Examination of Witnesses (Questions 80-99)|
17 MARCH 2008
Q80 Chairman: The Anderson review
was absolutely clear. It said it was a failure of the regulatory
system. Do you not agree with that?
Mrs Lysons: No.
Q81 Chairman: Anderson's conclusion was
Mrs Lysons: Dr Anderson made a
number of conclusions including that the good things Defra did
to manage the outbreak far outweighed the not so good or the problems.
Also, Dr Anderson pointed out that the top managers at the facilities
that conduct the work are responsible for managing the risks associated
with that work.
Q82 Chairman: Let us turn to the
HSE because you are the good guys for a moment, until Dr Gibson
starts. It seems that you have been vindicated. Your approach
in terms of risk assessment that has been the basis on which to
have good regulation seems to be the right approach. Do you take
that reading from what has happened, from both the Anderson report
and also from Bill Callaghan's report?
Dr Logan: I guess the answer is
yes. Our risk assessment approach is seen as a modern way of regulating
rather than issuing licences.
Q83 Chairman: Can you tell me how
you make sure that you have good quality when you are having risk
assessment with individual laboratories or individual premises?
Talk us through that. How do we get a consistent, high standard
because at least with a licence you have to tick the various boxes
before you get your licence. Is this approach a little more problematic?
Dr Logan: In the earlier session
there were some questions about the differences between licences
and concern that at the higher levels of containment people make
their own assessment and then they can just get on with the work.
The regulatory system for example under GM currently almost combines
the two. You require a formal consent before you can start the
work. Although you have to notify in advance and carry out a risk
assessment of the process, you cannot start the work until the
competent authority, which is HSE and Defra in England and Wales,
gives you a formal consent for that. That will set out conditions.
You will have stated how you are going to carry out the work and
the consent will confirm that that is how you are going to be
judged to work against. The strength of the system is that it
recognises that, for different pathogens, there may be a very
different risk profile. For example, if you are working with prion
agents which are not transmitted by the airborne route and are
not susceptible to fumigation, you may have a level three laboratory
that does not include those measures. You can in the consent have
a derogation for those particular measures. That is why it is
a strength. It gets people to think about what they are going
to be doing and put that in a consent application.
Q84 Chairman: The COSHH regulations
do not work like that, do they?
Dr Logan: No. The COSHH regulations
are based on a different European directive which does not have
that same feature built into it.
Q85 Chairman: How are you going to
pull these together?
Dr Logan: It is a challenge. We
have started to look at that with our legal advisers' offices,
both in Defra and HSE. They are currently looking at how we can
pull the three sets of regulations together under a single regulatory
Q86 Chairman: Dr Penrose, should
the new system regulate the premises, the person or indeed the
process? What is your thinking?
Dr Penrose: HSE's remit has always
been that the organisation with responsibility for creating those
risks should manage those risks. From whatever health and safety
matter that is ongoing, the responsibility ultimately rests with
the body corporate. That would very much complement Sir Bill Callaghan's
report and what goes on in practice in that the organisation is
responsible for ensuring that the risk assessment is done, is
submitted to the HSE and gets the regulatory approval but it is
at the organisation level because they can then put the systems
in place to ensure that the standards are being met throughout
Q87 Chairman: You feel that is sufficient
to bring all three together, to make sure that there is not slippage
between the institutions? We have heard Dr Gibson describe what
happens in universities where someone who does not have a job
suddenly gets to be the biosecurity officer which terrifies me,
if that is the level at which we are working.
Dr Penrose: It is true that there
is a culture change. The system is changing. Organisations and
employers recognise the risks not only to their workers but also
to their business of this kind of incident. I manage a team of
inspectors that goes out week in, week out and our experience
is that this message is getting through, that organisations really
need to take more responsibility and become more accountable.
In those organisations that show strong leadership, you can really
see that the senior managers are getting involved right down to
the grass roots level with what is going on in these laboratories.
Those leaders and senior managers taking the interest and making
sure that the standards are being met is starting to spread.
Q88 Chairman: In your view, we had
a systemic failure of the regulatory system under the old regime?
Dr Penrose: Obviously the way
HSE regulates is different to the way that Defra have regulated.
I feel that the system Sir Bill has proposed and this unified
framework will be a more robust regulatory framework in order
to ensure that these issues do not happen again.
Q89 Dr Gibson: Do you talk much together
at Defra and HSE or is it just recent? Have you just met?
Dr Logan: We have been working
very closely, particularly since the summer.
Q90 Dr Gibson: And before that?
Dr Logan: We do. It depends. In
different areas it is obviously fragmented. The main area of commonality
was under the GM regulations where Defra and HSE are joint competent
authorities. Consent applications have to be signed off both by
Defra and HSE.
