Australia - Measures Affecting Importation of Salmon Report of the Panel (Continued) Dr. Winton 281. Yes, for a couple of reasons. One, the fish that go directly in the water course bypass some of the exposure methods that might be imagined, some of which are not so likely that would accompany human consumption products, and, secondly, because some of these fish are known to be carriers of diseases and if they are particularly uncertified or unexamined, could be carrying that disease at a level as high or higher than that of an eviscerated product. Chairman 282. And you can make that statement without having a scientific risk assessment? Dr. Winton 283. You can make that statement for certain species of fish in certain areas of the world. I could make that statement with a high level of certainty for Pacific herring in North America. As bait fish those fish contain a significantly and quantifiably higher incidence and prevalence of infection than do Pacific salmon. Thank you. Chairman 284. Australia, you have a follow-up - ? Australia (Mr. Gardner Murray) 285. Gardner Murray, Yes, I will just make more of an observation more than anything else. As a sweeping generalization, everyone agrees with these kind of three levels of risk. What Australia is saying is that you have got to do more than that. You have go to do more than sweeping generalizations if you are looking at product which may have a different intended purpose. So therefore, Australia contends that whether ornamental fish, or whether bait fish, we need to do a risk assessment because the source, which are - the country factors, the number of diseases, the intended use, the pathways, the socio-economic consequences, might give you a different equation. So in short, we agree with generalizations, but the specifics are really what we are dealing with. Chairman 286. Dr. Wooldridge. Dr. Wooldridge 287. I think actually, that was precisely the point I was trying to get at perhaps when I said that you actually need to be able to have the data for each part where a difference may occur and compare or put into the model those differences. So for example, if you are talking about eviscerated versus uneviscerated you need to have the two parts of information to compare in the model that you are using. If you are talking about a different use for fish, for example bait fish as opposed to human consumption, you need to be able specifically to put the data for the different exposure pathways into that model. That is, I think, we are saying something like the same thing there. The question asked whether it would require a complete, detailed scientific risk assessment. The simple answer is, yes - but many parts of that risk assessment, many parts of the model, might already be present in your previous model for one of your other scenarios and that certain parts of that model would need to be altered specifically to take account of each of the differences which are present in the different scenarios which one might be attempting to compare. Chairman 288. Thank you. I do not want to labour this too much, but if you were going to do a risk assessment in these three areas that are mentioned, would it not be a logical approach to start with what you perceive the highest risk area rather than the one that you perceive to be the lowest risk area. I mean, if you were going to commit resources to a risk assessment at all - Panel (Mr. Kari Bergholm) 289. My questions goes that, in fact, I think we are here speaking not about risk assessment so much as to hazard identification. You have said that the first stage always must be a hazard identification. We know that the objective of the Australian measure is to protect their domestic salmon stock, that is the aim, the objective of their measure. Then I think the first stage of risk assessment should be hazard identification. What is your opinion as expert, what would pose the most likely hazard, in this case: the eviscerated salmon or the bait fish or the ornamental fish? If you make the hazard identification, where should you then concentrate your risk assessment? Thank you. Chairman 290. Dr. Wooldridge. Dr. Wooldridge 291. Yes, the hazard identification is the first step. From there, one would prioritize in whatever seemed the most logical way. I am not, as you know, a fish expert. If I had got the various scenarios suggested in this particular question, I would go and ask a fish expert which was the appropriate order of prioritization to tackle the risk assessment, and that is passing the buck, but that is the best way to do it. There is no point in me, not an expert, deciding which to do. So yes - but, and starting from a completely open beginning, it would be sensible to assess that which you have prioritized initially to have the highest risk first, but, until you have done the risk assessment, you actually cannot be sure you have got that right. So there is a circular argument here, it is a problem, you could get it wrong whatever you do, and you might never know. Chairman 