PANEL ON AUSTRALIA - MEASURES AFFECTING IMPORTATION OF SALMON PANEL ESTABLISHED AT THE REQUEST OF CANADA
Document: Transcript of the Joint Meeting with Experts, Held on 4 February 1998 Chairman
Date: 4 February 1998
Complainant: Canada
Respondent: Australia
Third parties: EU, India, Norway, U.S.
Dispute stage: Implementation & Compliance
Agreements cited: Art. 2, 3, 5  Sanitary and Phytosanitary Measures (SPS)Art. XI, XIII  GATT 1994

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ANNEX 2
PANEL ON AUSTRALIA - MEASURES AFFECTING IMPORTATION OF SALMON
PANEL ESTABLISHED AT THE REQUEST OF CANADA
Transcript of the Joint Meeting with Experts, Held on 4 February 1998
Chairman
1. Let me first of all begin by welcoming the scientific experts and the parties to this meeting, 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. I think there is one other thing in that context, if
you could also speak reasonably slow ly and clearly because there will have to be a transcript prepared
afterwards and it will help to facilitate that process.
2. Now 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.
3. Now I would like to take the 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 do have to operate under time constraints and we must produce reports within certain
periods. This puts considerable pressure, not only on use but on you as well and I am grateful to you for
responding as you have.
4. For your information, that is to say for the information of the experts, following today's meeting
and a second meeting tomorrow with the parties to the dispute, the Panel must then proceed to prepare its
report. The first part of this repor t summarizes the facts of the case and the arguments of the parties and
will be provided in draft form to the parties for their co mments. An element of this first factual part of the
report will be a compilation of your written responses to the Panel's questions, and this will be circulated to
you and you will be given the opportunity to make any necessary corrections to this summary of your
responses. Subsequently, the Panel must provide first a complete, interim report to the parties and then its
Final Report, and we intend to include a transcript of today's meeting as an annex to the report, it will
probably appear at the interim or even the final stage because I doubt that the transcript will be ready in
time to go out with the factual part, in any case it will appear and will be a verbatim record of what has
taken place today. So I thought you might like to be aware of that before we actually launch into the
proceedings.
5. Now I must stress that the process of this Panel, the proceedings in the Panel meeting are
confidential and everything which is said in this room is subject to the WTO rules of dispute settlement
and the Panel's working procedures. 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, so we expect that the
Final Report will be circulated in that form in, probably late May.
6. 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 they believe to be appropriate. There
is no need to repeat at length what is already in your written responses, but I would invite you to highlight
your main points in the areas wher e you see the most important issues and points of contention. Should
you wish to comment on any points made by another expert, please feel free to do so. I would also draw
your attention to a number of additional questions that were sent out by the Panel, they were additional to
the first round of questions. Perhaps if you could take the opportunity of your opening statements to
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address the ones that concern you - they are not all of them for all experts -but please address those which
concern you. It would be helpful if you could do that in your initial statements.
7. When this is concluded we will then open the floor open to the parties and begin with Canada.
Canada will be given the opportunity to put questions and comments on the experts' views and the experts
will then be invited to respond. We would like to take the questions one-by-one in order to ensure an
orderly process, but should Australia have any follow-up question directly linked to one that has just been
raised by Canada, it would then have the opportunity to raise that question at the same time so that we do
not subsequently crisscross backwards and forwards betw een the subjects - if we get into a subject let us
deal with it and dispose of it. Similarly, after the responses from the experts to Canada, Australia will be
given the opportunity to raise their questions and comments on experts views. If Canada has any directly
related follow up questions, they would be permitted to insert those as well. Again, the experts will have
the opportunity to respond to each question as they are raised. Now I would emphasize that it is really up
to the experts how they respond to these questions, this is not an interrogation or court of law, they should
feel relaxed about it and obviously o ffer their expertise as they see fit. I have to say that my experience
with these sort of sessions in the past, has been that they have been conducted very satisfactorily from the
point of view of the expert advice, there is no real, no element of interrogation in any way.
8. That said, the primary focus today, is the discussion with the experts and I would ask the parties to
refrain from the sort of statements and re-battle arguments which they will have the opportunity to deliver
tomorrow. Tomorrow, however, will be the final opportunity for submissions from the parties but today
the priority is to give time to the experts and the scientific factual issues under discussion with them.
9. Subsequent to the interventions of the parties, the Panel may wish to raise some further questions
or seek some further additional clarification, and finally, I will give the experts an opportunity to take the
floor again individually for any final statements which you may wish to make, so that you may stress what
views and conclusions you consider most important. I would ask all of you, both experts and parties to try
and be as succinct and to the point as possible and to avoid, for example any lengthy repetition of what has
already been submitted in writing. So, with these remarks, I would now turn to the experts themselves,
they are identified by name-plates and I will name them as I give the floor to them. I would ask, when we
get to the parties, if whoever is going to speak from the parties would identify themselves, would introduce
themselves as they take the floor, not just only for the benefit of the experts and ourselves but also so that
we can identify them for the purpose of the transcript.
10. That said, unless there are any questions on procedure, I would propose now to invite the experts
to take the floor. I will offer it to them in alphabetic al order for want of any other basis, so perhaps I could
begin by welcoming Dr. Burmaster to this meeting and to invite him to take the floor.
11. If you which to make a presentation or make use of the slide machine there is a portable
microphone, but if you do not then please you will find it is better there.
Dr. Burmaster
12. Good morning and thank you it is a great pleasure to be here this morning and I must say that this
is my first such experience so please bear with me as I work along to assist the Panel as best I can. I guess
I have one or two comments only that I would like to make now, to supplement my written statement from
last November.
13. The first is that I said in November, and I contin ue to say now, that a risk assessment for this type
of issue, I believe should be done in quantitative fashion; that it should involve a numerical calculations as
best as is known and with stated uncertainties. At its heart, I believe a risk assessment should be
conducted with numerical arguments and to persist on that, I would think that it would use probability
distributions and those probability distributions could take a number of different forms - there is no unique
correct way to do this style of analysis - but I do believe that however one put together the information that
it would include probabilistic descriptions of the variability of what we do know about events and the
nature of fish diseases and transmission of fish diseases and so on. It should also somehow state
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numerically as best as possible the degree of certa inty or the degree of uncertainty in human knowledge
associated with those calculations. I have been asked from time to time what would be the minimal, the
minimum requirements of such a risk assessment an d coming as I do from the United States, I would say
that we, in the United States, have adopted a sort of generally, a four step pro cess for risk analysis. The
first step would be hazard identification, the second would be dose response assessment, the third would be
the exposure assessment and the forth and final step of the risk assessment would be risk characterization.
Typically, in the States, the hazard identification step is done qualitatively; one identifies the nature of the
problem and in this instance what diseases might occur and what species of fish may be susceptible to
those diseases. That would be a discussion qualitative in nature. But then, and the remaining steps, dose
response assessment, exposure assessment and risk characterization, those steps would all be quantitative
steps done with numerical calculations to display th e probabilities of occurrence, the probabilities of dose
response, the probabilities of exposure and the probabilities of risk characterization. That would conclude
the risk assessment steps and then to go on, there woul d be additional steps: risk communication and risk
management steps such as you and other risk managers might undertake.
14. On the second question that came up, here we have, in this situation, multiple fish diseases,
potentially multiple fish diseases and potentially multiple target species of fish. The question has arisen if
there are ten diseases of fish - ten different diseas es - and five different fish species, to make up a
hypothetical argument, do we have to multiply those and do fifty, ten times five, different risk
assessments? I think, as a practical matter one need no t have to do fifty different risk assessments. I think
that there are ways to sort through that, it may be that you would have to do one or two or smaller number
of risk assessments not a full number of fifty. Let me stop there and thank you.
Chairman
15. Thank you very much Dr. Burmaster, let me now welcome Dr. Rodgers and invite him to give his
opening comments and you have the floor Sir.
Dr. Rodgers
16. Thank you Mr. Chairman, I will be a little more expansive than Dr. Burmaster, because I think my
particular background expertise involves fish diseas es, fish disease transmission and prevalence so there
are some relevant points to make in these sections. But before I make some comments, I would like to
thank the Panel for the opportunity to address them and also I hope so far my answers have proved useful
to them in their understanding of the background to th e case. I personally found it a fascinating exercise
which at times for me has been both difficult and frustrating. Not necessarily because of the nature of the
problem but certainly the 20 kilos or so of paper which arrived on my doorstep to evaluate and assess,
which is almost one kilo for each year of the dispute, which is not too bad going really.
17. My own answers to the questions posed for the experts have tried to clarify any contentious
points, if you like, within which is a very complex scen ario. I have also tried to be non-technical where at
all possible using fact to support my own personal opinion, which again, I hope has helped the Panel so
far. Consequently, I think my answers and possibly those of the other experts should be taken as a whole
and not taken out of context and dissected down into phrases because as I say it is a very complex situation
we find ourselves in but, having said that, I recognise that in certain cases it is almost inevitable that
phrases are taken out of context. With hindsight, I pa rticularly enjoyed answering questions such as eight
and fourteen because at the end of the day both parties seem to agree that my answers were supportive of
their own particular stances so that puts me in a better position today.
18. I will try to summarize the answers that I have already given by making some general comments
related to selected relevant points, as I see them, perhaps some of the more important points, while at the
same time responding to the supplementary questions which were sent to us some weeks ago. Although I
will not necessarily name the supplementary questions by number. The original sections were divided -the
original questions rather - were divided into three sections, those related to risk assessment procedures, fish
diseases, transmission and prevalence, and also the OIE procedures. I will deal with them in traditional
reverse order because I did not attempt to answer the OIE section at all, because I did not really have
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enough working knowledge of the OIE to comment. I also do not propose to dwell too much on the
section concerning fish diseases because the respons es from the parties were largely in agreement with
some, what I would call minor, exceptions, although th ey themselves may not agree that the exceptions
were minor.
19. Essentially though, what I would say about the dise ase section is that the most accurate up to date
information concerning disease prevalence in an exporting country is usually held by the exporting country
itself, providing that country is of course recognised as a competent authority. In this case of course,
Canada has a well respected monitoring system in place for this type of situation. The degree of scientific
confidence in disease detection with existing methods relies really on the lowest limits of detection of each
particular test, or series of identification methods. However, this can lead to difficulties in isolating certain
fish viral pathogens and also certain bacterial strains. In addition there is a cut off sensitivity point for
most diagnostic methods which leads to the carrier state in particular being difficult to detect, except with
the most sensitive methods that are available. Nevertheless, any deficiencies in sensitivity for existing
methods are generally accepted by the scientific community both in terms of the supportive science and
also by the legislative policies that actually stipulate their use in regular surveillance programmes. It is
also true to say that regularly tested stocks are norm ally considered as a lesser risk than occasionally or
untested stocks, since regular monitoring will provide a background database if you like, of information
over time. However, post harvesting testing for disease in fish, tested for human consumption is very
rarely undertaken at all.
20. As far as actual disease transmission is concer ned, this of course combines many biological,
behavioural and environmental factors which are interr elated - we cannot get away from that fact. As
such, the epidemiological factors relevant to disease transmission would not necessarily be the same for
each disease since they are comple x and numerous, although the general aspects would be common.
Perhaps the most relevant factor to my mind, in this particular case is the introduction of potential
pathogens into an already stable environment. Since the natural balance of an indigenous fish population
could be altered perhaps irreversibly, this is one factor which perhaps is overriding in this particular case
of transmission. However, having said that, there is a generally accepted lack of information about the
occurrence of fish diseases in wild fish and the potential interactions between wild fish and the
mechanisms of disease introduction themselves.
21. The question of evisceration is also relevant here obviously. I think that we are all in agreement
generally that it is an effective means of reducing the level of risk although the level of reduction would
largely depend on tissue location of the disease-caus ing agent and the effectiveness of the evisceration
process. Nevertheless, we do not know of any specif ic cases where fish diseases have been transmitted
from one area to another by imported eviscerated salmoni ds, or in fact any other species of eviscerated
fish.
22. Also the post-harvest organoleptic examination for grading purposes should remove unsightly
looking fish such as those which may have ulcers or extensive haemorrhaging or some sort of superficial
damage. These conditions could occur as a result of di sease, although again, carrier subclinically infected
fish could still remain after such an examination.
23. Now, I do not propose to comment any further on the consequences of disease entry because I
think in general again we are in agreement as to which main step-wise criteria need to be fulfilled for this
to happen. However, we should bear in mind that early detection of disease entry and subsequent
eradication following any disease establishment woul d be very difficult in any country. The only
supplementary question which does not fall easily within the three main sections that the original questions
were divided into was directed specifically at myself , which basically asks what is "steelhead trout" or
"rainbow trout", so if I may I will deal with it at this po int before I move on to the risk assessment section.
Essentially steelhead trout and rainbow trout are salmonids not salmon and they are the same species, that
is they are Oncorhynchus mykiss). There are some salmon within the same genus of Oncorhynchus but
they are true salmon such as coho salmon and sockeye salmon. The main difference between steelheads
and rainbows is their ability to migrate. The steelhead trout is the anadromous, migrating fish compared to
the rainbow trout which is the non- anadromous, non-migrating equivalent. These fish were originally
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placed in the genus Salmo as the Atlantic salmon still are, but rising taxonomic evidence, if you like, in
1989 led to the change being made because these fish were considered more closely related to the
Oncorhynchus genus than the Salmo genus which contains more Atlantic European species, and at that
time all specific drainage trout were placed into the genus Oncorhynchus.
