Australia - Measures Affecting Importation of Salmon Report of the Panel (Continued) Dr. Wooldridge 49. Good morning, thank you very much for inviting me here. I would like to just first of all say I think I have got friends in both parties here, so I reiterate some of Jim Winton's comments. What I have tried to do is look at this with an unbiased approach and actually look at the methodology that has been used. So first of all I am going to go through a few comments, a brief summary of what I think about this, and then I am going to specifically focus on the questions, the additional questions after that. 50. First of all I must apologise for having labelled my written answer to question 17 as an answer to question 16. However, it appears that this was realized by all parties and therefore caused no major problems. 51. I then spoke about the terminology in my original written report and I think that what David Burmaster has said does show that there are different terminologies in use. But I will just reiterate the terminology which I am coming from again, which is that a risk analysis comprises hazard identification, risk assessment, risk management and risk communication. A risk assessment may, in my opinion, be a either qualitative or quantitative, but either way the essential components are: identified and defined hazards and identified and defined unwanted outcomes, a clearly set out and biologically feasible pathway or sequence of events from the hazard of interest to the unwanted outcome for which the risk is being assessed, and information to assess the probability of the steps in the pathway occurring, from which can then be assessed the overall probability of the outcome occurring. In addition, all information must be referenced, and the whole assessment transparent. 52. In my opinion, it is not simply enough to demonstrate the possibility of an outcome occurring, as I said in my written report and as Jim also reiterated, I think you can always find a feasible way in this question, at any rate, of the possibility occurring and that I do not believe is enough. 53. Just a few words here on the OIE guidelines, which I did in fact refer to, I did mention in one of my answers, which I think was to question 29. They are currently undergoing a rewrite as many of you will probably know, and because I was actually involved in that rewriting, it was a little bit difficult for me to separate out what the original guideline said and what I knew was going to come up very soon. There are in fact, many areas which are similar and one is that quantitative assessments are not required in either the original or the new guidelines and that once you have assessed the risk then the acceptability of that risk does depend upon local factors which then need to be highlighted and brought out when trying to decide what the appropriate risk management strategies are. Basically, the draft guidelines for risk analysis and risk assessment coming out from the OIE hope to reflect the best methodology currently available, which means that it will always be to a certain extent out of date unless it is rewritten all the time and my own personal feeling is that we do not and should not use outdated technology and methodologies simply because they are in older guidelines if we can actually demonstrate an improvement on those methodologies and that would be in fact, an argument for changing the guidelines, which is what is happening. 54. Anyway, to go back to the question in hand here, in my opinion, the Draft 1995 Report fulfils these requirements of qualitative risk assessment. It contains a clearly set out and transparent qualitative risk assessment. The Final Report is the result of the process of risk communication. In my opinion, the process of risk communication has two major functions relevant here: (i) to uncover errors in the factual information used, and (ii) to gather opinions on the level of acceptable risk amongst all those concerned. Factual changes may affect the assessed or scientific risk, that is the probability of something actually happening. Opinions will not - or at least they should not, in a well executed risk analysis -affect the assessed risk, they should be used only in management decisions as to whether assessed risk is accepted or not, and that is a value judgement depending upon local requirements and conditions. The two issues should be clearly separated, so that the accepted risk can be agreed - or challenged, if necessary - and the issues relevant to the locally acceptable risk level can be understood, and modified be negotiation, if necessary. 55. In my opinion, the Final Report, also qualitative in nature, is far less clear or transparent than the Draft. Like Dr. Rodgers, I had difficulty in differentiating between the various parts in it, in particular between assessed and acceptable risk, and the effect risk communication had on these two different things. In particular, the Final Report does not make clear where any factual errors in the Draft may have occurred which may have altered the assessed risks. And since it came to the opposite conclusion to that in the Draft, this clarity for any factual changes is essential. It is very difficult to see from this whether different conclusions to an adequate assessment would be valid. However, since it looks only at the possibility of the unwanted outcomes of infection and disease importation, rather than the probability, in my opinion, it does not in any event fulfil the essential requirements of a risk assessment. As I said in my written report, I am not a fish pathologist or a fish expert in any way and so I am unable to assess whether the data given to assess the risks is accurate and complete. As I stated, this will affect the final outcome and the final conclusions from either assessment and this is where Dr. Rodgers and Dr. Winton actually have a far greater input. 