Examination of Witnesses (Questions 1-19)
SIR BILL
CALLAGHAN AND
PROFESSOR GEORGE
GRIFFIN
17 MARCH 2008
Q1 Chairman: Could I welcome our witnesses
this afternoon to this Sub-Committee on Biosecurity in the United
Kingdom Research Laboratories, and it is a pleasure to have our
two witnesses with us today. Could I start with you, Sir Bill,
and ask you about your report and, in particular, your recommendation
that we needed a new regulatory framework, which was accepted
by Government and seems to be accepted by most, but not all, people
in terms of framework for handling animal pathogens. Was this
really a failure by the previous regulators?
Sir Bill Callaghan: I think it
is fair to say that the regulatory system before did not work.
We are talking about the highest level of containment for a SAPO
laboratory, and although no individual was hurt physically or
killed by the outbreak, the economic harm was significant, so
adopting the principles of proportionality, which is one of the
key criteria of good regulation, we think a more effective regulatory
system is needed to make sure that this risk is controlled.
Q2 Chairman: But no matter how good
the regulation system was, if, in fact, people do not follow those
regulations, then clearly you are going to have problems like
you had at Pirbright, are you not?
Sir Bill Callaghan: That is one
of the points I make in my report, Chairman. If you want to have
effective outcomes you need a regulator that is competent, independent,
firm and fair, but you also need what we describe in our report
as a strong safety culture. There has to be that leadership from
the top of an organisation that says: "We really want to
manage the risk", and along with that commitment from the
top you need competent, well-trained and involved staff.
Q3 Dr Harris: Just to put the Chairman's
question from another direction, in another way, in a sense, even
without this outbreak, your report implies that it did not require
this outbreak for you to have made these recommendations. Is that
fair? In other words, if someone had been on the case and had
thought about this, they might have suggested a different system
of regulation. It is not solely because there was a single failure
in this particular case, is it?
Sir Bill Callaghan: The initiating
act, of course, was the review which the Secretary of State commissioned,
but it is fair to say in reply to Dr Harris that we know that
Defra internally were considering changes at least to the way
the SAPO licensing system worked, and a few years ago had considered
other possible regulators apart from Defra, and we mention that
in our report.
Q4 Dr Harris: Obviously there is
the benefit of hindsight but, in a sense, many people have said,
because your report has a lot of support, that this was obvious,
that (a) there was the conflict of interest and (b) there are
good arguments for a unified regulatory system, so could it be
argued not necessarily that it was a failure but it was unfortunate
that the initiative had not been taken to do the sort of review
you were asked to do following the outbreak?
Sir Bill Callaghan: It is not
for me to comment on what Defra and the sponsoring department
could or should have done. Our report drew on a number of recent
government reports, relatively recent reports, the Hampton Review
of regulation and also the McRory Report on penalties, and I think
it is fair to say the mood now in Government is towards a smaller
number of key thematic regulators, and that is clearly a government
policy following the adoption of the Hampton Report. I do not
think, looking back ten or so years ago, necessarily there was
that particular mood of viewing regulation in Government.
Q5 Dr Harris: To what extent would
you say that the outbreak at Pirbright was a result of failure
of regulation?
Sir Bill Callaghan: It was quite
clearly a failure in terms of the systems at Pirbright taken as
a whole. We say in our report that we think an independent regulator
such as HSE would have at least, and this is quoted at length
in our report, taken steps to ensure that the drains were functioning
properly.
Q6 Dr Harris: Yes, you do make that
point. You recommended a system based on risk assessment and notification
rather than licensing, that Defra currently uses for SAPO. The
implication is that people, as long as they did the risk assessment
and notification, would not need a licence to start work. Clearly
you can defend that, because some people would be worried that
people were essentially making their own decisions and simply
letting people know?
Sir Bill Callaghan: We mention
in our report two separate strands of legislation, the COSHH regulations
and the GMO (Contained Use) Regulations, and the model we have
for the single regulatory framework is based on the GMO (Contained
Use) Regulations. Now, HSE is a risk-based regulator and it means
that, once a risk assessment is then presented to it, HSE will
assess that, and obviously the degree to which HSE then ask for
further information or let the matter rest would depend on the
nature of the risk involved[1].
Q7 Dr Harris: But people could start
the work having done the risk assessment and sent the notification
without formally being licensed under the new system. They would
be subject to inspection every now and then.
Sir Bill Callaghan: We think it
is a more flexible system, and the danger of a licensing system
is it becomes more rigid, and because it is risk-based system
HSE would intervene on the basis of the risk and, of course, make
subsequent inspection decisions on the basis of the record of
the operator.
