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

Examination of Witnesses (Questions 1-19)


17 MARCH 2008

  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[1].

  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.

1   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." Back

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