Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 36

Supplementary memorandum from the Health and Safety Executive


  You requested further clarification from HSE on the information submitted to the Committee in my letter dated 17 December 2007.

  I provide this below under the different headings you used:

1.   What collation of information occurs as a matter of course so that the HSE and/or DEFRA and other Government departments (eg the Home Office) and agencies (eg HPA) know who is working with which pathogens at which site?

  1.1  HSE collates information on wild-type human pathogens (under Control of Substances Hazardous to Health Regulations 2002—COSHH) and on genetically modified pathogens (under the Genetically Modified Organisms (Contained Use) Regulations 2000—GMO(CU))


  1.2  Since 2002, all new work with wild-type human pathogens has had to be notified to HSE under the COSHH regulations. These regulations require that an employer shall not use premises for the first time, unless he has notified HSE, of the use of one or more pathogens in Hazard Group 2, 3 or 4. Subsequently the use of any other Hazard Group 3 or 4 pathogen (and three named hazard group 2 pathogens—Bordetella pertussis, Corynebacterium diptheriae, and Neisseria meningitidis) at these premises, must be notified to HSE in advance.

  1.3  However, these requirements were not retrospective, and some employers using these organisms prior to 2002 were not required to formally notify HSE. That said, through surveys and information obtained during inspections, HSE has built up a comprehensive list of premises where work with dangerous pathogens is carried out, and details of the organisms being used.

  1.4  The term "premises" is not clearly defined in COSHH and there is flexibility in its interpretation. Whilst the majority of notifications tend to be made at the site[49] level for Hazard Group 2 & 3 agents and at the individual laboratory[50] level for Hazard Group 4 agents, some organisations[51] notify Hazard Group 2 and 3 agents at the organisation level and do not link this to specific sites or individual laboratories. For HG 4 agents it is much more likely that the information will tightly linked to both site and individual laboratories.


  1.5  The GMO(CU) regulations require that all premises are notified before they are used for the first time. Again there is flexibility available within the law in how dutyholders choose to define `premises' but in practice HSE holds a list of all separate sites that an organisation will use to work on GMOs. The regulations require that all work with class 2, 3 and 4 GM microorganisms (GMMs) is notified in advance to the Competent Authority, and clearance/consent is obtained before work commences. Subsequently, individual activities with class 2, 3 or 4 GMMs must be notified in advance. For class 3 and 4 activities, written consent of the Competent Authority is required every time before the activity commences.

  1.6. Defra and the Scottish Government act jointly with HSE as the Competent Authority for GMO(CU) and receive copies of notifications for comment and/or consent. HSE acts as the lead within the Competent Authority, and administers the notification system. Consequently, details of all premises and the nature of the class 3 or 4 GM microorganisms being used are held by HSE, Defra and the Scottish Government.

  1.7. The notifications provide information on the organisation (eg XX University) and frequently individual sites (eg the Department of ZZ) where work is to be undertaken, but not necessarily on the individual laboratory. When work at Class 3 is notified at a new site, HSE will normally inspect the site before consent is given. Where additional work at Class 3 is notified at a previously consented site, HSE will not normally inspect prior to giving additional consent. However, the site will be inspected in the normal course of HSE's inspection programme. All new Class 4 projects will be inspected prior to starting, irrespective as to whether the laboratory has been inspected previously.

  1.8. The information held by HSE under GMO(CU) and COSHH is not routinely shared with other agencies such as Home Office or the HPA, although may be provided in specific cases.

  1.9. Where work under GMO(CU) and COSHH involves pathogens that are listed on Schedule 5 to the Anti-Terrorism, Crime and Security Act (ATCSA), must also be notified to the Home Office. Much of the research work being carried out at containment level 3 and 4 is covered by Schedule 5. The main exceptions to this involve work with the hazard group 3 blood-borne viruses—HIV and Hepatitis B and C, and work with parasites. Where work under GMO(CU) involves pathogens listed in the Specified Animal Pathogens Order then this must also be licensed by Defra or SEERAD.

  1.10. The Callaghan review (published in December 2007) recommended that the COSHH, GMO(CU) and SAPO regulations are replaced by a single regulatory framework. The initial policy work to implement this recommendation is currently being undertaken by Defra and HSE.

2.   The details provided to the Committee refer to both "sites" and "organisations". Where organisations are licensed to work with dangerous pathogens at multiple sites, what level of detail is known about the exact number and location of the sites? What are the requirements for an organisation wishing to use a pathogen at a new site where they already use this pathogen at another site? What determines whether a record is held of sites or organisations handling pathogens?

  2.1  As a minimum HSE holds information on:

    —  what organisations are working with biological agents;

    —  the number and location of the different sites of that organisation where work with biological agents is undertaken; and

    —  the different work activities involving biological agents which that organisation can undertake.

