Memorandum 34
Submission from the Society for General
Microbiology (SGM)
INTRODUCTION
The Society for General Microbiology, founded
in 1945, is an independent professional scientific body dedicated
to promoting the "art and science" of microbiology.
It has now established itself as one of the two major societies
in the world in its field, with some 5,500 members in the UK and
abroad.
GENERAL COMMENTS
The Society for General Microbiology (SGM) welcomes
the Select Committee's inquiry into Biosecurity in UK research
laboratories.
SPECIFIC COMMENTS
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
Research involving these hazardous agents is
absolutely essential in order to combat the threat of existing
and emerging infectious diseases. Any regulatory framework must
achieve a suitable balance—providing appropriate safeguards
whilst not unduly restricting crucial research. It is compulsory
that research involving hazardous pathogens or toxins is conducted
in appropriately equipped and resourced facilities. Associated
requirements are robust safety and security procedures that ensure
minimal risks of harm to laboratory workers, the wider public
and the environment.
With the exception of some MoD establishments,
the UK capacity is lacking in training and facilities. The area
of infectious diseases, which underpins much of this work, has
been identified as needing strategic boosts for example by studentship
programmes funded by MRC. The SGM is concerned that the UK should
maintain and indeed strengthen the capacity for research into
dangerous pathogens that may emerge or re-emerge through natural
processes and through malicious release.
The state of biological containment facilities
in the UK
Modern, well maintained facilities are required
for research on dangerous pathogens and biosecurity should be
considered when allocating budgets. Several Universities are building
level 3 containment suites in order to increase the capacity to
work with higher level pathogens and respond to emerging disease
threats meaningfully. However, the state of central large animal
facilities is deplorable. These need to be provided centrally
as few or no Universities would have a sufficient volume of work
to sustain these on a full economic costs basis.
The UK needs to continue to invest in this area
so as to set up facilities at the Institute for Animal Health
or elsewhere. The state of the highest category containment laboratories
(BSL 4) in the civil sector, such as at the Health Protection
Agency and at the National Institute of Medical Research, has
been deteriorating over time and will probably require significant
capital investment in order to maintain state-of-the-art capacity.
Laboratory inspection regimes and the rationale
and practicalities of the licensing system
Old facilities can be difficult to inspect,
so regimes would benefit from an overall updating of facilities.
In general, there are few inspectors and inspections of licensed
facilities are rare. Laboratory inspection regimes conducted by
the Health & Safety Executive are good, but there appears
to be over-emphasis on a spurious rationale for respiratory safety
containment even for pathogens that do not spread by this route;
therefore some rethinking about practicalities concerning true
dangers and possibly false security would be advisable.
Any licensing system needs to be confined to
category 3 pathogens and above and should not be bureaucratic.
A very considerable amount of time is spent on dealing with the
bureaucratic implications of some work, including research on
animals using genetically modified micro-organisms. It is difficult
to say what should be jettisoned but the cumulative effect of
the bureaucracy is stifling. Having said this, licences for new
facilities should be considered carefully.
Biosafety training provision for staff working
in containment facilities
It is the responsibility of research institutions
working with hazardous biological agents to ensure that this research
is safely conducted. All clinical and academic researchers, students
and technicians working with hazardous agents should receive correct
and specific training before they begin this work. Training programmes
must include refreshers at regular intervals thereafter, including
updates on regulatory developments.
Dedicated Biological Safety Officers (BSOs)
in institutions must take the leading roles in responsibility
for organizing and delivering effective staff training, tracking
developments, and advising institutions' senior management. Government
must ensure sufficient long-term funding is provided to key national
institutions for provision of research facilities equipped to
undertake work on these agents, and for retention of technical
expertise in research institutions. This also includes maintenance
of culture collections. Institutions themselves should develop
appropriate succession planning arrangements to ensure continuity
of skills within their staff.
While biosafety training provision for staff
at universities and research institutions appears to be rigorous,
there is a danger that the UK is gradually losing expertise to
investigate and handle certain dangerous pathogens through previous
lack of interest and lack of adequate funding, both in the medical
and in the veterinary fields. Greater emphasis on training is
needed; as the UK is a signatory to the Biological and Toxic Weapons
Convention, it needs to take its responsibility in this area more
seriously. Reviews of training (which is controlled by individual
facilities) should be more proactive.
The maintenance and recording practices surrounding
the storage and transportation of dangerous pathogens
The maintenance and strict recording practices
of the storage and transportation of dangerous pathogens is an
area that needs to be continually monitored in order to improve
security and to introduce better recording practices afforded
by computerised methods. If any changes are envisaged they should
be applicable only to the highest categories of pathogens. The
term dangerous pathogens as defined in UK legislation covers too
wide a range of organisms.
The primary responsibility for ensuring safety
and security must rest with institutions. However, relevant regulatory
agencies also have an obligation to coordinate effectively in
developing and implementing regulatory processes. There seems
to be lack of consistent guidelines and regulations on the transport
of potentially hazardous biological materials between different
countries.
Measures implemented when pathogenic material
cannot be accounted for
It is of crucial importance to ensure appropriate
measures to follow up investigations into the provenance and destiny
of dangerous pathogens, without triggering unnecessary panic if
an audit of the pathogens appears faulty. It should be made applicable
only to category 3 organisms or above. Better contingency plans
are needed for loss and damage during transportation.
