House of COMMONS
MINUTES OF EVIDENCE
TAKEN BEFORE THE
Innovation, Universities, Science and Skills Committee
Monday 17 March 2008
SIR BILL CALLAGHAN and PROFESSOR GEORGE GRIFFIN
and DR NICK COULSON
USE OF THE TRANSCRIPT
Taken before the Innovation, Universities, Science and Skills Committee
Biosecurity in UK Research Laboratories Sub-Committee
on Monday 17 March 2008
Mr Phil Willis, Chairman
Mr Tim Boswell
Mr Ian Cawsey
Dr Ian Gibson
Dr Evan Harris
Dr Brian Iddon
Examination of Witnesses
Witnesses: Sir Bill Callaghan, former chair of the Health and Safety Commission, Chairman of the review of the regulatory framework for handling animal pathogens, and Professor George Griffin, Chair of the Advisory Committee on Dangerous Pathogens (ACDP), gave evidence.
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.
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.
Q20 Mr Cawsey: So should one body, for instance, HSE, take responsibility for all aspects of the regulation of pathogens, including anti‑terrorist provisions and transports, to give laboratories a single point of contact?
Sir Bill Callaghan: It may well be going a bridge too far to say that HSE would take on all of the work of the security services. I am told that there is good contact between HSE and colleagues in the security services, and that is absolutely right, and is an issue perhaps you would want to address to my former HSE colleagues, but I do know on other issues where matters of national security have emerged that HSE has always played a responsible part in activities of Cobra and its associated committees.
Professor Griffin: There is another very interesting and important aspect here as well. if you consider there are four different types of laboratories at P3 and P4 level - there are diagnostic laboratories in hospitals, there are academic laboratories in university institutions doing research, there is the Ministry of Defence with biodefence, or bioattack, whatever you want to call it, and that is three of them - and each of those are inspected. In the Hospital Diagnostic Service inspections are carried out by private organisations who will come once a year at the request of the hospital diagnostic facility, and they will inspect the hoods and the procedures and so on and sign those off, and if the hospital is happy with that then they continue. So there is a private sector involved in this. The fourth arm of this, of course, is industry - the big pharma, antibiotic development growing dangerous pathogens. So you have four main sectors from government through to big pharma operating, each using the same regulations but being inspected maybe in different ways, and that should be joined together.
Q21 Chairman: Bill, just briefly, what I certainly did not fully understand, and perhaps you will clarify this, is that at the moment a university can apply for a licence. It satisfies the criteria and it gets a licence. It can then use in a variety of laboratories a particular pathogen, let's say a Level 3 facility. In fact, it can use that pathogen in a number of different laboratories without having to have each of those laboratories licensed. Are you saying that under your new proposals there would be a risk assessment of each of those laboratories before, in fact, they were licensed? Is that the process that you describe?
Sir Bill Callaghan: At the moment under SAPO licences are given, as I understand it, to individuals to work in a particular laboratory. Under COSHH and GMO (Contained Use) there has to be notification, and Mr Cawsey was bringing out the different bases of who was, as it were, given the notification. What we are suggesting is that, for work on all pathogens, both animal and human, there should be a risk assessment conducted by the duty holder that should then be submitted to HSE.
Q22 Chairman: So it will be, if you like, the biosafety officer who would be responsible wherever those pathogens were being used, rather than the individual?
Sir Bill Callaghan: Well, I am not sure it would necessarily be the biosafety officer; it would be the body corporate, the university, the hospital, the research institute, and of course one issue which we touch on is who is the controlling mind where you have a number of organisations on one site, but there is someone clearly in charge who has to put in the application and in health and safety law who would be responsible. There are then clear responsibilities on the BSO and other members of staff, but it would not be the BSO, in my understanding at least, who would be putting in the application: it would be the body corporate.
Professor Griffin: At the moment in academia, and I am sure Dr Gibson will concur with this, it is the head of the institution who is finally responsible, and if there is a serious incident or accident then the head of the institution is the one who would bear the brunt.
Dr Gibson: But here it is often the registrar who delegates his authority to some minion who then gets the boot thrown at them, and that is quite legal. That is how they slip out of their responsibility.
Q23 Mr Boswell: I have two questions about classification. The first one is, are the current risk classifications of pathogens accurate and sufficiently comprehensive? Have they in turn been properly risk assessed, and maybe at that point also is the regime there coming together between zoonoses, human pathogens and animal pathogens?
Professor Griffin: The risk groupings are looked at each year by ACDP in the light of new information. For example, if there were to be a change in resistance patterns to an antibiotic or an antiviral drug, then the category of risk for an organism could be moved upwards.
Q24 Mr Boswell: Or virulence of the organism?
Professor Griffin: Exactly.
Q25 Dr Gibson: How would you know there is a resistance?
Professor Griffin: Because there is surveillance going on all of the time. For example, in routine endemic influenza we know that the main drug, Tamiflu, many of the ordinary strains of influenza now are resistant to Tamiflu, so it is not just the H5N1 bird flu which is the serious strain of flu. There is on‑going surveillance and assessment.
Q26 Mr Boswell: Without talking about, as it were, the whole medical profession, which is a separate issue, in terms of those who are needing to work with these pathogens, your change of assessment or your annual review of assessment, that information, would be known to them?
Professor Griffin: Very much so, yes.
Q27 Mr Boswell: And the animal pathogens under this new regime would tend to adopt the same pattern, and you would advise the veterinary profession?
Professor Griffin: Yes. When the assessment is made you take into account many factors. Virulence is a major one, of course. If there are drugs which can combat the infection, if there are vaccines against that infection, all of that comes in, and the CL4 ones are the ones with no drugs and no vaccine.
Q28 Mr Boswell: So what at least I think you have reassured me on is that it is not as if there has been some assessment done in, say, arbitrarily, 1956 about the virulence of F&M, or indeed a human pathogen like influenza which is now still applicable. It is looked at every year.
Professor Griffin: Absolutely.
Q29 Mr Boswell: Secondly, how logical and evidence‑based are the current classifications of laboratories under SAPO, COSHH and GMO(CU)? How well are they understood? That is partly the training issue, but are they logical and rational in themselves? You cannot look at them every year, for example.
Sir Bill Callaghan: We did find some confusion, I must say, talking to laboratories about the different classifications, but I think foot and mouth disease virus is at the extreme end of the spectrum as something which has the highest level of SAPO classification and the lowest level of ACDP classification because it is unlikely to cause human disease. One of the reasons for perhaps bringing this together in the round is that if you say that something is Level 1 it sounds as if it is not really important, and my opening remarks were trying to address this issue, that failure at Pirbright led to considerable harm.
Q30 Mr Boswell: Following on from that, are the principles of design and operation for containment laboratories at the different levels based on evidence? This presumably includes economic risk as well as human risk.
Professor Griffin: Yes, there is good scientific evidence for the procedures carried out. In fact at the very highest level they are based on good evidence and they are so secure that they often have failsafe procedures, such as the heating that we were talking about.