24. That brings me to the final section, which is perhaps for us as experts the most contentious section
on risk assessment procedures, and in particular, the comparison between the two reports as presented to
us. For me the 1996 Final Report is generally less specific than the 1995 Draft Report. It is also more
confusing in layout but includes the product of a communication exercise which the Draft Report does not.
In fact, we are led to believe it was never within the original remit of the Draft Report to contain a risk
communication exercise. Neither report can be classified as a quantitative risk assessment exercise, but the
Draft Report, for me, is a clear qualitative assessment of importation risks. Although both reports largely
rely on interpretation of the same risk assessment da ta, the Final Report reaches a different risk analysis
conclusion which is a result, for me, of public consultation. In general, the 1995 Draft Report is acceptable
for me and meets the minimum requirements as a qualitative risk assessment.
25. As far as the 1996 Final Report is concerned, of course it is based on the earlier Draft Report, that
was the intention, and also includes the results of a risk communication exercise which should make it
equally acceptable. I think we have the luxury, if y ou like, of being able to compare the two reports and
when you do, there does, for me, appear to be something lacking in the Final Report which is surprising
because, following the 1995 Report it should have all the basic elements in place. This missing element
seems specifically related to its clarity and its detail and the underlying methodology which almost appears
to be a straight forward literature review without conclusion.
26. To be honest, I got completely lost in the Final Report looking for sections which were possibly
out of place and this, in my opinion, makes it less transparent then the original Draft Report. It assesses
risks on a disease-by-disease basis but in a textural form and does not assign any probabilities that would
be needed to reach a conclusion. In this respec t, therefore, I think, it possibly does fall short of
determining any probability based on the information available. This concept of probability is embodied
in OIE guidelines which indicate that the risk factors should be used to estimate the probability of an
adverse event occurring with point estimates of probability distributions, employed to represent the values
either quantitatively or qualitatively.
27. Therefore, taken alone without reference to the Draft Report, it is probab ly not acceptable overall
as a risk assessment exercise, although it does include more components. There seems to have been a
change in style, content and approach in the Final Report following the risk communication step. I
personally think this has devalued the report as a whole, which is after all supposed to be the published
face of the whole analysis process.
28. If you are concerned with several diseases, effect ively the risks are identified by drawing up a list
of the potential diseases of concern that would be associated with the importation of a particular fish
product, followed by an examination of the consequences of their entry and establishment. Now, although
many risk factors are common between different dis eases, each disease may have unique factors to
consider and each of these will have a variable quality and quantitative of available data that will need to
be dealt with separately, which does make it necessary to assess risks on a disease-by-disease basis. But
following on from what David Burmaster said, of course you might be able to analyze a higher risk disease
in order to arrive at an answer, rather then having actually to look at every individual disease in turn.
29. So where does all that leave us? I got a little confused, and its probably relevant at this point to
make an overall summary, purely from a scientific point of view, as I see it. This means effectively that
we can now bring in the 1997 risk assessment which was submitted by Canada, that uses a quantitative
method to consider the data already available in 1995 for the two most serious diseases of concern, namely
those caused by Aeromonas salmonicida and Renibacterium salmoninarum . To illustrate the point, we
fortunately do not have to look, in my mind, into greater depth at the report because we could be here until
tomorrow, but rather look at the overall conclusions of the various reports following the various risk
assessment components. Here I will read, I am sorry, I will have to quote from the various reports.
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30. In the 1995 Draft Report AQIS concludes that "wild, ocean-caught Pacific salmon from Canada
and the USA that have been eviscerated and had their heads removed, when consumed in the domestic or
restaurant setting, are considered to present a negligible risk of disease introduction and establishment". It
also states that "it is considered extremely unlikely that the importa tion of headless, eviscerated, wild,
ocean-caught Pacific salmon would introduce infection into Australian fish populations" (and here it is
referring to Aeromonas salmonicida in particular), and that "the risk of disease introduction is acceptably
low, having regard to the potential serious consequences of such an event".
31. In the 1996 Final Report there is a reference which says "there are risks of exotic disease agents
occurring in salmon products; however, the risk of establishment of an exotic disease is low if suitable risk
management interventions are made".
32. In the 1997 Canadian Risk Assessment (the so-called Vose Assessment), there is a statement
which says "the risk of native salmonid infection with Aeromonas salmonicida or Renibacterium
salmoninarum from Canadian salmon is exceedingly small" and that "the information available to
Australia at the time of writing their reports was sufficient to enable them to conclude that the furunculosis
and BKD risk posed by Canadian salmon must be considered negligibly small" there is also a final
statement which says "head-on and heads-off, chilled and frozen eviscerated Canadian ocean-caught
Pacific salmon all present negligible risk of disease introduction".
33. Now for me, I take it to mean that all these reports actually reach a similar scientific conclusion,
unless negligible in one report refers to a different leve l of risk in another report, which is quite possible, I
do not know whether Marion Wooldridge or David Burmaster can comment at a later stage on the
difference between phrases such as "negligible", "extremely unlikely", "acceptably low", "low",
"exceedingly small" and "negligibly small". The interesting thing is that both the original qualitative 1995
AQIS Draft Report and the quantitative 1997 Vose Assessment use the same concluding phrase,
"negligible risk". What neither of them have is risk communication.
34. The problem for me seems to be the change in emphasis and conclusion in the 1996 Final Report,
which seems to consider the scientific advice but then reaches a political decision, following public
consultation, as I have said. Now the OIE revised guidelines state that the importing countries shall decide
whether the risk determined in the import analysis is acceptable or not, but that the importing country must
be prepared to justify their decision. The question of scientific advice versus final political decision, for
me, is a very difficult one to address, since the existence of risk, irrespective of the level, may be
ultimately unacceptable.
35. The SPS agreement includes th e requirement to undertake a risk assessment in these
circumstances by stating "the measure be based on a risk assessment, as appropriate to those
circumstances, and that the risk assessment takes into account the techniques developed by the relevant
international organizations", which for aquatic animal health, is the OIE. In their relevant
recommendations at no time is there a requirement to undertake a quantitative exercise. The OIE state that
"a risk analysis must be able to deal with the complexi ties of real life situations and that no single method
is applicable in all cases. For this reason, countries wanting to conduct import risk analysis may find it
necessary to design their own methodology or their own process for carrying out such an exercise".
36. In summary, from a purely scientific point of view, I agree personally with the AQIS
recommendation in the 1995 Draft Report based on a qualit ative exercise. I also agree with the disease
summaries of the BRS Review and the most recently commissioned quantitative exercise from Canada,
which taken together accept that there is a risk and that risk is "low", "exceedingly small" or "negligible"
which ever phrase you want to use. There appears to be no argument that a risk exists, none at all. But the
key fact for me, is not whether the risk assessment exercises should be qualitative or quantitative, or even
whether one report is better than another, because at the end of the day, using similar phrases they all reach
a similar conclusion. For me, the key fact is what you do with that information that identifies a certain
level of risk, the next step if you like, which in this case, identifies a negligible level of risk. The final
decision, after a risk communication exercise which considers additional factors, is going to be a political
decision, not a scientific decision. That decision can agree or not with the scientific advice, which
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identifies as I have said a certain level of risk. Whether that risk is then acceptable, following socio-
economic and internal political consid erations (to which, fortunately, in this case I am not a party), is not
really for me today to say. What I would say though is that additional fears about the acceptability of such
a low level of risk should be allayed by considering a series of risk reduction factors. But those risk
reduction factors should be accepted by both parties. In this way, the application of such a series of
measures may demonstrate that the extent to which ri sk is reduced is sufficiently great that an accurate
assessment of the initial unrestricted risk is unnecessary and here again I quote from the OIE manual. For
me, risk assessment is a piece of the process that helps decision makers arrive at a final conclusion, is not
an answer in itself.
37. That is all I would like to say except to finally conclude by congratulating both parties on their
presentations because analysing and finding the necessar y scientific information for this exercise is not
easy. I know from experience how difficult it can be, and I would make a plea if you like for them, as the
New Zealanders have done to a certain extent, to make that information available following the Panel
decision, irrespective of what that decision is, for ev erybody, because it is extremely valuable information
that should be used, possibly through the auspices of the OIE in some way, for anybody else coming after
to help support subsequent risk assessment exercises. Thank you Mr. Chairman.
Chairman
38. Well thank you very much Dr. Rodgers, perhaps I could continue now with the order and turn the
floor over to Dr. Winton. You have the floor.
Dr. Winton
39. Well I would like to begin by thanking the Panel for the invitation to attend, I have found this a
very interesting exercise. I would also like to state that both parties in this dispute, I regard as friends and I
have scientific colleagues in both countries and the amount of effort and time that has been expended is
substantial and I second Dr. Rodgers comments that a lot of very good information has been generated in
this exercise. I tried to restrict my comments to that of the OIE Fish Diseases Commission for two
reasons: partly because I consider this to be a dispute among friends and not to take sides, but secondly
because Dr. Blancou the Director-Gen eral of the OIE, feels that the OIE should be impartial in these
matters and so I have tried to restrict my comments pretty much to areas in which I believe the Fish
Diseases Commission has some role.
40. First of all, the Fish Diseases Commission of the OIE and the OIE itself is not necessarily the
repository of all information or all judgement on these things. We do not, in fact, sit in judgement, we
gather information to the best of our ability throu gh a network of colleagues, reference laboratories and
friends, but much of the information generated by both parties and by Dr. Rodgers has been useful to us
and we are in the process of learning about this ourselves. We found several of these exercises to really be
quite in advance on what we estimated risk assessments might be in the areas of fish diseases, because the
Fish Diseases Commission has adopted very much the risk assessment approaches drafted by the OIE itself
for large animals and Dr. Wooldridge can comment more about that. But it is an evolving area, it is an
area where new scientific information is required in order to develop quantitative assessments, if you do
not know survival curves of pathogens, it is difficult to estimate some of the factors that have to go into a
quantitative risk assessment, and certainly the OIE recognizes that.
41. The Fish Diseases Commission has, as I said, ad opted the approach of the OIE and that is that a
risk assessment should be the method by which disputes can be resolved between parties, particularly in
the case here of the fish disease. We generally had imagined that such risk assessments would be
quantitative to maximum extent possible, and I think, as Dr. Rodgers and Dr. Burmaster have indicated,
this is possible. I think the New Zealand and to so me extent the Australian an d certainly the more recent
Canadian reports have gone a long ways towards showing what can be done in the areas of risk
assessment.
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42. The Fish Diseases Commission has not tried to address every possible disease risk between any
possible trading partners because virtually every case has unique elements. Those unique elements have
to do with the species in the exporting and the importing countries, the volume of trade, the type of product
that might be in trade, etc. But what the Fish Diseases Commission has tried to do is to establish a group
of diseases for which there is general agreement that these are significant diseases in worldwide trade. The
Fish Diseases Commission has also imag ined that the most significant areas of risk involve live fish, live
gametes and secondly, uneviscerated products.
43. The OIE Fish Diseases Commission has not consid ered eviscerated fish to represent a significant
risk. But I agree with Dr. Rodgers that probably th ere is no trade that has zero risk. I think as Dr.
Burmaster and Dr. Wooldridge have pointed out, you have a balance between benefits and risks, the only
no risk option is no trade. So if there is going to be trade, you can always co nstruct some scenario by
which some agent might pass. In an effort to bala nce this, the Fish Diseases Commission has created a list
of Notifiable Diseases which we believe there is ge neral agreement on and a method, or set of standard
protocols by which certifications can be obtained for international trade to proceed, primarily in the case of
aquaculture products. Outside of that sphere, is a huge grey area which includes the dispute here in
question, wild fish or eviscerated fish. For that th e OIE Fish Diseases Commission has really not much to
say other than, in our view, as a series of experts and based on our evaluation of the scientific literature, we
do not find scientific evidence that such eviscerated products have constituted a risk in the past. Should
such scientific data be forthcoming, we would perhaps modify the types of products or the types of
diseases and it is a very dynamic process, and we probably will never get it completely right.
44. In response to some of the questions then about the Fish Diseases Commission and detailed
minutes, etc., and how this body works there are five elected members of the Fish Diseases Commission.
We are often joined by one of two experts, Dr. Beers for example attended, I think two years ago one of
the sessions and we appreciated his input at that time. We try to invite experts periodically to provide
input in areas in which we think we are weak. We ar e admittedly weak in areas of risk assessment and we
rely on the OIE and other authorities such as we have here with us to provide guidance in that area. We
are also somewhat weak in areas of crustacean and shellfish diseases and we will invite experts to assist us
in some of these areas. But we do have a large network of reference laboratories and colleagues to provide
that information. We do not keep detailed minutes of our debates and consultations, they are essentially a
consensus agreement, if the five members do not agree, we simply do not do anything for a while until we
do agree or we get new information. The minutes that we do provide are somewhat summary in nature and
are presented to the general session at which each member country has a voting delegate. So we serve
really as a technical body to the OIE itself.
