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

Memorandum 7

Submission from Robert W Osborne


  This paper presents a University Biological Safety Adviser's view to 6 of the 7 criteria laid out for the above Inquiry. The precise scope of the Inquiry is open to differing interpretations; the writer has attempted to define his contribution to specific limits. In the author's restricted view, the UK has many quality facilities at medium to high containment status but there may be a need for further infrastructure at the highest level. The standards and requirements dictated by legislation and formal guidance are world class but there is room for improvement in various factors of the management and oversight of medium to high hazard level activities. Some suggestions and recommendations are highlighted.


  This paper is submitted to the Innovation, Universities and Skills Committee of the Parliament of the United Kingdom for consideration in their Inquiry entitled—Biosecurity in UK Research Laboratories, published 6 December 2007. It is restricted in its views as the author, although respected in his field, can only have limited information consequential to his role within two specific organisations. Compared to the regulators his understanding nationally and internationally can likewise only be limited, based on visits when opportune and professional conferences etc. However, many of the comments are shared with peer professionals.

2.1  Contributor's background

  Current role: Biological Safety Adviser [BSA] University of Glasgow [UG] UK

  Remit: To advise on the handling of pathogens and genetically modified organisms [GMOs] by the University community ensuring control of the associated hazards/risks and preventing harm to persons the institutions neighbours and the broader environment.

  Expertise: A brief resume is given as an Appendix.

2.2  Representation/the University environment

  This submission is primarily based on the writer's engagement in a University environment. UK Universities have a very open culture albeit the last decade has seen the imposition of greater security driven by the need to counter terrorism. In addition, University management of all activities is extensively delegated to Departments/Divisions and in turn to leading academics—scientists, Principal Investigators (PIs)—as managers. The latter may cover large but often small groups and thus may not have a corporate overview. Typically Universities operate within the legislative framework of both European Directives, national (GB) and delegated and international regulation, (details will not be presented here). In the biological context, delegation to local parliaments adds some additional burden.

  University Biological Safety Advisers and Officers: The role of BSAs is outlined in the remit above. BSAs do not have managerial authority operating by education and persuasion. If necessary, to take corrective action resort is made to line management structures and/or the regulators; professionalism would preclude inaction. In contrast, University Biological Safety Officers [BSOs] have an authoritative but directed role that will vary with institution and remit. When addressing genetic modification responsibilities, typical BSO duties are laid out in the formal Compendium of Guidance that accompanies legislation 1.


  The following limiting factors for this contribution are brought to the Committee's attention.

    (i)  Biosecurity: This term has more than one meaning depending on context. Firstly, as a means of containing an infectious agent or secondly to preclude removal of a biohazardous agent by those with nefarious intent. The two control regimes are intimately related but not identical; this contribution focuses on the first definition.

    (ii)  Dangerous Pathogenic Material (DPM): DPM falls into various hazard classification schemes. This text assumes that it will (/may) contain agents of [human] hazard groups (HGs) -3 and -4 and selected microbes of HG-2, (ACDP). For animal pathogens, infectious agents will be exotic and cause serious economic harm (compare human infection), animal HGs -3 and -4. Containment Levels (CL) discussed correlate to equivalent HGs.

    (iii)  The Competent authority [CA]: The several regulatory bodies that specifically overview this University's activities with DPMs include the Health and Safety Executive (HSE) (human pathogens/all GMOs), the Scottish Executive Environment and Rural Affairs Department/Department for Environment, Food and Rural Affairs (SEERAD/DEFRA) (animal pathogens) and the Home Office [anti-terrorism]. Such bodies may/do act collaboratively. In this paper, the term CA will apply to any of the regulatory bodies.

    (iv)  The Callahan Report 2: Whilst inevitably there are shortcomings, this is an excellent document. It re-affirms the responsibilities of senior management towards organisational operations including biosecurity, demonstration of leadership and establishment of a strong safety culture. Further, it recommends many approaches that the writer and colleagues have been promoting to the SEERAD/DEFRA inspectorate for years. The principal shortcoming is the proposal for full cost recovery; that is not seen worldwide and could further drive the science outside of the UK.

