Examination of Witnesses (Questions 180-199)
PROFESSOR CHRIS
THORNS, DR
JOHN STEPHENSON,
SIR LESZEK
BORYSIEWICZ AND
MR STEVE
VISSCHER
31 MARCH 2008
Q180 Dr Gibson: Would the health
and safety department do that then? Would they put them in place?
Who would put them in place?
Dr Stephenson: The ones which
are operating at Porton have been set up in conjunction with the
Department of Health?
Q181 Chairman: Sir Leszek and Steve
Visscher, do you support the Callaghan proposals? Do you feel
that a single regulatory framework is the right way forward?
Sir Leszek Borysiewicz: Yes, with
one proviso, and that is the proviso that the introduction of
the regulatory system does not actually end up making it more
bureaucratic and confusing. I think all the research councils
in their response are quite happy with the Callaghan proposals
but it is quite a minefield of bureaucracy when you actually get
involved in it. I would hope that this conjunction would lead
to a simplification of the bureaucracy as well.
Mr Visscher: We support it too.
We are keen to see transparency in the process and ensure that
there is full expertise within the regulator, and consultation
in the development of the detailed regulations with researchers
who are working in the field.
Q182 Chairman: Sir Leszek, you talked
about simplification of the regulation and one regulatory framework
rather than two seems to be a simplification. The other key aspect
of the Callaghan report was that the new system should be based
on risk assessment and notification. Do you feel that that is
the best solution? Will that lead to less regulation?
Sir Leszek Borysiewicz: I think
the risk assessment should be at the heart of all these developments
in relation to protection and we have to have responsibilities
that are very clear on all of the agencies so far concerned, firstly
a risk assessment in relation to the operator and a risk assessment
in relation to leakage, spillage and then the security assessments
that have to take place. Those are inherent. It is essential that
we continue a risk assessment based on the purpose of a particular
facility because, for example, as we have already heard, if you
raise the issue around prions there are specific aspects that
have to be brought in in relation to prion research that are very
different from even the standard Category 4 facilities because
of the very nature of the pathogen you are dealing with.
Q183 Chairman: MRC are awarding a
significant number of grants through university responsive grants.
Do you feel that permission should be required before work begins
or should it simply be based on the institution taking a risk
assessment approach? That is the bit that perhaps worries us a
little.
Sir Leszek Borysiewicz: That is
what I was saying, that the system has to be relatively simple
for the investigators themselves so as not to discourage their
involvement in this research because we do have to remember that
the reason for investigating these dangerous pathogens is because
they are dangerous and therefore it is very important that we
actually have more information about them. At the present time
it is to make sure that you have ownership of the work that is
in progress, be it a university or an institute in our case, that
it is very clear that somebody is willing to pick up the responsibility
for ensuring that the facilities are correct. We also have to
ensure that the staff who operate those facilities are both cognisant
with the regulations but also able and have the capacity and training
to be able to handle this material safely, catalogue it and make
sure that we can actually deal with it, particularly in some of
the other areas that the Callaghan review looked at.
Q184 Chairman: You were nodding your
head so I presume you agree with what Sir Leszek was saying, but
the other issue for us was brought forward at one of the hearings
we had with Dr Paul Logan of HSE who indicated that there was
still a significant number of bodies that were actually involved
with regulating work on dangerous pathogens and their transport
to and from laboratories. Should there be a one-stop shop? Should
there be one point of entry in terms of that in that organisation?
How do we actually streamline that so that we not constantly have
different bodies looking at different parts of the organisation?
Do you share that concern?
Dr Stephenson: Absolutely. That
is one of the reasons why I think this is a golden opportunity
to merge all those regulations and those various authorities.
Like Sir Leszek we are concerned about the bureaucratic burden
which is constantly being placed upon researchers. We have an
opportunity here to merge those various regulatory bodies and
those instructions coming to the laboratory workers such that
they are not over-burdened by the amount of bureaucracy and the
number of people that they have to contact in order to start the
work.
Q185 Chairman: Chris, do you share
that?
