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


Memorandum 13

Submission from Biosciences Federation and the Institute of Biology

SUMMARY

  1.  IOB and BSF welcome this inquiry by the IUS Committee. We recognise not only the serious potential threat posed by deliberate exploitation or accidental escape of many laboratory collections but also the essential and beneficial contribution to society of research involving such material. We hope that this consultation process will lead to improved practices and increased peace of mind for researchers and the public.

  2.  The current capacity for work on dangerous pathogens is limited and may not be sufficient to allow the desired level of Category 4 research both in terms of facilities and of fully trained personnel.

  3.  There is concern that, despite Full Economic Costing for universities, the pressure to generate measurable output and income causes infrastructure funding to be shifted towards short term projects to the detriment of routine maintenance. Licensing and monitoring should require full costing of, and budgeting for, maintenance as well as provision for decommissioning at the end of each licensing period to accommodate the possibility of non-renewal.

  4.  The role of Safety Officer should be responsible, visible, highly trained and senior. While moves to avoid negative effects of health and safety regulations may be appropriate in some areas, biosafety must always be paramount in the handling of pathogens. Moreover, biosecurity should be given priority over other matters such as trade agreements etc.

  5.  Routine and unannounced inspections are infrequent in the absence of reported incidents. Transport of dangerous agents between facilities needs to be examined, particularly with regard to planning for critical incidents and communication of these strategies. Training advice from the Advisory Committee on Dangerous Pathogens (ACDP) is well regarded, however, actual training is heavily dependent upon internal procedures at each facility.

January 2008

APPENDIX 1

Q1.   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

  A1.  The current capacity for such work is limited[11] and may be inadequate to allow the desired level of Category 4 Pathogen research both in terms of facilities and of sufficiently trained personnel. Research on Category 4 and 3 agents is necessary to allow recognition of new variants, to identify and trace contacts of potentially exposed travellers and animals, and to compare outbreaks from different areas.

  It is important for researchers and regulators to recognise that release of notifiable animal, bird and plant pathogens can hamper trade and transport within a country and have a detrimental effect on the economy, and that security against theft should therefore be as high in these cases as for agents of dangerous human and zoonotic diseases.

Q2.   The state of biological containment facilities in the UK

  A2.  Category 3 pathogens pose a very serious risk and how and where to do research on agents and infected animals needs to be considered very carefully. Any facility dealing with microorganisms dangerous to man or commercially important animals and plants should have modern well maintained systems that are guaranteed to inactivate the agents before disposal of the residue of experiments. All systems should be visible to inspection, and old-fashioned hidden pipes or inaccessible filtration units cannot be allowed.

  There is considerable concern that economic pressure shifts focus towards short term budgeting at the expense of routine maintenance and replacement. It is essential that the need for excellent biosecurity is considered in reviewing budgetary requests to funding bodies. Applicants should be encouraged to apply for the full cost of maintaining top class systems in the knowledge that the need for the research will be the deciding factor and not the cost of the biosecurity.

Q3.   Laboratory inspection regimes and the rationale and practicalities of the licensing system

  A3.  The rationale of the licensing system is well thought out and implemented. However, there are a number of potential areas of concern; old facilities are difficult to inspect and there are areas where identification of poor internal processes might be unlikely. There is an impression that once licences have been issued routine and spot inspections are rare, unless an incident is notified, and that even change of organism does not necessarily trigger a site inspection.

  We note that Category 4 inspection in particular, and indeed Category 2 and 3 facilities are under the care of very few inspectors.

  The granting of licences to new facilities at new locations needs to be carefully considered to ensure that qualified and experienced personnel are available to establish mature, expert and responsible practices.

Q4.   Biosafety training provision for staff working in containment facilities

  A4.  The need for exemplary practice is obvious and within the limited facilities in the UK standards appear to be good. The advice which we have received from experienced managers is that biosafety rules should be simple and adhered to totally. Moreover, in order to aid this, the safety officer should be highly trained and have an important and responsible position in the organisation allowing good communication with all levels. Requirement for routine, recorded and frequent (weekly) timetabled internal reporting from Safety Officers to Heads of Department or Directors of Research should be recommended. In addition facility for communication directly with the licensing authority to raise concerns and seek external advice should be considered.

  The ACDP has a series of useful booklets and guidelines but does not specifically govern training. Training is left very much to local conditions. These are generally good but collaboration between sites and indeed international collaboration requires a high degree of trust between licensees. Training records are reviewed but review is reactive rather than proactive.

Q5 & 6.    The maintenance and recording practices surrounding the storage and transportation of dangerous pathogens and measures implemented when pathogenic material cannot be accounted for

  A5 & 6.  Maintenance and storage are generally covered by internal training but transport (and international transport) of dangerous agents needs careful consideration. The OECD has recently considered this in relation to Biological Resource Centres.[12] Moreover, there are cultured organisms not listed as Category 3 or 4 which pose a threat to agriculture and thus to productivity (yield) and quality (producing toxins and damaging stored product) and we would urge improved practice and rigour in the handling and distribution of these organisms also.