45. I think that ... understand that the OIE Fish Diseases Commission as a subgroup of the OIE is
developing essentially as we go and I think this dispute actually has been very informative to us. The OIE
code and manual for terrestrial animals and animal di seases has been around for quite a while. Over
twenty years ago this approach was imagined to be extended to aquatic animals for which trade was
increasing and the Fish Diseases Commission was created. Until the GATT Treaty, the Uruguay Round of
GATT, the OIE was not given as much authority in these issues. But following the Uruguay Round of
GATT OIE was seen to some extent as a reference body and the Fish Diseases Commission was increased
to five members to increase its geographic distribution and to some extent its expertise. We do not
represent geographic areas per se and certainly not countries, but we assemble information on the
epidemiological situation in various parts of the world and for that some geographic input is important.
Certainly we could use experts from other areas of the world including Australia or New Zealand.
Presumably our network of reference laboratories, of which we have two in Australia, are important
sources of information.
46. I think that I can comment on one or two of the additional questions that the Panel has raised. Dr.
Rodgers has expertly answered the question on salmon and st eelhead. This is an areas that is of a little bit
of debate, the geneticist will tell you that all members of the genus Oncorhynchus are probably closely
related, but by convention Pacific salmon are really those traditional species of Pacific salmon that migrate
to the ocean and that the rainbow trout, the anadromous form, the steelhead, is seen as a trout, to some
extent, so it is in fact a salmonid but perhaps not a Pacific salmon in most people's general agreement.
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47. To the other questions, most of which involve risk assessment, I would certainly defer to
Dr. Wooldridge or Dr. Burmaster. The 1996 Final Report of Australia, in many ways took into account
some of the risk assessment techniques developed by the OIE in that this is an evolving process. We
imagined that a risk assessment might be necessary, but in fact the OIE right now is moving along and
refining and adapting its techniques, and in fact I think has gone quite a ways farther then some of us who
are not familiar with risk assessment methods might have imagined. To that extent, the 1996 Final Report,
as Dr. Rodgers I think mentioned, falls short of a quantitative assessment, one that Dr. Burmaster perhaps
had argued for. Yet I certainly acknow ledge the fact that there are large gaps in the scientific information
by which a quantitative risk assessment can be fully done. But I think that the New Zealand Report and
perhaps some others have made a good effort given the existing scientific information of trying to quantify
those risks, and whether the probability is one in a hundred thousand tones or one in fifty thousand tones, I
am sure there is some margin of error. But the idea at least that you can begin to assess probability
estimates, I think is important and I think that all of us will be looking towards that approach in the future.
At that point I think that will conclude my comments.
Chairman
48. Thank you very much Dr. Winton. Perhaps I could now invite Dr. Wooldridge to take the floor.
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 labelle d my written answer to question 17 as an answer to
question 16. However, it appears that this was real ized 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 th e 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 sim ilar and one is that quantitative assessments are not required in either
the original or the new guidelines and that once you have assessed the ri sk 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
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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 demonstrat e 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 ri sk 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 se e 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 importatio n, 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 wh ere 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 requ ired 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 - no body is arguing, there is no dispute and there is no
problem. The problem, of course, does come when th ere 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
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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 wh ether 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 wa s 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 su mmary 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 unnecessar ily 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 ri sk assessment (see my original answ ers: 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 no t 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 ti tres of bacteria present would be
sufficient to cause a disease outbreak". I cannot fi nd 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 co mpares two parts - the Draft and the Final Report.
There is an interesting and important difference in the wording on environm ental 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 (Renibacteriu m salmoninarum) has potential to survive in the
environment for significant periods." Checking the da ta and the reference given, these conclusions in
both cases appear to be derived from the same refere nce: 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.
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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, existi ng 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 accepta ble 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 string ent practical combination of these in place, and demonstrate that the
risk were still unacceptable, in or der 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 cons idered to represent an un acceptable 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
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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 expert s 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 w eeks. 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.
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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 an imals, 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 th e 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 vol untary minimum guidelines that should be applied in
international trade by importing and exporting countries.
83. The most immediately apparent feature of the Fi nal 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
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note that the SPS Agreement does not prescribe risk assessment methodology bu t 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 qu antitative 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 exam ple, 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 th at 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 empha sise that the IAAHC is in its deve lopmental 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 Sc ientific and Technical Revi ew of the OIE, 15th of
June 1996, page 378.
88. Australia has also raised concerns about the wa y 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 notif iable 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 anim als and aquatic animal products, nevertheless a disease
is not listed if it has a broad geographical range. Furu nculosis 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.
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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 opti on that importing countries
should consider in the addressing the risk of diseas e 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 alon e 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 potentia lly 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 th at there is little chance of proving the source of
outbreaks of salmonid diseases. Indeed, once a diseas e 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 redu ce 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 expe rts 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.
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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 Dise ases 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 an nual 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 disagr ee, one country may wish to add a
disease, another can make an argument to remove a diseas e and in this case we try to use scientific weight.
But I even brought with me an example of Australian co mments 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 th ere are not cases of possibility with transmission of
fish or other animal diseases in a variety of situatio ns. 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 cas es 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 seem s 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 sa mple 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 Co mmission 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.
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Dr. Wooldridge
103. OK, I have got one or two areas to talk about which I think all fall within the broad area of risk
assessment and risk analysis methodology. I noted the comment that the type of risk assessment most
appropriate depends on an examination of the data. I would suggest that actually, well, in my opinion that
is not the appropriate way to view it. I would suggest that one normally undertakes the qualitative risk
assessment first and then, if necessary, follows up with an attempt to undertake a quantitative risk
assessment, and this does not depend upon an examination at the initial stage of the data to decide which
type of assessment one wishes to undertake. I think a qualitative assessment gathers the information and
categorizes it and orders it and comes up with a qualit ative assessment. Leaving aside the meanings of the
words, this may be things like high, low, negligible - and if everybody agrees that the risk is too high from
this basis to be acceptable, we do not have a problem; if everybody agrees that the risk is negligible, we do
not have a problem, and it does not matter what those words mean at that stage.
104. When you have a dispute, I would maintain again - there may be other occasions - but particularly
when you have a dispute, I would maintain that the most appropriate way to then follow it up to try and get
further on the matter is a quantitative assessment. I would here like to reiterate the point I made earlier in
my written evidence that the basis of a quantitative risk assessment is the putting together of a model into
which you feed data and the whether or not you have the data, you can still put together a model and put
dummy-data to actually clarify the pathways by whic h you think your identified hazard may become the
unwanted outcome that you are attempting to assess. I think the big value of this is that it does clarify the
pathways required and the data that you need, and if you say "I do not think I have got the data to do a
quantitative risk assessment" without actually attempting to make the model required for that quantitative
risk assessment, I do not believe you can categorically state you do not have that data. That is my
theoretical point. From a practical view point I would say that when you do try and put together a
quantitative risk assessment you almost always do find that you have got a lot more data of appropriate
type than you initially anticipated that you would have. So I would say that you cannot tell whether you
have got the data to do a quantitative risk assessment until you try and do one.
105. I think, following on from that I would like to say I am afraid I did not find the Final Report
transparent. I think there is a quote or a comment th at the final version was transparent. I personally
found it far less transparent than the draft and difficult to find the information for which I was looking,
sometimes I found it, sometimes I did not. It did not appear to me to be set out in a way which made it
easy to find the information and to differentiate between what is the assessed risk and the acceptable risk.
106. Having said that, I would like to reiterate and I agree with Australia's contention here that it is up
to the country or a local ar ea or the particular place in question to decide what is an acceptable risk for
them, and therefore whatever came out of Australia's Draft or Final Report as far as the assessed risk is
concerned and whether I believe that was done well or ba dly is immaterial in this instance, it is up to them
to say that is an acceptable or not acceptable risk. However, I think international guidelines would suggest
that if they come to the conclusion it is not acceptable, they have to be able to justify it at a meeting such
as this.
107. A word about diseases themselves, not specifi c diseases but which diseases are appropriate to
include in a risk assessment and how this interacts with Notifiable Diseases and standard lists of diseases
and so forth. We had many discussions on which information it was valid to include in an international
risk assessment, when we were redr afting the OIE Risk Analysis Code Guidelines. There were opinions
that the only diseases which could be included from a given source were those which had been notified and
there were opinions that said "no, you need to be able to include any disease for which you have reason to
suspect, or knowledge to backup, that it might be in the product which you are considering". That was my
opinion and it was actually the final opinion of the working party, that those diseases which one may
legitimately look at are any that one has evidence could be in the product, and that might not simply be the
information notified to the OIE, but it might be from a literature search or personal reports or
communications. The rational for this was that one wi shes when one is doing an import risk analysis and
risk assessment to have the best, th e most appropriate, the fullest data available and that is not necessarily
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only the data that has officially notified to OIE or any other body. I think those are my only comments at
the moment. Thank you.
Chairman
108. Thank you very much. Turning to the other table, can I ask Dr. Burmaster? You have the Floor.
Dr. Burmaster
109. Well I have a couple comments in response to this overview statement from Australia. Risk
assessments, at least the way I use the word, are alwa ys anticipatory of some future event. So by
definition, if some group of people are thinking of doing, changing a policy or taking a new action in the
future, by definition we never have enough data to describe it. A risk assessment is always lacking some
data which someone, somewhere thinks are important. It is part of the process, we are looking ahead, and
by definition we are missing some part of it. Nonetheless, I would agree with Dr. Wooldridge that by
putting together a model has very beneficial results. It sharpens the thinking. By this I mean a quantitative
model, a mathematical model, whereby we can put in numbers or put in distributions and make
calculations about what if, what if this were true? wh at if that were true? what if we did this? what
evidence do we have? But we will never have - I am not aware of any situation where risk assessment has
ever been conducted in any field, at any time, for any purpose, where they had perfect data. The concept
of perfect data does not exist in risk assessment or, for that matter, may not exist in all of science.
110. Nevertheless, there are ways working with the model to use a combination of data and a
combination of expert opinion and expert evidence and evidence from other fields to come up with
calculations which somehow give a numerical value to the proposed action. It can also highlight where
data is missing, where to go looking for data. That would then show where the data are most missing and
could most beneficially help (this is called the value of information approach). Now this is still in risk
assessment, this is still trying to ascertain what risk s may occur in the future. Then comes a separate step
called risk management, is this risk that we have calculated acceptable or not? I strongly separate risk
assessment from risk management. Let me stop here.
Chairman
111. Thank you very much. Can I ask if Dr. Rodgers would like to respond to Australia? You have the
floor.
Dr. Rodgers
112. Thank you Mr. Chairman. One of the beauties of coming last is that you do not have much to say
providing the other experts have said it for you and in this case to a certain extent that it is true. So I will
be brief. At the last European Association of Fish Pathology International Biannual Meeting, in
Edinburgh, in September of last year, we organized a workshop on risk assessment for aquatic animal
health. In a room of 120 seats th ere was standing room only. It wa s freely available meeting for anyone
that was present at the main conference. We addressed many of the issues which have been raised by both
parties in their submissions. What came out of the meeting was not only a sense of relief because
somebody had actually got people together to talk about this subject, but that there was a lack of data in
certain important areas in aquatic animal health for use in either qualitative or quantitative risk assessment.
These areas are particularly related to species suscepti bility, diagnostic techniques, survival parameters of
the pathogens themselves in the fish, particularly after harvest, and pathogen inactivation.
113. Now I would think that there is a real need for risk assessment in aquatic animal health but this is
already leading to a parallel need for basic epidemiol ogical studies to be carried out to support the data
gaps, if you like. I personally ha ve not known this situation before as a scientist because, what normally
happens in this sort of situation, is you generate da ta through research projects which then lead to a need
for something else, like risk assessment. This has been driven the other way around, it is coming down
from the top and it is being led by agreements such as the SPS Agreement, in my opinion, which says you
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must use this technique. It is new, it is evolving okay, but at the end of the day it is pointing out where the
data gaps are occurring and that is something which David Burmaster has just eluded to. I think that also
one of the most important things at the moment for ri sk assessment is that it can drive research projects
because it does show you where the missing information is. But at the same time sometimes we do seem
to be standing on thin ice because we are looking for information, some of which is there, but most of the
time it is not there. Where the information is not there, there is a need for expert opinion. I think this has
not yet been addressed sufficiently in aquatic animal health. Nobody has actually got experts together
other than in this sort of forum, where they can actually give their opinion about missing data. In risk
assessment and statistical terms this is acceptable for supporting risk analysis. The beauty of the technique
is that the experts do not need to agree either, in fact it is probably better if they do not agree, because you
end up then with a range of probability, a range of distribution, a probability distribution - Dr. X would say
"there is a one in a million chance of that happenin g" and Dr. Y will say "no it could happen tomorrow".
That is useful and I do not believe that it has yet been done for aquatic animal health. I have no further
comments to make on that.