Q31 Mr Boswell: Finally, on the international perspective of all this, you operate as ACDP and you will clearly be in contact with professionals in other countries, and there is a European Directive as well that we are aware of. There is a huge interest, of course, across the world - easy transmissibility by air travel, for example. How much can we be reassured that there is a common approach to this, even if legal forms or slight regulatory differences occur, across the major developed countries at least, and that we are not going to have difficulties where something gets through because somebody, it may not be in the United Kingdom, is a weak link in a regulatory chain in relation to a particular pathogen?
Professor Griffin: This, I must say, is a concern. We heard three or four weeks ago of the American gentleman, Dr Sharma, and really we are ahead of the States in my view in our regulation of CL4, and I will be visiting some of their sites soon. There is no doubt, however, that we have a much tighter framework than that in the States, and you remember he said that anybody who wants to have a CL4 can just build one on their facility with little in the way of regulation. So we are ahead in that. In terms of Europe there are two main sites, one in Marburg and one in Lyon, and there are European regulations which deal with this, as you say, which keep the developed world as safe as it could be. At the end of the day, of course, a single individual travelling on an aeroplane with a pathogen is not covered by COSHH or SAPO; they are covered by themselves.
Q32 Mr Boswell: At least if we take the specific answer you gave me earlier about your annual update of pathogenicity, that information would be immediately transmitted to your counterparts, and they would take it into account, and if you had some aberrance or new experience that would go through the community internationally pretty quickly?
Professor Griffin: Yes.
Q33 Dr Iddon: In your view do we have enough capacity in the United Kingdom for handling research on dangerous pathogens, either now or projecting into the future?
Professor Griffin: I do not know at the moment, and I am just conducting a review on behalf of the Medical Research Council; it has just started to look at this. The MRC are charged to look at newly emerging pathogens and dangers to public health from these, so there must always be surge capacity available when something like bird flu or another of the emerging viral infections happens. There probably is enough at the moment but we are not well endowed. The Ministry of Defence has a facility at Porton which is largely doing biodefence, of course. There is spare capacity there, we know, and we would be able to use that if necessary. The MRC is thinking of a new facility when it moves in NIMR, as I mentioned, and the question is where would that be sited. In Boston they have a CL4 facility in the middle of the city, which is causing great perturbation at the moment, and this may well be a very important guiding factor for the siting of future facilities in the United Kingdom.
Q34 Dr Iddon: I am coming to that aspect in a moment. What about the handling of large animals? Can we do that in Britain adequately?
Professor Griffin: We can do that in limited places. We can handle small primates at Porton at the HPA facility for TB and HIV research and vaccine research. In terms of large animals such as horses, cows, and maybe sheep, the Pirbright facility, the new one that I hope you saw, will be able to do that. Up to that time the only facility in the world, as I understand, for very large animal Containment Level 4, post mortem, was in Australia where they were doing work on Hendra virus, but the new facility at Pirbright when commissioned and tested will be able to work on cows.
Q35 Chairman: They, in fact, said that that would not be able to ‑‑
Professor Griffin: For cows?
Chairman: Yes. At level 4.
Q36 Dr Iddon: For the CL3 and 4 laboratories, in your opinion, from what you know and what you have seen in your experience, is there enough maintenance money to maintain these facilities in good condition?
Professor Griffin: In academia, which is my own place of work, there is not. We have to beg and scrape and get money for routine maintenance; every year we have to have inspection of cabinets, replacement of filters, and this is costly, very costly, and this, by and large, has to come out of either research grants or out of the consumables which the university has. It costs a great deal of money to keep these facilities going.
Q37 Dr Iddon: You have mentioned the HSE a number of times as being a regular agency in this sphere. Do we know how many CL3 and 4 laboratories we have in Britain and where they are situated? Who has that knowledge? Who has the strategic overlook?
Professor Griffin: That is a very simple question with a complicated answer, I am afraid. If you look at CL4 there are elements of security and so on, and so these lists are not easily available for newspapers and so on for obvious reasons. Defra has a list of CL4 and SAPO4 which we have all seen but is not for public consumption; I have a list for the MRC for this Committee that I am looking at at the moment; there are two industrial sites which do CL4 work, two vaccine companies, Merial and Schering. The rest are either government or academe, so we do know what there is in terms of CL4. In terms of Containment Level 3, the exact number is round about 350, I do not have that list, and that is made up of diagnostic facilities in hospitals, of industry, farmer, academe and government facilities.
Q38 Dr Iddon: Should there be one body that overlooks this, like the HSE which you have mentioned?
Professor Griffin: I think that would be incredibly useful and important.
Sir Bill Callaghan: In our report we note the number of ACDP CL4 facilities, which are eight in GB, and 352 CL3 facilities. For SAPO there are 68 laboratories with a SAPO licence, and 10 are for work on pathogens categorised as Category 4. In my previous existence I was part of a Commission recommendation to take this information on laboratories out of the public domain. This was after 9/11, for security reasons.
Q39 Dr Iddon: Professor Griffin, you hinted at the fuss over a CL4 facility in the middle of Boston. I understand the Germans are quite happy to have one in the middle of Berlin, and we are considering putting one in the middle of London. What is your advice to the authorities on the presence either of CL3 or 4 in the middle of large conurbations?
Professor Griffin: I will give you better advice in about three months' time when I have been around, but at the moment I would try to avoid it, to be quite frank. I would wish to have high security outside of a major city.
Q40 Chairman: Why?
Professor Griffin: Because of the danger of spills or breakdown of facilities; because of what would happen if there was a very major leak, and if that leak was perhaps even terrorism‑related, to the general population.
Q41 Dr Iddon: That is quite a clear answer. Thank you. Regarding universities, do you think any university, however well off it was financially, should be allowed to establish a CL4 laboratory to work on dangerous pathogens, or do you think it would be more cost‑effective for them to share existing CL4 facilities elsewhere, outside the universities?
Professor Griffin: I do not think any university should do now. I think there should be clearly a university with a programme looking at dangerous pathogens with experience in microbiology and having important questions to ask. If it is possible to share facilities, then that is very cost‑effective, of course; as I have said earlier, it is very expensive to run these facilities, so I do not think every university should have one, and I think universities should be encouraged to share.
Q42 Dr Iddon: Professor Griffin, you are leading a review of CL4 capacity in the United Kingdom by the Health Protection Agency, I think, but I think the research is commissioned by the MRC.
Professor Griffin: That is right.
Q43 Dr Iddon: Could you tell the Committee what your terms of reference are, please, and when you are likely to report?
Professor Griffin: Yes. We have had two scoping meetings now, the last on Friday, and the report will be available on 1 October this year. The report will look at capacity, answering one of your questions, and will look at the ability to have surge capacity in terms of serious incident or serious new infection. It will look at security in terms of siting to see if there is real evidence that a greenfield site is better than a brownfield site: it will look at international co‑operation and international regulation, in particular the States and Europe.
Dr Iddon: Thank you.
Q44 Dr Gibson: As you said yourself, a major part of this whole enterprise is the training of people. Have you any comments on that to begin with? Is it uniform, or left to individual universities and individual units to do themselves, and does that make for ambiguities and problems?
Professor Griffin: That is a really important question, and I have been wrestling with this myself since I took on the Chairmanship of ACDP and you have put your finger on the two most important aspects. If we look at CL3 and 4 together, just for a moment, there are no lists of competences required in order to have someone work inside a laboratory. It is either P3 or P4 level. Each institution will have its own training schemes, will assess competence and will match that against the risk of the procedure being carried out. There is no national certification or diploma to say that somebody has reached a level of competence. It is an apprenticeship scheme, Dr Gibson, and it does concern me, to be quite frank.