292. I thank you. Dr. Winton, you have anything to add to that? No. What about Dr. Rodgers, as the fish expert - about hazard identification? Dr. Rodgers 293. Thank you. I get the distinct impression in this case that we are talking about wild caught Pacific salmon and not ornamental fish, which is why we are here. So the first place where you would start, if that was the premise, would be to do your risk identification, your risk assessment exercise on that group of fish. However, if you were also concerned that there were other potential imports, or existing imports, in another group of fish which had been demonstrated already through the scientific literature to be carriers or to undergo certain clinical disease outbreaks which you confidently believed by monitoring did not exist in your country, then you would almost certainly have to do a risk analysis and a risk assessment on that group as well. So as Marion said, it is a circular argument. If the issue is wild ocean-caught Pacific salmon, there is not much point in starting with ornamental fish, although they may come into the equation. Chairman 294. But if the issue is measures to protect Australian salmon, then what would your answer be? Dr. Rodgers 295. That is a political decision. I would have to undertake a scientific risk assessment which would give me an answer as to which was the most risky group and that advice, irrespective of which group that would be, would then be past to my civil service equivalent. I was a civil servant, I was good at saying "Yo". No, you cannot say, without doing the risk analysis, the full risk analysis, which includes risk communication, so - Chairman 296. I think we have probably had all that we are going to get out of that. Not much point in trying to squeeze the lemon any further. Can we go on to number 14 which is addressed to all? Who would like to start on that one? Yes, Australia, are you still on 13? Australia (Mr. Gardner Murray) 297. Yes, I was just going to sort of make another observation. One which deals with your logical approach, and second which deals with the issue at hand. The reason we are here is because there has been a request, and so therefore we have conducted a full-blown risk analysis to meet our obligations. On the second issue, that is the logic of the situation, our government has decided that a series of risk assessments need to be carried out on a range of products, and this includes additional staffing, it includes a timetable for those risk assessments. These include ornamental fish, a re-evaluation of our approach on ornamental fish; this includes a re-evaluation of our policy on bait fish. But at the same time, the quarantine service has still got to deal with requests from countries for access so it is an enormous effort. Concurrently you have got to deal with requests from Canada and other countries and do risk assessments while at the same time you have got to look at those areas that you wish to examine because you continually want to protect your fish health status and this is the balancing act that Australia is involved in at the moment. Chairman 298. Thank you. Right, well, obviously we will no doubt have the opportunity to go into that sort of issue a bit further tomorrow. For now I think perhaps we could pass onto the next question. Which of the experts would like to address number 14? Dr. Burmaster? Dr. Burmaster 299. Thank you Mr. Chairman. I am unaware of any advances in scientific knowledge that occurred between May of 1995 and 1996 which would justify the changes between those two documents. Chairman 300. Thank you. I am sorry, could you repeat that answer again please. Dr. Burmaster 301. Yes, I will repeat it. I am unaware, I am not aware of any advances in scientific knowledge that would justify the changes and conclusions between the May 1995 Draft Report and the 1996 Final Report. Chairman 302. Dr. Rodgers. Dr. Rodgers 303. I think all the experts are in agreement. Chairman 304. Right, well in that case, let us go on to number 15 and this is the one where I had an addition. I suppose you have noted my addition to that, Dr. Winton. Dr. Winton 305. You have only made the question more difficult but I will attempt to answer it. I think I have already tried to state that evisceration really is seen as a way to reduce the risk, perhaps not just of Notifiable Diseases but of other diseases, but certainly in different levels with respect to the nature of the disease, where the organism might be found and at what levels . For each disease we have some, but perhaps not enough information, to be able to rank them convincingly. Relative to evisceration for Renibacterium salmoninarum, IHN virus, salmon leukaemia virus and Henneguya it is sort of tough. For example, Renibacterium salmoninarum, is generally regarded to be a pathogen exclusively of salmonid fish and, as its name suggests, Renibacterium is primarily associated with bacterial kidney disease. It is found in large amounts in the kidney and in other haematopoietic