Chairman
114. Thank you very much. Can I ask ... any further questions or comments for the experts? Australia.
Australia (Mr. Ric Wells)
115. Thank you Mr. Chairman. Yes we do have some questions for the experts, I wonder however,
whether we could have the indulgence of five minutes among ourselves just before we ask those
questions?
Chairman
116. We will have five minutes in that case.
[Break]
Chairman
117. If we can now resume, perhaps I can put the question to Australia again if they have any further
questions or comments for the experts please feel free to give them now. Australia you have the floor, Mr.
Wells.
Australia (Mr. Ric Wells)
118. Mr. Chairman, I will ask Dr . Gardner Murray, the Australian chief veterinary officer to ask
questions. Thank you.
Australia (Mr. Gardner Murray)
119. Thank you Mr. Chairman, I am Gardner Murray, Australia, despite the Scottish accent. We have a
number of questions. I suppose the first question I would like to pose relates to consequences. I think only
one of the experts talked about consequences this morn ing, the potential consequences of irreversibility of
disease, should enter Australia. My question is this: how can one best resolve the issue of the low
probability of establishment of a disease with the high socio-economic consequences that could result
should such a disease enter a country? Because this is the point that is made in the Australian submission,
low probability but very high consequence. Thank you.
Chairman
120. Thank you. Is that addressed to all the experts or to anyone in particular? Dr. Burmaster.
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Dr. Burmaster
121. Well, perhaps I can shed some light on that, certainly that is a key issue in this dispute between the
two countries, but it is a common feature of many, many, many risk assessments. For example, people do
risk assessments of large earthqua kes in Los Angeles, California, in the United States. Now if a low
probability earthquake occurs in Los Angeles, Californi a, there could be hundreds or thousands of deaths
along with property damage valued in the hundreds of millions of dollars or more. So this is not the first
time, I do not want to be deflected into thinking that this is the first time that anyone, anywhere has ever
thought about low probability high consequence events. It is a very standard question that occurs many
times in many risk assessments and I will stop there for the moment.
Chairman
122. Thank you. Other responses? Dr. Rodgers.
Dr. Rodgers
123. Yes, the only thing I would say in answer to that is that you can reduce the low probability to an
even lower risk, if you like, by addressing certain risk reduction factors, as I mentioned this morning.
Providing those risk reduction factors were agreed to by both parties, I do not see that there would be a
problem. Obviously you do need to consider the high consequences of disease introduction although even
that may not reduce the level of risk to an acceptable level for Australia in this case.
Chairman
124. Dr. Burmaster.
Dr. Burmaster
125. Yes, I guess I can go back to it now and say that it is precisely in the situations of low probability
and high consequences where numbers help. If we thought that an even might recur in hydrology, with
floods and so on, people talk about storms of a certain magnitude, and they talk about a storm that may
recur every hundred year, a storm so large that a st orm of comparable size might occur only once every
hundred year on average, or once every five hundred years, or once every ten thousand years, different
sizes of floods. It is important to begin to talk about those numerically, rather than just saying "well it is a
big flood". Different people have completely different interpretations of what "big" means, there is no
common definition. I think if you posed to people in this room "what is a low probability?" we would
have no agreement here in this room, even amongst the Australian delegation, or just amongst the
Canadian delegation. If I describe something as a low and each of you wrote down on a piece of paper
what you think that might be, there would be orders of magnitude, differences of opinion here. I am using
one word, I am saying "low probability", yet amongst the audience here today, there would be orders of
magnitude, differences of opinion as to what that word meant in that context on the spoken day. So
without numbers we are engaged in an exercise that cannot converge. The English language was not
designed to handle this, but mathematics was designed to handle this kind of question. It gives us the tools
that we need to try to resolve this kind of dispute and to find out what we know and to find out what we do
not know. What we know is important, what we do no t know is important. Both of those have to be
brought up in a way where we can talk about them and understand what each other means. Thank you.
Chairman
126. Thank you very much. Dr. Wooldridge.
Dr. Wooldridge
127. Yes, I think I am more or less concurring with what Dave Burmaster says here but I will just go
through it and put it the way I see it. I think what we need to do is decide first what we are talking about in
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terms of consequences and work through similarly to hazard identification listing each of the consequences
about which we are worried. These can be simple consequences or very complex consequences. For
example, we are talking about the pr obability of the import of disease, and that is perhaps the simplest
consequence that we can envisage in this case. So importing disease is a consequence. We then might
think about another consequence perhaps, whether one consequence is an epidemic of that disease. Now
the import of disease may or may not lead to an epidem ic of that disease. So there are various different
consequences resultant upon the previous consequence, some of which may happen, some of which may
not, and if you are talking about a quantitative model you can actually model that as the next part in your
model pathway, so you can work out the probability of the import of disease, then you can work out the
probability of an epidemic of that disease in a given sp ecies or in all species or whatever you are interested
in. You may also have on your list of consequences that you are worried about and that you have
categorized, the loss of a certain amount of economic good in some way. I am not an economist and I do
not plan to try and describe this in any more detail - I have just written down loss of X pounds of money
due to this epidemic occurring. You can in fact add that onto your model and work out the probability of
that given loss, albeit all these probabilities will probably have very wide uncertainty limits on them.
128. So quantitatively, with each of your high impact consequences, you can work out your probability
of it happening. You have assessed that risk, you have assessed the loss of that amount of money. What
you then got, assuming everybody agrees with the methodology and that is the probability of loss of that
amount of money or the probability of that epidemic occurring or whatever - you have then got a risk
management decision, "is that acceptable?" This is quite different from your risk assessment. You have
actually included your high impact consequences in your risk assessment by calculating this probability of
each happening. So then, ar e we prepared to accept th is probability of this epidemic happening? Are we
prepared to accept these particular se ries of consequences? That is very difficult to make a decision on but
one potential way is actually to do something similar to a risk assessment, but a cost benefit analysis. That
can also be done quantitatively if you are actually in a position where you have something which has a low
probability of happening, you can actually look at the benefits that might accrue by letting the process go
ahead and then compare the two - as I say, a cost benefit analysis, which can be done in a similar
methodological way to a risk assessment in that you can put uncertainties into your benefits as well as your
potential for disease importation. So that is perhaps the most straightforward way I can see of actually
judging this particular kind of problem. But I accept it is a difficult problem and of course different people
from different areas with different backgrounds and di fferent perceptions, and different cultures will view
different risks in a di fferent way with regard to th eir acceptability all over the world. So as I say, I would
recommend something along the lines of a cost benefit analysis, which again is lengthy and difficult and
time consuming but there we are.
Chairman
129. Thank you very much. Dr. Winton?
Dr. Winton
130. Just maybe a brief comment, Dr. Murray is certa inly correct in that the consequences of certain
introductions of certain diseases can be quite high in some cases but certainly not all cases. The range can
be from nearly not effect or to a manageable leve l. For example when VHS virus was introduced by,
presumably, uneviscerated marine fish into turbot culture in the UK, United Kingdom lost its VHS free
status, but that disease was able to be quarantined and was eradicated and the UK has now regained its
status as a VHS free zone. So, while there was potent ially a very large impact, that impact was contained
and managed. Certainly Australia has seen in wild fish, the impact of an introduction for example in the
Pilchard mortality which I think by most agreement is probably the largest fish kill ever recorded on the
planet occurred in a wild fish. Once a disease is introduced into wild stock it becomes much more difficult
to eradicate. In the case of whirling disease in th e United States, is an exam ple, where introduced from
Europe, this disease has proven virtually impossible to eradicate from large areas due to its presence in
wild fish.
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131. The consequences can also range from biological which may be losses of natural stocks of fish to
economic, which are generally those in aquaculture. So I certainly support Dr. Wooldridge's contention
that a risk assessment can also include, for exampl e, those range of consequences and perhaps try to
quantify those.
132. Earlier, Mr. Wells talked about Furunculosis as an example of a disease that is not on the OIE
notifiable list presumably because it is broad spread. It is also because that disease is manageable in
context of aquaculture now through th e use of therapeutents or vaccines to an extent that makes it of less
concern to the aquaculture industry. Australia also has a strain of Furunculosis that is certainly not virulent
in its own right, and so Furunculosis is certainly an example of a disease which might be more concern in
certain areas or less in others, but I do not think that it s absence in Australia, and its presence in other parts
of the world, argues that it could be used for example as a special case. I think there are a lot of cases of
diseases that are either present in other areas in the world, or even strains of diseases which are already
present in Australia that might be significant in some ways. So both the range of probability of import go
from nearly zero to very high, but the consequences also can go from very minor to relatively high
depending on where it is introduced and what pathogen into what species of fish. It is virtually impossible
for the OIE Fish Diseases Commission or perhaps any group of experts to foresee all of these various
permutations. That is where I think the strength of these risk assessments comes in, in that you can then
begin to then estimate those probabilities and those consequences in a more quantitative manner that can
be discussed more clearly. Thank you.
Chairman
133. Thank you. Well that is the responses to the Australian question. It is now five minutes to one
and this is probably a good moment to break for lunch. But before I actually adjourn, can I ask if there are
further questions coming from the parties? Certainly from Australia, Canada too perhaps.
Canada (Ms. Valery Hughes)
134. Not at this time.
Chairman
135. So there will be further questions coming from Australia this afternoon. Well lets resume at
three o'clock in this room, we have this room at - Mr. Wells.
Australia (Dr. Gardner Murray)
136. Mr. Chairman, Gardner Murray, I do not have a question at this point but I would just like to make
an observation on one of Dr. Winton's comments. That was in relation to Pilchard mortalities. It is our
view and also the view of New Zealand that in fact the causual organism Herpesvirus is endemic to
Oceania, and we could find no relationship between the importation of feed st uff and the event, in
particular, as it started first in New Zealand. But that is an opinion that we have and others have different
views of course. Thank you.
Chairman
137. Dr. Winton.
Dr. Winton
138. Yes, I appreciate that clarification and I think earlier I had mentioned that while scientifically
Koch's Postulates had not been fulfilled and I do not think that epizootic is clearly understood, I appreciate
that clarification and perhaps it is not a very good example of an imported disease in that case if that is in
fact the case. I do not know, is ther e an explanation for the sudden appearance of such a large loss, is it an
environmental issue in addition then? What is the other explanation?
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Australia (Dr. Gardner Murray)
139. The explanation, and they come in large part from New Zealand as well as Australia, is that the
virus in question, Herpesvirus occurs in Pilchards but when stressed disease can manifest. The stressors in
this case appear to have been a sudden drop in te mperature, Pilchards are very sensitive to sudden
temperature drops, plus probable physiological changes, hormonal changes at that time of the year. That is
the explanation of stressors. Thank you.
Chairman
140. Can I just clarify, is that the only remaining question from Australia or are there going to be
others? There are going to be others. So lets resume at three o'clock in this room and we will take the
further questions at that time. Before we leave the room, the Panel does have questions which will be
putting in later to the experts. We will circulate those in writing right now, so before you depart, if you
would like to pick up a copy of that. It will be available in about five minutes time, we are just going to
finalize the questions.
Chairman
141. Let me start by inviting Australia to continue. Australia you have the floor.
Australia (Dr. Gardner Murray)
142. Thank you Mr. Chairman, Gardner Murray. Now this first question is to those experts who care to
answer: To the best of your knowledge, is it the exception or the norm for countries to base their import
policies on purely quantitative risk assessments?
Chairman
143. Dr. Wooldridge.
Dr. Wooldridge
144. I think at the moment it is probably still the exception but I think there are quite a lot of us who
think that it is probably the way forward that things are going to go.
Chairman
145. Any other, Dr. Burmaster.
Dr. Burmaster
146. Well I guess I do not know the worldwide answer, but it certainly is the way for the future and this
is how these kinds of disputes and disagreements will be settled, I think starting in the last year of two and
proceeding into the future.
Dr. Rodgers
147. If I can only say that I agree with Marion, since I do not think there are too many examples of any
legislation in aquatic animal health being based on a quantitative risk assessment exercise or any risk
assessment exercise. I am thinking in particular of the EU directives which now govern the movements of
fish into and out of the Community and I think that was done simply by negotiation, based on expertise
rather than a fully functioning risk assessment exercise.
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Chairman
148. Thank you. Next question.
Australia (Dr. Gardner Murray)
149. Thank you Mr. Chairman. This again deals with quantitative risk assessment: Assuming one has
conducted a quantitative risk assessment, is it not then still a matter of judgement as to how this relates to a
country's acceptable level of protection?
Chairman
150. Dr. Wooldridge.
Dr. Wooldridge
151. Yes.
Chairman
152. Dr. Burmaster.
Dr. Burmaster
153. Well, I will say yes also, with the 'but'. I guess I will take my examples from another area where
risk assessment is performed, and this might be with pesticides residues in foods - not the topic of
discussion here. The notion of risk assessment is partly comparative in nature: you want to compare the
risks of one activity compared to a different activity, and if a risk assessment finds, or as the fields develop
and it is found, that there is great differentials in two different activities that result in two different levels of
risk, that is an insight, that is what we are thinking about and trying to understand how that differential
arose - is it really intended? Do people wish to mainta in that differential policy? Or is there some desire
upon viewing this differential to change policies and practices to bring the two risks to be more
commensurate - by either raising one risk or lowering another risk? So the purpose of risk assessment is
partly specific and partly general.