Q45 Dr Gibson: Do you think there should be such a scheme?
Professor Griffin: I think there should be.
Q46 Dr Gibson: Is there any chance of that happening?
Professor Griffin: Yes. In preparing to come to this meeting I have been investigating what courses there are around, and how diagnostic laboratories accredit their workers to work in CL3 particularly, which is relevant to the diagnosis of TB or HIV. The first thing to say if we look at hospitals first is that the MLSOs who work in the laboratory for containment diagnosis all have to have a First degree in a biological subject, and that degree has to be accredited as having 75 per cent of human biology, in loose terminology. They then have to work within the laboratory for three years keeping a portfolio of what proceedings they have carried out, and they are only allowed to work at CL2, which essentially is open‑bench and small ventilated hoods. At that point they are accredited and can start to work in CL3 under supervision, and then they have a two‑year apprenticeship during which time their competence is assessed, but at the end there is no signing off, no diploma, no certification. Now, one of the problems if we now look at academic laboratories is what do you do when you have a visiting distinguished professor coming to work in your department who wishes to do P3 work and he or she might not have had proper training but he or she wishes to work in a P3? What do you do for a newly graduated First degree person who is doing a PhD in TB or HIV who has very little laboratory experience and requires to get up to speed very quickly? I contacted the Medical Research Council to see the courses that they run and they run a two‑day course for laboratory managers, so the managers are familiar with the sort of rules that we are dealing with, and they run a half‑day course for graduates just going into research to work in P3 ‑‑
Q47 Dr Gibson: On site or in a centre?
Professor Griffin: In a centre.
Q48 Dr Gibson: So people have to go to them? They do not go out to people and instruct the individuals?
Professor Griffin: No. They run it on a site and then individuals go back, and then it is the responsibility of each of the home laboratories to risk‑assess the project on what is going on and then to supervise in really great detail the individual carrying out those procedures.
Q49 Dr Gibson: I guess you remember how Sheila McKechnie came to fame in health and safety work; it was a smallpox outbreak at Birmingham and it was not the people in the laboratory where it was being carried out, it was the people below, the photographer, who actually died. Now, I worry about cleaners, technicians, porters, firemen and firewomen who go there under certain conditions. How are you going to instruct them, or do we just forget them?
Professor Griffin: Well, they depend on the governance of the institution and on the risk assessment on the equipment and particularly on the good safe handling ‑‑
Q50 Dr Gibson: But I am a cleaner and I go in at six o'clock and it is rather like this place, they do not know what hazards there might be around. It seems to me they are not instructed either, besides your PhD student and your very eminent Professor.
Professor Griffin: They would have restricted access and restricted ability.
Q51 Dr Gibson: You hope, but they have the keys usually.
Professor Griffin: For P3 laboratories and CL4 laboratories they would not have keys.
Q52 Dr Gibson: And you are convinced that happens everywhere, given that each centre, as you say, has its own rules?
Professor Griffin: Well, I have not visited each and every centre, of course, but in my own experience of Porton and St George's, yes, that is the case.
Q53 Dr Gibson: Porton is a de luxe institute and it has had its experiences, but I doubt if the average university department has that kind of condition appertaining to it because it goes against the grain. There are two things about academia and laboratories - you can go in any time of day or night, because that is the way it is, you go in and work overnight, and, secondly, they kind of object to a biological safety officer telling them what to do. I see you smile there but you know what I mean, because universities get round it by appointing a safety officer who probably does not know as much as you might do on the issue but who has the responsibility from the registrar, or whoever, to carry it out.
Professor Griffin: Yes. I understand exactly what you are saying and this really then comes down to risk assessment, the head of a division doing this work and the serious nature of this work.
Q54 Dr Gibson: Do you think that is carried out?
Professor Griffin: It is certainly carried out in my own group ‑‑
Q55 Dr Gibson: I am sure it is.
Professor Griffin: ‑‑ and I hope it is carried out elsewhere.
Q56 Dr Gibson: How do you feel about your peers? Yes. I think I know.
Professor Griffin: But it gets down to individual responsibility. No matter how good a licence is and how many times it is inspected, an individual counts.
Q57 Dr Gibson: But is there a culture in universities and these kinds of research laboratories that we are talking about who are worrying about health and safety? Does it get in the way of the Nobel prize at one end, the Grade 5 at the other and so on, the pressures that are on people?
Professor Griffin: I think in groups handling dangerous pathogens, yes, people are aware.
Q58 Dr Gibson: Are they worried?
Professor Griffin: Yes, they are worried for their own health as well.
Q59 Dr Gibson: So what about the undergraduate and the MSC student? In their training, whatever it is, do they get enough instruction in the health and safety problems? It always seemed to be in undergraduate practicals there was very little said about safety and health, whether it be chemistry, biology or whatever, and I am as guilty as anybody else, because you want to get on with the job, you have three hours to do it, and you do not want to spend a whole hour talking about the possible hazards when you want them to learn how to do it.
Professor Griffin: Yes, I would entirely agree. There is not proper instruction on containment levels and risk, and, of course, practicals would not be going on with people using HIV.
Q60 Dr Gibson: Whose responsibility do you think that is to do it ‑ and do not say it is the Government's because they will have deflected the responsibility, I am sure.
Sir Bill Callaghan: There was an HSE commissioned report some years ago which recommended that health and safety should feature in undergraduate courses, not just in chemistry but engineering and so on. I have to say we did not get as far as we would have liked because ultimately the responsibility for courses lies with the academic institution.
Q61 Dr Gibson: Suppose you got radical and said: "There must be in this course twenty lectures in this, and twenty experiences in practicals in that", what would happen in universities? Because as you know in schools when people talk about experiments they always say, "Oh, health and safety is a real pain. We cannot do things now because of health and safety". Would you get the same kind of reaction from the professionals, do you think?
Sir Bill Callaghan: I am not sure. I can only speak with some knowledge of what happens I think at Imperial on civil engineering, where I think as part of the Master's course health and safety features very much in terms of the course and in terms of the practical work the students are meant to do, and that is welcomed by all concerned, but certainly when I was at HSE we would have liked to have seen health and safety featuring in all scientific degrees and, indeed, in MBA courses as well.
Q62 Dr Gibson: Do you think there should be a certificate attached to it? That you pass something?
Sir Bill Callaghan: I would not necessarily say a certificate but building that into undergraduate training I think is very important.
Professor Griffin: There are ways to present it, of course. There are ways which are enabling rather than disenabling, and the way I would approach it is to say "I wish to enable you to work on these pathogens because" ‑ and then I would try to enable people to do it, not disenable, and I know that is what my colleagues at HSE do when they visit laboratories.
Q63 Dr Gibson: Lastly, what do you think of biological safety officers then, as a class or group? I remember quite clearly when they were brought in and I remember how difficult it was to recruit them. Usually the junior lecturer got the job if they could not recruit somebody. Health and safety was right at the bottom of the agenda when you were appointing heads of this, that and the other. Junior lecturers were told, "You'll do health and safety, won't you?"
