Memorandum 6
Submission from Andrew Thompson, Biological
Safety Officer, Oxford University
BIOSECURITY IN UK RESEARCH LABORATORIES—THE
EXPERIENCE AT OXFORD UNIVERSITY
SUMMARY
The full implementation of required construction,
security, and management standards for laboratories working with
micro-organisms and appropriate training and monitoring of personnel
and work being undertaken at Oxford University provides the necessary
level of biosafety and biosecurity to prevent inadvertent release
of bioagents into the population or environment.
It would be difficult for an uninformed outsider
to gain access to material from University premises. Therefore
the implementation of any further security measures is extremely
unlikely to prevent the misuse if biological but is likely to
be extremely detrimental to ongoing research. Any desire to improve
the situation is better directed at identifying insiders intent
upon perverting ongoing research but such an informed individual
is more likely to use material obtained more easily elsewhere.
Terminology—Biosafety and biosecurity
Biosafety is concerned with protection of the
human population from accidental exposure or release whereas biosecurity
is concerned with protection of the human population from deliberate
and unauthorised removal of bioagents (and requiring controls
over and above those of biosafety) OR accidental or deliberate
release of environmental (plant or animal) pathogens. Animal or
plant pathogens do not pose a threat to human health and therefore
do not require "biosafety" measures but they do pose
an environmental hazard and require biosecurity measures to be
put in place to control them. These do however, overlap with biosafety
controls.
Licensing
The use of ACDP listed Hazard Group 2 and Hazard
Group 3 pathogens is notified to the Health and Safety Executive
prior to work commencing. However, once notified and permission
granted, the University is at liberty to continue working with
the pathogens throughout its premises. The University maintains
a very close liaison with the HSE with regard to working with
such pathogens and further controls are enacted via the notification
and fee required to undertake any genetic modification on such
pathogens. Between 80% and 90% of all work with HG2 and HG3 pathogens
involves genetic manipulation ensuring that almost all specific
work is identified to the HSE.
Work with non-modified plant and animal pathogens
and administered through DEFRA requires a specific renewable license
to be granted rather than simple permission to commence work being
granted via a letter as happens with modified pathogens. The process
is, if anything, more vigorous and more controlled than that undertaken
for human (ACDP) pathogens and again, there is very close monitoring
of specific work. NB there is crossover between human pathogens
and animal pathogens with some being subject to both DEFRA and
HSE controls.
Storage of pathogens
There is a significant level of inventoried
long-term storage of micro-organisms at Oxford University. Such
storage tends to be very controlled with accurate maintenance
of records. This enables researchers to retrieve stored samples
and replenish stocks in a controlled manner allowing for continuity
of the research effort and provides a contingency in the event
of loss of working material. Anecdotally, the issue of stocks
going missing is not perceived to be a problem although it may
occur. It might be possible to circumvent inventory controls in
some large scale storage facilities in order to obtain material
when it would otherwise not be readily available but where detected
this would not automatically result in an investigation unless
it was obvious that the removal of stocks was malign.
Experimental material is subject only to the
control of researchers at the bench and may not involve detailed
records being held beyond a simple note in an experimental notebook.
Additionally, there is a degree of fluidity between stored stocks
and cultured stocks with the capacity for a small frozen vial
to be rapidly expanded to litres of cultured material in very
short time. Individual researchers or groups controlling their
own experimental material at the lab level would not therefore
necessarily identify the unaccountability of material as significant
as it is easy to expand from frozen stocks and experimental material
may be readily lost through contamination with adventitious agents
or failure to expand. This makes the keeping of detailed and accurate
records of exact quantities both difficult and meaningless.
