that I have regarding this particular qualitative risk assessment, and one of
them I would apply to qualitative risk assessments in general. The one, as I
have already said, that I have about this particular risk assessment is the
exposure issue. I am not convinced that it was dealt with in a full and
appropriate manner. However, if it had have been, in my opinion, dealt with
fully, i.e. the general chapter on exposure had been brought in and discussed
with regard to each of the particular diseases and the overall likelihood of
establishment, then as I said in my answers, I believe that the likelihood of
establishment would probably have come out lower in most cases. I say
"probably", because having not done it I can't be sure, however, so I don't know
whether that would necessarily give a different level of assessed risk. But what
we are dealing with here is what is acceptable, and it might well have been, and
that would still have been perhaps Australia's prerogative to decide that that
lower level was still unacceptable. Therefore what I'd like to see is the
highest quality risk assessments possible, regardless of what is considered to
be the acceptable level of risk, because muddling the two up, and I think we are
in danger of doing that here, means that one tends therefore to be less clear in
actually assessing the risks. I feel that maybe there is a worry that if you
actually reduce the risks to the level which they really might be, then they
would look so small that one couldn't possibly justify applying certain
measures. Nevertheless, I don't agree with that. I think it would still be the
prerogative of Australia to set its own acceptable level of risk. I am just
disappointed that the assessed risk wasn't actually dealt with slightly more
fully from that point of view.
161. The other problem was the over-complexity in the terms used to actually
specify the qualitative levels. It is part of the same issue really. I would
have preferred to see a less specific attempt to discriminate. Something that
simply said this is low risk, but nevertheless this low risk is still too high
to fit under our acceptable level. From a methodological point of view I would
have been happy with that. I fear it was an attempt to be over-complex here that
caused me problems. I am conscious that that might have actually not necessarily
clarified it terribly much, but I guess what I'm trying to say is I want to see
good risk assessment separated from what people believe to be acceptable levels
of risk, and then the two things should be looked at. But I don't think trying
to be very precise on a qualitative assessment is the way to do it.
Chairman
162. Thank you very much. Well, as I indicated earlier the transcript of this
meeting will form part of the attachment to the report at the end of the day, so
everything that has been said will be reflected in that way. But if the experts
feel that they wish to clarify in writing or confirm or elaborate on anything
that they have said, could they please let us have that within the next two
days. Friday morning in other words, so that we can deal with that before the
end of the formal meeting.
Australia
163. In Dr. Wooldridge's final comment, she mentioned in introducing her final
points, that there were two points she wished to make, one which was specific to
qualitative risk assessments, Australia's 1999 risk assessment, the other which
was a more general criticism of them. I just wondered, was it the second point
about the complex terms, is that a general criticism of �.
Dr. Wooldridge
164. Sorry, yes, I mean as I said earlier, you cannot avoid being subjective, I
don't believe, when you are doing a qualitative risk assessment. And given that,
I just think it is a big error to try and become too precise, too complex. I
think if you can differentiate between a high, a medium, a low and a negligible
risk, I don't actually think in a qualitative assessment you can go further than
that. I think to attempt to do so spoils, in my opinion completely ruins, what
might otherwise be a reasonable way of looking at the risks.
Chairman
165. Well, I think that brings the substance of the meeting to a conclusion. I
would just like to make one procedural timetable suggestion to the parties to
see how this would suit them. Tomorrow afternoon we are scheduled to meet with
the parties and the third parties for a session that might not turn out to be a
very long session. We wonder whether the parties might like to take the
opportunity, after the third party session is finished, to then go into the
meeting which we had scheduled for Friday, and just deliver the formal
statements tomorrow afternoon, so that you then have time after that to consider
what your questions are going to be to each other. Then we would meet on Friday
morning to take those questions. I don't know whether you are in a position to
do that, but it might at least give you a break between the two parts of the
meeting if we advance the formal statements to Thursday afternoon. Any views on
that?
Canada
166. I am happy to give you Canada's views first, Mr. Chairman. We would prefer
to deliver our prepared statement on Friday after we have had a chance to fully
consider the questions you have put to us today, what we have heard today in
addition, and the third parties' comments.
Australia
167. That would be Australia's position also. We would prefer to stick with
Friday morning.
Chairman
168. That's alright. We thought we could probably start earlier on Friday. Yes,
lets contemplate that one. Because the real reason is that we are in such a
tight time-frame we need time ourselves to consider the outcome of the whole
meeting, so we really want to have the whole of Friday afternoon, so we would
like to finish the session on Friday morning. Formal statements will take a
certain amount of time, but perhaps if we were to start a little earlier, say
9.15 am, would that suit? Good, with a view to trying to complete the session
with the parties in the morning.
169. Thank you very much I think it only remains now for me to record the
Panel's thanks to the three experts for all the work that they have put into
this and for very kindly bearing with us during this afternoon's session. And
thank you very much for responding so promptly and so comprehensively to
everything that has been put to you. Thank you very much, and on that note I
think we are now adjourned.
