Examination of Witnesses (Questions 80-99)
19 JANUARY 2004
DR JON
BELL AND
DR ANDREW
WADGE
Q80 Ms Atherton: Earlier we heard a suggestion
that the transportation issues in this country are very different
perhaps to New Zealand. What is your reaction to that? Do you
think that might have been a contributory factor and have you
taken that into account?
Dr Bell: I do not know whether
that is a contributory factor. I am not sure that we have done
any particular work on that. The National Reference Laboratory
lays down the requirements for transportation and the way that
the samples should be treated on receipt. One would hope that
they have taken account of that but I cannot answer that definitively
at this time.
Q81 Ms Atherton: You talked a little
bit about testing the methodology. Can you tell us a little more
about how you reacted and what your response was to the Shellfish
Association's suggestion that poor scientific methodology at CEFAS
is responsible for the atypical results?
Dr Bell: We considered it very
carefully. We could not see any immediate grounds for that. Although
the shellfish interests said that they considered that solvent
carry over was a serious problem, working on what Professor Yasumoto
had told us when he reproduced the results himself in his own
laboratory, the fact that he came over and witnessed the work
being done over here and took a similar view that a novel toxin
could not be ruled out, taking into account that Professor Makin
did not think the solvent was the issue, we saw no immediate reason
to suppose that was the answer and to alter policy on the basis
of it. Having said that, obviously we recognise that this could
be an issue. We have done quite a lot of work on it. We have published
quite a lot of work on trying to get to the bottom of whether
solvent carry over or other factors of this nature might have
been the reason for this, but that is as much as one could say.
We certainly did not immediately draw firm conclusions.
Q82 Ms Atherton: Since the current assay
was introduced, I gather there have been numerous insufficient
sample and operator error reports in the results. Is that true?
How could you explain that?
Dr Bell: I do not think any of
us are aware of that.
Q83 Ms Atherton: Perhaps you would be
kind enough to come back to us with the extra information if that
is the case?
Dr Bell: Yes, certainly.
Q84 Ms Atherton: What is your response
to the Shellfish Association's assertion that other laboratories
have been unable to replicate the CEFAS results?
Dr Bell: I am not aware that other
laboratories have been asked to do that sort of thing.
Q85 Ms Atherton: Would it not have been
a sensible thing to do?
Dr Bell: Yes, but it is difficult.
You have to recognise that you have to use the same material.
You are dealing with very small amounts of material in most cases
in this sort of issue, so trying to reproduce across laboratories
is quite a difficult process in these cases. We have seen a lot
of similarity in the way that at least two laboratories have turned
up these results and it is fairly clear that the third laboratory
would not necessarily turn up the same results with the methodology
they were using. There may be a variety of reasons associated
with that, including the method of extraction.
Q86 Ms Atherton: I understand some other
countries such as Holland have tried to replicate the results
and have been unable to do so.
Dr Bell: I do not have the information
at my finger tips. We will look into that and write to you if
that is the case.
Q87 Chairman: We are quoting Professor
Makin who said that there was no evidence that the atypical result
was due to the presence of ether, but Dr Askew tells us in his
evidence that he also agreed that he could have said there was
no evidence that it was not caused by ether. In relying on his
endorsement either way, we are going to fall down because that
is not really saying one thing or the other.
Dr Bell: I do not think we did
rely on his opinion in that regard. We took note of it and that
was his considered, professional view. That is what he said, but
we did not rule out the possibility that—
Q88 Chairman: He also said it is not
caused by ether; there was no evidence that it was not.
Dr Bell: His considered view was
that he did not think that solvent carry over was the reason for
the effects. Nor, come to that, did a number of other experts
including Professor Yasumoto. We did not however rule out that
possibility. We have done work to see what we are dealing with
in the way of solvent carry over and the amounts that have been
found are far below those that are known to cause toxic effects
in laboratory animals. It is very difficult to prove negatives
with these things.
Q89 Chairman: Surely the cases Professor
Yasumoto dealt with when he came over would be based on samples
which were produced by the methodology which the Shellfish Association
is saying was flawed and you are saying was not, so he was working
on the same material?
Dr Bell: Yes. He witnessed this
methodology when he came over. He did not think it was seriously
flawed, but he did not do it himself at the bench. He witnessed
it being done. He did however do some work on some extracts. I
do not have the detail at my finger tips but I would imagine,
since he is somebody who has been immersed in this area of work
for very many decades, that he would not just have taken a sample
and tested it in animals without having a look at things like
whether it had a large amount of solvent in it.
