Memorandum 10
Submission from Research Councils UK (RCUK)
Research Councils UK is a strategic partnership
set up to champion the research supported by the seven UK Research
Councils. RCUK was established in 2002 to enable the Councils
to work together more effectively to enhance the overall impact
and effectiveness of their research, training and innovation activities,
contributing to the delivery of the Government's objectives for
science and innovation. Further details are available at www.rcuk.ac.uk
The Research Councils welcome the opportunity
to respond to the House of Commons Committee's Call. This evidence
is submitted by RCUK on behalf of the following Councils:
Biotechnology and Biological Sciences Research
Council (BBSRC).
Medical Research Council (MRC).
Natural Environment Research Council (NERC).
It represents their independent views. It does
not include or necessarily reflect the views of the Science and
Innovation Group in the Department for Innovation, Universities
and Skills.
In addition to this response, the BBSRC is submitting
separate information to this Inquiry. The BBSRC response deals
more specifically with its sponsored institutes and, in particular,
the Institute for Animal Health at Pirbright.
1. Introduction
CLARIFICATION OF
TERMS
(i) Biosecurity and biosafety
The title of this Inquiry refers to "Biosecurity"
without defining the term. One definition is in the guidance issued
for the Anti Crime and Terrorism Act 2001 (ACTA), where it is
used in a very precise way. The ACTA treats biosecurity and biosafety
as two complementary but distinct concepts, and deals specifically
with biosecurity for a limited number of both animal and human
pathogens and toxins.
Definitions of the two concepts, which are in
accord with the ACTA, can be found in the document "Biorisk
Management—Laboratory Biosecurity", published by
the World Health Organisation in 2006[8].
In this:
— Laboratory biosafety describes the
containment principles, technologies and practices that are implemented
to prevent the unintentional exposure to pathogens and toxins
or their accidental release.
— Laboratory biosecurity describes
the protection control and accountability for valuable biological
materials (including pathogens and toxins) within laboratories
in order to prevent their unauthorised access, loss, theft, misuse,
diversion or intentional release.
[In addition, the term biorisk management has
been used for risk management relating to failures in either biosafety
or biosecurity].
This response refers to both biosafety and biosecurity
(as defined above).
(ii) Dangerous Pathogen
The term dangerous pathogen means different
things in different pieces of legislation and may or may not include
all or part of a pathogen's genome or genetically-modified organisms
(GMOs) containing parts of the genome. For the purposes of this
Inquiry, we have taken dangerous pathogens to mean any human or
animal pathogens including genetically-modified forms, identified
by formal risk assessment or through mandatory regulation to require
handling in containment level 3 or 4 laboratories. It also includes,
when specified in the same legislation, any DNA sequence from
that pathogen which is potentially infectious or pathogenic, or
any genetically-modified organism containing such material. This
is a `catch-all' definition which reflects the diverse work of
the Research Councils and the complexity of the regulations.
(iii) Containment level
For the purpose of this Inquiry, we have defined
containment level 3 and 4 laboratories as laboratories that meet
the requirements in the guidance from ACDP, SACGM or DEFRA (see
below) for levels of containment required that are appropriate
to the work being done. This reflects the fact that Research Council
containment laboratories may work with animal or human pathogens
or both, and that pathogens vary in terms of modes of transmission/infection,
and susceptibility to disinfection/inactivation.
REGULATORY CLIMATE
Scientists using containment laboratories work
in a very complex regulatory climate outlined below. Working with
dangerous pathogens therefore has to be very carefully managed
by well-informed staff. The ACDP SACGM and others have made great
efforts to simplify this by producing excellent guidance documents
which aim to integrate the requirements of all of the regulations.
Even so it would be extremely beneficial for scientists if this
regulatory climate could be simplified further.
Regulation and guidance concerning the safe
handling, storage and disposal of human pathogens and genetically-modified
human and animal pathogens is provided by the Health and Safety
Executive on the advice of the Advisory Committee on Dangerous
Pathogens (ACDP) and the Scientific Advisory Committee on Genetic
Modification (SACGM). These advisory bodies have produced excellent
practical guidance bringing together all of the relevant legislation.
Transportation regulations, such as those of the International
Air Transport Association (IATA), are extremely complex and only
small sections apply to dangerous pathogens. Until the ACDP incorporated
the relevant sections into their guidance, they were not well
understood. Staff managing transport regulations require specialist
mandatory training.