ATTACHMENT
CANADIAN DELEGATION LIST
AUSTRALIAN DELEGATION LIST
Revised Working Procedures
The Panel will follow the normal working procedures of the DSU where relevant
and as adapted to the circumstances of the present proceedings. In particular,
1. The Panel will meet in closed sessions.
2. The deliberations of the Panel and the documents submitted to it shall be
kept confidential. For the duration of the Panel proceeding, the parties to the
dispute are requested not to release any papers or make any statements in public
regarding the dispute, except as provided for in paragraph 3 of Appendix 3, ie.,
"...Nothing in this Understanding shall preclude a party to a dispute from
disclosing statements of its own positions to the public. Members shall treat as
confidential information submitted by another Member to the panel which that
Member has designated as confidential. Where a party to a dispute submits a
confidential version of its written submissions to the panel, it shall also,
upon request of a Member, provide a non-confidential summary of the information
contained in its submissions that could be disclosed to the public."
3. Before the substantive meeting of the Panel with the parties, both parties to
the dispute are expected to transmit to the Panel written submissions and
subsequently written rebuttals in which they present the facts of the case,
their arguments and their counter-arguments, respectively.
4. At its substantive meeting with the parties, the Panel will ask Canada to
present its views first. Subsequently, and still at the same meeting, Australia
will be asked to present its point of view.
5. Parties shall submit all technical and scientific evidence to the Panel no
later than in their rebuttal submissions, unless in response to subsequent
questions by the Panel. Exceptions to this procedure may be granted upon a
showing of good cause. In such cases, the other party shall be accorded a period
of time to comment, as appropriate.
6. In the interest of full transparency, the presentations, rebuttals and
statements will be made in the presence of both parties.
7. Both parties should provide a copy on diskette (Word or similar) together
with the printed version (10 copies) of their submissions on the due date.
8. Written submissions and rebuttals shall be provided at the latest by 5 p.m.
on the due date, (except if such a date falls on a Friday in which case the
material has to be delivered by 12 noon at the latest) so that there is still
time for distribution to the Panel members on that date. Moreover, each party's
written submissions, be they first submissions or rebuttals, (and responses to
questions, if any, put by the Panel) will be made available to the other party
by each of the parties involved at the same time as they are made available to
the Panel.
9. The working language for the submissions and the meeting with the parties
will be English only.
10. If necessary, the Panel will put questions to the parties to clarify any
point that is unclear. Answers to questions shall be submitted in writing by the
date specified by the Panel.
11. Any material submitted shall be concise, as brief as possible and limited to
the only question of relevance in this particular procedure: implementation.
12. To facilitate the drafting of the report as far as possible in the extremely
limited time available to the Panel, parties are requested to submit an
executive summary of their submissions and rebuttals.
13. The parties to this procedure have the right to determine the composition of
their own delegations. This may include private counsel and advisers. The
parties shall have responsibility for all members of their delegations and shall
ensure that all members of the delegation, as well as any other advisors
consulted by a party, act in accordance with the rules of the DSU and the
working procedures of this Panel, particularly in regard to confidentiality of
the proceedings.
ADVICE FROM EXPERTS
14. The Panel will seek technical and scientific advice from experts. In view of
the short time available for the proceeding, the Panel, after consulting the
parties, already selected at an early stage in the proceedings the following
three individuals: Drs. Gideon Br�ckner, James Winton and Marion Wooldridge. The
Panel may consider it appropriate, in particular in light of the issues raised
in the parties' submissions, to seek advice from other individuals. If so, the
parties will be provided with an opportunity to make known any objections in
respect of specific candidates before the Panel finalizes its selection of
additional experts.
15. The Panel will prepare specific questions for the experts. The parties will
have an opportunity to comment on the proposed questions, or suggest additional
ones, before the questions are sent to the experts.
16. The experts will be provided with all relevant parts of the parties'
submissions on a confidential basis.
17. The experts will be requested to provide responses in writing; copies of
these responses will be provided to the parties. The parties will have an
opportunity to comment on the responses from the experts.
18. A meeting with the experts will be held prior to the meeting with the
parties. The parties will be invited to be present at the meeting with the
experts, and provided the opportunity to immediately comment on the statements
of the experts.
TREATMENT OF INFORMATION DESIGNATED AS CONFIDENTIAL
19. Any information that has been designated as confidential by the party
submitting it and that is not otherwise available in the public domain shall not
be disclosed in the report of the Panel. However, the Panel may make statements
of conclusion drawn from such information without referring to the author of the
information.
20. After the circulation of the Panel report or, in case of an appeal, after
the circulation of the Appellate Body report, the Panel, Secretariat staff,
parties and third parties shall return any information that has been designated
as confidential to the party that submitted it, unless the latter party agrees
otherwise
The Panel may amend these working procedures at any time. In such circumstances,
the Parties will be consulted and immediately informed of the changes.
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