Examination of Witnesses (Questions 1
- 19)
TUESDAY 11 APRIL 2000
BARONESS HAYMAN,
MR RAY
ANDERSON AND
PROFESSOR IAN
AITKEN
Chairman
1. Minister, Professor Aitken, Mr Anderson,
I hope I am not breaching some terrible constitutional convention
in starting early but the clerk has not yet had apoplexy, so I
assume we are all right! We wanted to talk to you basically about
the process rather than about substance of the issue, although
that is bound to come up because you cannot separate the two entirely,
but essentially it is the decision-making processes which caught
our attention. First, could you identify yourselves?
(Baroness Hayman) I am Minister for State
at MAFF, with responsibility for veterinary medicines.
(Professor Aitken) I am Chairman of the independent
Veterinary Products Committee.
(Mr Anderson) I am Director of Policy at the Veterinary
Medicines Directorate.
2. Thank you very much indeed. As you know,
there has been a lot of research conducted into the impact of
OP sheep dips especially on human health but even on the day of
recall MAFF itself issued a press release saying, "any ill
effects from prolonged low-level exposure to OPs remain unproven",
and the same document said that the government's "regulatory
committees advise against any general withdrawal of OPs from the
market". The obvious question occurs why was the risk from
OPs deemed so great when the recall was decided upon and why the
did Veterinary Products Committee think this urgency was there
in November 1999 but not in the previous July when it was issued.
Was it a panic measure? Was it a proportionate action? That is
the key opening question.
(Baroness Hayman) I will start and then Professor
Aitken can talk about the decision-making within the committee.
I think the theme, as you say, throughout many years of debate
about the effects on human health of organophosphate has more
and more concentrated on the effects of the concentrate itself.
The IOM report which sparked off the response by my predecessor,
Jeff Rooker, in July went to the VPC, the ACP and the Committee
on Toxicity, for urgent consideration. The interim advice from
the VPC then in July focused very much on container design of
the concentrate for OP sheep dips and it was at that point that
they first asked the manufacturers for plans to minimise the risk
to operators from the concentrate. So the later finding from the
COT report that the effects of long term exposure at low levels
were still not certain, did not justify complete withdrawal of
the product, and needed more research to see if there was a sub-group
that was susceptible, did not detract in any way from the concern
that has always been there about exposure to the concentrate and
concern to improve container design which goes back to 1994 when
the first work was done with the manufacturers about trying to
improve container design for the concentrate.
3. So how was it being delivered? Talking hypothetically,
if it had been delivered in bulk tankers in its dilute form, would
you not have been so concerned? Was it the containers of concentrate
which marked the difference between the concerns expressed in
July and the decision taken in December?
(Baroness Hayman) I do not think there was a difference
at all. I see this very much as part of the continuum. It was
about container design—I am not sure whether large scale
bulk containers of dilute have ever been suggested as the way.
4. I was seeking to crystallise the nature of
the concern.
(Baroness Hayman) It is much more about the valves,
the prevention of accidental spillage, the possibility of delivering
dip in containers. Water solubility, for example, has been one
suggestion that has been put forward and work has been done on
pesticides on container design. That was what was focused on in
July. Plans were submitted by the companies in November as the
VPC had asked them to do and those were plans for both interim
and long term solutions to the risks of concentrate, so it very
much was a continuum. But in looking at the advice of the Committee
on Toxicity, which we had asked to bring together all the strands,
the VPC were then, as I understand it, given the choice of whether
they allowed product to remain on the market with the added concerns
that have been expressed while containers were changed or whether,
while containers were being changed, product should come off the
market. That was the advice I then received unequivocally that
products should come off the market, and I accepted that advice.
(Professor Aitken) If I may, the Minister has summed
it up very succinctly and very correctly. There were two areas
of concern which focused immediately in July when the meeting
was rather hastily convened at short notice, one of which the
Minister has identified: the risk of contamination from use of
the concentrate and the disregard which operators had for the
recommendations for the wearing of protective clothing, and these
at the time identified the interim recommendation that there should
be plans for containers which would not expose operators to the
risk of contamination.
Mr Jack
5. For the record, could I ask if Mr Rooker
or you yourself, Minister, have watched sheep dipping operations
and the use of the existing containers and the proposed new ones?
(Baroness Hayman) I cannot answer for Mr Rooker; I
have not seen sheep dipping in operation.
6. And you have seen both the new and the old
ways of doing it?
(Baroness Hayman) I have not, I said.
7. You have not?
(Baroness Hayman) No.
8. Is there any reason on a practical matter
like this that would stop you from going and looking at it to
assess whether the advice actually worked in reality?