Professor Griffin: That is because it is seen as disenabling rather than enabling, Dr Gibson, and I think the concept of enabling and getting things moving is important to get over, and we have not done that.
Q64 Dr Gibson: And you recognise the symptoms?
Professor Griffin: Absolutely.
Sir Bill Callaghan: That is why we say we welcome the moves towards a more professional status for BSOs and we would hope the Regulator will encourage that. Indeed, I think the recent reports probably will have enhanced the role of BSOs.
Q65 Chairman: Finally, Professor Griffin, you talked very strongly when Ian Gibson began his questioning in terms of having a scheme which promoted good biosafety practice within all laboratories, not just simply Containment Level 3 or Containment Level 4 facilities. What you did not make clear is who should have overall responsibility for that. Should it be the institution, in which case is that a portable, if you like, certification or qualification or whatever you want to call it? Who should be responsible?
Professor Griffin: At the moment it is the institution.
Q66 Chairman: But should it continue like that?
Professor Griffin: This is a very difficult question, with many facets to it.
Q67 Chairman: You cannot have it both ways, can you?
Professor Griffin: No.
Q68 Chairman: You cannot say there are problems, because an institution could be quite lax in that way. We were in Germany two weeks ago and the Isle of Reims, which is arguably a very good facility, said: "We do not want people to be trained elsewhere; we need to train them when they get here in terms of our work", and that really puts a spanner in the works.
Professor Griffin: Yes. Even if there were a list of basic competences which were ticked off and somebody came to my laboratory to work I would take them in the lab and watch them, not just depend on a certificate. A certificate is useful as far as it goes but, at the end of the day, there would have to be assessment.
Q69 Chairman: So it is a starting point, really?
Professor Griffin: It is a good starting point, and it could be - and I hate the word - a minimum level of competences which are essential in order to undertake this work, and they would be pretty minimal at the end of the day, but I think all of us who would have somebody working in a CL4 laboratory or P3 laboratory would wish to watch somebody very closely for a considerable length of time.
Q70 Dr Gibson: What do you say to the problem that you are working on something but that is not the hazard? Suppose I was working on a cancer cell. That is not in itself - I hope - a problem, but the viruses that might be growing in the cancer cell or the bacteria certainly are. Now, we would never ask to screen for them; we would screen for mycoplasmas and things, but nobody ever assayed your cultures for viruses, and you know how cultures get mixed and all the problems and so on. So how do you handle that one?
Professor Griffin: Now, because we know of oncogenes and so on, you would have to say you need a minimal level of safety and that minimal level of safety would cover the worst contingency, so you would not be going for CL3 but you would have absolutely minimal guide; you would have strong guidance on contact of body with cells, contact of body with biological fluids and exactly what to do if that happened, and you would not just ignore it.
Chairman: Thank you very much indeed. Could we put on record our grateful thanks to you not for just coming today but for the excellent report you prepared following Pirbright. Everybody benefited from that and certainly, when we were abroad, people spoke in very strong words about the way that report had been put together. So thank you very much indeed, and the best of luck, Professor Griffin, in producing for MRC the sorts of guidelines which some may want to see and others may not. Thank you.
Witnesses: Dr Paul Logan, Principal Specialist Inspector, Specialised Industries Division, HSE, Dr Matthew Penrose, Principal Specialist Inspector, Specialised Industries Division, HSE; Mrs Ruth Lysons, Deputy Director, Food & Farming Group, Defra, and Dr Nick Coulson, Head of International Animal Health, Defra, gave evidence.
Q71 Chairman: Can I welcome Dr Paul Logan, principal specialist inspector at the Specialised Industries Division of the HSE, Dr Matthew Penrose, principal specialist inspector at the Specialised Industries Division of the HSE, Mrs Ruth Lysons, deputy director, Food and Farming Group, Defra, and Dr Nick Coulson, the head of international animal health at Defra. Mrs Lysons, why did it take the Callaghan review to highlight the flaws in the regulatory system work on dangerous pathogens? Why did Defra not pick it up before?
Mrs Lysons: The review makes clear that the primary responsibility for managing risks lies with the facility that does the work that generates those risks. As regulators, Defra's responsibilities do not extend to taking responsibility for those risks.
Q72 Chairman: Do you agree with Callaghan's report?
Mrs Lysons: Yes. The government has accepted all of the recommendations that pertain to government within the Callaghan report. We were certainly content that our intention was to identify any shortcomings that there may be and act to remedy those. That was why we commissioned an independent review of the system.
Q73 Chairman: The point that we find a little odd is, if it was so obvious following the Callaghan review, why was it not picked up before. Why were people not beating a path to government's door, whether Defra or elsewhere, to say, "We need the regulations changing"?
Dr Coulson: We were considering as the landscape to change with Hampton and the better regulation agenda whether it would make sense to move to a single regulator and we have had some discussions with HSE on that matter. We were not aware that the situation as it was currently standing was going to lead to the type of situation that it did. We did expect the management of the facility to be implementing the standards that were in place at the time.
Q74 Chairman: In terms of the outbreak of foot and mouth at Pirbright last summer, was it principally, in your view, a fault of the regulatory system?
Dr Coulson: No. As the reports from HSE and Spratt have found, with the series of events that occurred that led to the outbreak at Pirbright, we will never exactly know what happened but there is a likely pathway that was established where a series of events occurred in order for the chain to be made. There were regulatory issues that we were aware of at Pirbright and we were working with them. We had action plans when we found things that needed improving. We do though recognise from the Callaghan review that the system can be improved, that there is a role for a single regulator. We highlighted a potential conflict of interest. We recognised that the system could be improved and that was why we were happy to accept his recommendations in full.
Q75 Chairman: Pardon me for being somewhat na´ve but what you both seem to be saying on behalf of Defra is that somehow Defra was not culpable here and yet there is an agreement with the HSE approach, which Callaghan recommended and you have accepted in its totality, so either something was seriously wrong before which needed putting right, in which case Defra that was responsible did not have it right, or somebody else was responsible. I do not know who else was responsible if it was not Defra.
Dr Coulson: We accept that the regulatory system can be improved. We do not accept that the regulatory system was responsible for the release from Pirbright. There was a series of failings that the HSE found on the site. We do not accept that that was the responsibility of the regulator. The regulator is not responsible for biosecurity. We are responsible for issuing licences in respect of the site but the responsibility for biosecurity on the site is for the management of the site.
Q76 Dr Gibson: Why do we not combine the two functions, licences and the regulation?
Dr Coulson: Within Defra the current regime under SAPO is that we issue the licence and inspect.
Q77 Chairman: I find it staggering, if you are responsible for regulation, for issuing the licence and the inspection, that you are not responsible somehow for the outcome. There seems to be something seriously wrong there.
Dr Coulson: You asked if we were to blame for the outcome and I said I do not think we were.
Chairman: I did not mean were you personally responsible.
Q78 Dr Gibson: I remember Hilary Benn said in a debate that there was something wrong when the two functions were combined like this. He has just been speaking. Do you agree with that? Should they be separated?
Dr Coulson: The licensing and the inspection?
Q79 Dr Gibson: Yes.