  2.2  Due to the flexible nature in which the law permits notifications to be made under both COSHH and GMO(CU) it can be difficult to capture intelligence on what particular work is being undertaken at a particular site. For example some employers choose to notify at the organisational level: once HSE have given permission for the work to proceed they are permitted to move this work between different sites (so long as those sites have been previously registered and meet the required standards) without notifying HSE. Other employers choose to notify at the site level: once HSE have given permission for the work to proceed these are not permitted to move this work between different sites without each new site notifying the work. This can apply to work at CL2 and CL3 but not CL4.

  2.3  HSE's information systems capture the minimum level of information which is required by law as outlined above. This was used to prepare the information submitted in December 2007. In practice for all larger organisations with multiple sites HSE's systems can be interrogated to give a fuller picture of what work is going on where but this is a resource intensive process. This is used by inspectors in preparing for inspection visits or assessing notifications.

3.   Do the HSE and DEFRA have a systematic approach as to whether they deal with organisations or directly with sites?

  3.1  The overall responsibility for health and safety rests with the employer at the organisational level. It is up to the employer to determine how they wish to interface with HSE. Most employers interact with HSE at the organisational level, nominating a central contact point (eg the biological safety officer in the safety department) who has an appreciation of the all the sites used for work with biological agents and the work going on there. Some employers choose to interact with HSE at the site level, nominating a contact point for that site only. For the larger organisations with multiple sites (eg Universities or Research Institutes), HSE has developed "intervention plans". These involve a lead HSE inspector working with the organisation to develop a plan to improve safety over a defined time period. This results in a centralised approach, with contacts between HSE and the organisation being made through the safety office, via the biological safety officer and the HSE lead inspector.

4.   In relation to organisations working with dangerous pathogens, at containment level 4 and level 3, the Committee would be grateful for more details of the locations, capacity and capabilities of these laboratories and the pathogens they currently handle.

Containment level 4

  4.1  There are 10 Containment level 4 sites within the UK, all located in the South of England. These include seven owned by "government" sponsored research institutes; two by private commercial animal vaccine manufacturers and one "government" clinical diagnostic/research site. There are only a small number (nine) of class 4 GM activities currently undertaken at seven of these sites.

  4.2  Of the eight government run sites, five are designed to operate at HSE containment level 4 (although only four actually operate at this level), and three at SAPO level 4.

  4.3  Seven of the sites have the facilities to work with infected animals. All the SAPO level 4 sites can currently only work with SAPO infected animals, however 2 of these also have the capability to work with large animals. There is currently no UK facility designed for work with large animals infected with COSHH (ACDP) hazard group 4 pathogens.

  4.4  The size of the facilities varies. They range from single rooms through to sites with more than one suite of level 4 laboratories.

  4.5  Of the two commercial vaccine companies, only one currently manufactures in the UK. The other only stores virus for use elsewhere in Europe. The UK manufacturer has the capacity to work at large scale—1,000s of litres per production run—with both SAPO level 3 and level 4 agents.

  4.6  In addition, there are two High Security Disease Isolation Units (HSDUs) where patients with suspected Viral Haemorrhagic Fevers are transferred for medical care. These two units are designed to allow staff to care for patients infected with viruses such as Ebola and Lassa in a safe manner. One is located in the South of England and the other in the North East of England. Both sites are due to move in the next couple of years but will stay in the same geographical areas.

Containment level 3

  4.7  Containment level 3 laboratories are widely spread throughout the UK. Our latest figures show that there are around 600 individual laboratories in GB that were designed and built to operate at containment level 3.[52] However, many are routinely used for work at lower containment levels.

  4.8  The organisation with the largest number of CL3 laboratories is the NHS, which has approximately 170 laboratories, most of which are used for diagnostic purposes, although some research is carried out in the larger Trusts and teaching hospitals.

  4.9  The academic/research institute sector has approximately 350 CL3 laboratories, which vary considerably in size and capacity. Of these approximately 150 are in research institutes, and approx 200 in universities. Private companies account for around 75 laboratories. Differentiating between university and research institute ownership is often difficult; for example, the some research organisations have laboratories in many universities and medical schools.

  4.10  A large amount of CL3 capacity is held by a small number of universities and research institutes. For example, one institute has 60 CL3 laboratories, and two universities have 84 CL3 laboratories between them.

  4.11  The Russell Group of universities owns most of the academic CL3 capacity.

  4.12  Many of the larger organisations have the capacity to work with animals at containment level 3. Information and data on the location of animal facilities is carefully controlled due to the risk from animal rights extremists.

  4.13  A small number of research institutes and universities have the capacity to work with large animals at CL3. A number of factors including space, cost, and access to an on-site incinerator determine the location and capacity.

March 2008

49   Site: departments/locations/campuses. Back

50   Laboratory: individual room meeting all/the majority of containment measures for that particular level eg CL3. Back

51   Organisation: at the employer level eg University of X. Back

52   HSE are currently in the process of undertaking further intelligence on this issue. This figure reflects responses up to an including 7 March 2008. Further updates will be provided before 17 March 2008. Back

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