(Baroness Hayman) There is nothing that would stop
me doing that and I would be happy to do that. Equally I would
not take my own judgment from one or two visits in contradistinction
to the advice of the committee of experts set up to advise ministers
under the Medicines Act about appropriate action in these circumstances.
9. I understand the point that you make, but
this is a practical matter and all the evidence we have had is
from practical people involved in having to dip sheep and use
these materials. We shall probe what they have to say later on
but I would like to know, if you have not seen the operation yourself,
whether you could find out for us whether Mr Rooker went to see
this operation so that he too might have some practical insight
into what was involved?
(Baroness Hayman) If you think it is the appropriate
mechanism for me to act on behalf of the Committee to ask him,
I am very happy to do so and will pass back as a postman that
information.
Mr Mitchell
10. And do not omit to talk to the sheep while
you are on the job! I am a bit mystified by this because there
has been a groundswell of concern for quite sometime about OPs;
the Countess of Mar, Booker—not Rooker—in The Sunday
Telegraph and I myself have been concerned and have written
from time to time and we always get the bland assurance that nothing
is wrong. Are you now telling us concerning the press release
regarding prolonged low level exposure to OPs that the ill-health
effects remain unproven—so much for all those people who
have been complaining about health effects—but that there
is an effect on people who have splashed the concentrate all over
themselves? Is that the distinction you are making?
(Baroness Hayman) I think the weight of scientific
evidence is that there is no doubt that exposure to the concentrate
can be dangerous to human health and have very bad effects on
human health. I do not think there is dispute about that. The
scientific dispute or the evidence that has been accruing over
the years which has not come to a fixed point in terms of anybody's
certainty is whether low levels of exposure to OPs over a period
of time cause ill health or indeed—and this is one of the
issues that was raised in the IOM report and the COT report in
particular—whether there is a sub-group of the population
particularly at risk from this. I do not think, however, that
any of the bodies, whether it is the Health and Safety Commission,
the VPC or any of the committees that have looked into this, have
doubted that concentrate, if mis-used accidentally or deliberately,
is a dangerous substance—and that makes sense really. We
are dealing with a chemical designed to kill some living organisms
and it would be unlikely to be something you would want to use
carelessly or recklessly.
11. But you know from the research, and there
have been cases in the paper, and the OP Information Network in
Scotland have written to us and said, "We estimate that approximately
500 people in Scotland have had their health affected by such
exposure". Are you saying that those effects come not from
splashing around with the dilution, wrestling with the sheep in
it, but from being splashed by or making contact with the concentrate?
Have you made a distinction in the research?
(Baroness Hayman) I think the researchers find it
easier to establish cause and effect of harm between the concentrate
and exposure to it. The difficulty in assessing some of these
registers of potential sufferers is that it is a mixture of people
some of whom think that they have been exposed over long periods
of time to small amounts who may, in fact, have been exposed to
accidental spillage of concentrate: it is periods of time, these
people have never been very well investigated in terms of their
own symptoms and one of the pieces of research we are setting
up in response as part of the four-point plan that I announced
in December is actually to look at those sufferers and see whether
we can learn from them. Now that is a piece of research that there
has been a lot of criticism in the past has not been done - looking
at the self-reported people who feel they have suffered that damage.
We had a seminar on 28 March that I went to where scientists working
in the field on the effects of OPs on human health came and debated.
I cannot give you definitive answers because, if you listened
to the breadth of scientific advice there, there are differences
of view. This is a moving field.
12. But this is extraordinary. After all the
groundswell of problems arising over a number of years, all that
is ignored and then suddenly, wham bam, last year, we get this
ban.
(Baroness Hayman) I do not think you could say it
was wham bam, honestly.
13. Well, the industry was taken by surprise,
none was prepared for it, this is alternative packaging, quite
out of the blue?
(Baroness Hayman) Can we take that bit by bit and
start in 1994 with the concern over packaging and container design
that was discussed between the industry and the Veterinary Medicines
Directorate and the action that was then taken to improve container
design because in 1994 concern over spillage and the need to improve
the design was first being discussed and acted on. So we are not
talking out of the blue in 1999. Then we go to July 1999, when
the IOM report was published focusing concern on container design.
Jeff Rooker met the manufacturers then to talk through his concerns
about container design: it could not have been a total shock to
them because the Veterinary Products Committee looked at the issue
and communicated with them in July and asked for, within three
months, proposals for alternative container design and made clear
that regulatory action would be taken if suitable alternatives
were not found. So I do not think it is fair to suggest that it
is out of the blue. We are talking about a transparent process,
reported to Parliament that had been going on for some time and
of which the industry was aware. As far as alternatives are concerned,
I absolutely recognise—and Mr Jack will be glad to know
that I did at least talk to a lot of people who dip sheep—their
concerns about the lack of what is considered to be a satisfactory
alternative at the same price as OP sheep dip but there are a
range of other products, whether they are SP dips, injectables
or pour-ons, that are available for use, so we are not talking
about an absolute gap of alternatives, although I would not under-estimate
the fact that these are not considered satisfactory by many farmers
and sheep farmers.