Q90 Alan Simpson: A number of the people
who have made submissions to the Committee have made their own
references to the difficulties about having an independent laboratory
assessment of the evidence and the conclusions that you are drawing.
Would you accept that there is a perception of the non-independence
of the National Reference Laboratory?
Dr Bell: The difficulty is that
the National Reference Laboratory is embedded within the laboratory
in Aberdeen. We are assured by Aberdeen that they work independently
of each other and we have no reason to suppose that is not the
case, but from a perception point of view I agree it is difficult
to be able to demonstrate that conclusively when they are part
of the same organisation. That is something we need to look at
for the future, but we certainly would not take the view that
we consider they operate other than in an independent fashion
in this matter.
Q91 Alan Simpson: Would you accept there
is a case to be made for something that was genuinely independent
and seen to be independent?
Dr Bell: Yes, I think there is
a case to be made for that simply because of where they are housed
and which organisation they are part of. It has inevitably to
be a case of Chinese walls in that situation. It depends what
faith one puts in that arrangement but I agree that to be absolutely
certain one would want to have it perhaps based somewhere else
or clearly divided away from the rest of the organisation. I would
add that we have no reason to believe that they have not acted
independently in this matter. We have seen no evidence that they
have not, as I said before.
Q92 Alan Simpson: Without going down
the path of saying that, if that was the case, who should it be,
if I could focus on the principles of this, would you accept that
if we are to address the communications issue—and clearly
there is a problem to be addressed—there would have to be
a commitment that the science that underpins that reference laboratory
would be rigorous and open?
Dr Bell: Yes, absolutely.
Q93 Alan Simpson: One of the points that
really rankled with me was in this reference to the suggestion
that the FSA has banned communication, going so far as to threaten
officers under the Official Secrets Act. How do you justify that?
Dr Bell: I have no idea what that
refers to at all. Certainly we do not operate in that way. As
you know, we have prided ourselves since our establishment in
2000 on being an open organisation and hopefully a constructive
organisation with those we deal with.
Q94 Alan Simpson: Are you saying that
the FSA would refute that allegation?
Dr Bell: Yes, absolutely.
Q95 Alan Simpson: If we were to turn
that back to the industry and say that that is a pretty robust
accusation to make—
Dr Bell: If there is evidence
of it, I will look into it.
Q96 Alan Simpson: We can ask the industry
to come back on that?
Dr Bell: If they have firm evidence
on that, I will look into it.
Q97 Alan Simpson: Whether the FSA come
out of this well or the industry comes out of it well, it is quite
clear that the mouse comes out of it pretty badly. I want to raise
questions about the validity of the mouse bioassay and whether
you regard this as an adequate, acceptable form of testing, because
we have had disputes about the methodology and the consistency
of application of that methodology. I just wanted to get your
thoughts on the adequacy of the test itself.
Dr Bell: I think the test inevitably
has a number of drawbacks. There is no doubt that we would ideally
like to move, where we could, to a more precise chemical test,
but there are a number of difficulties associated with this. One
is that you have to have good standards on which you can base
your chemical test. They do exist for some of the toxins. We are
talking now about ones we know about. They do not exist for all
of them. You have to have a chemical test validated. We are pressing
within the Community to move in this direction as fast as possible
and we are pressing for the European Reference Laboratory to take
a lead on this. I am glad to say they are now getting a grip on
the matter. You can only really use chemical tests where you know
what the toxin is; it has been characterised, you know how to
recognise it and you know where the peaks are in the chromatogram.
Where the difficulty comes is that it is very hard to see how
you can avoid using a biological test at all because the only
way you can pick up new toxins is by using a biological system
by definition. It is very difficult to see how else you can do
it. What we would like to see is the mouse test used, if you like,
to support the rest of the tests and not be the definitive test.
We would like chemical tests to be the definitive tests wherever
possible but with the mouse test as the back-up to pick up anything
that may suddenly appear, as with this Irish toxin that they found
a few years ago which had not been known before and which you
would miss with a chemical test because you simply would not see
something you were not expecting.
Q98 Alan Simpson: Can I ask whether you
have taken a view on the appropriateness of the New Zealand regime,
the fully validated chemical testing regime?
Dr Bell: I think that is certainly
a step in the right direction. I do not think that brings all
the answers for the reasons I have described, but there is a lot
of work going on round the world now to develop good, robust chemical
tests for the known toxins. What we would like to see is this
being brought forward into Community law so that we get definitive
tests for the toxins we know about.
Q99 Alan Simpson: Have you made formal
submissions to the EU about your preferred chemical testing regime
to replace the MBA?
Dr Bell: We have written on a
number of occasions and made formal representations on the need
to move to a chemical based system where at all possible.
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