56. I initially stated that a risk assessment may be qualitative or quantitative and that a quantitative assessment is often initially undertaken. Now, and I also said that frequently you can not do a quantitative assessment based on two reasons. Partly the fact that often you would not have the data to actually complete it satisfactorily, but I also put the corollary on that, that when you start doing one you often find that there is a lot more data around then you initially thought. Secondly, very often because time constraints and requirements for action dictate that in the given circumstances a qualitative assessment, which is generally much quicker, is the thing that is required or the only thing that can be done. There is a third reason too, and that is that if you actually do a qualitative assessment more rapidly, and everybody agrees with the result, there is actually no point in carrying on and doing a quantitative assessment, and mainly this is where, if one concludes that an assessed risk is negligible, from a qualitative assessment, and this assessment is agreed as being correct, and if, in addition, all concerned also agree that this negligible level is acceptable, then there is unlikely to be a requirement for a quantitative assessment. Now, from this point of view, it really does not matter what people mean by negligible if everybody says "yes it is negligible and we are happy with that" then fine - nobody is arguing, there is no dispute and there is no problem. The problem, of course, does come when there is a dispute and people do wonder what is meant by 'negligible', and yes, it does mean at lot of different things to a lot of people which is why, when I get to my summary, I actually advise that one way around that is to carry on with a quantitative assessment. 57. Anyway, where it is not the case that everybody has actually agreed on a decision that there are negligible risks, or where further demonstration of a low level of probability is required, as I say, a quantitative assessment is in my opinion the next obvious process to attempt. This is what New Zealand have done, and I cannot actually see any reason Australia did not attempt to undertake the same kind of assessment - selecting the disease which, qualitatively they assessed as the most risky in their Draft Report. In my opinion, as I have stated in my written evidence, the basic New Zealand method and much of the data is equally applicable. In addition, and more importantly the attempt to undertake a quantitative assessment, whether you get all the data or not, and whether you can in fact feed everything into to the model and come out with a quantitative answer, clarifies your thought processes, and will, as a result, highlight those specific data inadequacies if and where they exist. This also helps to remove the subjectivity of a qualitative assessment and separate clearly the issue of assessed risk from acceptable risk. 58. In summary, I do not accept Australia's contention that it is impossible to attempt to undertake a quantitative assessment in this situation. In my opinion this is the obvious way forward. The specific method used to estimate the probability of the unwanted outcome can then be examined completely separately from the issue of whether that probability is acceptable or not. One example of this is the David Vose risk assessment, one could do a separate risk assessment if that was felt appropriate. It seems to me that it is the obvious way to go forward when any dispute of this sort arises, is to attempt to actually clarify everything through stages by doing this quantitative assessment, which I would say is the next obvious step. 59. I will just now go through the answers to the specific questions that came up this last week. Questions 1, 2 and 3 on that paper were either not addressed to me or not in my field. Question 4: Section 2 of the 1996 Final Report describes, with references, the diseases it considers relevant on a disease-by-disease basis, with a summary of the information given. However, in my opinion these summaries do not attempt to estimate the probability of importation of infectional disease. They therefore do not meet my minimum requirements for a risk assessment. 60. The individual diseases are also considered in the Final Report in Risk Analysis Factors, Section 1.4.2, page 37. This format seems unnecessarily repetitive and confusing - well I was confused anyway - re-iterating much of the same information that was given in section 2 but this time unreferenced. For 19 of the 25 organisms listed, the conclusion after considering the disease and some potential safeguards is worded along the following lines: "Because of gaps in the information base, there remains some uncertainty about how effective this (or these) treatments would be in practice." Again, this does not meet my minimum requirements for a risk assessment (see my original answers: that in my opinion is not enough to demonstrate only the possibility of an unwanted outcome). 