Mrs Lysons: The Secretary of State was talking about a potential conflict of interest in being a customer and a regulator. That is largely where we feel the strengthening of the regulatory system will come. We did have and do have a system of risk assessment and an assessment of protocols and documentary evidence, much as has been described for the way forward. We do recognise, as was pointed out by Sir Bill, that there is a potential for conflict of interest because we also are a customer and pay for quite a lot of the work that is done.
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 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.
Q100 Mr Cawsey: Dr Coulson might like to explain to us what the role of Defra will be after this?
Dr Coulson: The other role was as a customer for the research. What we will be looking at is to make sure that there is the capacity and capability for our research needs, including the ability to respond for exotic disease outbreaks, which is obviously a key component for us to be concerned about. Also, that the research base is there to develop control strategies and better diagnostic tests, vaccines et cetera, that can be fed into our control policies.
Q101 Mr Cawsey: You are on the lookout for what is coming next?
Dr Coulson: There are two things. One is that there is a capability to respond to a disease outbreak at all times. What the evidence base and the research can offer us is opportunities for the future.
Mr Cawsey: We have heard a lot about African horse sickness.
Mr Boswell: And climate change.
Q102 Mr Cawsey: There seemed to be some concern that Defra was not focused.
Dr Coulson: I think we are looking ahead. Climate change brings some challenges. We saw a blue tongue outbreak that managed to jump into north west Europe without the associated climate change issues that had been anticipated for it, so I think we do need to keep an open mind. It is a very global community with a lot of travel and a lot of factors which mean that emerging, new diseases may occur at any time. Having a responsive research base, because they may be working on diseases we know about today, means we may need them to switch that expertise onto new diseases at short notice and have the facilities and capabilities to do that.
Q103 Mr Cawsey: Does the HSE believe it would be better if you had responsibility for all aspects of the regulation of pathogens including for example anti-terrorism provisions and transport to give laboratories a single point of contact?
Dr Logan: I can see that there would be benefits in having a single point of contact. We do currently work very closely with the security services. We run training courses for example for the local police who go into laboratories. We advise them on toxins and pathogens so there is a very close integration of the work currently. They are looking at very different things at the moment in terms of vetting of staff, looking at physical security and how easy it is to break into premises and the wider security issues. They really are quite distant from HSE's normal roles and responsibilities. Working closely together is probably the best answer, rather than trying to take on those functions.
Q104 Chairman: Dr Penrose, in terms of veterinary expertise, HSE does not have any of its own. Where do you get that from?
Dr Penrose: Currently we have a range of ten inspectors and the inspectors come from a variety of different backgrounds from a human health point of view, so we have virologists and parasitologists. We train our inspectors to be experts in containment so that is laboratory practices and procedures with micro-organisms. You are right. We do not currently have any expertise in veterinary microbiology but we do have access to ACDP and another government committee, the Scientific Advisory Committee on Genetic Modification which could play a part in veterinary expertise. By and large, most of our work is concentrated on human health pathogens with some other environmental pathogens. We are looking to recruit new inspectors and we will be looking to get some veterinary microbiology experience brought in to the team. They will not be used for all inspections but they will be used to train and motivate other inspectors to get them up to speed with what it means to be working with a particular veterinary micro-agent.
Q105 Chairman: Is this a flaw at the moment in the system? I do not mean that in a negative sense but is there a gap?
Dr Penrose: If you are dealing with pathogens and micro-organisms, our inspectors are very competent at keeping these things contained, whether it be a human virus or a fungus or a bacterium. We need that contained within the systems. We are used to inspecting the facilities and systems used to keep those contained. On the route of transmission we can get up to speed quite quickly in terms of how it is likely to escape, so we can focus on that when we do our inspection. We have identified that we need to buy that in in terms of recruiting somebody and we are working to do that.
Q106 Dr Gibson: Do you have a map of all the laboratories and centres that have dangerous pathogens there? Do you mark them out of ten? Do you have a league table with them or are they all in the same league as far as you are concerned? Are they all up to speed or do you have good ones and bad ones?
Dr Logan: Clearly with any organisations you have good ones and bad ones.
Q107 Chairman: Tell us a bad one.
Dr Logan: Or should I say you have very good and not so good? We rate our inspections and we target organisations. When we have been looking at doing some mapping out of organisations for this Committee, there is a small-ish number of organisations that have a lot of the capacity for level three and level four. Obviously at level four, as we have indicated in some of the evidence we have given to you so far, there are ten organisations in total. There are another two high security disease isolation units. Obviously we will be focusing a lot of our attention on those organisations. In the next level down, the Russell Group of universities for example tend to be the main ones. The main grouping in the top 15 or 20 universities has most of the capacity at CL3. Two universities have 84 level three laboratories between them. It tends to be focused there and it does make it much easier to get a handle on what is going on and to work with those organisations to ensure that standards are kept high.
Dr Gibson: Do you keep the good ones and the bad ones secret within the department?
Q108 Chairman: You wish you had not said that now.
Dr Logan: I am sorry I was drawn into using the term. We do not have bad ones, I do not think. Realistically, we go and inspect them. We do occasionally have to serve improvement notices. We have in the past served prohibition notices on organisations and we tend to find that when you take enforcement action against an organisation it raises the standards very rapidly in that organisation. There are always organisations where improvement can be made and that is really what I was referring to. With most of the capacity at level three, we do focus resources on the higher containment end and most of the capacity in a small-ish number of organisations is reasonably easy to keep a good handle on in terms of what is going on.
Q109 Mr Boswell: I am interested in the implications of the liaison between you in terms of epidemiology if there is an outbreak of disease. It happens that I have been one way or another round and about MAFF type issues for about 40 years and my immediate reaction when I saw the reports of foot and mouth in the animal population was to say, "I bet it is Pirbright." Without wishing to say, "I told you so" that is what happened because one is aware these things can happen. I do not want to reopen that but can we be assured that when you are keeping the list - and that will change over time - there will be the closest possible linkages with Defra and indeed also your colleagues in the Department of Health in relation to human pathogens so that, if something strange happens, somebody can at least eliminate the accidental release route and look for other possible causes for an epidemic?
Dr Penrose: From working with Defra, we endeavour to continue to maintain that relationship. We have been working very closely with Ruth and colleagues to identify the laboratories that we are taking on. We will work very closely with the security services that have a separate list in terms of national security. We update those on an annual basis as to whether anything has changed from our intelligence. I guess it is fair to say that your question about the Department of Health is something that we need to work on, in terms of improving our relationship with the Health Protection Agency. That is something we have identified and are working closely on. We share information with ACDP and SACGM as well so, yes, we will work very closely with colleagues on the regulatory framework.
Q110 Dr Gibson: Could you be missing some sites that were there before COSHH in 2002 for example? Could they have slipped through your net? How would you know about them anyway?
Dr Penrose: It is a very good question. We have been looking at this. There is always a possibility we could but I do not think in practice we have. All the centres that need to be registered with us are registered with us.
Q111 Dr Gibson: Do you check on people who get research grants for example who say they are going to work on an organism, or not?
Dr Penrose: We do. We look at websites and research interests when we prepare for visits. We look and see what the department is working on and what the particular research is working on. You might find some smaller biotech companies that will start up working on quite low risk GM issues that have failed to maybe register as quickly as they should have done but certainly at three and four I think we have a very good handle on all the organisations that work with those.