tissues (kidney, spleen) and to that extent would be reduced significantly by evisceration. But foci Renibacterium salmoninarum have been found in other places in the fish, maybe less frequently, but behind the eyes is one, occasionally in the muscles. Renibacterium is generally vertically transmitted from adult to progeny through the egg, in many cases of Chinook salmon and salmon in the North West, and occasionally by water-borne exposure but the water-borne exposure levels are somewhat lower. But the effectiveness of evisceration for Renibacterium salmoninarum, in general, is quite good in that the visceral organs would be the areas in which you would expect to find the highest levels of bacteria. Similarly with IHN virus - this is primarily a virus of the haematopoietic cells - the kidney, the spleen of the fish, and likewise would be found at high levels in the viscera. But examinations of different tissues and organisms, organs of fish, have also revealed levels of IHN virus in the mucus and skin of the surface of the fish and certainly in the blood, so again, evisceration could be judged to provide a substantial, but perhaps not complete level. I am unaware of sufficient data on salmon leukaemia virus to be able to make a judgement but presumably it would be found primarily in the blood cells of the fish and to the extent that evisceration removed the blood which must be 90 some per cent, it could be expected to be somewhat effective there as well. For Henneguya I would refer to Dr. Rodgers, a little bit because I am not a parasitologist by training, but Henneguya does not survive all that well except on live animals like a lot of parasites. I think it would be tough to judge in my view, and I guess evisceration probably would not make as much difference as it might for the other diseases. Chairman 306. Thank you. Dr. Rodgers. Dr. Rodgers 307. I agree, but I am a bacteriologist as well so - No, I agree that it does not survive particularly well outside of the host, and this probably would be an effective method particularly with the washing step included in evisceration. Chairman 308. Thank you very much. So if there is nothing more on that perhaps we can go onto 16 which is addressed to all. Who would like to start? Dr. Wooldridge. Dr. Wooldridge 309. We have - and I think I touched upon this in the written answers that I gave you (the extra ones) this morning. With a risk assessment one would normally look at a baseline with either no safeguards in place or the current level of safeguards in place. If that produces an unacceptable risk, then one needs to look at the assessment with various safeguards in place. If you already have quarantine requirements as part of your normal safeguard then I can see no reason why they should not be included in your initial assessment. If you actually end up by having an assessment result that gives you an acceptably low risk having put in place vast numbers of additional safeguard measures, then, without looking at the intermediate stages, I think that probably is not acceptable. But we do not have that situation here; we have a situation where even putting in place all the safeguard measures, the risk assessment has come out giving an unacceptable level of risk. So the conclusion is to my mind that in order to be acceptable as things stand at the moment to Australia, they would need to be even more safeguards in place which we are not sure what they might be at the moment. So - in their terms we have not yet reached the appropriate level of protection. So what I am trying to say is that if we have reached what they consider to be the appropriate level of protection and that perhaps in fact that had been reached at some way prior to putting in all those safeguards, then the appropriate methodology would be to actually go back and look at the problem with fewer safeguards in place. But in their terms we have not reached that point, so that is not, from their point of view, yet an appropriate option. Does that answer the question? Chairman 310. I think so but I think we may need to provide a bit of clarification. I am going to ask the legal advisor to just say a word or two on that. The Secretariat (Mr. Jeff Gertler) 311. Thank you Mr. Chairman. Just to point out that the current safeguard as we understood it here what heat treatment and should that be built in? Does that change your - modify your response in any way? Dr. Wooldridge 312. In as much as heat treatment changes the product, we are then effectively looking at a different scenario so what you are then saying is that - I think logically you should, well, what, - What am I trying to say here? Let me try and get this right. Heat treatment did not even - if the level of protection is acceptable without heat treatment, then any other safeguards, for example, removing offals, de-boning etc., it is acceptable to include them in the methodology. If heat treatment takes you to the stage where you change from unacceptable to acceptable, then you do need to have two