61. In my opinion, therefore, the Final Report has not assessed the risks on a disease-by-disease basis, although it has categorized information on a disease-by-disease basis. Just to illustrate the difference between the disease-by-disease sections in the Draft (May 1995) and the Final Report in December 1996, I will just compare the sections on Renibacterium salmoninarum . The Consideration (Section 4.2.8, page 75) in the Draft concludes that: ".... it is very unlikely that titres of bacteria present would be sufficient to cause a disease outbreak". I cannot find any comparable conclusions in the Final Report Summary (Section 2.4.9, page 162) nor in the Risk Analysis Factors Section on Renibacterium salmoninarum (Section 1.4.2, pages 41-42) either agreeing or disagreeing with that conclusion. I cannot actually find a conclusion based on the information at all, not in the obvious places to look. 62. However, just to highlight the subjectivity and the problem with a qualitative assessment, I would like to just make another little point which compares two parts - the Draft and the Final Report. There is an interesting and important difference in the wording on environmental survival of the particular bacterium Renibacterium salmoninarum. The Draft Consideration states that: "Renibacterium salmoninarum does not survive well in the environment..." whereas the Final Report Summary states that: "The organism (Renibacterium salmoninarum) has potential to survive in the environment for significant periods." Checking the data and the reference given, these conclusions in both cases appear to be derived from the same reference: Austin and Rayment (1985), Journal of Fish Diseases Volume 8, pages 505-509. I think this illustrates as well as anything, the potential problems with, and potentially subjective nature of a qualitative risk assessment. The bottom line there is: if you do a qualitative assessment and you cannot get to an agreement, I think you are then forced to proceed down the route of attempting a quantitative assessment. 63. Question 5. This question appears to be asking whether, in an import risk analysis, there is a requirement to assess risks using each of the different potential risk management option being considered. Risk management options generally involve the putting in place of risk reduction measures, otherwise called safeguards. The baseline risk assessment would be one with no safeguards, and it is sometimes appropriate to assess this risk. Often however, some safeguards are integral to the initial risk assessment as they are either already in place (for example, existing legally required testing regimes), or would be incorporated automatically into the risk pathway in question (for example, the safeguard of cooking, if estimating a risk from a cooked product only). 64. In an import risk analysis, if the assessed baseline risk, or the risk with current regulatory or "usual" safeguards in place was considered acceptable to the importing country, there would be no requirement or need to assess any further scenario. Only if this baseline or initial risk is unacceptable would one need to go further. If, in such a case, there are additional safeguards identified which are considered practicable to employ, then in my opinion, it would be necessary for the importing country to assess the risks with the most stringent practical combination of these in place, and demonstrate that the risk were still unacceptable, in order to refuse imports. Whether it is necessary to assess intermediate combinations of safeguards separately depends on the precise problem being addressed. 65. For example, suppose import-risks of fresh whole unchilled unprocessed uncooked carcases of animal X into country Y are assessed and the result considered to represent an unacceptable risk. Then it may be that the removal of offals would be adequate to lower the risk to an acceptable level. But if offal removal is always, and here I mean always undertaken, for example, in conjunction with deboning and smoking then there is no point in assessing the effect of offal removal in isolation (unless you are actually testing out a risk with a new product). An assessment with the three processes included would be the appropriate one here, but, if more than one completely separate sets of safeguard options are available, practicable and mutually exclusive then in my opinion an assessment of all those sets of options is necessary in order to demonstrate that there is no method of reducing import risks to an acceptable level. 66. Question 6 was not actually addressed to me but I will just comment on the wording of the question. In my opinion the OIE has advised that certain risk assessment techniques are used, however, these techniques were developed by others rather than the OIE developing the techniques itself, they are more concerned with publishing and collating those techniques. That is all I have to say at the moment. Thank you. Chairman 67. Thank you very much. I think before I invite the parties to participate, perhaps it would be useful if I could just invite the experts again to, well, let me ask them if they wish to respond or follow-up on anything that has been said so far. There were one or two specific points that were put to each other, for example, Dr. Rodgers on "negligibility", which has already been responded to by Dr. Wooldridge, but I think it was also addressed to Dr. Burmaster, so I do not know