Chairman
154. Thank you. I think that is the response unless anybody wants to say anything more to that. Thank
you.
Australia (Dr. Gardner Murray)
155. As far as Australia is concerned, we contend we have conducted a probability risk assessment.
But having said that, how can one distinguish between a low probability and a possibility? Is not assessing
risk as low or small a statement of probability?
Chairman
156. Dr. Burmaster.
Dr. Burmaster
157. Well it is a statement in the English language to say that something is a small probability. But
again I would go back to the example I raised this morning, if we were to conduct a quiz in this room, and
I said: I am thinking of a certain activity that has associated with a low probability; and then I asked each
of you to write down on a card what you do you think Dr. Burmaster might be thinking of? What could
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possibly constitute a low probability? I think we would get back answers ranging over several orders of
magnitude, such that in my view, let me just continue on that thing, I think that therefore the phrase, low
probability is essentially meaningless, it has no meaning. It has no consistently agreed upon meaning even
in this room, even in a ten minute interval. By the time you step outside of this room, and by the time you
step into different times and locals and different pl aces and speak with different people, many of whom
may not have any education beyond high school, and so on, that the word "low probability" becomes a
meaningless phrase. It is an absolutely meaningless ph rase. So if we wish to proceed, if you wish to do
something that is rational, if that is your goal, if your goal is to do something rational - maybe it is not - but
if your goal is to do something rational, I think you have to attach numbers or ranges of numbers or
probability distributions in order to make any kind of sensible discussion.
Chairman
158. Thank you. Dr. Wooldridge.
Dr. Wooldridge
159. I think I more or less agree with Dr. Burmaster. It is a problem and I think partly it is a pragmatic
problem in that if you, theoretically I think, if you are talking about the pathway for a given disease to get
into a particular country, you can always sort out a pathway which makes that possible. You can always
make the most unlikely, and therefore improbable assumptions, about a given part of that pathway to say
something is possible. But from the point of view of actually doing a risk assessment on whether
something really will get in, and if you have come up with the answer that you say it is a low probability,
obviously, you are also saying it is a possibility. If you say something is a possibility, you are not
necessarily saying it is a low prob ability, you could also be saying it is high probability or any other
probability. I mean, if you look up the words in the English language, they are different in meaning, but
from the point of view of really being helpful to distinguish in terms of a risk analysis or risk assessment, I
think it is a pragmatic thing; if you have come to the conclusion that you have something that you are
calling a low probability, and you need to go on from there, I think the only way you can advance, if
somebody is not happy with that, and is not prepared to accept that as is, is to try and make it into a
quantitative assessment. So in the end, what one is saying I feel, in my own opinion, if you left in that
position that you have a dispute over what "low pr obability" or "negligible probability" actually means,
you have got to go down the quantitative road, that is my opinion.
Chairman
160. Dr. Burmaster.
Dr. Burmaster
161. If I could pick up on further elaboration of the problems with not just the English language, this
language is not unique, the semantic problems are not unique to English, I would imagine that they occur
in French and in Spanish and in many other languages as well - the problem is even more profound. The
problem, - one of the things scientists like to be able to do, the first most elementary scientific activity in
risk assessment is trying to rank two things, you have two alternatives, and you are simply trying to say
which is more likely to occur, and which is less likely to occur. You just want to be able to take two things
and compare them without attaching an absolute magnitude to their occurrence, you are simply trying to
rank and say "this one I think is more likely", "I think it is more likely today that the sun will set". I do, I
believe it is more likely today that the sun will set, that than we are going to be struck with an earthquake
in the next ten minutes and we are all going to spend the afternoon in the lake. Now, both of those are
possibilities. It is possible today that the sun could set, that is a possibility. It is also possible that we
could have an earthquake in the next ten minutes and we could all be swimming for our lives out of the
lake, those are both possibilities. I happen to believe that it is more likely - the ranking - it is more likely
the sun is going to set and less likely that we are going to swim out of the lake together. But that is my
own personal ranking, some of you may have different rankings on those two possibilities. The problem
with English is that if I say, event A (skip those two examples), if I say one activity I personally rank is "a
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low probability" and another situation I rank is "unlikely". You do not have any way to compare those.
You do not know which I am thinking of is the greater probability and which is the lesser. The semantic
problems are severe. The only way out, I maintain, of this semantic debacle is to start to attach numbers or
probabilities or probability distributions to those things. Then we can have a consistent conversation. If
we cannot have a consistent conversation, we are just running in circles.
Chairman
162. Thank you. Dr. Rodgers.
Dr. Rodgers
163. Thank you Dr. Wooldridge and Dr. Burmaster because really effectively you have just answered
question 2, which is exactly what I wanted to say, but they have done it for me. You can get confused with
terminology, since there is always a possibility of something happening, but if you can attach a probability
to it, it is more understandable. I did not mean to confuse the Panel in any way in my written answers.
What I would say only, I would add, is that even with a probability distribution, or an estimation, you still
have to backtrack and attach a textual phrase, if you like, to qualify that statement for the non-experts.
Because at the end of the day, a zero point thirteen noughts one probability, is something which most
people cannot understand - it is just not something they can tangibly get hold of. So you still have to use
phraseology such a "negligible risk" or "low" or "high" or whatever the terminology. That was all I had to
say.
Chairman
164. Thank you. So you have helped to shorten our subsequent process. Any further questions from
Australia.
Australia (Dr. Gardner Murray)
165. Yes. What we were just discussing, and I apologize, what we should follow-up on some of the
answers given. I suppose there are many lines we could take. The fact that using, for example the term
"low probability" is meaningless - in fact most countries in the world deal in these kind of terms, really. It
does not all look very well, in some ways, for practices in place. But a question I would like to ask, and
this is dealing with acceptable risk of quarantines, or acceptable level of protection, and I think I know the
answers, but, - is it the exception or the norm to express acceptable risk and quantitative terms?
Chairman
166. Dr. Burmaster.
Dr. Burmaster
167. In my experience, practising risk assessment in the United States as I do, I have not seen, - How
do I express this? I have only seen quantitative risk assessments done. So I was quite surprised when I
first was asked to join this Panel and read through the background materials. I was really taken by surprise
that the, in my view, that the materials prepared had all been qualitative. That struck me as highly unusual.
Chairman
168. Dr. Wooldridge.
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Dr. Wooldridge
169. The answer is, I think is, sort of again I would agree with Dr. Burmaster, - in some fields I think it
usual to actually look at the quantitative risk and decide whether that is acceptable or not. Some of those
are not fields with which I am particularly familiar, but I mean, for the agricultural import exports,
veterinary kind of field, which I am more familiar, I think up until now or up until very recently, an
acceptable risk has much more often been by negotiation on words than actually mathematical numbers
and an agreement on those. Again I would go back to a comment I made earlier, that I think things are
beginning to change, and I think it would make for clearer basis for negotiation and challenge and/or
agreement or disagreement if one did have a numerical value to work around. Because you could get your
numerical value, you could agree or disagree that the method had been done correctly, and if you
disagreed, one could go back and look at the individual parts of the model and agree it. Then we would all
be talking about the same thing: "yes we agree this is the assessed risk", "we do not actually find that
acceptable" or "we agree it is the assessed risk, we do find that acceptable". I think that would make a part
of the negotiation process much easier. But it would not give you an answer as to whether it was
acceptable or not, as we have said before.
Chairman
170. Thank you. Australia.
Australia (Dr. Gardner Murray)
171. Thank you. This is again a question to an y expert who may care to answer: Transmission of
disease through product for human consumption is well known for many terrestrial animal diseases. Do
you think that there is a scientific reason to assume that this could not occur in aquatic animals?
Chairman
172. Dr. Rodgers.
Dr. Rodgers
173. You are talking about a human disease or an animal disease? An animal disease. Because
certainly Cholera is one disease which is possible to be transmitted from fish to humans, but I am not
familiar with the terrestrial side. Sorry I was thinking out loud.
Chairman
174. Dr. Wooldridge, would you like to carry on from that.
Dr. Wooldridge
175. A quick comment. I think, in terms of risk assessment, when one is actually starting out on this
process, in part of this hazard identification step of this, you need to consider whether these are possibly
transmitted diseases through the product for human consumption. As I said before, I think you can put
together a number of pathways that show the possibility of that happening. Whether there is any scientific
evidence to say whether that would or would not happen, would depend partly on the available state of
evidence, but also if it had been shown to have happened in a particular instance, there you have got your
evidence. If not, then if you actually did follow your pathways through and had done a quantitative
assessment, again you would come up with a probability of that happening, albeit that if your data was not
very full, it would be a probability with very wide uncertainties.
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Chairman
176. Thank you. Dr. Burmaster.
Dr. Burmaster
177. I guess, at the most general level I work in a profession where - this sounds like a contradiction in
terms - but there is no such thing as a zero probability . There is always a risk of something. There is
always some - even for rare events - there is some small, finite probability greater than zero, that the
undesirable consequence might occur. For example, in under the laws of statistical physics (this example
has been around for fifty years and it is in many textbo oks), there is a small chance that all of us in this
room are going to suffocate to death in the next minute. How could this occur? How can we start to
discuss it? Well, through the statistical mechanics of the air molecules and the oxygen and nitrogen
molecules that are in this room right now, there is a small chance greater than zero that all of those
molecules are going to end up in that corner of the r oom sometime in the next minute and stay there for a
long enough time, just a normal fluctuation, that we will all die. Is there a zero probability of that? No.
Well, how big is the probability? It is kind of small, it is probably so small that we would have a hard time
in calculating it. But it is not zero. So back to this question: "is there a chance that some disease might be
introduced from country Number One into country Number Two?" Can we rule it out and say that there is
a zero probability? No. We can never say there is a zero probability. But it might be small, it might be
large, we have to do the numbers to find out.
Chairman
178. Dr. Winton.
Dr. Winton
179. Probability and numbers aside, and I have specifically tried to stay away from this, and if you saw
my scores in mathematics as a graduate student you would understand why. From a more fish disease
perspective, the answer and it is largely opinion, is that probability is relative to other sources of
introduction of fish diseases in the case aquatic diseas es, is relatively low with human products. You are
correct that in the case of [hams ?] for example and Foot and Mouth Disease, and other products, African
Swine Fever - there have been estimates that those contain risk; that products for human consumption do
carry risks of animal diseases. But there is such a large body of scientific evidence associating movements
of live fish and eggs with diseases, and the absence of scientific data associating any other products for
human consumption that the preponderance of data seem to be that the risk is quite low. In addition, as I
said in my comments, there are some unpublished studies of people who have actively looked for diseases
in products destined for human consumption and been unable to find them, at least using standard
methods. I do not think anyone would say it cannot happen, but at least I think it is my view, that
probability is quite low relative to perhaps other sources of risk - those might be ships or tourists or other
import products, all of which are not a zero risk opti on. Until proven otherwise, I think, the risk is
estimated to be quite low.
Chairman
180. Australia.
Australia (Dr. Gardner Murray)
181. Thank you. I think the answers to that question more or less indicate that in fact salmonid product
could contain exotic agents, in terms of product. On relative terms, as Dr. Winton said, well, gametes and
all the rest pose greater risk, but, nevertheless, it can happen. But just to follow on from that, Mr.
Chairman, I have got a fairly long kind of list of questions here, and, please accept my apologies, but it
kind of deals a bit with the absence of evidence issue that you raised. What does a country do if there is no
evidence? Does it wait until the problem happens - and then says "Oh, Hallelujah, we have got evidence
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now!", or does it take action, the Australia approach? I apologize if I am long and convoluted today, if I
could get some sort of answers I would appreciate it. Given the high cost of investigating disease
outbreaks, in cases where the cause is not immediately apparent, determining the cause of an outbreak may
be a low priority compared to implementing disease co ntrol measures. In countries where many or all of
the diseases of concern occur endemically, it is likely that the cause of all new outbreaks of any of these
endemic diseases would be investigated with sufficient thoroughness to determine the origin. Could
outbreaks of endemic disease cause by products imported for human consumption occur and not be
recognized? Could outbreaks of endemic diseases caused by newly introduced strains occur and not be
recognized?
Chairman
182. Dr. Winton.
Dr. Winton
183. Certainly it is possible that it would be difficult or impossible to see very low level of
introductions in the background of a number of cases. Your are correct, some of these are expensive to
investigate. In a few cases, some investigations have been undertaken and our laboratories, using some
molecular tools now to begin to trace some of the epidemiology of some outbreaks. This kind of approach
I think will help in this regard, but yes, I do not think anyone would say, "no, of all of the cases of
Furunculosis in North America, could some of those actually have come by imported Atlantic salmon from
Norway and not be an endemic disease problem?" We would not know that. So your assumption is
correct. However, unusual outbreaks, for example, wh en viral haemorrhagic se pticaemia was first found
in North America, tremendous amount of effort went into that. In our laboratory, we investigated those
strains at the molecular level, we have since developed ways to identify those strains uniquely, and we now
have a surveillance mechanism in place to be able to differentiate between a European strain and a North
American. So at least for this particular disease and in this particular case, such work was done and we
know that all of the isolation of VHS in North America, every single one has been typed in our laboratory
and they are all of North American origin. So, in some cases we know that. But in the background of
large numbers of cases, no, we would not - or for lower priority conditions.