Transport of pathogens
Regarding the transportation of pathogens, in
my opinion, the enforcement of existing legislation administered
by ICAO represents the best method of controlling this area of
vulnerability. The legislation requires samples to be correctly
identified, classified, labelled, and packed appropriately. There
is sufficient information and protection to enable each package
to be transported securely but not identified as containing specific
pathogens and once in the transportation system the package is
effectively lost until it reappears at its destination. There
is an inherent degree of security in this and it would require
a great deal of intelligence to intercept such a parcel with any
degree of effectiveness. Having stated that, an individual at
any courier agency could intercept all packages marked as UN2814
or UN2900 and divert them to be trawled for likely contents but
this would probably be detected fairly quickly. Again, the appropriate
co-ordinating authority should discuss this with courier agencies
and ICAO/IATA to address personnel security issues to ensure rapid
detection in the event of such an instance.
Pathogen and laboratory biosafety
Individuals working in containment laboratories
at Oxford University are offered a series of increasing levels
of training starting with basic biosafety provided at the corporate
level. Due to the large number of researchers, students, and visitors
it is not always possible to ensure full training is received
immediately as marrying training programmes with short term visits
or ad hoc start dates is not possible. However, there is
an expectation that supervisors will provide the necessary and
specific training required to work with the particular agents
being used on a research or teaching project in addition to basic
training. Supervision then becomes the key factor where initial
basic training has yet to be received.
All laboratories handling micro-organisms or
cell cultures at Oxford University are built or are refurbished
to a minimum Containment Level 2 standard. Enactment of the construction,
security, and management standards of CL2 and CL3 ensures that
the possibility of accidental exposure or release is minimised
to be effectively zero irrespective of the level of training and
supervision being received. These measures are audited via a series
of annual spot checks and full inspections in each department
to ensure standards are constantly being checked and improved
where necessary. Hazard Group 3 pathogens are subject to more
rigorous controls, the most effective being highly restricted
access, with permission to work only being given to individuals
who have been suitably trained with a period of supervision prior
to being allowed to work alone. With such measures in place it
is unlikely that inadvertent exposure to, or escape of,dangerous
pathogens will occur.
Pathogen and laboratory biosecurity
At Oxford University we have sought to enact
the requirements of the Home Office standards for laboratories
holding substances and pathogens listed in Schedule 5 of the Anti
Terrorism Crime and Security Act. I have some issues with those
requirements in that potential targets for theft become more clearly
identified by storing them in specific marked areas whereas in
the normal running of a lab working at Containment Level 2 or
3 samples are stored in a fashion that's familiar to each individual
researcher and often subject to a coded nomenclature. This actually
makes samples far more difficult to identify to anybody else and
they therefore become "lost". Storing samples in specific
and identified areas makes them more vulnerable to removal by
the determined illicit entrant. Additionally, live cultures are
more difficult to secure in such a manner as they are held in
incubators that are generally easy to gain access to.
However, by enacting the physical standards
and treating the curtilage of the lab and/or the building as the
secure area I feel that Oxford University labs are not particularly
vulnerable to theft of samples by outside agents and whether or
not samples are stored more securely becomes irrelevant if the
outer security is sufficient. A determined entry would still require
pathogens (or substances) to be identified from the myriad others
held.
Misuse of micro-organisms
Many hazardous pathogens are widely available
in the environment to somebody with a little knowledge and understanding
so it would be unnecessary to attempt to obtain them illicitly
from a lab. Ungulate or primate carcasses discovered in central
African countries represent a likely source of many pathogens
suitable for use in crude bio-terrorism weapons rendering the
need to obtain pathogens from Western labs unnecessary.
The main threat from research labs, in my opinion,
comes from modification of micro-organisms, or access to modified
micro-organisms, by an inside agent, either as part of an approved
modification experiment or illicitly. It is impossible to monitor
what individuals undertake as there is no accountable product,
there being no finite quantities as in radiological or chemical
agents, and only a small quantity need ever be removed if facilities
for propagation existed elsewhere. It would also require unattainable
levels of supervision and control that would completely remove
the ability of researchers to work effectively to ensure unauthorised
work did not occur. The reality is that in an open research environment
it would be relatively easy and entirely undetectable for an individual
to obtain, wild type pathogens or notified GMMOs with increased
pathogenicity, or pervert their work and produce modified pathogenic
agents such as "flu" virus. As the work would be it
would not be undertaken at the otherwise required higher level
of containment and would not therefore be subject to the scrutiny
of working in those conditions. The use of biological safety cabinets
and simple good technique could ensure an operator could work
safely and undetected at Containment Level 2.