whether any of you want to say anything more to develop any points or to respond in any way at this stage. Dr. Burmaster. Dr. Burmaster 68. I have no further comments now. Chairman 69. Right, then in that case lets go on to the parties and, as I said earlier, we will start first with Canada and I would ask that in putting your questions or comments that you do identify the speaker at the beginning. Canada, you have the floor. Canada (Ms. Valery Hughes) 70. Thank you Mr. Chairman, my name is Valery Hughes and I am the General Counsel of the Trade Law Division of the Department of Foreign Affairs in International Trade. If I may just start by expressing on behalf of my delegation and the Government of Canada, my thanks to the experts for agreeing to participate in this process and for all the work that they have done so far. We very much appreciate their taking time out of their other duties and responsibilities to be with us here today. We have had an opportunity to comment on the responses provided by the experts to the questions put to them by the Panel and therefore, much of what Canada has to say has already been said and we need not repeat it here. I wonder, Mr. Chairman, if you might give, perhaps, me five minutes with my delegation just to confer about what we have just heard so that I can determine whether or not we have other things to mention at this time. Chairman 71. OK, well let us just have a short break at this stage, we will reconvene here in ten minutes time, so those who want to go down and have a coffee can do so. [Break] Chairman 72. Well lets resume now and I would give the floor to Canada for questions and comments to the experts, Canada. Canada (Ms. Valery Hughes) 73. Thank you Mr. Chairman, I at this time would like to thank the experts for the additional comments and information they provided to us this morning and very useful and helpful, [microphone problem]. As I was saying, if I could thank the experts for their further interventions this morning and the clarifications that they provided, they have been most helpful to us. I do not have any further questions to put to the experts at this time although I would like to reserve the right to do so later if, in the course of the day, other matters are raised that we have questions about. I do have a brief question for you Mr. Chairman, if I may in terms of process and the transcript. I was wondering if that would be made available to the parties today, this evening, tomorrow or ever. Chairman 74. I am afraid the production of the transcript can be, depending on how long the meeting goes, it can be quite a long process, all we can say is that they will issue it as soon as they have completed the task. If there is a lot of material it can really take a matter of weeks. So I am sorry about that but it is just a fact of life. But we will get it out as soon as possible and it will be verbatim so there should not need to be any question of commenting on it or confirming anything that you have said here in writing. 75. Well in that case, perhaps I could turn to Australia and ask if you have any questions or comments for the experts, you have the floor. Australia (Mr. Ric Wells) 76. Thank you Mr. Chairman, I am Rick Wells, the Deputy Permanent Representative at the Australian Mission in Geneva. Mr. Chairman, I would like your guidance, we do have an overview statement with regard to issues that have come up in this experts' discussion and we would like to make that statement at some point. Chairman 77. Well, as long as it is related to the issues under discussion here with the experts then by all means it comes under the rubric of comments and if it contains questions, fine, but if it does not we will still give the experts the opportunity to respond to anything you say in it, so please continue. Australia (Mr. Ric Wells) 78. Thank you Mr. Chairman. First of all, Australia does not propose to go into WTO legal issues at this point and our comments are without prejudice to our legal position on certain questions, responses and evidence. First of all, we would like to thank the experts for their participation in these hearings and for the time and effort that they have taken in responding to the Panel's questions. 79. The basic science examined and evaluated in the Final Report has not been challenged by the experts or by Canada, nor has any new evidence been provided to Australia that would warrant a revision of its assessment and risks. However, I would like to note, Mr. Chairman, that the experts themselves have underlined at the point that the science and the methodology are dynamic and evolving, a point which of course we have made in our submissions. I would note however, that the one thing that is not changing, is Australia's appropriate level of protection. Australia has adopted a structured approach to the development of quarantine policies, including the assessment and management of risk. The third component of risk analysis, risk communication, is a very important and integral part of Australian Import Risk Analysis. This is often lead to a series of consultations with consequent revision of Draft documents and reassessment of the risks to ensure that the decision is consistent with Australia's appropriate level of protection. 