different risk assessments, one included and one not, in order to compare the differences and say "this is where we find it acceptable and this is where we find it unacceptable". It would not I think be enough to just do a risk assessment with heat treatment in it, quantitatively, now I am talking about, and say "we need this safeguard". I think it would be necessary to show that without that the risks were unacceptable. Does that clarify the - Chairman 313. Thank you. Dr. Rodgers. Dr. Rodgers 314. I would just add that I think what Marion is trying to say is that you can adapt the model, if you like, by putting in and taking out your, in this case risk management measures, your risk reduction factors, to see how it effects the final result. Heat treatment is a potential risk reduction factor, as well as evisceration for instance - but it may be the last one, the most effective, but you would not know until you had incorporated it into the model and seen how it would effect the overall result. Dr. Wooldridge 315. I think the point of the question, I think, was to try and work out whether simply saying "we need to do that in order to make it acceptable" is good enough. Do we need to actually show that the level below that is unacceptable. I think if you are going to say we need to do that as an extra over and above the normal measures of quarantine or testing that we would take, then you do have to actually do the two and show the difference. To just go straight in and have a risk assessment that includes heat treatment when heat treatment is not your normal baseline safeguard is not appropriate methodology. Chairman 316. Thank you. Yes, Jeff. The Secretariat (Mr. Jeff Gertler) 317. But let us assume, as my understanding of it is to be the case in Australia, that heat treatment is the normal baseline safeguard, is it then appropriate to build it in to your risk assessment or should you still do one with and one without that safeguard? Dr. Wooldridge 318. Since I think heat treatment effectively changes the product, I mean, if you are looking for muscle meat and you eviscerate and you de-bone, you have not changed the product, you are giving the consumer the product that they think they are getting. If you heat treat that actual muscle you are changing the product, therefore you are effectively importing a different product. Therefore if you are talking about the import of salmon, uncooked, unheat-treated, fresh salmon, then that is not actually a safeguard that you can put in place and still have the same product. So you do need to actually do a risk assessment which does not have that in place to get a level of risk out of that to decide whether that is acceptable or not. Chairman 319. Thank you. Sorry, go on. Dr. Burmaster. 320. Okay, thank you Mr. Chairman, that is an interesting answer. It is very difficult to import fresh salmon that had been cooked. I think that is a contradiction in terms. If you are interested in doing a risk assessment on fresh salmon I think you do it on fresh salmon and there is an old adage in computer science I want to bring up, but first let me sort of set the stage. I think that the type of risk assessment that needs to be done in this situation is one that would be done somehow using computers and software to do a simulation. It would have many of the characteristics in the report as prepared by David Vose. This report would be a computer simulation that would consider various risks, various options. Now the adage from computer science, is that the purpose of computation is insight and it seems to me that if there is a contention here in the room about what effect does cooking have, well you could build a computer software to include a toggle switch where you have cooking yes or cooking no and you run the software two different ways, one with the toggle on, you get some results, and one with the toggle off and you get a different set of results and you compare the difference. From that difference you try to figure out what is going on, what is going on in the computer programme and what is going on in the real world. So I guess those are my two thoughts. Chairman 321. Thank you very much. Does anybody have anything else to add to that? Well, I think that brings us to the end of the list of questions. We have dealt with seventeen. I propose at this stage to invite the experts one by one to make any concluding remarks that they may have, rounding up the discussion and stressing any views and conclusions that they regard as important. Perhaps we can proceed in alphabetical order again. Dr. Burmaster. Dr. Burmaster 322. Well, at the risk of simply reinforcing what I have stated in my written response, and in my spoken comments here today, I think there is a consistent theme and I may just as well round out the afternoon by stating it fairly bluntly. To my mind, the documents prepared, both the May, sorry, let me get the dates out here, the two risk assessments, so called, prepared by Australia in 1995 and 1996, do not meet what I