Q8 Dr Harris: But other regulatory
systems do not work like that. The HFEA, for example, where there
is no risk, as it were, of the sort we are talking about, requires
researchers to get peer review from the Regulator and wait for
a licence, and that is a relatively recent regulatory scheme,
and presumably that was done to reassure the public that nothing
was going on that would worry them without it being specifically
licensed. So do you feel there is a potential public worry risk
from the idea that people can go ahead and start work on these
dangerous pathogens without being formally licensed?
Sir Bill Callaghan: I can understand
that. What I would answer in reply was that the way the SAPO licensing
system worked did not actually protect the public, in this case
the farming community, and one of the reasons why it was a defective
piece of regulation, and here I am blaming the system rather than
the individuals, was that the tools that the Regulator could apply
were very limited, and this comes back to my point about sanctions.
Virtually the only sanction that the Regulator has is to refuse
a licence and, of course, this is the equivalent of the nuclear
deterrent. People are loath, as it were, to jump to that sort
of action immediately. There is no halfway house.
Q9 Dr Harris: I just want to ask
you about the idea of bringing animal and human pathogens together.
What problems do you anticipate even at this stage in doing that
because there are different issues presumably, that is why it
has grown up separately, about the way one treats pathogens that
are dangerous to humans and pathogens that are dangerous to animals.
One always has in the armoury the idea of culling in an outbreak
of animal viruses but no government has yet suggested that for
infected humans. That is one example, obviously, and a semi-serious
one. Do you anticipate there will be problems, and will the requirement
for flexibility really be the rule not the exception?
Sir Bill Callaghan: I think there
are problems under the current system. We talk about the current
system as complex and disjointed, and this point was also brought
out in the HSE report. There is a lot of confusion about the different
containment levels, what did they mean, and, indeed, George has
been tasked with ACDP in bringing out guidance on containment
levels, so I would contend that the present system is not working
satisfactorily. What our proposals will do, of course, is reduce
regulatory complexity, and although, of course, there are differences
between human and animal pathogens, one might note that many animal
pathogens are zoonotic so they affect humans. Now we contend that
a laboratory is a laboratory is a laboratory, and if one is talking
about a safety cabinet or the system of autoclaving or waste disposal,
we are talking about systems which are common to all sorts of
laboratories, so yes, there are differences and I am sure my former
HSE colleagues will be able to tell you about what steps they
are taking to prepare for this change, but to my mind managing
the risks in a laboratory dealing with animal pathogens is just
the same as managing the risks in a laboratory dealing with human
pathogens.
Professor Griffin: I would agree,
and what I am hoping is that when the new regulation comes through,
when SAPO and COSHH join together, what will happen is that animal
pathogens under SAPO will have tighter regulations than before,
and the reason is that the effect of a breakdown, as we saw with
foot and mouth, is so huge for the country and globally that it
is just as serious as having a very serious human disease which
infects an individual. So when the rules are brought together
I am pretty sure, and we have not yet formulated it, that we will
have a regulation that says: "SAPO is very important for
the country and because of that we propose the following".
Q10 Mr Boswell: So it is the highest
common factor rather than the lowest common multiple?
Professor Griffin: Exactly.
Q11 Dr Harris: You were not implying
that economic damage to farming was more important than human
life?
Professor Griffin: Not more important,
but of at least the same significance.
Q12 Dr Harris: You recommended COSHH
recovery be part of the programme, in other words I guess those
were inspected to pay for the inspector, and whenever this is
done elsewhere, and I know this is common, again some in the media
say: "Ah well, they are in the pockets of the industry or
the researchers". Did you weigh that in, or was it mainly
going with the grain of what the Government like to see in its
inspection?
Sir Bill Callaghan: It is certainly
going with the grain of Government policy. There is some limited
cost recovery at the moment for GMO (Contained Use) applications
but not for inspection, and I do not think anyone looking at HSE
from afar would say it was in the pockets of the employers.
Q13 Dr Harris: There are a few newspapers.
Sir Bill Callaghan: They may say
things about HSE but I do not think they say that.
Q14 Mr Cawsey: I would like to ask
a few questions about how the new system may be implemented. It
strikes me that one of the difficulties in bring together the
regulations is that they are not quite comparable, it is not eggs
with eggs as such, so under the new system do you envisage that
you should regulate the premises, the process or the persons involved?