80. I would like to emphasize here that the Final Report, as we have said before, includes all considerations covered in the 1995 Draft Report and all of the scientific papers that are referenced in the Draft Report. I would note too, that consequences are an integral part of Risk Analysis as much as Risk Evaluation. The very favourable health status of animals, in particular aquatic animals in Australia is generally higher then in many other countries, underpins in a very significant way the cost efficiency of Australian primary industries and the wide acceptability of products, both in Australia and internationally. Consequently, successive Australian Governments have adopted a very conservative approach to Risk Management with the objective of preserving the advantages derived from avoiding production loss due to these diseases to help maintain export markets and to protect the environment. 81. In practice, Australia is willing to accept only a low likelihood of the entry establishment or spread of diseases of quarantine concern, if the consequences from the entry of a pest or disease are expected to be significant. When through the lack of important epidemiological information there could be no reasonable assurance that disease will not enter, establish or spread, then due caution is used throughout the risk assessment and appropriately conservative risk management measures are taken. 82. Australia has undertaken a comprehensive risk analysis, including a risk assessment that, in its judgement, used a methodology appropriate to the circumstances. The risk assessment factors identified in the SPS Agreement and by the OIE's International Aquatic Animal Health Code, were all considered in the Final Report. The International Aquatic Animal Health Code is under continuing development and is subject to ongoing refinement. There are important issues that remain to be resolved, including the criteria by which diseases are listed. The code provides voluntary minimum guidelines that should be applied in international trade by importing and exporting countries. 83. The most immediately apparent feature of the Final Report is the large number of disease agents potentially present in Canadian Pacific salmon that have not been found in Australia. For these agents, there are many gaps in the information base, including the infectious dose and root of infection, prevalence in the source populations, numbers found in the various tissues of the host and the agent's ability when subject to various physio-chemical treatments. All of these factors could have a significant impact on the level of risk. 84. In the following, Australia would like to cover three main issues, namely: Risk Analysis, International Standards, and Fish Diseases. It is clear from the expert responses to the question of what constitutes an appropriate risk analysis that there is a variety of acceptable analyses, ranging from the purely quantitative as advocated by Dr. Burmaster, to the more qualitative approach of Doctors Wooldridge and Rodgers. The Australian Final Report is a risk analysis falling within the latter range of descriptions, one that has taken into account the guidelines recommended by the OIE. It is important to note that the SPS Agreement does not prescribe risk assessment methodology but rather requires that whatever approach is taken it should be appropriate to the circumstances. The variety of expert comment on this issue testifies to the highly subjective nature of what is appropriate in terms of the risk assessment, and the impact that the particular circumstances can have on the judgement to be made, and we would note that the experts appear to acknowledge that there is no obligation to undertake a quantitative risk analysis. Paramount in deciding on the type of risk assessment most appropriate to the circumstances, is an examination and evaluation of the available data. There may be legitimate differences of views between experts as to whether a quantitative or qualitative approach is preferable depending on individual perspective on issues, such as the value of applying qualitative methods where little empirical information is available. The judgement by New Zealand, for example, that it was appropriate in its circumstances to perform a quantitative risk assessment on salmon imports has no direct relevance to Australia's situation. For these same reasons one cannot use outcomes derived from other countries as an indicator of how Australia should have undertaken a risk assessment on Canadian salmon. 85. In its Final Report, Australia took full account of all available knowledge and determined that there was insufficient data to undertake a quantitative analysis, particularly in view of the conservative approach of Australian quarantine policy and the high level of uncertainty involved. The risk assessment conducted by Australia was both comprehensive and intensive. It was the most thorough risk assessment feasible in the circumstances. By world standards, as judged by the risk assessments published by the other countries, Australia's risk assessment is exceptionally thorough, rigorous and transparent. It considered all the relevant scientific information and the gaps and found the probability of pathogene establishment to be low. However, given the uncertainty inherent in this assessment, for example, because of the limited amount of data on infectious dose, prevalence and rate of transmission, and the very severe potential consequences, the report concluded that the risk posed was inconsistent with Australia's appropriate level of protection. I would note here that the experts appear to acknowledge that it is up to Australia to take a decision on the acceptability of risk, and I would repeat again that Australia did take that decision based on its appropriate level of protection. 