  Considerable attention is given to receipt of specimens and dangerous material within facilities and to labelling of items for transport but there does not appear to be good knowledge of contingency plans for loss of, or damage to, items in transit.

  Q7.  The role of universities in overseeing security clearance for research students working with dangerous pathogens

  A7.   There is little enthusiasm for an increased role for Universities in monitoring and vetting potential staff. The Security Services are experienced and resourced for this and the establishment and expansion of good communications between the two sectors should suffice. There should never be unauthorised personnel in secure laboratories and employment procedures should afford an opportunity for security checks.

January 2008

APPENDIX 2

MEMBER SOCIETIES OF THE BIOSCIENCES FEDERATION
Association for the Study of Animal Behaviour

Association of the British Pharmaceutical Industry

AstraZeneca

Biochemical Society

Bioscience Network

British Andrology Society

British Association for Psychopharmacology

British Biophysical Society

British Ecological Society

British Lichen Society

British Mycological Society

British Neuroscience Association

British Pharmacological Society

British Phycological Society

British Society of Animal Science

British Society for Developmental Biology

British Society for Immunology

British Society for Matrix Biology

British Society for Medical Mycology

British Society for Neuroendocrinology

British Society for Plant Pathology

British Society for Proteome Research

British Toxicology Society

Experimental Psychology Society

Genetics Society

Heads of University Biological Sciences

Heads of University Centres for Biomedical   Science

Institute of Animal Technology

Institute of Biology

Institute of Horticulture

Laboratory Animal Science Association

Linnean Society

Nutrition Society

Physiological Society

Royal Microscopical Society

Royal Society of Chemistry

Society for Applied Microbiology

Society for Endocrinology

Society for Experimental Biology

Society for General Microbiology

Society for Reproduction and Fertility

Universities Bioscience Managers Association

UK Environmental Mutagen Society

UK Federation for Culture Collections

Zoological Society of London

ASSOCIATE MEMBER SOCIETIES

BioIndustry Association

Royal Society

Wellcome Trust

Medical Research Council

Merck, Sharpe and Dohme

Biotechnology & Biological Sciences Research Council

ADDITIONAL SOCIETIES REPRESENTED BY THE INSTITUTE OF BIOLOGY
Anatomical Society of Great Britain & Ireland International Association for Plant Tissue Culture
Association for Radiation Research& Biotechnology
Association of Applied BiologistsInternational Biodeterioration and
Association of Clinical EmbryologistsBiodegradation Society
Association of Clinical Microbiologists International Biometric Society
Association of Veterinary Teaching and Research Work International Society for Applied Ethology
British Association for Cancer Research Marine Biological Association of the UK
British Association for Lung ResearchPrimate Society of Great Britain
British Association for Tissue Banking PSI—Statisticians in the Pharmaceutical Industry
British Crop Production CouncilRoyal Entomological Society
British Inflammation Research Association Royal Zoological Society of Scotland
British Marine Life Study SocietyScottish Association for Marine Science
British Microcirculation SocietySociety for Anaerobic Microbiology
British Society for Ecological Medicine Society for Low Temperature Biology
British Society for Research on Ageing Society for the Study of Human Biology
British Society of Soil ScienceSociety of Academic & Research Surgery
Fisheries Society of the British Isles Society of Cosmetic Scientists
Freshwater Biological AssociationSociety of Pharmaceutical Medicine
Galton InstituteUniversities Federation for Animal Welfare
Institute of Trichologists

ADDITIONAL SOCIETIES REPRESENTED BY THE LINNEAN SOCIETY
Botanical Society of the British Isles Systematics Association

OPENNESS

  The Biosciences Federation and the Institute of Biology are pleased for this response to be publicly available and will be placing a version on www.bsf.org and on www.iob.org once the committee's permission to do so has been granted. For any queries regarding this response, please contact Dr Laura Bellingan, Institute of Biology, 9 Red Lion Court, London, EC4A 3EF, email: l.bellingan@iob.org or Dr Caroline Wallace, Biosciences Federation, email: cwallace.bsf@physoc.org

  The Biosciences Federation (BSF) is a single authority representing the UK's biological expertise, providing independent opinion to inform public policy and promoting the advancement of the biosciences. The Federation brings together the strengths of Member Organisations and Associate Members (Appendix 2), including the Institute of Biology. The Institute of Biology (IOB) is an independent and charitable body charged by Royal Charter to further the study and application of the UK's biology and allied biosciences. IOB has 14,000 individual members and many specialist learned Affiliated Societies (Appendix 2). Together, BSF and IOB represent a cumulative membership of over 65,000 individuals, covering the full spectrum of biosciences from physiology and neuroscience, biochemistry and microbiology, to ecology, taxonomy and environmental science.






11   The Callaghan Report (p10) notes that there are 10 Category 4 held licences in England. Back

12   OECD Best Practice Guidelines for Biological Resource Centres. Available at http://www.oecd.org/dataoecd/7/13/38777417.pdf Back


 
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Prepared 25 June 2008