The role of universities in overseeing security
clearance for research students working with dangerous pathogens
The role of the universities is to educate and
train students and research fellows in the proper practice of
safe microbiology. Students and fellows should be selected on
merit without prejudice as to the country of origin. However,
security clearance should be sought for access to those pathogens
that represent a threat to public health if released.
A role for the Universities in overseeing security
clearance is opposed. Universities already need to identify projects
and get these approved for the issuing of visas to foreign students.
A role for Universities in overseeing clearance of UK or EU individuals
could be considered a breach of trust between the organization
and its students. Universities are not particularly well equipped
to make the proper security investigations and more clarity of
guidance would be welcome in this regard. The Security Service
is well equipped to carry out such clearances and improved communication
between the Services and Universities working with dangerous pathogens
would be advantageous.
It should be borne in mind that there are several
dangerous pathogens which are dangerous only to those who handle
them and not to the community at large. Care should be taken that
security clearance is not so risk averse as to become over-zealous
because the UK could lose its microbiological experts. For example,
the President of this Society understands that he would not pass
positive vetting at the Department of Defence yet his advice in
civilian biosecurity is frequently sought to the benefit of the
UK.
ADDITIONAL COMMENTS
The SGM is also concerned about which microbes
are classified as "dangerous". Like its sister organisation,
the American Society for Microbiology, it notes that certain US
microbiologists have been arraigned for handling or distributing
microbes which for the past 50 years have been safely handled
in undergraduate microbiology practical classes. While it is always
wise to reappraise the classification of microbes (which themselves
can change in virulence from strain to strain), conventional use
of microbes should not lead authorities to regard professional
microbiologists as traitors or terrorists.
There is complex existing regulation relating
to biosecurity with at least several Government departments and
agencies involved at different levels within the biosecurity framework.
The regulatory framework could be improved through simplification,
clarification and co-ordination of procedures to protect biosecurity
of research conducted in UK laboratories. However, development
of new sets of regulations would unnecessarily raise the existing
administrative burden on the research community.
The Royal Dutch Academy has developed a document
inspired by the fact that many countries have ratified the biological
and toxin weapons convention (BTWC) in which they commit themselves
to stopping the development, production or storage of biological
weapons. A number of high level rules for behaviour have been
identified in the document:
Awareness
— Ensure that in the education and
postgraduate education of life sciences researchers there is a
specific and explicit part of the programme that indicates awareness
and the risks of misuse of biological, biomedical and biotechnological
research and ensure that people understand the limitations of
the BTWC.
— Disseminate concerns in professional
journals on a regular basis.
Research and publication policy
— The application and evaluation procedure
for research proposals includes consideration of potential dual
use.
— If there is a dual use, make a potential
risk benefit analysis of the to-be-expected result of the research.
— Limit, as far as possible, the risk
that scientific publication of results of potential dual use research
could make an unintentional contribution to the misuse of the
knowledge.
Whistle-blowing
— Ensure that every potential view
of misuse of dual use technology is reported to the appropriate
authorities.
— Take whistleblowers seriously. Ensure
there is no detrimental effect to their career from their activities.
Internal and External Communication
— Ensure there is extra security in
relation to internal and external email, mail and telephone and
data security in relation to information on potential dual use
research and material.
Accessibility
— Ensure there is extra security for
personnel and visitors in places and companies where potential
dual use research is being carried out and where material is stored.
Transport and Transfer
— Ensure that extra security screening
and interest in biosecurity is developed in those people who are
transporting, as well as in the recipients of potential dual use
biological material.
SOURCES
This evidence has been prepared on behalf of
SGM by Professor Robin Weiss (University College, London), Professor
Bert Rima (Queen's University, Belfast), Professor Howard Jenkinson
(University of Bristol) and Dr Michael Tully (Leicester School
of Pharmacy)
ABOUT THE
SGM
Society membership is largely from universities,
research institutions, health and veterinary services, government
bodies and industry. The Society has a strong international following,
with 25% of membership coming from outside the UK from some 60
countries.
The Society is a "broad church"; its
members are active in a wide range of aspects of microbiology,
including medical and veterinary fields, environmental, agricultural
and plant microbiology, food, water and industrial microbiology.
Many members have specialized expertise in fields allied to microbiology,
including biochemistry, molecular biology and genetics. The Society's
membership includes distinguished, internationally-recognised
experts in almost all fields of microbiology.
Among its activities the Society publishes four
high quality, widely-read research journals (Microbiology,
Journal of Medical Microbiology, Journal of General Virology and
International Journal of Systematic and Evolutionary Microbiology).
It also publishes a highly respected quarterly magazine, Microbiology
Today, of considerable general educational value. Each year the
Society holds two major scientific meetings attended by up to
1500 microbiologists and covering a wide range of aspects of microbiology
and virology research.
The governing Council of the SGM has a strong
commitment to improving awareness of the critically important
role of microbiology in many aspects of human health, wealth and
welfare. It has in this connection recently initiated a "Microbiology
Awareness Campaign" aimed at providing information to the
government, decision makers, education authorities, media and
the public of the major contribution of microbiology to society.
An issue of major concern to the Society is
the national shortage of experienced microbiologists, particularly
in the field of clinical microbiology and in industry. To attempt
to improve this situation long-term, the Society runs an active
educational programme focused on encouraging the teaching of microbiology
in university and college courses and in the school curriculum,
including primary schools. Some 400 schools are corporate members
of SGM.
January 2008
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