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 Biologists | International Biodeterioration and
|
| Association of Clinical Embryologists | Biodegradation 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 Research | Primate Society of Great Britain
|
| British Association for Tissue Banking |
PSI—Statisticians in the Pharmaceutical Industry
|
| British Crop Production Council | Royal Entomological Society
|
| British Inflammation Research Association |
Royal Zoological Society of Scotland |
| British Marine Life Study Society | Scottish Association for Marine Science
|
| British Microcirculation Society | Society 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 Science | Society of Academic & Research Surgery
|
| Fisheries Society of the British Isles |
Society of Cosmetic Scientists |
| Freshwater Biological Association | Society of Pharmaceutical Medicine
|
| Galton Institute | Universities 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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