consider to be the minimal requirements of a risk assessment. So in the last couple of weeks I have posed myself - well, they are long thick documents and there was a great deal of effort put into the preparation of these documents, it was a sincere effort on behalf of Australia to prepare those documents. What could they possibly be? If they are not risk assessments what could those wonderful, those long thick documents be? And I guess I come to the point of view that they are hazard identifications. They are long, and I think thorough, and if I understand Dr. Winton's and Dr. Rodgers's comments, they have really looked at a comprehensive list of the bacterial and viral diseases that could possibly be transmitted into fish in Australia. But because there is no quantitation, there are no quantitative arguments, it is for that reason, I believe that these documents prepared by Australia, do not meet my definition of what the minimal requirements for a risk assessment. So I think we have all been reading very thorough hazard identifications and we are yet to read a risk assessment from Australia. Thank you. Chairman 323. Thank you very much. Dr. Rodgers. Dr. Rodgers 324. Thank you Mr. Chairman. I really have not got any extra comments and I would not like to sum up the whole day in two minutes. I stand by what I said this morning in my opening 20 minutes. The only point I would like to reiterate from what I said this morning is that I think that everybody is in general agreement that there is a level of risk, and whether that risk is then acceptable or not is the key issue. That level of risk can only be acceptable providing you put in place a risk management procedure which is a risk reduction, a set of risk reduction factors, which are acceptable to both parties. That is the only way you can get some leeway in the situation. But personally I think that looking at the SPS Agreement and the OIE guidelines that it does seem that a country can set its own level of - its own acceptable level of risk, whatever that is. Just coming back to what Marion was talking about now, is that somewhere down the process, somewhere, by building in a set of risk reduction factors, you reach a point where you do find an acceptable level of risk. Now that may be when you have finally put in the last risk reduction factor or it may be in the middle. It is just something which has to be done by risk analysis and also by negotiation if the parties cannot agree on what that acceptable level of risk is. Chairman 325. Thank you very much. Dr. Winton. Dr. Winton 326. I only have two comments and I hope they are relatively short. One from the OIE Fish Disease Commission standpoint, in question 6 which we actually ignored, in the last statement is this actually the OIE recommendation, i.e. evisceration or a de facto standard. I think I have tried to explain that the OIE Fish Diseases Commission, in the absence of information to the contrary, viewed evisceration as taking that risk to below that would remain in the purview. But to some extent it is also a de facto standard in that many salmon-trading countries have viewed evisceration as acceptable for imports, for example regulations in the United States, the entire European Community and in Canada, now allow the importation of eviscerated without inspection regardless of origin. So to some extent, many of the salmon-trading partners have already decided this by themselves and so it is hard to say it is a de facto standard but it is not the OIE Fish Disease Commission that is actually pushing this, it is more widely I think understood. 327. Secondly, I think today has pointed out the very great need for additional scientific information. As a researcher I go away from here really with the understanding that we need a lot more information on things like decay curves of pathogens, reservoirs of infection, transmission mechanisms, the basic epidemiology of fish diseases. I think many of these disagreements are partially a reflection of the absence of information, and Australia's coming down in the absence of information with a more conservative approach; Canada in the absence of the same information with a more trade-orientated approach. But in neither case are all the data available by which to construct the final perfect quantitative risk assessment. For example, as detection methods improve it would not surprise me to find Renibacterium salmoninarum in some Chinook salmon in Australia. I cannot predict that for certainty but I would be willing to bet a substantial amount of money on it. The same issue occurred in New Zealand when we developed a new test for Renibacterium salmoninarum. We went looking for negative control tissues for our test and we were sent some tissues from New Zealand, and in fact we found low levels of positives, and by exhaustive examination we actually in our laboratory have evidence that very few numbers of those salmon are in fact at that very low sub-clinical level. This is not unexpected given the fact that Chinook