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

Memorandum 2

Submission from the Veterinary Laboratories Agency (VLA)


  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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