Examination of Witnesses (Questions 60-79)
19 JANUARY 2004
DR JON
BELL AND
DR ANDREW
WADGE
Q60 Chairman: In asking people to frame
bids, did you set out a standard operating procedure for what
they should do?
Dr Bell: Not in the way that we
now talk about the standard operating procedure. Certainly it
was made clear what was required. It had to be done in line with
EU legislation and that meant effectively following the Yasumoto
approach. That was understood.
Q61 Chairman: You had a competitive bid.
In comes this bid from CEFAS. They start doing the tests. It is
argued in a different way to the way it had been done in Aberdeen
and all of a sudden you find yourself massacring mice. Did a bell
not ring that it could have been due to a change in the lab, a
change in the methodology or the climate?
Dr Bell: The story is not quite
as straightforward as that. We might well have drawn that sort
of conclusion, quite rightly, if it had been straightforward.
Although there was a change in England and Wales as to who was
doing the testing, there was not a change in Northern Ireland.
The Northern Ireland testing had always been done for very many
years by the Department of Agriculture's laboratory there and
they carried on doing it. They started to get exactly the same
results at about the same time.
Q62 Chairman: Did they change their methods?
Dr Bell: They did not. They had
been operating at that time for a while, certainly some time,
using the mouse test and they began to see quite independently
much the same sort of results.
Q63 Chairman: There was no change in
Scotland.
Dr Bell: No. They were using a
rather different approach in Scotland. You have heard some of
the detail of that in terms of the amount of extractions they
were doing, over what period and whether they stood their extractions
overnight. There were some differences in the way that they were
doing the work. There is no real evidence for this one way or
another but you could argue they might not have been as vigorous
in the extraction of material. That is a possible interpretation.
I am not saying it is the only one. We were not clear why these
differences should appear.
Q64 Chairman: At what stage did you begin
to think, "This is not a new toxin", a killer toxin
or whatever; "This is a change in the way it is done"?
Dr Bell: We never thought that.
We never have thought that. We took the view that we did not know
what was causing this effect. We still do not know clearly what
is causing this effect. What we had to ask ourselves was: "Are
we certain this is not a new toxin?" If we are certain of
that, we can proceed as normal but if we think that one possible
explanation here is a new toxin, and we cannot rule it out, what
position should we take in terms of protecting human health? We
were very mindful of the lessons that have been learned since
the days of BSE about what one does in the face of uncertainty
in such a situation and that is that you take reasonable precautionary
action to ensure that you do not learn after the event that it
might have been a toxin.
Q65 Alan Simpson: When you talk about
not knowing what caused the effect, is it correct that when you
changed the procedures, since doing that, there has not been an
effect?
Dr Bell: There have been no atypical
results in the last two or three months. When we plotted out what
had been happening previously, it is clear that there had been
a drop in the number found before the changes were made. One could
not necessarily draw the conclusion that it was as a result of
making further changes to the methodology that it has now dropped
down effectively to zero. Two positives were found immediately
after CEFAS made the changes and then it dropped away after that.
Positives were being found in Northern Ireland consistently because
it was effectively their methodology that was transferred across
to CEFAS and the Aberdeen laboratory with some changes.
Q66 Chairman: You were taking reassurance
from Northern Ireland but Northern Ireland changed from feeding
it to rats in 2000 to using the mouse tests. They did not have
the experience that the Aberdeen laboratory had in using mice,
so you were both going down the same track.
Dr Bell: That is true, but they
had been doing the mouse test for some while before these atypical
results started to turn up. You would think, if it was their inexperience
with the methodology, you would see it almost immediately that
they moved away from the rat and that was not the case. The other
factor we have to take account of here is that not every cockle
result turns up positive. Far from it. A good 60% over the three
years we are talking about have turned out negative.
Q67 Chairman: You have just said to us
you did not think and you do not think now it is the methodology.
Dr Bell: We do not say that at
all. We are not clear what it is.
Q68 Chairman: You must have been suspicious
because you then commissioned studies of the methodology.
Dr Bell: We have been looking
at all the facets of it, which is what you would expect us to
do. If we had been clear it was a toxin and we had good evidence
for that, it would not have been necessary to have done anything
else on that, except perhaps to try to characterise what that
toxin was. Because we were not clear and there was a range of
possible explanations, we thought it necessary to do work right
across the spectrum. We have done quite a lot of work looking
at the methodology and we are doing some toxicological work to
look at the possible threat to human health as well. We are under
way with that now.