salmon were brought to New Zealand from the United States, and that this disease is commonly transmitted with the eggs. So I think that as detection methods and our understanding and our data improve, many of these issues will begin to resolve themselves and I apologize, as a scientist, that we do not have sufficient data that this large exercise has been necessary. I think perhaps had we been better at our jobs a lot of this information would have been available and it would have been easier to make these sorts of decisions. Thank you. Chairman 328. Thank you very much. Dr. Wooldridge. Dr. Wooldridge 329. I am not sure that there is a lot left to say really, we seem to have said quite a lot already but I would just like to reiterate, restress two points which are very important from my standpoint and the way I see things. The first one is the absolute necessity of differentiating between the assessed and the acceptable risk and I think at the beginning of the day maybe that was not quite so clear. I think we all know now that there is a difference between the two and they both need to be taken into consideration but in different ways. The other point I would like to make is that I see risk assessment as a sort of a fairly pragmatic process, in a way, in that you start at the simplest level with what I would call a qualitative risk assessment, what Dave Burmaster would call a very thorough hazard identification, and if everybody agrees on the results then that is as far as you need to go, bearing in mind things like these are incredibly costly, time-consuming etc.. However, if there is disagreement then you need to go to the next step, and the next step is probably to undertake, or attempt to undertake a quantitative assessment. And if you do that successfully and everybody agrees, fine. But if you find that you do not agree on the data or the data is not available, then you need to go to the next step and put in place the required epidemiological or bacteriological or other studies or experiments to get the evidence in order that you can complete a quantitative risk assessment. So I think you go as far as you need to go until you can get appropriate agreement on the level of risk by all concerned. And when you have got that - that was the easy bit - you then have the difficult bit sorting out what is acceptable. Because we have all discovered that varies, and I think that is actually much harder to agree on and that is really all I have got to say, thank you. Chairman 330. Well, thank you very much. I think it only remains for me to thank the experts for their very patient and expert answers to our not always very expertly phrased questions. I think at the end of the day it will be clear that your input has been extremely valuable to the work of the panel and we are very grateful to you for participating in this process today and for the written work that you produced before that. So thank you all very much indeed. We will meet tomorrow morning with the parties at 10 o'clock in Room C, downstairs, and continue our process there but as far as the experts are concerned, thank you. That now concludes our session for today and have a safe journey home. Thank you very much. ATTACHMENT Questions Posed during the Joint Meeting with Experts, held on 4 February 1998 1. To Dr. Winton: With reference to the Panel's initial Question 3, do you believe that a risk assessment must consider the probability of risk or is it sufficient to identify the possibility of risk? 2. To Dr. Rodgers: We remain somewhat confused regarding your views on probability versus possibility in terms of risk assessment. In some of your written responses, you appear to equate estimates of probability with quantitative risk assessments and conclusions of possibility with qualitative ones. In another response (to initial Question 1), you indicate that the May 1995 Draft Report uses a qualitative risk assessment methodology to identify probabilities to disease introduction. Could you please clarify your views on the differences in these terms in the context of risk assessment. 3. To Dr. Rodgers/Canada: With regard to the identification of possible diseases in Canadian salmon, Dr. Rodgers has identified four disease agents not included in Canada's list (Kudoa thyrsites, Parvicapsula sp., flexibacteriosis and proliferative kidney disease (PKD). Canada argues that these should not be included in the Panel's consideration because the first two disease agents have not been found in adult, wild ocean-caught Pacific salmon and PKD is not known to occur in any of the five categories of adult salmon. Furthermore, Canada notes that Australia does not include Kudoa thrysites or flexibacteriosis on its most recent list of diseases of concern. To what extent does Dr. Rodgers believe these diseases are of sufficient concern to be considered in the evaluation of risks? 