Q112 Dr Gibson: There could be one or two that slip through at any one moment?
Dr Penrose: Certainly not at four. At three we really do not think there are any.
Q113 Dr Gibson: What about the frequency of the inspections and the average time that you do them? In London it is easy; you just get the tube.
Dr Logan: At level four we have a commitment to inspect annually. For containment level three we have said every three years they will be inspected. We said in the previous answer that a lot of capacity is set in a number of organisations such as the bigger universities and so forth. As an organisation starting to work on what we call intervention plans, we work with the organisation. We meet with them and set a plan of how we will interact with them, who the contacts are, what training is going to go on. A lot of the time we tend to do it through that and we will sample within that organisation to check on the status.
Q114 Dr Gibson: Is the frequency really not determined by the number of staff you have? I seem to remember motion after motion about HSE not having enough staff and it just got worse. It does not get any better.
Dr Logan: We focus our resources primarily on a risk basis. By targeting the levels three and four we can focus.
Q115 Dr Gibson: You have enough people to do that every year?
Dr Logan: We have enough to meet out targets at the moment, particularly when we have taken on the three new staff that we are looking to recruit.
Q116 Dr Gibson: The thing we do not often talk about in health and safety is near misses. Do you record them as well or do you hear of them?
Dr Penrose: We do. There is a separate set of regulations that requires accidents and injuries to be reported. One of those is dangerous occurrences. We have given a lot of guidance on what we mean by a dangerous occurrence. That is if there is any loss of containment or any accidental spillage. Compliance in the sector is very good. People do tend to report quite a lot of things, even if it is a slip in a laboratory or somebody has fallen over by the Coke machine that was outside the laboratory. We do feel that the reporting mechanisms are good and well understood.
Q117 Dr Gibson: Are they anonymous?
Dr Penrose: No.
Q118 Dr Gibson: They get a yellow card or a red card as far as the department is concerned?
Dr Penrose: Yes. We will use that intelligence. We will either investigate it if it is worthy of investigation or follow it up or close it down. It is used to factor into the rating system.
Q119 Dr Gibson: Do you think you would increase your figures if they were anonymous? There is a tendency in that culture not to report things because you do get the finger pointed at you and you feel shamefaced.
Dr Logan: You do sometimes get accidents or complaints made by members of staff. If a complaint is made anonymously we would follow that up in a way that maintains the anonymity of the person who has reported it and we will feed back to them. We have had a number of occasions where that has occurred.
Q120 Chairman: Who do you report to? You were saying you have to give critical reports of particular facilities. Who do those go to?
Dr Logan: Inspectors write a report following an inspection visit. They will make recommendations which go back to the organisation.
Q121 Chairman: I did not mean that. Who collates all that other than yourselves? Is it kept? Does it go to government ministers? Where does it end up?
Dr Logan: It goes up through HSE, through our board. Some of that information ends up in the annual report.
Q122 Chairman: In terms of the government, in terms of making policy and ensuring there is policy, who is the responsible minister or department for instance?
Dr Logan: The Department for Work and Pensions. Lord McKenzie is our responsible minister at the moment. Briefings between the head of our organisation and Lord McKenzie will pick up some of these types of issues.
Q123 Dr Gibson: We could find that information out, I guess, if we wanted, could we?
Dr Logan: Yes, certainly.
Chairman: I have never seen that reported.
Q124 Mr Boswell: Can I turn to the regulation itself? I am conscious that there is always a complexity about the detail of regulation as against the general duties within health and safety principles about keeping a safe environment and so forth. I am glad you are nodding because I think that acknowledges it. Are you satisfied that the current regulations, even if they are not perfect, if they are properly adhered to, are adequate now to prevent failures in biosafety and biosecurity?
Dr Logan: Are you referring to the COSHH and the GM regulations?
Q125 Mr Boswell: I am. SAPO is not in your remit at the moment.
Dr Logan: Inevitably there are breaches in containment in that people can get infections in the laboratory. We see a small number every year of laboratory infections. We see other minor problems, as I said earlier.
Q126 Mr Boswell: They do not arise from defects in the regulations or maybe ambiguities in the regulations?
Dr Logan: Occasionally there is a misapplication. You always have individuals working in a laboratory and sometimes they will do things that they should not be doing. There may be local rules that say they should not have done something in a particular way but I think the regulatory system under COSHH and GM is adequate. The sector generally has a very good health and safety record over the years.
Dr Coulson: At the moment we are working on joint inspections with the HSE and we take account of any advice that we get from them about the premises that are inspected.
Q127 Mr Boswell: Given the constraints, the need to seek a balance and also the point you quite reasonably make about there being individuals who fail, even if that is at the level of local instruction rather than within the regulation, do you feel that there are any gaps in the regulations which at the moment are covered only by best practice guidelines or the more general health and safety matters which would benefit by being covered more prescriptively? The kind of thing we have had suggestions about would be the keeping of inventories and notification of missing pathogens for example.
Dr Logan: The keeping of inventories is something that is quite often raised. At the high containment level people do tend to keep inventories and particularly now a lot of the high containment laboratories are covered as well by the anti-terrorism legislation. The keeping of inventories is becoming much more commonplace.
Q128 Mr Boswell: On the whole you find that good practice even though it is not necessarily specified in the regulation?
Dr Logan: In a very busy research department keeping inventories can be very difficult, particularly when people are modifying organisms on a constant basis.
Q129 Chairman: What about notification?
Dr Logan: Notification of?
Q130 Mr Boswell: If there are missing pathogens, when they are not there when you go to pick them up and use them?
Dr Logan: To notify they need to have a decent idea of what was there in the first place which goes back to the inventory side. We do occasionally have under the RIDDOR regulations notification of missing pathogens.
Q131 Chairman: Should there be standardised notification under the new framework or under COSHH? Should you standardise the way in which you notify? Should it be standardised in terms of the site or in terms of the organisation? How should it operate?
Dr Logan: Under the GM regulations for example it is much more prescriptive.
Q132 Chairman: You are pulling everything together. What is your recommendation?
Dr Logan: The political imperative appears to be that people want to know down to very specific levels and if that is the case I think it is quite easy for organisations to provide that information - i.e., this organisation is working on these organisms in these particular laboratories at this particular address.
Q133 Mr Boswell: It is also keeping score.
Dr Logan: Yes.
Q134 Mr Boswell: If I can chip in on that, it is a formulation I used with Professor Griffin earlier. Your approach to bringing together the regulations will be highest common factor rather than lowest common multiple broadly?
Dr Logan: Yes.
Q135 Chairman: When you are talking about the organisation, is that what you mean? It is the organisation that collates it on behalf of an individual lab or an individual site?
Dr Logan: Yes, absolutely.
Q136 Chairman: I do not know what would happen at Pirbright where you have the Merial laboratory and the Institute of Animal Health laboratories on the same site.
Dr Logan: They are two separate organisations.
Q137 Chairman: This is organisation, not site.
Dr Logan: It is the body corporate.
Q138 Chairman: Even if the two organisations share common facilities, which clearly is the case at the moment and may well be the case in the future given some of the improvements for instance to the drainage system there, you still are not looking at making it site specific?
