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

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[2].

  Q81 Chairman: Anderson's conclusion was wrong?

  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 framework.

  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 their control.

  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 department?

  Dr Logan: That is up to government to decide.

  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

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