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

Memorandum 6

Submission from Andrew Thompson, Biological Safety Officer, Oxford University



  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.


  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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