Memorandum 7
Submission from Robert W Osborne
1. SUMMARY
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.
2. INTRODUCTION
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.
2.3Clarification
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. THE COMMITTEE'S
SELECTED CRITERIA
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.
4. SUMMARY OF
RECOMMENDATIONS
(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]
References
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.
APPENDIX
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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