Dr Logan: No. We have been working closely with Defra to ensure that there is much better liaison between the two organisations at the Pirbright site, so there is much better communication but in terms of the way HSE would traditionally work Merial is a completely separate legal entity from the Institute of Animal Health.
Q139 Chairman: In terms of a university where you may well in fact have a number of laboratories which are working on level three pathogens, it would still be the organisation which would be the university that you would hold resonsible?
Dr Logan: Absolutely, yes.
Q140 Mr Boswell: On record keeping and reporting, if it is RIDDOR it requires at least a judgment that a dangerous incident has occurred. Is it in your mind that you might have either a standard format, which would be quite a simple thing, or a protocol which would drive everyone at least to report when something had gone missing?
Dr Logan: Yes.
Q141 Mr Boswell: It would seem to me, certainly at level four and presumably level three, potentially a dangerous incident.
Dr Logan: Yes.
Q142 Mr Boswell: The other one is about the staff side. We have heard quite a lot about training this afternoon. Is it sufficient that staff working with dangerous pathogens are trained at a local level or should there be nationally or centrally recognised training programmes, minimum standards and so forth? What is your take on that?
Dr Penrose: Clearly training is something that our inspectors focus on very intensively during their inspections because they are looking at competence and how you define competence. Inspectors need to leave that site assured that the people doing the work are fit to do that work. The regulatory requirement is that it is left to individual organisations and sites as to how they want to train their staff. George Griffin alluded to training for diagnostic staff. In the university setting there is not that legal requirement for all staff to be trained to a common level but as inspectors we make sure we interview staff. We interview PhD students. We will take them away from their line manager to give them the opportunity to say what training they have had and what they understand by the work they are doing and what are the hazards. In practice we find that organisations do train their staff.
Q143 Mr Boswell: When you are inspecting, do you observe staff in operation?
Dr Penrose: We do.
Q144 Mr Boswell: Would they be aware of where you came from? Would you be a visiting academic as far as they were concerned?
Dr Penrose: If I am talking to somebody I will take them aside and introduce myself and say what I am doing. Through observations and questioning you can get a good feel for what their competence level is. If somebody is quite happy to say, "I have never been trained in this field" we will pursue that. We can observe people and say, "Why are you doing it that way?" You can see by the way the laboratory is set up as to what custom and practice is. By and large people treat this seriously because they are the ones that can get infected, particularly with the human pathogens, because they have their own health and safety and that of colleagues. In terms of the wider initiatives, it is something that has been looked at on a number of occasions in terms of biosafety training and I am aware that there is a group at the Institute for Safety in Technology and Research, a separate group, looking at trying to standardise biological safety and training but it is not mandatory.
Q145 Mr Boswell: In your reporting now, would you be able to recommend that an individual should undergo some further training on the basis of what you have seen or indeed that some laboratories should be reconfigured on the basis that people are not handling the stuff as you would like to see?
Dr Penrose: Absolutely. We will give a comment on the training levels that we have observed and we will look at logbooks and training records. If that is not appropriate, we will raise that with the nominated senior manager to rectify.
Q146 Mr Boswell: To go back to the point you made about a group looking at the idea of common standards, just to be clear, that is something on the whole in principle that you would favour?
Dr Penrose: Yes. HSE are supporting that initiative.
Q147 Dr Iddon: Regarding a strategic overview of the number and capacity of CL3 and CL4 laboratories, in your opinion should there be one body that does this? If so, should it be the HSE? I think I should start with Defra first.
Dr Coulson: One body that oversees the capacity that we have in the UK?
Q148 Dr Iddon: The capacity and number of CL3 and CL4 laboratories. Should it be one body?
Dr Coulson: There needs to be a number of people involved. The main customers for the research need to be involved. There is the issue of what we need in order to deliver the outcomes that we need. I have mentioned the exotic disease response and developing new control strategies as part of Defra's need. Obviously the Department of Health will have a view on that. We have heard that for surge capacity in the outbreak of an emergent disease we need to take a view of what the UK has and we certainly have discussions - HSE have been involved in them as well - with the ACDP community and Defra's community about how we might use each other's facilities in a national crisis. We do need to look with these very expensive facilities at how we get the best use out of them for the UK.
Q149 Dr Iddon: What you are telling me is that there are a lot of different organisations involved. This was the case with marine safety until we had three critical disasters. I will not name them all but one of them was the Torrey Canyon disaster and the government decided that the different units were not talking to one another so they set up one person in one organisation, a SOSREP, a Secretary of State's representative who takes control in an extreme emergency. My question really was: should somebody take the strategic overview and, in an extreme emergency, pull all these organisations together and be responsible for making them work? You did not answer my question, in other words. You just told me who was involved.
Dr Coulson: There is not somebody with that strategic ability to take control at the moment, as far as I am aware.
Q150 Dr Iddon: The question was do you think there should be and, if so, should it be the HSE.
Dr Coulson: At the moment I have not seen that that is a gap. I think the community does work together and talk to each other and the indications we have had from those discussions with people who own other facilities are that they would make them available. If Defra had a new, emerging animal disease and needed to do work in one of the other facilities, a health facility or an MoD facility, I think that would be facilitated at the moment.
Q151 Dr Iddon: What does the HSE think? Are you agreeing with that proposal or do you disagree with it?
Dr Logan: I do not think it is the job of the regulator, the people regulating the safety standards in those laboratories, to be looking at having an overview as to whether there is sufficient capacity. There is a lot of capacity at containment level three in particular across the UK. We often see laboratories that are under-utilised. They are containment level three laboratories that are not being used at containment level three because they do not have the work going through them. A lot of different universities and organisations have facilities like that. At containment level four there are ten facilities. There does appear to be a reasonable level of capacity. The only one that was mentioned earlier is ACDP level four large animal capacity and there is probably a decision for Defra and some people in government to be made as to whether that capacity is needed.
Q152 Chairman: I do not feel that is satisfactory, if I am perfectly frank, from either of you in answer to Dr Iddon's question. Correct me if I am wrong, Dr Coulson. We now appear to have a system whereby nobody really takes a strategic oversight in terms of how much capacity we need. You said you think that there were people who would be able to loan you facilities if there was a serious outbreak but you do not particularly know. Is there a group that comes together to discuss overall capacity? Who brings that group together and who does it report to?
Dr Coulson: I am not aware that there is a standing group that looks at that because the capacity changes in incremental steps. When we were reviewing the rebuild at Pirbright, a group came together and the central question was: do we need to rebuild the facilities at Pirbright post 2001. Do we need that capability? That group looked at the whole UK situation. It had people from all the various groups and it came to the conclusion that, yes, we did need a national centre and Pirbright was the best place for that. Until there is another new, incremental change in the capability, that group would not come together again.
Q153 Chairman: Who is this group?
Dr Coulson: It was an ad hoc group put together by Defra under the deputy chief veterinary officer at the time who ran it, who brought together people from a variety of backgrounds in the containment world who did a review of whether Defra needed to invest.
Q154 Chairman: Until there is another problem, you do not meet?
Dr Coulson: That was a specific meeting to decide whether to invest in a rebuild of the facilities at the Pirbright site.