Chairman
184. Thank you very much. Dr. Wooldridge.
Dr. Wooldridge
185. Just another very quick comment about a completely different disease. I can say from personal
experience of attempting to differentiate between the va rious different sources of a particular disease with
similar clinical and pathological manifestations, that actually, even when you know what different sources
you are looking for, it can be actually very difficult to decide whether you have got a different disease
from a different source or whether it is another endemic outbreak. Nothing to do with fish, in that
particular practical instance I am talking about.
Chairman
186. Thank you. Dr. Rodgers.
Dr. Rodgers
187. I would just like to echo what Jim Winton said. I would just like to add also that it is very much
easier to characterise and identify di sease causal agent in a clinical outbreak than it would be in, for
instance, a routine monitoring programme. When you are doing routine monitoring, unless you are
selecting fish, in this case which are diseased looking or sick or dying, to actually weight your sample
towards finding something, then you are really looking at the limits of your detection tests, which is
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something I have mentioned this morning. Routine monitoring nearly always brings you around to a
negative result, if you like, but based on the limits of the detection tests.
Chairman
188. Thank you very much. Dr. Winton.
Dr. Winton
189. Maybe one additional comment too, that in the face of this is a compounding factor as well. At
some point today I wanted to mention this and this is as good a time as any. That is as detection methods
improve there always appear now to be cases that you have missed before or low level sub-clinical carriers
and disease agents, not all of those of course are intr oductions but they are first-findings. I think in many
times we have difficulty even distinguishing between what is in fact an introduction and what is in fact a
discovery because of improved methods in diagnostic methodology. Many times the first case of a disease
in a country is assumed at first to be an import until proven otherwise. But I think that we have some
experience now suggesting that many of these are simply better detection methods and more observation.
In the case of Canada and Australia, the distributions of all of the diseases that have even been mentioned,
I do not think are know with certainty at this partic ular instance. That will become more clear over the
next decade of centuries.
Chairman
190. Thank you. While you have got the floor, Dr. Winton, I wonder if could just help the Panel by
explaining what the term "gametes" means. We have h eard it used a couple of times but we are not very
clear on what it is.
Dr. Winton
191. Gametes, are the sperm or e ggs and they are often imported separately to fertilize eggs in a
country or to use just the eggs or just the sperm as opposed to eggs or fertilized eggs, which is the other
term. Gametes would simply be the seed stock. Many pathogens, particularly viral pathogens and a
couple of bacteria can be transmitted with gametes themselves as they can with fertilized eggs or live fish.
Chairman
192. Thank you for that clarification. Dr. Rodgers.
Dr. Rodgers
193. Yes, I would just like to make one comment, not on gametes, but following on from disease
identification and characterization. I do not know, perhaps Jim can correct me if I am wrong, but I do not
know of any national legislation anywhere that would, on the finding of a disease causal agent, unless that
disease causal agent was isolated and fulfilled Koch's Postulates you would not act, for instance, on a
molecular technique which pointed to the fact that you had detected VHS but that you could not isolate it
in culture. I think most monitoring programmes and most national legislation is based on the
understanding that to take action you must actually isolate the organism itself.
Chairman
194. Dr. Winton.
Dr. Winton
195. I think that is generally true and I think that is going to run into some problems as some of the
molecular techniques are more wildly adopted because we now have techniques that, as you say, can find
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evidence of agents in the absence of the infectious dose or even sometimes viable agents themselves, just
genomes or killed organisms. So this is going to be a problem but not just obviously in fish.
Chairman
196. Australia.
Australia (Dr. Gardner Murray)
197. Just on that last comment. There are occa sions and circumstances in Australia where we might
take action without insolating the organism, particularly in emergency situations.
Chairman
198. Before you go on to another subject, would Canada like to come in on that point?
Canada (Ms. Valery Hughes)
199. I am certainly not going to comment on the science. I wonder if I just might seek a clarification as
the questions are piling up and as they seem to be getting longer it is more and more difficult for us to
follow them and I wondered if we could have a copy of those questions. It would certainly facilitate things
for us.
Australia (Dr. Gardner Murray)
200. Yes, well the good news is there are only two questions to go. I suppose the bad news is that they
are both fairly long, so I apologize. We had to make a number of modifications to these questions over
lunch which is why did not have a chance to type them up and give them to you. I apologize.
201. The second last question is to Dr. Winton, and I think you have covered it a bit this morning, but I
would just like a bit more clarification. Dr. Winton , you have stated that the Fish Diseases Commission
was unanimous in its belief that evisceration is an effective measure to reduce greatly the risk of
transmission of notifiable diseases. What are your views on the efficacy of evisceration as a measure with
respect to the other significant diseases such as epizootic ulcerative syndrome and viral encephalopathy
and retinopathy. Does this apply in the case of fish harvested from emergency slaughter, that is
evisceration? Or would evisceration of Canadian salmon result in an equal degree of reduction of
infectivity for all of the pathogens identified in the Final Report?
Chairman
202. Dr. Winton.
Dr. Winton
203. Well that is a difficult question. I think first of all, I should say that it is not entirely correct to say
that the Fish Diseases Commission felt that evisceration would, per se, reduce Notifiable Diseases and was
therefore somehow thought to be a measure that was recommended. To a large extent, and I think that it is
important to clarify, the Fish Diseases Commission wa s unanimous in its feeling that eviscerated products,
by themselves, represented a low enough risk that they were not really within the purview of the Fish
Diseases Commission to consider. We were more concerned with the aquaculture products, and
particularly live fish and eggs moving international shipment. As several countries have done, there was a
presumption that if the product was eviscerated, wh ether it came from a wild source or even from an
aquaculture facility - even from an aquaculture fac ility at which a disease outbreak was occurring - that
evisceration removed that product from the purview of the OIE recommendations. So we do not
necessarily have an opinion, per se, about evisceration other than the fact that it seemed to reduce the risk
significantly such that it was no longer of interest to us at that particular point. If the scientific evidence is
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such that eviscerated products are a risk, then pe rhaps, we would reverse that opinion. We have
considered for example, uneviscerated bait fish and wh ether or not we should include these as a source of
discussion, but we currently do not discuss them either.
204. In addition to saying that evisceration of fish was thought to reduce notifiable diseases, you are
correct that evisceration would probably be more effective for some diseases than others. More stable
agents, and particularly agents that might be found in the flesh of the animal, as opposed to viscera, might
well be expected to survive longer in such product and therefore perhaps be of slightly higher risk. We are
not able to carry out such an analysis because we do not have the survival curves of all of the potential
pathogens in such products. But I think it is safe to say that for both the Notifiable and the Other Diseases,
we assume that evisceration significantly reduced the risk to a level that we no longer were concerned
about.
Chairman
205. Thank you. Dr. Murray.
Australia (Dr. Gardner Murray)
206. One final question to Dr. Winton. Dr. Winton, is it anomalous that a disease occurring in the
Southern Hemisphere, EHN, is made notifiable, but one occurring exclusively in the Northern Hemisphere,
for example ISA, is not - especially when the later is much more devastating then the former? What
implication does this have for the application of the Code?
Chairman
207. Dr. Winton.
Dr. Winton
208. Well, you raise a point that has behind it a suggestion that somehow Australia is being treated
unfairly in the case of EHN versus ISA. Diseases ar e so called listed diseases by the Fish Diseases
Commission not only on the basis of their geographic distribution. In the case of ISA it is now know to be
confined to Norway and to Canada. EHN, initially, was believed to be only in Australia. But the second
thing and third things that we consider are how treatab le they are. In this case neither one is treatable
being viral. The last thing is how robust are the diag nostic and certification methods. In the case of EHN,
good, robust cell culture detection in serological identification were in place, such that you could in fact
certify a population of fish as free of EHN virus such that it could be moved. That was not the case of ISA
for which, until the last month or so, no standard diagnostic method had been available, except clinical
signs. It was impossible, literally, to certify a population as free of ISA.
209. Now the Fish Diseases Commission may well, based on the findings of ISA in Canada and the
now improved diagnostic methods, including a cell line which will replicate the virus and a molecular
method - may well choose to add ISA. The second point is that EHN is now seen as part of a much larger
pool of iridoviruses of fish. Our biggest problem on the Fish Diseases Commission in the next year is how
to define this group. I can almost guarantee you that this group will expand from being simply an
iridovirus in Australia, primarily of Redfin Perch to a pool of viruses, and the noda virus in the marine
environment are going to represent the same difficulty. It is a pool of strains of very closely related viruses
which can have devastating effects for which there is a limited geographic distribution but a fairly wide
species distribution. We are going to have some troubles trying to decide how to define this new thing. I
have asked for example, Dr. Ron Hedrick (on the Fish Disease Commission) to help us define these
iridoviruses of fish. It is as you said, a work in progress and we will make some adjustments accordingly.
But I would say, and you only have to believe me on this, I guess, but there is no bias against the situation
in Australia regards to ISA versus EHN virus.
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Chairman
210. Just for the benefit of the Panel, I wonder if you could just clarify what EHN and ISA are.
Dr. Winton
211. Ok, is an iridoviral disease, initially found in Redfin Perch and we have experts here that can tell
us a lot more about it than I can. It was formally thought to be confined to mainland Australia, and it now
appears related to a series of viruses from Sheatfish and Catfish in Europe and the United States, that are
very difficult to differentiate from each other, and are somewhat related to a frog virus and amphibian
virus, and this particular disease, so called Epiz ootic Haemorrhagic Necrosis was first described in
Australia. ISA, Infectious salmonid anaemia was first described in Norway, and that is now know to be
caused by an orthomyxovirus.
Chairman
212. Thank you very much, sorry for that diversion. Another question?
Australia (Dr. Gardner Murray)
213. No, I have - we have kind of finished. I would like to, in finishing, thank the experts very much
for the effort they have put into this exercise and answering my questions so frankly and honestly. Thank
you very much.
Chairman
214. Thank you very much. Can I take it that we have come to the end of the parties questions? Does
Canada have anything to add at this stage? You have the floor.
Canada (Ms. Valery Hughes)
215. Thank you Mr. Chairman, I wonder - I realise that the day is getting long - but I wonder if you
might give me five minutes just to check with the experts that I brought with me because there is of course
a lot of information that has been raised since we have returned?
Chairman
216. Ok, five minutes.
Canada (Ms. Valery Hughes)
217. Thank you.
[Break]
Chairman
218. Well thank you for observing five minutes more or less exactly. You have the floor Canada.
Canada (Ms. Valery Hughes)
219. Thank you Mr. Chairman, and thank you for giving us that time. We have no questions at this
time.
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Chairman
220. Right, well in that case that seems to bring us to the end of that stage of the meeting. Perhaps we
could now turn to the questions from the Panel * that were tabled just before lunch. I am going to ask the
experts if they would address these questions. I will give the experts the floor one-by-one and ask them to
run through the whole list. I think in the light of the discussion we have had this afternoon, that some of
them actually fall away and do not need to be addressed further; I am thinking particularly of 1, 2 and 6,
which I think we have covered. But by all means feel free to add something if you want to, but I think we
have dealt with those this afternoon. We would like to change the order to bring number 17 up to number
1, if you would. Also, I have something to add to question 15. We have had some discussion on
evisceration and we want to put a rather specific addition to that question which is as follows: What is the
effectiveness of evisceration in reducing risk from Renibacterium salmoninarum , IHNV, Salmon
leukaemia virus, and Henneguya salminicola, that is just for those four diseases - so that is an addition to
question 15. If that is clear perhaps I could start by offering the floor in alphabetical order. Perhaps start
with Dr. Burmaster, if you would be kind enough to address the questions.
[Dr. Rodgers took the floor first]
Dr. Rodgers
221. Could you clarify whether you want to run throu gh them as they are or do you want each expert to
go through all of the questions one by one.
Chairman
222. Well, I will offer floor to each expert and ask each one to run through them and address those
questions which you feel you can, - no, perhaps that is - Let us take them question-by-question. Yes,
sorry, I am confusing the issue. Let us take them question-by-question and let us start with question 1
which is now 17, renumbered 1 and on the sheet 1, 2 and 6 have disappeared.
Dr. Burmaster
223. I am, question 17 now renumbered to become Number 1. I do not fully understand the question,
so it might be better if we went in reverse alphabetical order for a moment. I am sorry.
Dr. Wooldridge
224. I have to say I think I know what the question means but I am not quite sure either. So I wonder if
it is possible to clarify the question at all.
The Secretariat (Mr. Joost Pauwelyn)
225. Well the question relates to the third requirements invoked by Canada; the idea that you should
assess the SPS measures you, upfront, want to consider. So if you think this is a requirement, do you think
it is enough to just assess each option separately? Or do you have to - once you have made such an
assessment - do you have to compare the different options? Do you have to compare and examine the
relative risks related to each of these options? And, in the end do you have to justify the option you finally
choose, as to whether this option reduces your risk appropriately?