4. To Dr. Rodgers and Dr. Winton: With regard to concerns about "carrier fish" as "reservoirs" of a disease agent, to what extent is this concern applicable to dead fish (rather than live fish)? to eviscerated fish? 5. To Dr. Rodgers: Are salmon scavengers? Will they eat scraps of salmon meat? 6. To Dr. Winton: The Final Report refers to the "... current international standards for trade in salmon product for human consumption, that is, OIE recommends that product be eviscerated and that no other risk reduction measures need be taken". Is this actually the OIE recommendation, or a de facto standard? 7. To Dr. Wooldridge: Could you please clarify whether you believe that a risk assessment should consider risk on both a disease-by-disease and a product-by-product basis, or one basis or the other? Response to 2.4.3 seems to suggest two alternative approaches - what is the risk of exotic disease Y being introduced by product X? or what is the risk of introducing exotic disease Y, independent of the product. Are these two alternative models or once you decide there is evidence or suspicion that exotic disease Y might be in product Z, do you need to broaden the risk analysis for any other product of which you have evidence that carries disease Y? 8. To Dr. Rodgers: To the extent that a particular disease has not been found in a category of fish, can one assume that the probability of its existence is very small? 9. To any/all of the experts: If a disease has not been found to exist in fish from specific waters/area, should this disease nonetheless be considered in a risk assessment of fish from this area? If several diseases are included in a risk assessment model because there is suspicion that the product in question may be a carrier, and during the analysis evidence does not show that the disease is known to exist in the product in question, i.e. the first event in the chain of events does not occur, should you narrow the analysis to the diseases confirmed to be in the product in question? 10. To all of the experts: solicit comments/reactions to the "Vose Assessment" provided by Canada. 11. To Dr. Burmaster: In responding to Question 6 regarding the consequences for disease establishment regardless of the imported host, you indicated that you believed the statement was correct and that you could not think of a counter-example to this principle. Do you believe that this principle is valid in virtually all circumstances? Do you believe that this principle is valid in regard to the fish diseases of concern as identified by Australia? 12. To any/all of the experts: Do you believe that adult, wild, ocean-caught Pacific salmon pose less of a disease risk than the other categories of salmon identified by Canada (i.e., (i) adult, wild freshwater-caught Pacific salmon; adult, Pacific salmon cultured in seawater on the Pacific coast; adult, Atlantic salmon cultured in seawater on the Pacific coast; and, adult, Atlantic salmon cultured in seawater on the Atlantic coast)? 13. To any/all of the experts: Australia contends that the "generalization that uneviscerated baitfish or live fish pose a greater threat than eviscerated fish of a different species cannot be substantiated without reference to a risk analysis including detailed scientific risk assessment." Do you agree with this contention? 14. To any/all of the experts: The Panel previously asked (Question 18) if there were any advances in scientific knowledge that would justify a change in the conclusions from the May 1995 Draft Report to the 1996 Final Report? Are you aware of any such new scientific information? 15. To Dr. Winton: Australia characterizes your responses with regard to evisceration to be limited to the FDC list of "notifiable" diseases. Do you believe that evisceration provides the same effective reduction of risks for "non-notifiable" diseases? 16. To any/all of the experts: Australia indicates that "Options for pre and post entry quarantine conditions on imported product were built in to all stages of the risk analysis and can not be separated out. This includes .... evaluation of measures for reducing risks and consequences in the context of the appropriate level of protection." Is this an appropriate methodology for consideration of various sanitary options for reducing risks to the acceptable level? Article 5.6 of the SPS Agreement requires that "... when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility." A footnote to this provision indicates that: "For purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive than required unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is significantly less restrictive to trade." 17. To any/all of the experts: If, in your view, an option-by-option assessment is one of the minimum requirements of a risk assessment, is it enough to "assess" the risks associated with each of the SPS options (i.e. risk reduction measures) a country is considering? Or does one also need to "compare" the risks related to these different options and in the end give a rational explanation, in terms of relative risk, why one option is chosen rather than another?

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