Select Committee on Innovation, Universities, Science and Skills Minutes of Evidence

Examination of Witnesses (Questions 180-199)


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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