Dr. Wooldridge
226. Starting somewhere in the middle of that question first - if you actually undertake a quantitative
risk assessment for each of the options under consideration, your answers will automatically give you a
comparison of the different options. Therefore, if you have undertaken a quantitative assessment, I think

* See Attachment of Annex 2.
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the question is redundant, or at least the central part of the question is redundant. I suspect, with regard to
giving a rational explanation as to why you have c hosen those measures, if th ey are measures that are
acceptable to whoever else is involved in the questi on under consideration, you will not need to give a
rational explanation because they will be accepted with out any explanation. If they are not accepted then
you would have to give rational explanation if you wished to persuade somebody to accept them. So again
I cannot quite see that there is a quest ion there, the answer is almost au tomatic. If there are - and I think I
have sort of answered this morning when I answered the questions that were put additionally to the original
questions - but, if there are several different options that one can undertake, then if you are going to say
that the risks are unacceptable in importing a particular product, then you do have to have looked at the
most stringent feasible combination of safeguards and concluded that the risk is still unacceptable in order
to adequately demonstrate your position in denying impor ts. Is that clear? Have I answered the question?
Well I have done my best at answering the question, anyway.
Chairman
227. That is helpful, thank you. Dr. Burmaster do you want to say something on this subject.
Dr. Burmaster
228. Well having heard that answer, I have nothing to add.
Chairman
229. Thank you. Can I just clarify whether - right, yes. Well, I think unless anybody else want to
address that question perhaps we can go on to the one that is numbered 3. Now this is primarily for Dr.
Rodgers, but it also relates to something that has come from Canada so perhaps we can start with Dr.
Rodgers.
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Dr. Rodgers
230. Yes, thank you Mr. Chairman. I did not mean to confuse anybody with my non-inclusion of the
citations from the public literature. I was, for the sake of completeness, trying to answer the question
which says "which disease agents" it does not actual ly say "which disease agents from the Australian list",
it just says "which disease agents", so I was trying to be complete. I will agree that flexibacteriosis is
probably ubiquitous as is Kudoa, and is probably not of concern. However, there are references in the
scientific literature to Kudoa appearing in Canadian salmon, whether the Canadians are aware of it or not I
do not know. There is for instance a reference by Kaba ta and Whitaker in 1989 which says that all species
of returning adult salmon in British Columbia, Pacific salmonids, except Chum salmon and Sockeye
salmon had Kudoa, isolated from cardiac muscle and I believe it was also reported at a Kudoa workshop in
Nanaimo in 1994. But, as I say, Kudoa is ubiquitous and I would agree if is probably of no concern now,
specifically as it has been taken off the list by Australia. As far as the other one is concerned -
Parvicapsula, there is a report in 1992 by Kent which says that wild Sockeye salmon, did have an isolation
of Parvicapsula and they occurred off the coast of British Columbia which I assume was in shore, I do not
know, - I assume in Canadian waters. There is a very recent publication by Kent et al in 1997 which says
that adult Sockeye salmon recently re turned to the Weaver Creek from the Pacific Ocean, have had what
has been identified as a new species of Parvicapsula, isolated from them. So there are references, as far as
I am concerned as a scientist, in the literature to both these species - both these disease causal agents
rather. But I would agree that they are not of overriding concern for us today. Does that answer the
question? I thought there was another aspect to it. Oh, PKD. PKD I believe has not been found in adult
Pacific salmon, it does occur in juveniles and with previous exposure to PKD as a juvenile, most adult
salmon would become resistant anyway to subsequent exposure. But I believe it has not been reported
from adult salmon. That is true.
Chairman
231. Thank you very much. I do not know whether Canada wants to come in on that at all. Yes,
Canada.
Canada (Ms. Valery Hughes)
232. Mr. Chairman, I would just remind the Panel that Canada has commented on this previously in the
comments filed on December 18th, and we stand by the response provided to question 2, on October the
7th. I think that Dr. Rodgers has confirmed that point. Thank you.
Chairman
233. Thank you very much. Perhaps we could now go on to question 4, I do not know whether
Dr. Rodgers, you would just like to carry on with that one.
Dr. Rodgers
234. Thank you Mr. Chairman. Ther e is a distinction here between dead fish and eviscerated fish, I
assume they are one and the same. Because a dead fish which is not eviscerated - well, in fact, a dead fish
which has been eviscerated also ha s autolytic processes which would re nder some disease agents inactive
simply because of the autolytic enzy mes which are present as an actual process of decay. Any fish which
entered the evisceration process as a carrier fish co uld still remain with some level of disease agent
depending on what that agent was, as we have alread y heard today, because the evisceration process is not
totally efficient at removing all pathogens, particularly those pathogens which occur in the kidney, for
instance. The evisceration machine (if the machine is being used) tends to leave some kidney behind in the
backbone of the fish and any viral agent, for instance, would remain also in blood - but as to how long for,
there are very few studies done on pathogen survival in eviscerated fish, so I could not say at what level
they would occur. But as we h eard from Jim Winton, evisceration is an effective way of reducing the
level, but to what level, and whether that level is acceptable, is another question completely.
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Chairman
235. Right, thank you. Dr. Winton.
Dr. Winton
236. One thing is the definitions of carriers and reservoirs. In a general sense, carriers and reservoirs
are live species, either the same or in some cases a different species, that serve to maintain those infections.
A good example might be Pacific herring which are now known to be an important reservoir and carriers
of VHS virus in North America. VHS virus has been introduced into some North American salmonids but
primarily from an enzootic pool of these carriers. A dead animal, probably more accurately comes under
the definition of a fomites, which is an inanimate object which serves as a potential source of
contamination, much as contaminated boots or other items might - the organism does not replicate in such
a state and it is really incumbent on the fomite to have been contaminated at some point and then you have
a decay curve that goes on depending on the organism, the length of time and the conditions. So a fomites
in general, or a dead fish, really is of less concer n in a way because it is not replicating the agent in an
active state or maintaining it such that it could be expected to have high level at any particular point in
time.
Chairman
237. Thank you very much. Unless there is anything else on 4 can we go on to 5. Dr. Rodgers.
Dr. Rodgers
238. Basically, yes. The salmon are quite high up the respective food chain. They would eat scraps of
salmon meat. The answer is yes.
Chairman
239. Thank you. Unless anybody else wants to say anything on that. We will skip 6, which we have
dealt with, and go strait to 7. Dr. Wooldridge.
Dr. Wooldridge
240. I gather from this question that you were not quite sure what I was trying to say in my
answer 2.4.3, is that correct?
Chairman
241. Yes, it is a clarification of that.
Dr. Wooldridge
242. On a theoretical level, the risk assessment that you wish to do depends on the risk that you wish to
assess and therefore, on a theoretical level, I have put down in my 2.4.3, two potential questions, and there
are many but I have chosen two. The first one being "what is the risk of an exotic disease being introduced
with product X", and here you are imagining a situation where somebody wishes to introduce product X
and you need to assess any risks of any diseases potentially in product X. So you need to go through a
hazard identification exercise looking at all pote ntial diseases which might be in product X, and in some
way assess the risk of each one of those being introduced with that product. However, if your initial
question is simply concerning one disease, for some reason, somebody has brought up perhaps the question
of a particular disease, then you only need to look at that disease becaus e that is the hazard that has been
identified as being the requirement that you have been given to do a risk assessment on. So that is the
theoretical background as to whether you would do a disease-by-disease or a product-by-product
assessment. It very much depends on the question you are trying to answer. But your question number 7
WT/DS/18/R

here then goes on to ask "are these two alternative models", well, the final sentence. In a real life situation,
if you are actually interested in every possible way in which exotic disease Y, might be introduced, then
you would have to consider all the products that could carry exotic disease Y. So you then you would have
your disease and your hazard identification will be saying "hazard of this disease in that product, this
disease in that product, this disease in that product". So in a practical situation you would then need to
broaden it out to look at other products. But the final analysis is that it very much depends on - the way
you approach it very much depends on what is the question you are trying to answer. Does that clarify or
not?
Chairman
243. Yes, I think that has got to the point, thank you very much. So if there is nothing further on that
one, perhaps we can go on to number 8. Dr. Rodgers.
Dr. Rodgers
244. Thank you Mr. Chairman. Basically, I cannot answer question 8 without doing a full quantitative
risk analysis. Following what you have heard this morning about terminology, would you like to qualify
what you mean by the term very small.
Chairman
245. Negligible.
Dr. Rodgers
246. I think the answer is linked to the sensitivity of your detection method. If you bear that in mind
then - yes, you cannot say that the disease will be totally absent if you have not found it, unless you have a
background database with time of regular testing, and even then, if you have never found a single fish out
of - maybe you have tested thousands - even then, you cannot say the disease is absent. That will give you
a probability - thank you, I was just about to say it - a [beta-distribution] which will indicate the level of
probability of it being absent. Perhaps Marion would like to elaborate further?
Chairman
247. Thank you. Dr. Wooldridge.
Dr. Wooldridge
248. It think yes - if you do not look for something you will probably not find it. You have a number
of different problems here. If a disease has not been found in a category of fish it might simply mean we
do not have a test that is able to find it, yet. Or it might mean that we have not actually tested any fish yet,
and, so - yes, we are talking about the numbers of fish that one has tested, we are talking about the
sensitivity of the test and if you have found no fish in a given number that you have tested then you still
have a probability because you may find in the very next fish that you test that you have actually got that
disease. You cannot - to say that it is a very small probability, well, again, you are talking about how
many you have tested. If you have tested every fish out of two and you have not found it, you are not
necessarily talking about a very sm all probability. If you have tested every fish in ten million and you
have not found it, you are probably talking about a very small probability given that you have got a test
that will pick it up.
Chairman
249. Thank you. Dr. Burmaster.
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Dr. Burmaster
250. I agree with both of the previous statements and I think it is summed up in science as saying that:
in science, one can never prove the negative. You can never prove the negative, it just cannot be done in
science.
Chairman
251. I am not quite sure how much those answers have already addressed 9 as well but perhaps we
could just have a look at that and see whether we have - Dr. Wooldridge.
Dr. Wooldridge
252. I think they have partly addressed 9, but the format of question 9 is slightly different. It is the first
sentence: "should this disease nonetheless be considered in a risk assessment of fish from this area?" I
think the answer is yes, this disease should be considered in as much as when you do a hazard
identification, which should be your first stage, you would start off with thinking about all potential
diseases that might be in that particular species of fish and then reduce it down to those - or you might then
prioritize - looking next at those diseases which had been found in that species, in that area. So you would
consider them, you would not throw them out. What you might then say is, well, if they have not been
found, given the things we have already talked about in the previous question, and if something else has
been found, then our initial risk assessment, where are perhaps going to get further details and do a
quantitative assessment perhaps needs, perhaps, to be prioritized first on the ones that have been found.
253. Given the assumption that you have got equally sensitive tests, and you might not have, and given
the assumption that you have tested an equal number of fish for both diseases, which again you might not
have, if you have found one disease and not found another, then the probability - or it is likely that you are
going to end up with higher risks overall from the one you have found. So if you wish to pursue the
quantitative argument and do a quantitative assessment based on the prevalence of the disease you actually
have found, and if you find that gives you a risk which is, when you have quantified it out, acceptably low,
then it might be considered safe to say (if you agree with the use of the word "safe"), that something with a
lower prevalence would have an even lower probabil ity of being imported, therefore that is also
acceptable. If you come to the conclusion that the disease which was found, an d therefore of probable
higher prevalence, has an unacceptably high risk, and there is no safeguard, or mitigating, or disease
reduction measures you can put in place and you are left with something that because of this disease you
found is unacceptably highly risky, then it does not really matter if the other diseases are there or not
because you are not going to have it, because it is too risky for that reason. So you consider these things
but whether in the last analysis they make a practical difference, depends on the exact circumstances, but
you might argue that actually maybe you do not need to worry too much given the proviso, you have tested
for it and you have got a sensitive test.
Chairman
254. Thank you. Anything else on that, Dr. Burmaster? No. Unless anyone else wants to add anything
on 9 lets go on to 10. I think this was mentioned as an example by one of the experts this morning. I do
not know whether you have got anything else to add on the subject of the "Vose Assessment".
Dr. Wooldridge
255. Well in broad terms this would be the kind of wa y that I would like to see any problem of this sort
tackled. I am not talking about the detail of this because I have read through it but I have not actually
committed to memory all the details - but in broad terms this is the way I would like to see any dispute of
this nature taken forward to the next step. Something along these lines that David Vose has produced. I
think it is very relevant.
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Chairman
256. Thank you. Dr. Burmaster.
Dr. Burmaster
257. Yes, I agree with Dr. Wooldridge's formulation exactly.
Chairman
258. Thank you. Unless there is anything else on that, lets go on to number 11 which is addressed to
Dr. Burmaster.