  SEERAD have not had a strong inspectional culture. This University's experience has shown a lack of continuity and a continuing evolution of interpretation of its own Guidance. That Guidance lacks the application of the risk assessment process adopted for human pathogens, at times it is excessively prescriptive and is difficult to "sell" and justify. Further, in parts it goes beyond ACDP standards. However, the regulator has been helpful and supportive with licensing and applications. The Report's recommendation for a single inspectional regime pursuing common standards for human/animal DPM is to be applauded. However, as a single, distant regulator, HSE will need to extensively further develop its understanding of the best of the veterinary culture.


3.1  The capacity to conduct research on DPM

  Currently the most hazardous materials (HG-4) are not handled outside of specialist research institutions, (eg the Porton complex, NIBSC, MRC-Mill Hill) none of which are in Scotland. Following the escapes of smallpox in the 1970s, no UK Universities have suitable facilities (a confidential source indicates one University is currently proposing such a development). It is thought that picture is common to Europe. In contrast, there is emergence of suitable facilities attached to American Universities, suggesting the UK may be disadvantaged. If UK Universities are to be licensed to work at CL-4 a significant but achievable improvement of biosafety culture and overall management will be fundamental. It is suggested if there is an identified need for such facilities their construction should be limited to a central strategic resource accessible to University projects with suitable support for staff training etc. Location will be a major public issue [eg USA].

  For CL-3 activities the UK is well served. Many facilities exist in UK universities. Within this University, they have been built on a piece-meal project/grant approval basis rather than as a strategic investment. Concomitantly, typically they are small, disparate and have been developed with extensive inefficiencies emanating from a poor understanding of the requirements by design and construction teams, despite the writer's deliberations, with much "reinvention of the wheel". Whilst meeting the required standards after extensive development, most within this University are currently underused or non-operational due to funding changes but could be readily returned to active status. The described scenario is not atypical of peer Universities.

  Facilities at CL-2 are also readily available. Most but not all of this institution's biological laboratories will be suitable for handling HG-2 agents/GMOs. Rooms for small animal experimentation meet CL-2 standard as a minimum; limited facilities for CL-3 studies can be returned to front-line use. There are no facilities for large animal experimentation at CL-3/4 but the organisation has links to the Moredun Research Institute.

  This University cannot match the capacities of large peer organisations in the "golden triangle". Staffing capacity for many of the CL-3 facilities in UG would need some minor investment, particularly refresher training.

3.2  The state of Biological Containment facilities

  The standard demanded by formal legislation/guidance at the various levels is as good as any in the advanced world with the UK often leading the field. Within this University, current facilities range from excellent to poor. This institution has shown progressive development with much new build or refurbishment; the latter has seen/is seeing upgrading from CL-1/2 to CL-2 as a minimum in most cases. Subject to 3/1 above, all CL-3 facilities are good. Both CL-2/3 meet and exceed legal requirements, however, they do not equate to the best in private industry. Limited resources induce a need to share facilities/equipment with the inherent risk of compromising containment; that too is not unique to this organisation.

3.3  Laboratory Inspection regimes, rationale/practicalities of licensing

    (i)  General comments: The regime of a formal permissioning/licensing procedure authorised by an external independent professional CA is excellent in principle. All interested parties, active stakeholders, funding bodies, the general public, need to be confident that high standards driven by diligent inspection within a precautionary approach are extant when handling agents which could have a profound effect on populations, the ecological environment or economically. The carrot and stick approach supported by an appeal procedure for the scientific community remains fundamentally important. High hazard activities—work with agents of HG-3 or -4—tend to be extremely well managed but in certain but not all disciplines, CL-2 activities, tend to have a more relaxed culture. For the latter, the writer encourages a more disciplined approach backed up by CA action.

    (ii)  CL-4 facilities: The current regime operated by the CA whereby formal approval and authorisation following intense scrutiny precedes any handling of DPM is commended.