14. I am not complaining about the final action.
I am pleased that a new government and new ministers have produced
action in an area where a number of us have been ferreting around
for years with no effect, and nothing has been done. What I want
to know is why so suddenly? Let me ask how many suspected adverse
reactions have occurred as a result of contamination while dispensing
concentrated sheep dip from these containers? How many can you
pin it down as?
(Baroness Hayman) Could I ask Mr Anderson to answer
that?
(Mr Anderson) Under the suspected adverse reactions
surveillance scheme which was set up in 1985, since then 751 reports
of human reactions which the reporters attribute to contact with
organophosphate sheep dips have been received by the Veterinary
Medicines Directorate.
15. How many are from the concentrate, and how
many from the dilution?
(Mr Anderson) It is very difficult to say. Part of
the problem is that a lot of these reports are historical and
to some extent they might have been triggered by expressions of
concern about the safety of OPs. Certainly in terms of dates of
reporting, the peak was in the period 1991/1993 when concerns
were first raised, but in terms of the exposure to OPs, many of
those reports are historical going back with a history of sheep
dipping over many years, so it is quite difficult to disentangle,
so many years after the event, just how many were definitely attributed
to exposure to concentrate and how many were attributed to long
term low level exposure.
16. But you will be aware that again, the OP
information unit from Scotland tells us that the Committee on
Toxicity working party report was highly critical of the lack
of substantive data on OP patients submitted by the various adverse
reaction schemes. Here you have a chorus of complaint, claims
in the newspaper that people are having their health affected
adversely, and we have not got an adequate adverse reaction scheme
functioning. Then, suddenly, you pin the blame on the concentrate
and that goes.
(Professor Aitken) May I just say in response to the
line of questioning that Mr Anderson has pointed out the number
of reports that have been received and has emphasised that many
of these are historical; people casting their minds back over
several years to try to recollect whether they were dipping with
a particular product and very often they have forgotten the days
they were doing it and over what period of time. It is just a
factual record of a report being received that adds up to the
750. The number that can be ascribed sufficiently to ascribe a
probable or possible cause is much smaller than that—I do
not have the figures with me but I would suspect it is of the
order of 20 per cent at the outside of that total and it is a
subject which the appraisal panel of the suspect adverse reaction
scheme, a subcommittee of the VPC, is looking at actively at the
moment.
(Baroness Hayman) But I think the area of dispute,
if I may say so, is around the issue about low level exposure.
I do not think there is an issue of dispute amongst doctors or
amongst scientists that the concentrate can cause immediate obvious
and attributable harm. The dispute is over the longer term and
that is why I have taken forward the work on the investigation
of the patients who are self-reported, on the networks, to see
if, in these much more intangible, more difficult to pin down
cases, we can get better information. But that does not detract
from what I think is commonly agreed ground which is the potential
danger from exposure to the concentrate and therefore, in my mind,
the responsibility on government to ensure that we minimise risk
if that product is, we are told, to remain available.
17. Does that not bring up the question of whether
the Veterinary Products Committee, which seems to rely largely
or even solely on information from the product manufacturers when
it is assessing a product, should be responsible in licensing
the product for assessing the health implications as well on a
continuing basis, which does not seem to have been adequately
done in this instance?
(Professor Aitken) The Veterinary Products Committee
does, in the process of authorising any application that comes
before it, go through a very rigorous exercise of judging its
quality, safety and efficacy and it takes into account in that
process the issues concerning possible harm to human health.
18. But on information supplied by the manufacturers
of the product primarily?
(Professor Aitken) That constitutes a considerable
part of the information presented but it has available to it a
much wider range of information deriving not only from the knowledge
of its individual members and, therefore, through its corporate
expression, but also by access to other reports dealing with the
chemical concerns that might be related to that particular incident.
I would have to say that much of the questioning that is addressed
to applications that come before both the Veterinary Medicines
Directorate assessors and to the VPC is based upon testing information
that is not presented within the documents that we are provided
with. So I would not accept your comment that it is exclusively
concerned with information derived from the manufacturers.
19. Not exclusively but it still has the responsibility
for assessing the health consequences which is an on-going process,
which does not seem to have been adequately done in this particular
instance.
(Professor Aitken) Absolutely.
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