Professor Thorns: Yes, and another
important factor I think with the single body is that when VLA
started working on BSE—mad cow disease—we worked quite
closely with the Health and Safety Executive and they provided
help and advice and support in terms of how to deal with that
particular prion. Indeed, as Sir Leszek has said, it came about
that he was given a certain derogation in terms of some of the
activities and they were much stricter ways of dealing with it
in other activities. I feel that many of us have good relationships
with the HSE and it should be a proactive approach as well as
a reactive approach by them.
Q186 Chairman: Callaghan was obviously
talking about bringing two regulatory systems together and everybody
seems to be in broad agreement with that, given the comments made
about not adding to the overall bureaucratic burden. In terms
of actually bringing in all the other organisations involved,
who should be pulling that altogether? Should it be Defra? Should
it be research councils? Should it be the HSE?
Mr Visscher: Going back to my
earlier comment about consultation, I think it would be helpful
for one body and I think we would see HSE as being the fulcrum
for this going forward and for that body to hold the ring in the
discussions with all interested parties. I think the interactions
between the Institute of Animal Health and HSE are developing
and are more involved than they used to be—and quite rightly
so—with the way the new regulations are evolving. I think
that would be the right way forward.
Q187 Chairman: HSE should be the
fulcrum in your view.
Mr Visscher: Yes.
Q188 Chairman: Do your colleagues
share that view?
Professor Thorns: Yes, except
that I think some transportation materials often go outside UK
borders and I do think some of the regulations we have to deal
with are based on worldwide legislation so maybe there is a slightly
broader role for bringing this together as well.
Q189 Mr Cawsey: I would like to ask
a few questions on Pirbright and the experience and where we are
following last year's events. I will ask Steve first, as Chief
Executive of BBSRC. As the sponsor of IAH Pirbright, employer
of its staff and owner of the site, how much blame should BBSRC
accept for the release of the foot and mouth disease last summer?
Mr Visscher: As previous reports
that have been published on this show, there were a range of events
leading up to the believed route of the release of the virus.
One of the key issues for BBSRC was the way in which the regulation
was exercised and for us there was one big surprise and that was
that it was permitted, under the licensing terms, for live virus
to be in the drains even after there had been some treatment.
That was an agreement between Merial and the regulator. Why that
was a shock to us was that the drains were not designed in the
first place with that in mind. Secondly, we had also put in place
arrangements between ourselves and Merial to have a lease prohibiting
the release of noxious substances into the drains. Despite all
that, we also had a fall-back mechanism in place, a so-called
chemical treatment plant which is there in the event of a virus
getting into the drains. The BBSRC had endeavoured to put in place
a framework and agreements and it was a surprise to us that it
was possible for the virus to be released into the drains. Had
we known otherwise then I think our risk assessment would have
been different.
Q190 Mr Cawsey: Why was that unknown
to you?
Mr Visscher: One of the lessons
learned from the overall experience of Pirbright is the sharing
of information between the parties was not as much as is in place
now. The licences were regarded as confidential and it was then
left to whether the parties chose to exchange those between themselves
or not. I believe that as IAH and Merial had existed on the same
site for some years there was an understandable expectation that
the same regulations would be applied to both parties, given that
they were handling the same material. That proved not to be the
case.
Q191 Chairman: Mr Visscher, you are
in charge of this site; it is a BBSRC site.
Mr Visscher: It is BBSRC owned
site which is leased to the Institute of Animal Health and the
Institute of Animal Health sub-leases it in part to Merial Animal
Health.
Q192 Dr Iddon: I find what you have
just said surprising, that it is permitted for live viruses to
be in the drains. Do any of our panel know whether any other licences
exist where live viruses are allowed into the public drainage
system?
Mr Visscher: It had been, it is
not now.
Q193 Dr Iddon: That is Pirbright
but are there any other sites where we might have licences in
force which allow live viruses to get into the public drain system?
Sir Leszek Borysiewicz: To the
best of my knowledge within the MRC that is certainly not the
case within the units that we operate in. We expect inactivation
of the agents before they are actually released.
Q194 Dr Iddon: So Pirbright was the
exception.
Dr Stephenson: That is my understanding.