Dr. Burmaster
259. Well, I continue to agree with my previous answ er, which is yes. But I am not sure maybe there is
some semantic detail here that I am missing, but let me tell you what I am answering yes to. Let us say
there is one bacterium which is responsible for some terrible disease in some stock of fish. And let us say
that bacterium could have originated in just two places on the globe. So it might have originated in
country A or in country B. Somehow that bacterium got to country C and damaged the fish, it caused fish
disease in country C. I think from the fish's perspective, the bacterium is there in country C and it is
damaging the population of fish in country C and from the fish's point of view, the fish really do not care
whether it came from country A or country B, they are sick fish and they are not liking this experience in
any way. I am trying not to be factitious about this, but it is only the humans who really care about where
it originates. The humans care a lot about whether it came from A or B because they may want to go back
and under some trade treaty or something they may wish to collect monetary damages or something else.
But it really the phrase I am sticking here with is "regardless of imported host", and I guessed that is where
I stand. Thank you.
Chairman
260. Thank you. Question 12 is addressed to all. Dr. Winton.
Dr. Winton
261. Question 12 is a very difficult question because it might be possible, given enough information
around specific disease, to rank these relative risks. In a general sense, fish that have been inspected by a
competent inspection set procedure, and which are in a pathogen free water supply, or at least a controlled
water supply, represent a rather high level of safety. These are the areas in wh ich the OIE Fish Diseases
Commission imagines most trade would occur. In the case of these Canadian fish here, we are talking
about ocean-caught Pacific salmon which has its own suite of diseases versus freshwater-caught Pacific
salmon, which have a slightly different subset of diseases, versus cultured fish on the Pacific coast which
well be inspected but are in an uncontrolled water supply, Atlantic salmon, a different host species. So
there could be different subsets - in fact very likely there are different subsets - of pathogens in all of these
different groups. So it is difficult to rank them to sa y that they pose less of a disease risk. If these were
wild adult fish that were being moved live, then I think that you might find one set of pathogens. If they
are dead fish or eviscerated fish you might see a slightly different set of surviving pathogens. So I think
that is a very difficult question to address. But in a general sense, wild ocean-caught Pacific salmon during
their ocean phase, would be probably free of several of the disease that might be expected to be either
present in freshwater, or present at higher level if the fish were reared in captivity. So that in a general
sense, the fresh water fish and the cultured fish, provided they were in an uncontrolled water supply might
in fact be somewhat more dangerous product than a wild open ocean fish at that stage of its life. But it
really depends a lot on which diseases you are talking about.
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Chairman
262. Thank you very much. Dr. Rodgers.
Dr. Rodgers
263. I agree entirely. I would just like to add - if you have a monitoring surveillance programme in
place and you are using diagnostic tests which you have faith in, if you then had to rank the expected
ranking, if you like, for these groups of fish in increasing risk, it would be the wild ocean-caught at the
bottom, the wild fresh water migrating fish in the middle, and the cultured fish at the top (being, as Jim
pointed out, the most risky fish). But it may also be that a non-monitored wild population of fish may have
normal pathogens which we have not even found anything about yet, we have not even discovered yet
which, put into another situation, such as a cultured situation, could cause a lot of damage.
Chairman
264. Thank you. I believe Jeff, you may have a follow-up on that. Yes, perhaps the legal advisor
would like to follow up a little bit on that.
The Secretariat (Mr. Jeff Gertler)
265. Thank you Mr. Chairman. This is not directly in this question by I think it something that is of
concern to the Panel here. Could you make the same so rt of comparison of the relative disease risk of the
Canadian salmon, that is wild ocean-caught Pacific salmon, versus risk from live ornamental fish or bait
fish.
Chairman
266. Dr. Winton.
Dr. Winton
267. Again, the subsets of pathogens in these different species will be different. Ornamental fish will
have their own subset of pathogens. But in a general sense, live fish that are introduced carry probably, in
my view, the highest risk of any category. We have documented examples of ornamental fish carrying
both Notifiable Diseases of the OIE and non-notifiable other fish diseases in international trade. Second
level, might well be those fish used as bait. Again Dr. Rodgers' point is good, we may not have ever
sampled them adequately to know, but in an example from the North American coast, for example, number
of years ago, everyone assumed that herring were se nt around as safe products up and down the coast and
used as bait. We now know that Pacific herring, and in fact Atlantic herring in the Baltic and North Sea
are probably the major reservoir for viral haemorrhagic septicaemia virus, and pr obably constitute a much
higher risk than a certified population dead salmonids or eviscerated salmonids. So I would put them in
the second most risky category. The most safe of the three groups would be uncertified uncontrolled open-
ocean salmonids such as I have talked about here.
268. Now there may in fact be even higher levels of safety in a well inspected aquaculture environment
where you have, say, a well-water source, the stock ha s come from a certified disease-free population, it is
a single species that has been looked at for years by very good methods. In my view, that might be the
safest of all of the possibilities, but of the three you mentioned, I would rank them the live ornamentals the
most dangerous, the bait fish second and the open-ocean salmonids third.
Chairman
269. Thank you very much. It might be a sensible precaution Jeff, if you would record that question
because I ...
WT/DS/18/R

Mr. Gertler
270. Mr. Chairman, - it is just this light that is not working.
Chairman
271. Right, good. That brings us to number 13, which again to any or all experts. Dr. Wooldridge,
would you like to start on this one?
Dr. Wooldridge
272. I think this is possibly the most difficult question to date actually. I think, by rolling all the things
under consideration into this one sentence, one tends to loose track of what we are actually talking about
here. I think one needs to break it down into its constituent parts, because we are talking about
uneviscerated bait fish, live fish, eviscerated fish of a different species and we have a number of different
things implicit in this sentence which need considering. Most of them have been considered somewhere or
another, but I think here we need to be clear about wh at we are trying to compare. The question is asked,
whether you need to do a completely detailed scientific risk assessment for each of these situations, I think.
273. My answer is that you need to take account of all the differences in your risk assessment. You
should be able to do that in a quantitative assessment in terms of the models you are using. For example,
you can compare directly evisceration and non-evisceration by looking at such things as where the
organism localizes in the animal or fish. So you may be able to say that the probability of the organism
being in the uneviscerated fish is this, and in the eviscerated fish is that. So then, depending upon which
type of fish you are talking about in your risk assessment model, you can put in the probability of whether
the organism is present or not. When thinking about whether you are talking about a fish that is intended
for human consumption after processing in a particular way or whether it is a live fish that is going into a
water-way as bait or whatever, then you are thinking in terms of adjusting your model with a different
exposure, and possibly different transmission pathways. So you would need to take account and put in the
appropriate pathway for this situation under considera tion. When you are talking about different species,
you may need to take into account that there might be differences in where an organism may localise or the
amount of viable organism that might be present in different species and in different tissues in different
species.
274. So my answer is: "Sort of". You can look at all these factors in one risk assessment but it might
end up with being - with looking like, or with including, several different models depending on which
particular aspect you are looking at. So you may in fact end up as having effectively done a number of
different risk assessments in order to compare the differences. So I am not giving a clear yes and I am not
giving a clear no to that. Because it really depends, I suppose, to a certain extent, what you call a single
risk assessment and how complex you need to get given the data you have got to actually compare the
differences.
Chairman
275. Thank you. Would anybody else like to have an answer to that? Claudia, do you want to - ?
Please.
Panel (Ms. Claudia Orozco)
276. If I may Chairman. Well thank you for that answer, and not being an expert on risk assessment I
am puzzled. Because, somehow, two minutes ago - or trying to clarify an answer for question 12, there
was a kind of generalization of what experts seem to understand as different levels of risk of different
situations. Now we will try to see if we need a complete risk assessment then we have this full
explanation. If we tie this back to question 7, it is not clear to me how far a risk assessment has to go if
there is a situation like the one that we are looking at where you have identified several diseases of concern
and it seems to be ... several products in types of fish and species of fish that are known to carriers of those
WT/DS/18/R

diseases. So, in trying to have a full risk assessment, do you need to incorporate a risk assessment of those
other products, because you have identified several diseases of concern? From what you are telling us now
it seems that you might need, you can - it is not clear if you can generalize or not that bait fish for example
poses a higher risk or not. It seems, from what you are saying, that you might need to have a risk
assessment - either complete risk assessment or part of the analysis that you are doing. But then in order to
have a complete picture, do you have to expand the scope to your original risk assessment once you have
identified several diseases concern and that you know that they are potential carri ers out there more than
the one product that you have in mind?
Dr. Wooldridge
277. I think this is partly why I said this is probably the most difficult question. I think, all I can really
say, and I would like Dave Burmaster's opinion on this as well in a moment, is that it, what you do depends
on the particular risk you are trying to assess. That goes back to question 7 and that takes care of varieties
of products. If you need to look at the risks - or if y ou are trying to look at a particular disease X, and it is
potentially present in certain products, you would need to do an assessment for each of those products.
278. In this question, what you are trying to do, perhaps, well - if you are trying to actually assess the
probability of, say import of a given disease in a given product, and you undertake a quantitative
assessment, you actually do not need to worry about the probabilities in a different product if you are only
thinking about this one particular product. However, if you are trying to say which is the most risky, then
you do need to know something about and possibly do a full assessment for another product. The most
likely - if you had full data for your original assessment, you really would not be worried about these other
products in that context. But the question, or as the problem comes, when you do not have the data you
would perhaps ideally want for your initial risk assess ment, and you have to base some parts of that model
and the data you put into it, on knowledge from a different source, and you would then say something like,
or one might say something like, "well, we have been importing this and" - or, "you have been importing
that and it looks riskier so it must be alright". Then if you wish to actually compare them in a proper risk
assessment fashion, you would need to actually pick out the bits that were different and show that the one
you were saying was riskier, actually was riskier in the particular part that you were talking about. For
example, if you are trying to compare the eviscerated with the uneviscerated you would want data to show
where the organism localized in the fi sh. If you were trying to compare the use of the product, you would
want data to compare the exposure pathways for example. I am not aware that act ually clarifies things or
whether I am making things more confusing. I would like Dave to come in and see if he can put it a
different way that perhaps clarifies the issue from a different perspective.
Dr. Burmaster
279. Thank you Mr. Chairman. Let us see, as th is question is written (question number 13), the first
sentence contains a contention - a very sweeping generalization. It is a very sweeping generalization, and I
guess I am sceptical of that generalization as it is written. I do not know enough to prove that it is
absolutely true, I could not tell you if it is absolutely true, I cannot tell you it is absolutely false either. I
cannot name here a counter-example. One of the things scientists like to do is to find a counter-example of
something and say "well here is specific counter-example" and that one counter-example makes the
generalization false. So I guess I cannot either sup port or criticize or condemn, or disagree with the
generalizations written. Nonetheless, it may contain so rt of the kernel of a truth. I heard one of the
previous experts say that there nonetheless maybe a something of a kernel of truth in this, that eviscerated
fish - I think, of the list of three that you had earlier - that eviscerated fish was the least risky. Am I correct
in that?
Chairman
280. Well I think that is partly where the Panel's confusion has come from because we understood from
the earlier discussion that fish put directly into the water course, which are the first two that are mentioned
here, the bait fish and the live fish, are likely to be a higher risk than product which is imported solely for
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human consumption and is not intended to go in the water course. So is that statement compatible with the
answers that we have now heard?
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 Pacifi c herring in North America. As bait fish those fish
contain a significantly and quantifia bly 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, th e 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 ta ke account of each of the
differences which are present in the different scenarios which one might be attempting to compare.
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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 st ep. From there, one woul d 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 whic h 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 prob lem, 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 ther e 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?
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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 numbe r 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.
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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 s een as a way to reduce the risk, perhaps not just of
Notifiable Diseases but of other diseas es, 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 behi nd 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. Simila rly 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 orga nisms, organs of fish, have also revealed levels of
IHN virus in the mucus and skin of the surface of the fi sh 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 some what 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
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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 sa feguard 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 th at 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 prod uct, 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 trea tment 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 unacceptabl e". 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
WT/DS/18/R

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 y ou heat treat that actual mu scle you are changing the
product, therefore you are effectively importing a differe nt 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 computatio n 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
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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 la st couple of weeks I have
posed myself - well, they are long thick documents a nd 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, th ere 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 accepta ble 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 pe rsonally I think th at looking at th e SPS Agreement and
the OIE guidelines that it does seem that a country can set its own leve l 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 informati on 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 evis ceration 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 path ogens, 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
WT/DS/18/R

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 understandi ng 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 necess ity of differentiating between the assessed and the
acceptable risk and I think at the beginning of the da y 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 disa greement 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 th e 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 bu t as far as the experts ar e concerned, thank you.
That now concludes our session for today and have a safe journey home. Thank you very much.
WT/DS/18/R

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 di sease 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 diseas e 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 th e 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 "... curre nt international stan dards 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 prod uct-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 intr oducing 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 consider ed 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 indi cated that you believed the statement was correct
WT/DS/18/R

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 th an eviscerated fish of a different species cannot be substantiated without
reference to a risk analysis including detailed scie ntific risk assessment." Do you agree with this
contention?
14. To any/all of the experts: The Panel previously asked (Questio n 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 m easures for reducing risks and consequences in the context of the
appropriate level of protection." Is this an appropria te 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 mainta ining sanitary or phytosanita ry measures to achieve the
appropriate level of sanitary or phytosanitary protection, Members shall ensure that such
measures are not more trade-restrictive than re quired to achieve their appropriate level of
sanitary or phytosanitary protection, ta king 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 enou gh 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?