Memorandum 2
Submission from the Veterinary Laboratories
Agency (VLA)
EXECUTIVE SUMMARY
The Veterinary Laboratories Agency (VLA) provides
a significant component of the national laboratory and animal
capability for conducting research on dangerous animal and zoonotic
pathogens up to SAPO4/ACDP3. Overall we consider the national
GB facility matches current and likely future requirements taking
into account the current joint redevelopment plans for IAH Pirbright
and VLA Virology on the single site at Pirbright, Surrey.
From an animal and zoonotic disease perspective
many of the current biological containment facilities in the UK
are modern and fit-for-purpose although others require significant
capital investment to bring them to acceptable bio-containment
standards. Before any new investment in national capability, their
needs to be a UK-wide strategic review to ensure current and future
capabilities, especially high containment animal facilities, are
sited appropriately and used effectively to ensure optimum capacity.
Implementation of the Callaghan review will
strengthen the current licensing and inspection arrangements by
harmonising in the UK all the procedures for working with dangerous
pathogens irrespective of their host.
Rigorous adherence to independent quality systems
such as ISO 17025 and ISO 9001: 2000 provide assurance that valid
audit trails and verifiable storage systems exist for all dangerous
pathogens received at, and transported and held within organisations
such as VLA.
At present security clearance of scientists
working with dangerous pathogens is not harmonised in the UK.
In particular, Public Sector Research Organisations (PSRE) such
as government agencies appear to have much stricter security processes
than many other organisations including research council institutes
and universities. As a major employer of scientists, Universities
clearly have an overseeing security clearance responsibility for
research students and employees. However, experience in PSREs
demonstrates the need for a sensible risk-based approach so as
to ensure effective security procedures do not restrict unnecessarily
the movement of students and scientists that is so vital for a
vibrant scientific economy.
1. The current capacity for research on dangerous
pathogenic material in the UK and the capability to conduct research
on the causative agents of disease that may emerge at a future
time
1.1 VLA has extensive capability for conducting
research on dangerous pathogens up to SAPO4/ACDP3, both in the
laboratory and in large and small animal hosts. There is a recognised
need for some new facilities in the UK to conduct research on
zoonotic pathogens at SAPO4/ACDP4, since current facilities are
very limited in number and focus solely on human disease, leaving
scientific questions regarding the disease in animal hosts unanswered.
Also, in the event of incursion of such a pathogen, current facilities
would not be able to deal with the disease in animals. This gap
has been recognised by Defra and BBSRC and a new joint veterinary
virology facility planned between VLA Virology and IAH on the
IAH's Pirbright site will comprise a research and diagnostic capability
for ACDP4 level pathogens including some capability to conduct
experiments with small animals. The completion of the new facility
is planned for 2012.
2. The state of biological containment facilities
in the UK
2.1 VLA places a high priority on maintaining
its laboratories and animal accommodation in order to fully meet
the requirements of national legislation and international recommendations
pertaining to containment facilities. There is an active programme
of replacement for older facilities in place, which includes the
provision of new facilities for VLA Virology and IAH Pirbright
by 2012. These new joint laboratory and animal facilities will
house one of the largest group of veterinary virologists in the
world and provide an expert knowledge base to ensure the UK is
well placed to deliver underpinning research and a rapid diagnostic
capability for future incursions of exotic diseases in animals
of which many are likely to be new and emerging zoonotic viral
pathogens.
3. Laboratory inspection regimes and the
rationale and practicalities of the licensing system
3.1 The current system is robust and workable.
This system, which is risk-based, provides a degree of transparent
flexibility, particularly in the area of diagnostics, where derogations
are provided for certain classes of sample or use of specific,
lower-risk laboratory strains of pathogens. The recent Callaghan
Review considered the current regulatory framework for handling
of animal pathogens in the UK. One of its main recommendations
was to bring together under a single body the laboratory inspection
regimes and licensing procedures for working with dangerous animal
and human pathogens. VLA welcomes the Government's decision to
vest responsibility and authority to the HSE and we believe this
will strengthen the current arrangements by harmonising in the
UK all the procedures for working with dangerous pathogens irrespective
of their host.