It is certainly true of the Health Protection Agency. All of the
material coming out of the Category 3 and Category 4 laboratories
were autoclaved on site within the same building, and for the
Category 4 facilities within the same laboratory suite. The only
exception to that was a vaccine manufacturing facility and the
HSE insisted that the chemical inactivation plant was too large
to actually go into the suite but was located adjacent to the
suite on the Porton site and there was a secure conduit from the
production facility into the inactivation chamber. That was a
very short distance indeed; I am talking about yards and that
was within the secure site at Porton. That was for a production
facility, not for a research facility.
Q195 Mr Cawsey: I am slightly worried
that the three of you have answered the question about Pirbright
being exceptional but there is bit of "it is my understanding",
"as far as I am aware", not very definitive from this
side of the table. Who is the person who would be able to advise
the Committee on that if it is none of you eminent people?
Sir Leszek Borysiewicz: Category
4 and Category 3 facilities do not have any inactivated agent
leaving them from the sites that we operate because that is usually
within the standard operating procedures of all of these facilities
and it is inherent in them. We do not have an industrial production
facility of that level operating with any of our materials. I
can be quite definitive on that point.
Professor Thorns: I can be quite
categorical about VLA.
Dr Stephenson: I can be quite
categorical about the HPA as well.
Q196 Chairman: I want to bring Mr
Cawsey back to BBSRC because it just seems to me it is a little
bit like Pontius Pilot here, that you have washed your hands and
said, "We own the site but other people actually operate
it,—two other organisations operate it—and therefore
it is not us, guv".
Mr Visscher: Our approach, as
a major sponsor and funder of the Institute of Animal Health,
is to provide a framework and support, whether that is through
guidance or funding or additional infrastructure. Coming back
to the regulation point, we were aware that IAH operated a procedure
that was based on inactivation through chemical means in the laboratory
and in the belief that that would not lead to any live virus in
the drains. In the unlikely event of that happening there was
the failsafe mechanism of a chemical treatment plant. The laboratory
procedures of the IAH were designed to inactivate the virus in
the laboratory which was using only very small quantities of the
virus whereas, in contrast, the arrangements which we are now
aware of that were operating within Merial and with the approval
of the regulator—as was outlined in the Spratt report—did
permit live virus to be in the drains. BBSRC, through its various
mechanisms of guidance, was working on the premise that there
was inactivation within the IAH laboratories. We had made the
erroneous assumption that the same would be happening in Merial.
We have subsequently put in place, working through the Institute
of Animal Health, a clear agreement with Merial for the exchange
of information, for all the processes to be validated, the results
of those validation tests to be shared and if any incident did
occur in the future there to be immediate notification between
both the parties. In terms of the lessons learned, that is an
improvement that has been put in place between the parties subsequently.
Q197 Mr Cawsey: Would you accept
that those people who were on the receiving end of the outbreak—I
represent people who were indirectly affected because of what
it did to the pig industry—would be staggered to learn that
this agreement was in place?
Mr Visscher: What BBSRC had done
was to put in place a lease that prohibited the release of these
viruses and we had placed, perhaps with the benefit of hindsight,
undue reliance on the regulator not permitting live virus into
the drains.
Q198 Mr Cawsey: We visited Pirbright
and one thing that struck all of us when we were there was that
it is an old facility that looks a bit beyond its sell by date
and needs to be redeveloped. We spoke to staff who had frustrations
about that as well. What can you tell us about the re-development
programme? Have all those who are funding this agreed to meet
their share of what are now increased costs to the project?
Mr Visscher: The project was formally
agreed in 2005 between DTI and Defra with BBSRC involved as well.
At that time the budget was £121 million. Subsequently, partly
due to redesigns and partly due to inflation, the cost of the
project has risen. We have been in discussion with our sponsoring
department, DIUS and with Defra over the funding of the additional
costs. We have received strong indications that that additional
funding will be made available. The details of it are still be
worked through because with the increased capital costs come some
increased running costs in terms of capital charges. I think it
is entirely appropriate that all the parties are clear that sufficient
running costs are available for the facility as well as the capital
costs.
Q199 Mr Cawsey: When do you expect
that finally to be put in place?
Mr Visscher: In terms of formal
agreement on the funding, within months; we are close to that
now.
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