    (iii)  CL-3 facilities: In the writer's experience, commencement of activities at CL-3 with human pathogens may precede complete CA inspection and scrutiny albeit that review will follow soon thereafter. In contrast to HSE, SEERAD/DEFRA pre-inspect prior to licensing and permissioning of "wet" work. The current HSE approach could allow poor-practice in the short term and that is insufficiently stringent, the author recommends the same regime as applied to HG-4 activities. A relatively recent change in legislation requires HG-3 and certain HG-2 activities to be formally notified to HSE. The regime is a little more stringent with GMOs.

    (iv)  CL-2 facilities: Apart from certain Notifications to HSE, in the writer's experience, there is no pre-activity inspection and review when handling pathogens. There is more stringency in the regime with GMOs whilst SEERAD/DEFRA do pre inspect before licensing "wet" work.

    (v)  Final points: The SEERAD/DEFRA approach has been found wanting at the Pirbright complex. The highest standards would have been expected from sites subject to multiple regulatory reviews. It remains unclear why matters of evident concern were not detected/rectified by/communicated between the regulatory bodies; further could this shortcoming be replicated? Whilst considerable effort is made to inspect experiences of SEERAD/DEFRA inspections indicates at times a lack of continuity and experience.

  Overall, the writer would like to see more frequent and penetrative inspection and auditing of facilities and activities particularly for higher hazard status projects. That does not need to be externally driven but could/should be effected "in-house" regularly and subsequently subject to CA validation. Although intimated, that is not definitively laid out in legislation and guidance, or enforced during local inspection/auditing visitations (HSE). Unfortunately, resources and expertise to permit systematic and detailed inspection/auditing are often insufficient. In addition, more frequent reviews by external bodies to CL-3 facilities, subject to adequate safeguards, are to be encouraged.

3.4  Biosafety training provision

  Two inter-related separate issues need to be considered—biosafety management—facilities, staff, procedures—and practitioner attributes—skills and practices. At CL-4, the necessary knowledge, skills and expertise can only be acquired in the few specialist facilities. The writer is aware of one week-long training initiative at Winnipeg, Canada which takes non-resident trainees, there is likely to be something similar in Australasia.

  At the lower levels, CL-3 and CL-2, there are limited courses. The most well-known and successful biosafety management course has progressively evolved and is run by MRC, [suggest the Committee approaches Drs Jackett or Mitchell via MRC HQ], designed for managers and practitioners within departments and is open to non MRC interested parties, the writer having contributed peripherally. However, it is understood it is likely to cease or be franchised elsewhere shortly. At the practitioner level MRC did run a series of workshop courses for their AIDS Directed Programme [ADP] in the late 1980s, the writer is not aware if these have been resurrected in any form. Commercial organisations provide some specific short courses, eg Transport of biological materials.

  The Institute of Safety in Technology and Research [ISTR] and MRC are preparing a curriculum for biosafety managers/practitioners at intermediate and senior professional levels, again the writer having contributed peripherally. The Committee is further directed to Dr. Jackett and Mrs Sheeley, [Mrs Sheeley will be contributing to the Committee]. These two initiatives deserve active support and should be firmly encouraged and adequately funded as a national resource.

  Specific practitioner courses are limited, most training will be acquired `on the job' from shadowing experienced staff or after previous roles including PhD and Post-Doctoral training and supplementary induction. There are occasional issues of insufficient supervision by Principal Investigators [PIs]. Similarly, a major concern of the writer is the use of GM techniques as a tool in a wide variety of biological and non-biological sciences by individuals who sometimes show insufficient understanding of the biosafety/containment requirements for handling infectious agents, albeit such work is generally of low hazard status. These concerns are local management issues but again are not unique to this University.