4. Biosafety training provision for staff
working in containment facilities
4.1 At VLA, a range of systems are in place
which provide proof of competency of all staff, before they are
permitted to work with pathogens unsupervised. These include training
in entry and exit procedures, laboratory manipulations, environmental
and personal risks and robust protocols for materials movement
that ensure biosecurity. There is also an active promotion of
a culture of continuous examination and incident/near-miss reporting,
to ensure that potential gaps or flaws can be detected and remedial
action taken, before accidents occur.
4.2 The technical challenges of such work
at the highest containment level (ACDP4) are formidable and staff
training is an essential component of any such capacity building.
Specialist staff in the Virology Department at VLA are currently
undertaking training in work on ACDP4 pathogens, along with developing
collaborative research programmes with counterparts in Europe
and USA, in order to ensure an active programme of work and staff
with requisite skills are in place when the new facility at Pirbright
comes online.
5. The maintenance and recording practices
surrounding the storage and transportation of dangerous pathogens
5.1 VLA has a robust and secure system of
biological archive storage of materials containing such pathogens.
However the funding of archives is an issue since maintenance
of the vast majority of these archives are not met by funding
bodies in the UK. VLA believes there should be funding available
to support the maintenance of biological archives of national
importance. This is particularly relevant to dangerous pathogens
and the increased awareness of the risks associated with bioterrorism.
We consider it is not really practical to similarly record day-to-day
storage of research materials containing pathogens to the same
level ie specific volume and titre, since this is often not known.
Also, it would not be difficult to mis-record volumes or substitute
material. We therefore additionally apply stringent security measures,
both in terms of physical security and access, along with criminal
record and counterterrorism checks of all scientific staff working
with SAPO3/ACDP3 pathogens and above. We consider this provides
sufficient assurance of security and provides a research environment
that is workable. Furthermore, VLA Quality Systems (ISO 17025
and ISO (9000) provide assurance that valid audit trails and verifiable
storage systems exist for all dangerous pathogens received at,
and transported and held within, VLA.
5.2 The role of VLA, as a World Organisation
for Animal Health (OIE) Reference Laboratory for 14 diseases,
EU Community Reference Laboratory for three diseases, along with
being an FAO World Reference Laboratory and WHO Collaborating
Centre, requires frequent importation and export of suspect samples
and pathogens. The current legislation is clear and is rigidly
applied, both for materials being sent and received both nationally
and internationally.
5.3 Occasionally, materials are received
without prior notification and incorrectly packaged, which could
constitute a risk to UK. In such a case, appropriate decontamination
and containment procedures are applied and a strong reply is given
to the submitter, pointing out such breach of international and
national legislation.
6. Measures implemented when pathogenic material
cannot be accounted for
6.1 Any incident where there has been potential
for material to have been removed from any bio-secure unit without
authorisation or unrecorded, an internal investigation is mounted,
led by the Safety Manager and appropriate Head of Department with
support from VLA Security. If such act has resulted in a potential
breach of biosecurity, Defra would immediately be informed. If
the pathogen was also an ACDP3 agent or above, HSE would also
be informed, under RIDDOR.
6.2 In any event where suspicion of removal
of material with malicious intent was revealed, the police would
immediately be alerted.
7. The role of universities in overseeing
security clearance for research students working with dangerous
pathogens
7.1 As mentioned, all scientific staff at
VLA are subjected to criminal record and counterterrorism checks.
It is our experience that the security clearance of staff and
students attending UK universities is variable and cannot always
be relied upon as compared with scientists and students employed
by Public Sector Research Establishments (PSRE). For this reason
we also require and perform identical checks on any students or
visiting scientists, before permitting access to bio-secure areas,
along with training requirements similar to core staff before
permitting unsupervised working. We also seek assurances from
the students' employer that they have completed a training programme
and are competent to work with dangerous pathogens.
7.2 Where, for reasons of geography or nationality,
security checks cannot be completed, visiting scientists are required
to be accompanied by trained VLA staff at all times.
January 2008
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