This kind of activity, in my opinion, represents
the biggest threat posed by research labs. If it were deemed that
such a threat does exist then one means of policing it without
being unduly draconian would be to implement random sampling of
experimental samples, as in dope testing sportsmen and women.
The Health and Safety Executive has powers of entry and could
enact this. Unannounced visits could be used to take samples for
verification elsewhere. However, the cost of such an exercise
and likely rate of discovering suspect samples (has it ever actually
happened in the UK? Unlikely) might make it unworkable but the
possibility of such a check might act as a deterrent.
Control of research activity is probably better
directed elsewhere. Ensuring lab personnel are bona fide, especially
where the work involves using known pathogens or adding pathogenic
traits such as virulence factors to higher hazard group agents
would be one area but how this can be achieved without fundamentally
affecting the freedom of academic research is difficult to foresee.
Ensuring references are in order should be undertaken anyway as
straightforward good employment practice and screening of new
and existing employees on police or other security databases could
be utilized (although in my civilian life, I have issues with
the use of such entities). This, of course, disregards pressure
being brought to bear on otherwise bona fide individuals
in the form of bribery, coercion or other pressures. The opinions
of principle investigators should be sought for confirmation of
my statements regarding threat source and the opinions of university
administrators/human resources personnel should also be sought
for discussion of the feasibility of better ensuring the integrity
of personnel.
Additionally, seemingly bona fide individuals
could simply be gaining experience in research laboratories to
be used elsewhere beyond the control of the EU. This again would
require vigilance by personnel departments but balancing academic
freedom with both restrictive practices might prove unworkable
without being over-authoritarian and might be perceived as institutionalised
discrimination. It also ignores the fact that many individuals
who might represent a threat through personal ideologies were
trained long before the perceived threat from bio-terrorism became
more pronounced and have the skills necessary.
Anecdotally, access to former Soviet weapons
facilities in the Stani republics is not well controlled, and
the inventories of pathogens may well have been lost in the turmoil
of the massive political upheavals of the early 1990s (see the
BBC's "Holidays in the Danger Zone" documentary series)
and this represents probably the biggest threat from lab-based
pathogens and is beyond the control of the EU.
Misuse of information
Regarding censorship of novel information, it's
my opinion that there is more than sufficient information already
freely available for the virulence and infectivity of pathogens
to be increased sufficiently for simple but effective bioagents
to be produced. Censorship would be just that and entirely undesirable
from a societal viewpoint.
Plant and animal pathogens
As noted, the use of such pathogens is subject
to certain controls and licences for obtaining and dispersing
are required but otherwise all the points applying to human pathogens
will apply to these pathogens or micro-organisms. The misuse of
a plant or animal pathogens could cause enormous economic impact
in both developed countries and in developing countries relying
on subsistence farming or dependent on cash crop for export farming.
Foot and mouth disease virus represents a significant
economic threat in the UK and Europe although this is an entirely
fabricated situation as the use of vaccines could prevent this.
Only the desire of the UK to be declared virus-free (otherwise
masked by the use of whole population vaccine) to protect a now
small export market creates this situation. This man-made issue
should be resolved elsewhere to remove an unnecessary but significant
threat, FMDV being extremely transmissible.
Essential equipment and reagents
Monitoring of purchases of essential equipment
and reagents to culture pathogens may be possible as this might
identify possible targets for investigation. The experiences of
the UN WMD Inspectors and control of supplies to Iraq may be applicable.
Microbiological safety cabinets are readily available on eBay
for instance so legislation would be required to control supply
of such items.
January 2008
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