86. Moving to international standards, given that the IAAHC has been identified as that most approaching international model, we welcome the participation of a member of the Fish Diseases Commission, Dr. Winton in these hearings, and the insight into the workings of the FDC that he brings to these discussions. During these proceedings, Australia has raised some concerns about the lack of ability to determine OIE-FDC opinion or intent with regard to the Code's guideline, as no minutes are kept of meetings, and the balance of global representation in the Fish Diseases Commission, particularly its impact on disease listing. Australia has detailed in its responses to questions, in page 22 of the October 1997 rebuttal, questions the process by which the current OIE notifiable and other significant diseases were selected. Australia would also emphasise that the IAAHC is in its developmental stage and is subject to ongoing review. Further it provides only minimum voluntary guidelines. In other words the IAAHC is a work in progress not a finished document. I would note here that Dr. Winton has acknowledged the usefulness of input that is now being provided on conditions in Australia and New Zealand. 87. This view that I have just given is supported by the current Director General of the OIE and I quote: "The OIE Aquatic Code and Manual are by no means carved on tablets of stone but are fully expect to be revised and refined on a regular basis as countries follow and gain experience of the guidelines", - end of quote which is drawn from the preface to the Scientific and Technical Review of the OIE, 15th of June 1996, page 378. 88. Australia has also raised concerns about the way the OIE implements the definitions used for the categorization of diseases and the resulting exclusion of diseases that may be of very significant concern to some countries. For example, although diseases notifiable to the OIE is a list of transmissible diseases which are considered to be of socio-economic and/or public health importance within countries, and which are significant in international trade of aquatic animals and aquatic animal products, nevertheless a disease is not listed if it has a broad geographical range. Furunculosis is one of the most significant diseases of salmonids, particularly Atlantic salmon, however, it is not listed by the OIE, presumably because it is endemic in most salmonid producing countries. In contrast, terrestrial diseases which have a broad geographic range and which have significant impact are listed in the OIE Animal Health Code. 89. The SPS Agreement allows a WTO Member to decide whether the OIE minimum recommendations can be an adequate basis for achieving its appropriate level of protection. It is not the role of any international organization to determine the appropriate level of protection for a sovereign country. The minimum voluntary guidelines provided by the OIE are one option that importing countries should consider in the addressing the risk of disease entry. Whether these guidelines are sufficient in themselves to make the countries appropriate level of protection is for the importing country to ascertain through a risk analysis. 90. I will move now to "diseases". Evisceration alone would not meet Australia's appropriate level of protection. Other factors will impact on level of risk, including the fact that disease agent may be found in flesh and blood. A more detailed evaluation of this issue is presented in Australia's October 1997 response to question 13 which identified muscle, remnant kidney tissue, bone, guilds, skin and appendages, head with its specialised organs and blood, especially in remnants of major blood vessels, highly vascularized areas and capillary beds as the main tissues potentially harbouring disease agents after evisceration. The FDC has taken an apparent stance without any form of risk assessment that evisceration is an adequate treatment of fin fish to reduce the presence of any pathogen to acceptable levels. 91. In contrast to terrestrial animals, there are no definitive proven instances of the spread of fish diseases via product for human consumption. However, as previously stressed in Australia's first submission, this must be seen in the context of the prevailing situation in most of world, where many or all of the diseases of concern occur endemically so that there is little chance of proving the source of outbreaks of salmonid diseases. Indeed, once a disease becomes established, the high costs in terms of scientific research to determine the source and pathway of its entry, may be a lower priority as compared to alternative use of government budgets for disease management. Diseases of salmonids have continued to spread throughout the northern hemisphere with significant production losses and economic consequences despite the OIE guidelines that were designed to reduce the risk of disease spread. It is Australia's contention that in time there will be definitive proof of the spread of aquatic animal diseases via product for human consumption. Thank you Mr. Chairman. I would like however to foreshadow that we will have some additional questions with respect to the experts responses. Chairman 92. Thank you very much, do you have that statement