Q91 Mr Boswell: You mentioned having
a responsible officer and the company or the undertaking being
responsible. One of the characteristics at Pirbright was a shared
site. It does occur to me that Professor Griffin gave evidence
indicating that there was a case for sharing facilities. Is it
important in those circumstances to be able to identify who the
boss is, who the controlling mind is, so that there is no doubt
about it even to the extent that they can overrule the practices
of other partners or joint undertakings?
Dr Penrose: Yes. That does happen
in practice. We are seeing that more and more particularly if
we are looking at high level agreements. You will have for example
employees of a university working in the same facilities as employees
of a research council or a charity. When we do inspections we
really have to tease out who is taking responsibility. What we
find when we gather evidence is that more and more there will
be high level agreements between for example a senior director
of a charity and a senior director of a university.
Q92 Mr Boswell: If that is absent,
that might influence your satisfaction with the level of inspection?
Dr Penrose: Absolutely.
Q93 Mr Cawsey: I would like to return
to the implementation of the new system. How much progress has
been made in implementing the Callaghan review?
Mrs Lysons: Defra welcomes the
Callaghan review. We feel that our inspectors for SAPO are qualified
in a lot of the very important areas but we recognise that there
are specialist skills which HSE has access to which we do not
have immediate access to. That would be one reason why we are
particularly keen to follow through with the Callaghan recommendations
as fast as we can with the outcome that we have a sensible, integrated
regime. To answer specifically, we said that there would be three
phases of implementation, the first starting immediately at the
start of this year, where we had formal collaboration between
Defra and HSE on SAPO. That is most definitely in place and is
working towards, in April, a situation where the Health and Safety
Executive will have primary responsibility for doing the inspections
and having rights of access to the premises. You have heard Professor
Griffin saying that his advisory committee on dangerous pathogens
is working on developing a unified, integrated framework with
human and animal pathogens and a consistent categorisation system.
That, along with other legal work, will be working towards, at
the end of this calendar year, a new legal basis for combined
regulation of pathogens.
Dr Logan: To concur, we are in
phase one of the implementation at the moment. I am leading a
team of people working from the HSE side, going out and carrying
out inspections. We are supporting licence applications at the
moment. From April, I have been given responsibility for delivering
the inspection programme across the board, including SAPO, GM
and COSHH. We are in the middle of preparing our staff, looking
at training needs for additional responsibilities, etc., making
sure that the legal framework is in place. Once that is in place,
phase two will continue until phase three is implemented later.
Q94 Mr Cawsey: I did not know this
but I see that SAPO is a devolved regulation so it involves the
Scottish Parliament and the Welsh Assembly. How has that been
handled with the coordination? Is it something that needs to be
de-devolved, if there is such a phrase?
Dr Logan: It does make it more
complicated. Obviously we are having to negotiate and discuss
with all three governments and indeed Northern Ireland has to
be brought into it as well. They tend to introduce parallel systems
so they are involved in the discussions too.
Q95 Mr Cawsey: I made this as a rather
flippant point. You said it has made it more complicated. Would
it be better for safety if it was just dealt with by a government
Dr Logan: That is up to government
Q96 Mr Cawsey: It is up to government
to decide but we expect people like you to advise.
Dr Logan: A laboratory handling
a particular agent should be working to the same standards whether
it is north of the border or south of the border, or in Wales.
The buy in from the Scottish Government and the Welsh Government
now is that they welcomed the recommendations in Sir Bill Callaghan's
report and are participating in the discussions.
Q97 Chairman: You mentioned Northern
Ireland. Given that Ireland has a very short border now across
to the Republic which relies very heavily on farming particularly
in mid-Ireland and the west of Ireland, what relationships do
you have there? Clearly what happens in the Republic of Ireland
will significantly affect what happens in the north.
Dr Logan: The relationships are
mainly between the north and the south in terms of government
access. The discussions that Defra and HSE are having are with
HSE Northern Ireland and Defra in Northern Ireland.
Q98 Chairman: Is that to try to get
common frameworks there?
Dr Logan: Absolutely.
Chairman: I have some sheep in Donegal
so I have a personal interest.
Q99 Mr Cawsey: Do you think the HSE
has sufficient resources to take on the additional administrative
burden and the new unified regulatory framework and will you be
ready for the sole responsibility in April?
Dr Logan: We have a team of inspectors.
We are going to recruit some. We are about to advertise to recruit
some more. The number of additional premises that we will be taking
on is quite small. A lot of the SAPO licensed premises were also
regulated by HSE and, for zoonotics for example, under COSHH or
GM regulations etc. Fewer than ten new centres have been taken
on in total, albeit some quite complex ones.
2 Note from the witness: "No regulator
can ever be in a position to oversee all operators, activities
and processes pertaining to biosecurity, all of the time, in all
of the facilities they regulate. The only people who can be in
a position to ensure that biosecurity is fully addressed throughout
a facility are the people who work there. It is therefore essential
that a culture of biosecurity exists throughout such facilities,
and the responsibility for ensuring this rests with those facilities." Back