Chairman: I understand that but the question that Dr Iddon was asking which you did not appear to give a reply to was: do you feel that there ought to be a standing group that meets on a regular basis, whatever "regular" means, in order to assess whether we have sufficient capacity and, if not, to do something about it?
Q155 Dr Iddon: It would not have to be a group. You have mentioned the chief medical officer. I was thinking in terms of the chief scientific adviser as well. Sir David King took a big interest during the foot and mouth outbreak and I think it was he that pulled a lot of things together and made things happen. If they had not happened, in my opinion, we would not have got on top of that outbreak. I agree with the Chairman. It seems a very unsatisfactory situation where there is no body or organisation having this over-arching look at what is going on in this area.
Mrs Lysons: There are inter-laboratory networks which meet regularly, which are senior directors of veterinary and medical laboratories. One of our approaches in assessing capacity, particularly if we need more capacity, would be to go to the relevant laboratory that we normally go to and say, "How would you cope with a ten fold increase in the demand?" They would use that network to tell us how they would cope.
Q156 Mr Boswell: I suspect - tell me if I am wrong - that there are two questions bearing on this which are slightly different. One is what you might call the strategic view of what capacity is needed for research and to assess the progress of these difficult pathogens. The second one is the crash plan you have to adopt when you have a major outbreak and you have to assess a lot of samples and so forth. Can you clarify that that is your understanding and I am not adrift on that? I suspect the inference, looking at the Defra side of the table, is that one way or another - as indeed Pirbright showed in 2001 - it is possible to scale up very quickly if it is necessary to do this work. You are not worried about that?
Dr Coulson: No. My answer was related to the strategic review and there is also this other mechanism for the more tactical review.
Q157 Mr Boswell: This is more to the HSE side. You did indicate a minute ago that there might well be a surplus of capacity at level three. Given that this is not absolutely cost free - it is expensive for the institutions to maintain; there is the possibility of escape at any one time and we have discussed urban locations for example - is nobody looking at this at all to say that perhaps after all we have more than we need and could we encourage some measure of agreed rationalisation?
Dr Logan: We have not taken that approach at the moment. We often get approached by organisations that want to set up a new laboratory and we encourage them to come to HSE to talk about commissioning and the standards that would be needed. We point out the difficulties in maintaining a level three facility if they are going to need it.
Q158 Mr Boswell: For example, there is no brokering function. You could not say, "We know that there is surplus there. Why do you not bolt into that rather than create your own?"?
Dr Logan: In another organisation?
Q159 Mr Boswell: Yes.
Dr Logan: They are all different organisations and that is the difficulty.
Q160 Dr Gibson: I was amazed when Debby Reynolds turned up on the telly and not David King. Who made the decision that she would front it?
Dr Coulson: Front the disease control outbreak?
Q161 Dr Gibson: Yes.
Dr Coulson: It has always been the arrangement post 2001 that the chief veterinary officer would run the disease control outbreak but there are now in place a lot of mechanisms for getting scientific advice into the decision making process. During the 2007 outbreak we met with Dave King and Howard Dalton, the government and Defra chief scientific advisers. We had many meetings to discuss the science behind the decisions that were being taken during that outbreak.
Dr Gibson: I cannot imagine Dave King not wanting to get onto Radio 4 and talk about it.
Q162 Dr Iddon: What is your view, Defra and HSE, on the placing particularly of category four laboratories in the centre of towns or cities like London, Berlin or Boston? Do you have any strong feelings about that?
Dr Coulson: Pirbright is sited where it is as much for historical reasons as anything else but we do recognise that, from a practical point of view, you can go to areas where it makes the movement of samples to and from the laboratory easier. Choosing a low livestock density area may be a sensible risk mitigation step, although we rely on biosecurity to prevent a release from the building, not on that approach. From an animal pathogen point of view, it is more the livestock density that might be a factor in siting it. There is also the practical issue about getting planning permission for that type of facility in a new location. That may be quite challenging as well and people have been concerned about it.
Q163 Dr Iddon: What about the HSE? Are you concerned about these category four facilities being placed in the centre of cities like London?
Dr Logan: There are currently three facilities in London working at level four and they have done for many years. Our inspection regime and regulatory regime are intended to make sure that they stay contained and do the job they are supposed to do.
Q164 Dr Iddon: You are not too worried about the facilities being in the centre of cities by the sound of it?
Dr Logan: It is another risk factor that needs to be considered in how they are controlled, managed and run.
Q165 Dr Iddon: What about planning approval? Is it right that the local authorities have the final planning approval unless it goes to the Secretary of State for appeal? Do you think that you should be consulted about the planning applications for category three and category four in large conurbations?
Dr Logan: We are consulted about plans for level four facilities. For level three facilities we encourage people to approach HSE because we have a lot of experience in discussing it with them so they do tend to come to us and talk to us about the facility. There is huge capacity in London currently at level three. These have been operating safely for many years.
Q166 Dr Iddon: If you were very unhappy about the siting of a category four, do you have the powers to stop it or is it just advice that you give to the planning authority?
Dr Logan: At the moment we would have the powers to stop the level four facility if we thought it was not going to be able to operate safely.
Q167 Dr Iddon: Do you agree with the previous panel that it would be preferable if universities did not have category four laboratories but shared the others that exist at the moment or ones that might be built in the future?
Dr Logan: I am probably going to contradict something I said a few minutes ago but at level four we have certainly had some discussions with a university about the development of a level four facility. One of the arguments cited for that is getting access to level four capacity when they want it is quite difficult. For example, you can book time and you may get bumped from that if something happens, if there is an outbreak somewhere. The other argument is that they do not see any reason why level four should be uniquely in the hands of government rather than universities.
Q168 Dr Iddon: There is a bit of a discussion we can have there, I guess. What about the present state of category four laboratories? Some of them, I guess, are rather old. Do you think old laboratories can perform as well as new category four laboratories or should some of these old facilities be replaced now? Are they out of date?
Dr Logan: There is a continuous programme of redeveloping these facilities. The reality is some of the older ones can still do the job but a lot of the equipment maintained is changed within those. We do look at the fabric of the buildings to make sure that they are up to grade and in a lot of them people do recognise that they need to be replaced. That is some of the discussion that is going on for example with the MRC at the moment on new developments.
Q169 Dr Iddon: If you found a category four or even a category three facility which you regarded as unsafe, would you have the powers to close that particular laboratory down?
Dr Logan: Yes.
Q170 Chairman: When Professor Griffin was asked by Dr Iddon about a level four new facility in central London as part of the NIMR development, he indicated that perhaps that would not be a good idea. What worries me is that sends out a message. Where you have level four facilities in urban areas, there is a risk. Is that the message we really want to send out?
Dr Logan: Obviously that was Professor Griffin's view.
Q171 Chairman: I am asking you.
Dr Logan: If I was not here this afternoon I would have been at a meeting at MRC discussing the new facility or their new plans. We are involved in the discussion as an organisation about the siting of those facilities.
Q172 Chairman: Would you be concerned about a level four facility at St Pancras?
Dr Logan: As long as it was designed, operated, maintained and run properly, I would not have concerns about it, no.
Chairman: On that note, can I thank you all very much indeed for being an absolutely splendid panel. I am sorry if we were a little bit critical of Defra. That is par for the course. Thank you all.
 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."
 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."