Memorandum 36
Supplementary memorandum from the Health
and Safety Executive
FURTHER INFORMATION
ON HSE-REGULATED
CONTAINMENT LABORATORIES
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))
COSHH
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.
GMO(CU)
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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