Sir Bill Callaghan: That is a
very good question. Indeed, one of the reasons why we talked about
a single regulatory framework rather than a single regulation
is that we are aware at the moment of the different legal bases
which apply to SAPO, COSHH and GMO (Contained Use). Now, colleagues
are working on this and I must say the more difficult job is for
colleagues in HSE and Defra who are working these proposals out
rather than the recommendations I made. I do not think these are
insuperable, but obviously the aim is to come up with a regulatory
framework that makes sense. Applying some of the lessons of the
GMO (Contained Use) Regulations, and I am here giving my personal
view, there is certainly a role in the regulations for setting
the framework but I think a lot of the success of what we are
recommending really does depend, then, on the guidance that is
followed, how the regulations are then acted on by duty holders,
enforced by HSE, and the guidance that George's Committee is going
to develop, because I think what people want to know is "What
does this mean for me in developing this on the ground",
but what we do think is that the rigour of a duty holder preparing
a risk assessment has got great value in itself.
Professor Griffin: I would like
to bring out another point as well which Dr Harris was really
alluding to, and that is that about a year and a half ago ACDP
produced the guidance for the Containment Level 4 facilities within
the United Kingdom, and this was a very comprehensive document.
If that document had been followed Pirbright would not have happened
because the effluent that was being discarded would have had inactivated
virus before it got into the drain, so it is back to Bill's comment,
namely the responsibility of the individual and the risk assessment,
so you can have a licence but poor responsibility. The individual
doing the tasks in the laboratory is the crucial thing we have
to get organised.
Q15 Chairman: The concern we had
when we visited Pirbright was that there was a feeling that the
chemical treatment of the virus was sufficient to kill the virus
before it was discharged into the effluent system, and clearly
the putting-in of another stage of heat treatment is a double-bind,
if you like.
Professor Griffin: Absolutely.
Q16 Chairman: Surely it should have
been known beforehand that the chemical treatment was insufficient?
That is the bit I do not understand, because we are not dealing
with stupid people.
Professor Griffin: No, and I think
that is a very reasonable point. If you look at the modern new
facilities, and you saw the new animal holding facility at Pirbright,
I am sure, so you will have seen the vats which both heat and
chemically inactivate, so I think the answer to your question
is yes, it was inactivated.
Q17 Mr Cawsey: As far as inspections
are concerned, do you think they are carried out frequently enough
at present, or should their frequency increase, and are you confident
that we will have inspectors with the right level of expertise
to be able to do the job?
Sir Bill Callaghan: I think it
is fair to say that under the SAPO regime resources were very
limited, under half the time of one person in Defra for Containment
Level 4 laboratories and three or four people, again part-time,
in the Veterinary Laboratories Agency. I was very keen in making
my recommendations, as HSE took on responsibility for this work,
that resources followed from Defra, and I understand in Phase
1, which we are now in, that that transfer of resources has taken
place. Concerning the issue of competence of inspectors, one of
the benefits of HSE, of course, is that it can draw on a wide
range of disciplines—obviously science of microbiology but
also other competences about control systems and, of course, if
we are talking about Pirbright we are talking about the drains,
and it is precisely because HSE can bring together such a wide
range of skills and draw on not just the skills and competences
of colleagues in the Biological Agents Unit but other colleagues
in HSE that I think it is more equipped to take on this task.
Q18 Mr Boswell: That is also true
presumably about experience on operator practice and reliability
and fatigue and so forth, some of which I have seen at the research
laboratories.
Sir Bill Callaghan: Indeed.
Q19 Mr Cawsey: We have seen with
the COSHH regulations that once notification of use of a pathogen
is made to HSE at an organisational level, the organisation is
then at liberty to use it at other premises provided it is licensed
to do so. What level of detail do you think should be kept by
the regulatory authorities about the exact location of laboratories
using a pathogen, the number of persons involved, and the quantities
of the pathogen in question?
Sir Bill Callaghan: I am not sure
I am competent to give an answer to that particular question.
Professor Griffin: I think I could
help there. Each of the laboratories, and I am now including CL3,
which would be pathogens such as HIV and so on, and in my own
establishment, has a local police officer who visits very regularly.
We keep an inventory which he or she inspects concerning the pathogens,
the amount of pathogen, and the experiments that have been carried
out. They visit about once every six months, and more often if
required, so they will visit more frequently than any of the other
regulatory bodies.
Sir Bill Callaghan: In terms of
the risk assessment that information, of course, will be given
to HSE, and HSE will then decide on what is the appropriate frequency
of inspections.
1 Note from the witness: "Under
the COSHH regulations HSE has to be notified; under the GMO (CU)
regulations HSE has to be notified and give consent." Back
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