  The writer remains most concerned that UK Universities did not actively contribute to the recent International Biosafety and Biosecurity Standard Development initiative. At that time, funds were not available locally albeit several approaches were taken. The writer was given short shrift on approaching the University Safety and Health Association [USHA]; he was unable to attend any of the meetings and the University sector was not appropriately represented by others. Universities are expected to and do operate in a global context, this non-participation [disinterest?] was a major faux-pas.

3.5  Inventories of stored agents and transportation of DPM

  Quality science demands retention and access to valuable DPM and the maintenance of detailed inventories. The security and professionalism of such databases is being instituted/improved driven by CA inspection and the application of electronic formats. Historically, institutions such as Universities, have not maintained corporate permissioning regimes for acquisition/supply of DPM. What is in place has been driven by individual scientists/managers and agent containment requirements. Typically, for higher hazard activities such inventories are good but there remains much wanting particularly at the lower hazard levels. Legislation (eg COSHH) makes stipulations and is assisting the ongoing changes of the culture with the introduction of approval procedures now becoming the norm. These comments do not apply for HG-4 activities, the writer does not have recent experience.

  National and international transportation of DPM between institutions tends to be via competent couriers though not guaranteed. Within an institution, mechanisms are continually improving to meet a professional standard although an ongoing continuous evolution requiring routine monitoring locally and by the CAs.

3.6  Loss of pathogenic material

  Regular checks of DPM will not be performed unless there are good reasons (scientific need, legislation). Losses also occur due to technical difficulties and theft, the latter might not be immediately realised. The actions that follow losses will be dictated by individuals, groups and regulation. Corporate responses will be at a later stage, usually in mitigation.

3.7  Overseeing security clearance for research students

  This section is more competently considered by colleagues, the writer will comment very briefly at this stage. Locally Policy has been developed with Human Resources dictated by Home Office guidance.


    (i)  If there is an identified need for further CL-4 facilities, it is suggested their construction should be limited to a central strategic resource accessible to University projects with suitable support for staff training etc.

    (ii)  Encouragement of a more disciplined culture for certain disciplines operating at CL-2, backed up by CA action.

    (iii)  A common permissioning regime be applied for HG-3 and -4 activities based on current practice for the latter.

    (iv)  More frequent and penetrative inspection and auditing is applied (a) of facilities and activities in general and (b) by external bodies to CL-3 facilities, subject to adequate safeguards.

    (v)  Training initiatives led by MRC and ISTR deserve active support and should be firmly encouraged and adequately funded as a national resource.

January 2008

Footnote: The writer had approached academic colleagues for contributions but it is thought that the short timescale following awareness of this initiative has not enabled such submissions.

R Osborne

[BSc, MSc, Dip2-OSH, CMIOSH, MISTR] [University Biological Safety Adviser] [25/01/08]

[SEPS, Pearce Lodge, University of Glasgow, Glasgow G12 8QQ, Scotland, UK]


1  Compendium of Guidance, SACGM, 2007.

2  A Review of the Regulatory Framework for Handling Animal Pathogens. Report of a Committee chaired by Sir Bill Callaghan, Defra Publications, 2008.


  Role of a University Biological Safety Adviser: The remit described at section 2.1 translates to taking a leading role in educating, (advising and directing) or assisting, researchers and managers of relevant legislation, in hazard and risk recognition, risk assessment and management and practical procedures for handling human, animal, plant or microbial organisms or materials, their pathogens and GMOs.

  Background experience: 26 years of laboratory based investigations of the diagnosis, biology, vaccinology and epidemiology, including vector borne transmission, of certain veterinary viruses of major economic consequence (1970-1986; Institute of Animal Health-Pirbright) and human/feline immunodeficiency viruses including biosafety management of high containment facilities [1987-1997; UG]. 12 years overseeing corporate biosafety management, as a BSA (1995—date; UG).

  Professional activities: Member of HSE's Scientific Advisory Committee for Genetic Modification (Contained-Use) (SACGM). Member of the following professional bodies: Society for General Microbiology (SGM); European Biosafety Association (EBSA) (and former member of the Conference Committee); Chartered Member of the Institute of Occupational Safety and Health (CMIOSH).

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