Select Committee on Innovation, Universities, Science and Skills Sixth Report

3  The HSE as a regulator

The HSE in its new role

45.  Implementation of the changes proposed by Callaghan required a transitional period between January and April 2008 during which SAPO inspections in England for SAPO Group 4 pathogens were carried out by Defra and the HSE, and inspections of facilities using SAPO 2 and 3 pathogens were being carried out by the Veterinary Laboratories Agency (VLA) and the HSE. In Scotland, inspections are (and were) carried out by a Scottish Executive Veterinary Advisor, assisted by veterinarians from Animal Health (there are no SAPO 4 laboratories in Scotland). The HSE has now taken sole responsibility for all inspections of facilities handling dangerous pathogens across Great Britain as recommended by the Callaghan Review. Defra agreed to pay for this stage of the transition but the new regulatory framework will be partially paid for by recovering costs from inspected premises.[86] This will increase the cost of this research, and Lord McKenzie, Parliamentary Under Secretary of State at DWP, who has ministerial responsibility for the HSE accepted that this may prove to be a sensitive issue.[87]

46.  Whilst the Callaghan review questioned the effectiveness of Defra inspections under SAPO, it found the HSE inspectorate to be "well trained and resourced to perform an inspection function efficiently and effectively,"[88] a view shared by others.[89] The HSE expects to inspect CL4 laboratories annually and CL3 laboratories every three years.[90] However, we received evidence that inspections are often infrequent unless problems are reported[91] and that the frequency should increase.[92] Concerns have also been expressed that the HSE may not have sufficient resources, especially with the new burden envisaged by the Callaghan Review, to inspect sufficiently,[93] although in fact the HSE has taken on fewer than ten laboratories with SAPO licences which they were not previously regulating via COSHH or GMO(CU).[94] Lord McKenzie assured us that he was confident that the HSE:

    will be sufficiently resourced to do the task … the three year review gives the HSE in aggregate something like a little bit better than flat cash in comparison to the 04 settlement. In the context of the DWP's minus five per cent real year-on-year you will see that we have tried to resource the HSE appropriately.[95]

47.  The HSE does not currently have the veterinary expertise necessary to administer the SAPO regulations, formerly undertaken by Defra veterinary officials. With the recruitment exercises underway, the HSE was confident that it would acquire sufficient expertise to take on its new, wider remit[96] and that the HSE could meet its targets for inspections with the new staff.[97] In addition, Dr Matthew Penrose told us that the HSE could refer to ACDP or the Scientific Advisory Committee on Genetic Modification for additional veterinary expertise,[98] and that the HSE and Defra are now working in close co-operation.[99]

48.  The Government must ensure that the HSE is sufficiently resourced to enforce the new regulatory framework properly. The shift of responsibility to the HSE for regulating animal pathogens following the Callaghan review should be accompanied by an appropriate increase in the resources the Government provides for this work. The HSE must ensure that it has the necessary veterinary expertise to allow it to regulate the use of animal pathogens and must co-operate with Defra to achieve this. The Government should review the additional resources needed to enable the HSE to deliver the new regulatory framework and publish this, accompanied by the rationale for the resource allocation.

Engagement by the regulator

49.  We agree with Professor Chris Thorns of the VLA and the Ministers with responsibility for Science and the HSE that it is critical that a good regulator engages with those building and operating high containment facilities before enforcement or intervention becomes necessary.[100] This should be a priority for the HSE as the regulator for the new unified framework and a task for which it will need to be resourced appropriately.

50.  A particular issue arises over the culture of reporting accidents or near accidents to the regulator. The United States Government Accountability Office (USGAO) has pointed out that near misses and incidents could be going unreported[101] and suggested that an anonymous system might help to achieve better reporting.[102] It identified a number of "barriers to reporting accidents in high containment facilities":

    It has been suggested that there is a disincentive to report acquired infections and other mishaps at research institutions because of (1) negative publicity for the institution or (2) the scrutiny from a granting agency, which might result in the suspension of research or an adverse effect on future funding … In order to enhance reporting, barriers need to be identified and targeted strategies need to be applied to remove those barriers. It is also important that these incidents be analyzed so (1) biosafety can be enhanced through shared learning from mistakes and (2) the public may be reassured that accidents are thoroughly examined and contained.[103]

We were reassured by the HSE's confidence that in the UK "compliance in the sector is good" and "the reporting mechanisms are good and well understood"[104] but we would caution that there is no room for complacency.

51.  We urge the HSE to engage as early as possible with those building and operating high containment facilities to avoid resorting to enforcement action. The HSE should review its procedures to consider how best to encourage reporting of incidents and near-misses.

Information held by the regulator

52.  A number of issues about the manner in which the HSE currently operates as a regulator arose during this inquiry, primarily as a result of the haphazard nature of the legislation it enforces. First, both the COSHH and GMO(CU) regulations require notifications of work on dangerous pathogens at "premises" without defining the term. The HSE receives notifications that refer to individual laboratories (the majority of notifications at CL4), sites (departments, locations and campuses) or the organisation (a university), but this is at the discretion of the notifier:

The HSE can use its systems "to give a fuller picture" of work carried out by an organisation but described this as "a resource intensive process". [106] Dr Paul Logan accepted that this should change in future:

    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.[107]

53.  Secondly, whilst all new work under COSHH must be notified to the HSE, COSHH regulations were introduced in 2002 and are not retrospective. For organisations which began to use the pathogen prior to this date, the HSE relies on information gained through surveys and inspections. Even if, as Dr Penrose believes, "in practice" the HSE is aware of all those using dangerous pathogens,[108] this is not an ideal state of affairs. This should be addressed by the new regulatory framework.

54.  Thirdly, that it is of paramount importance that the HSE build strong links with organisations who might need access to the information it holds on work using dangerous pathogens. This would include the emergency services who might attend an incident at premises handling dangerous pathogens and the security services if they suspect pathogenic material is being misused. In addition, the agencies who have responsibility for human and animal health should be informed so that they may best respond to outbreaks of disease and account for possible sources of disease in contingency planning. Where accidental release is involved, as at Pirbright, identifying the causative agent and its source at the earliest opportunity is vital. Dr Matthew Penrose of the HSE told us that such links do exist but he accepted that:

    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.[109]

55.  We recommend that the new regulatory framework require the HSE to maintain records of work on dangerous pathogens at a more detailed level than is currently the case and introduce clear guidelines as to whether organisations notify the regulator at a laboratory, site or organisational level. The new framework should be retrospective and should compel all those working with dangerous pathogens to notify the regulator. We urge the HSE to build relationships with those that may require access to such information, such as the animal and public health authorities and security services.

86   Q 313 Back

87   Ibid. Back

88   Sir Bill Callaghan, A Review of the Regulatory Framework for Handling Animal Pathogens, 13 December 2007, p 14 Back

89   Ev 96, 156; Q 263 Back

90   Q 113 Back

91   Ev 98, 156  Back

92   Ev 79 Back

93   New Scientist, 'Animal lab mishaps go unreported', 1 January 2008, Ev 98, 103, 156 Back

94   Q 99 Back

95   Q 313 Back

96   Q 43  Back

97   Qq 114-115 Back

98   Q 104 Back

99   Q 89 Back

100   Qq 185, 320, 324, 326, 330 Back

101   USGAO, High-containment biosafety laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States, October 2007, pp 23-24 Back

102   Ibid, p 16 Back

103   USGAO, High-containment biosafety laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States, October 2007, p 16 Back

104   Q 116 Back

105   Ev 161 Back

106   Ibid. Back

107   Q 132 Back

108   Qq 110-112 Back

109   Q 109 Back

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