Q69 Chairman: Somebody said tests are
done on Monday and Tuesday and you have the results by Thursday
or Friday. By that stage a lot of the stuff can have been eaten,
can it not?
Dr Bell: Yes. We are trying to
work in the most realistic way we can. We are trying to be as
proportionate as we can. Our main concern here with toxins of
this type is about consistent consumption over a period. We took
the view—you may say it was a wrong view to take—that
consumption over a period of a few days would not be an issue
in itself and we should act as soon as we definitely had positive
results that we felt we could act on.
Q70 Chairman: You had positive results
and people did not die or fall ill.
Dr Bell: No, they have not, so
perhaps we are not looking at an acute effect here. The difficulty
with all this is that these toxins do not only manifest themselves
in that way. We have had discussions with Professor Yasumoto and
he has been able to produce evidence that shows that some animals
on which he has done toxicological studies appear healthy until
he opens them up.
Q71 Mr Breed: Can we look at the way
in which differing laboratories came up with differing results,
differently interpreted by different people? Why was there no
standard operating procedure put in place right at the beginning
so that at least there was some comparability between the laboratories
involved?
Dr Bell: I take the point. With
hindsight, we should have taken steps to do that. This general
shellfish testing has a long history and it had never been considered
necessary to do it up to then. As long as you followed the Yasumoto
approach—and there were variations that scientists made
around the general core of that approach—nobody thought
it necessary to have an absolutely standardised method in every
regard. That had never been negotiated and agreed in Brussels.
As far as I know, no Member State had taken any action to do that.
Once we got into this position, it became very clear very quickly
that we needed to do some standardisation because obviously laboratories
testing within the UK around the same waters should, one would
presume, have been obtaining the same type of results, had variation.
Q72 Mr Breed: In the bid process, there
was no laid down procedure that you required of them in order
to fulfil the contract for the testing? They could do what they
liked?
Dr Bell: No, not to that extent,
not fine detail laid down, as every step would be laid down as
in a standard operating procedure, but making it quite clear that
the procedure had to follow the EU requirements which are the
Yasumoto method.
Q73 Mr Breed: That is then; this is now.
Do all laboratories now operate under an SOP?
Dr Bell: Yes.
Q74 Mr Breed: Which was laid down by?
Dr Bell: We drew the laboratories
together following Hugh Makin's report where he had found discrepancies
between the various laboratories we thought ought to be addressed.
He did not consider these materially affected the results but
nevertheless he thought it sensible that we should take action
to tighten these up so that is what we did. We called a meeting
of the laboratories and everyone agreed that the methodology which
should be followed would be the Northern Ireland methodology with
some small tweaks.
Q75 Mr Breed: The Northern Ireland one
is now being carried out in the other two laboratories?
Dr Bell: Yes.
Q76 Mr Breed: What effect has that had
on the test results?
Dr Bell: At the moment we are
in this period—long may it last—where we are not getting
positives.
Q77 Mr Breed: From anyone?
Dr Bell: From anyone. Whether
that is as a result of the change to the standard operating procedure
or whether it just happens that we have fallen into a period when
the problem has gone away for the time being, it is not possible
to say. We have looked at what was happening immediately before
this and sure enough the number of positives was falling away
anyway before we made this change. We do not feel confident that
we can make the decision, at this stage anyway, on only a few
months of negatives. Either the toxin has gone away or the change
in the methodology resulted in the change.
Q78 Mr Breed: If everything carries on
as it is at the moment, when would you expect to be able to say
that everything is okay?
Dr Bell: The principal thing we
have to do is to complete the toxicology. If this toxicology comes
out negative, I think we will be pretty confident that we do not
have a threat to human health here and that is assuming that the
toxicological experts on the independent committees agree with
that. Then we will be fairly confident that whatever the background
to this was there was not a threat to human health and we can
take action accordingly.
Q79 Ms Atherton: You appointed Professor
Hugh Makin to come in and independently audit the testing. What
was your response to Dr Askew's assertion from the Shellfish Association
that Professor Makin could not say that ether did not cause the
atypical results?
Dr Bell: Professor Makin did say
quite clearly in his report he did not consider the carry over
of solvent was giving rise to the observed results. That was his
professional view. Obviously, one combines that with other information
but we did not take that as an absolute, definitive answer to
the question of solvent carryover and we have done quite a lot
of work since to make sure that solvent levels are kept absolutely
as low as possible.
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