you have just given, in writing. Whilst it is not necessary for the record, it might be helpful to the experts in trying to respond to have the text to refer to because there was so much in it. If so, perhaps we could have it copied. Australia (Mr. Ric Wells) 93. We will be able to provide a final version of this shortly, Mr. Chairman. Chairman 94. I think perhaps it would be helpful to have that before we ask the experts to attempt to respond. Australia (Mr. Ric Wells) 95. We can provide an unedited version now. Chairman 96. Fine, perhaps the Secretariat could arrange some quick copying. I assume the experts would prefer to wait until they have got the document before responding. If you are ready to say something right away, then we can go right into it. Dr. Winton 97. I am not going to comment on the areas of risk assessment but there are two areas that I think Mr. Wells has raised that do go to the OIE Fish Diseases Commission's areas of interest. The OIE Fish Diseases Commission is certainly a work in progress and we rely on a number of experts around the world and also from input of the member countries: Australia, New Zealand, Canada, Sweden and several other countries have been very diligent in providing comments on both, the Code and the manual to the Fish Diseases Commission. These are discussed at the annual meetings of the Fish Diseases Commission and many of these recommendations are in fact adopted. Many of them are matters of technical precision, changes in language that we find very helpful. 98. Occasionally there are matters where even countries disagree, one country may wish to add a disease, another can make an argument to remove a disease and in this case we try to use scientific weight. But I even brought with me an example of Australian comments that were discussed at the last version and largely we have found these very helpful and the arguments well constructed. So we do appreciate the comments and the great amount of effort that Australia, Canada and other countries have put into this process through the OIE delegate. 99. I also feel that the OIE's list of transmissible diseases, while it varies somewhat from the terrestrial diseases in its focus, is a minimum agreeable standard and as the OIE has said that bilateral negotiations or even the process we are here today, may be required for those situations not covered by the OIE. But that in general the OIE Fish Diseases Commission has used both the lack of documented evidence of transmission by eviscerated products, some personal experience and in fact some unpublished studies to regard the use of evisceration as a method by which risks could be reduced to levels that took it out of the generally agreed upon category such as the Notifiable Diseases in live fish. 100. Now, I do not think anyone can imagine that there are not cases of possibility with transmission of fish or other animal diseases in a variety of situations. But the Fish Diseases Commission at least, in the absence of scientific evidence to the contrary, has viewed evisceration as a way to approach this or to actually remove it from the purview of the OIE's process. There are certainly cases where pathogens could be expected to be in filets or eviscerated product. I do not disagree that certain pathogens could be expected to be found in these, but, given the total sum of risks involved, i.e., is it transmitted with the product? Does it find its way to a susceptible host? etc. The total risk may in fact ultimately be exceedingly low, and we have many examples where fish diseases have been transmitted with the movement of live fish or even gametes, and a few cases where it has been transmitted with uneviscerated fish, particularly those used in aquaculture. Two examples that Dr. Rodgers raised are, I think, particularly relevant, where marine fish species are now seen as a major risk for movement of fish diseases when used in feeding aquaculture species. Australia is certainly familiar with the Pilchard epizootic that occurred in Australia and, while I do not think scientifically it has been proven and Dr. Barry Munday and others can comment perhaps more effectively then I can, there seems to be at least some supposition that that agent may have been introduced by the use of raw marine fish from the southern hemisphere, in South America. 101. Similarly, viral haemorrhagic septicaemia was introduce into the United Kingdom where it was formerly free by extensive sample efforts - probably also by the use of marine fish. So there are many cases where uneviscerated fish, particularly those fed directly to a susceptible species and where fish and gametes has transmitted fish diseases. But in the absence of such information for the eviscerated products, the Fish Diseases Commission has simply not chosen to address those issues. I do not mean to imply that the Fish Diseases Commission thinks that there is a zero risk option in evisceration, there is not a zero risk option perhaps in ballast water, certainly not in live ornamental fish and certainly not in marine fish that are uneviscerated. Relatively, the Fish Diseases Commission has assumed that that was a quite low if not zero level of risk. Thank you. Chairman 102. Thank you very much, perhaps I could ask Dr. Wooldridge if she would like to respond to Australia. To continue with Australia - Measures Affecting Importation of Salmon: Annex 2, Section 103

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