Guidance on transportation, safe handling, storage
and disposal of economically important animal pathogens, identified
by the Specified Animal Pathogens Order 1998' (SAPO) is provided
by DEFRA. DEFRA also regulates the importation of all other animal
pathogens from outside the UK. The requirements of this legislation
for containment laboratories are clear, but are not well linked
to the similar health and safety legislation. It would be helpful
to create such a linkage.
Finally, requirements concerning the biosecurity
of a subset of these human and animal pathogens which could be
used for terrorist purposes are contained in the "Security
Standards for Laboratories (in accordance with Part 7 of the Anti
Terrorism Crime and Security Act 2001—ACTSA)".
This guidance is generally clear and straightforward, but adds
a new set of elements to both containment laboratory design and
management. If these are not incorporated when the laboratory
is built, they can be difficult to fit subsequently. This guidance
is not safety oriented, and so is not concerned with containment.
It introduces the concept of critical areas where the pathogens
listed may be used, stored, transported or destroyed, and these
may be outwith the containment laboratory itself. Although this
is a simple concept, it is not an obvious one to scientific staff
used to the concept of containment levels and so requires training.
The guidance also introduces management procedures which are purely
security related, and which therefore may be outside the experience
of many scientists and laboratory managers.
2. Research Council work on Dangerous Pathogens
The MRC and BBSRC support research into infections
and microorganisms both through grants/fellowships to Universities
and to their own Units and Institutes. NERC's work in this area
is done mostly by its Centre for Ecology and Hydrology (CEH).
Scientists need to be able to work with dangerous pathogens to
help advance knowledge, and to develop novel vaccines, therapeutics
and diagnostics. Regulation to protect human health and the environment
is of course essential, but control measures need to be proportionate
and risk-based.
Where the research is undertaken through grants
to Universities, the University is responsible for biosecurity
and biosafety. Where the research is undertaken in a Research
Council Unit or Institute, then the particular Research Council
is responsible. The remainder of this submission refers mainly
to the latter.
BBSRC-sponsored Institutes are currently separate
legal entities to BBSRC, and therefore biosecurity and biosafety
are the responsibility of the Institute Director. The policy is
based on the legal requirements. Adherence to the statutory requirements
is also the responsibility of the Director on the advice of the
local Health and Safety Officer.
Where there is a joint (MRC/University) use
of a facility, the MRC always ensures that a single organisation
has overall responsibility. In all facilities managed by the MRC,
there are excellent relationships with the host institution (where
there is one).
For MRC establishments, policy on biosecurity
and biosafety is the responsibility of Head Office, in particular
the Head of Health, Safety and Security. The policy is based on
the legal requirements. In the establishments themselves, adherence
to the statutory requirements is the responsibility of the Director
on the advice of the local Health and Safety Officer, who in turn
is advised by the MRC Head of Health, Safety and Security.
In 2005-06, the MRC spent £8.0 million
on such research in total, £6.6 million of which was in our
own establishments.
In its response (7 September 2007) to the publication
of reports into Foot and Mouth outbreak in Surrey, the Government
indicated that it had commissioned a Regulatory Review, under
the chairmanship of Sir Bill Callaghan, of the current regulatory
framework. The report[9]
was published on 13 December 2007. This included comparison of
regulation of animal and human pathogens and considered whether
the differences were justified and what improvements might be
made. The Report recommended, inter alia, that DEFRA, DH, HSE
and other interested parties work together to develop a single
regulatory framework to govern work with human and animal pathogens;
and that the ACDP be tasked with formulating a common set of containment
measures to apply to both animal and human pathogens. The report
also recommended that the HSE become the single regulatory body
for both animal and human pathogens. BBSRC, MRC and NERC support
this recommendation, but caution against adding to the regulatory
burden if it leads to added costs or discourages continued research
on important pathogens. Any proposed changes should be risk-based,
and accompanied by an impact assessment and a consultation with
the research community.
The MRC is leading the ISTR (Institute of Safety
in Technology and Research) Working Group developing standards
for biosafety professionals. This will include entry qualifications
and requirements for continuous professional development. This
approach is supported by the HSE. (The Callaghan Report also refers
to this—paragraph 4.4.6.1).
The Health Protection Agency is shortly to undertake
a strategic review of high-level (ACDP and SAPO level 4) containment
facilities in the UK. This is expected to report in the first
half of 2008. This will be chaired by Professor George Griffin
(St George's Hospital Medical School, London). It will review
existing capability, and advise on future national requirements,
including the organisation of such facilities and the degree of
centralisation.
3. 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.
This section should be read in association with
the separate submission from BBSRC.
At present, the MRC establishments that undertake
research on dangerous pathogens (as defined above) are:
— National Institute for Medical Research
(NIMR), Mill Hill.
— Laboratory of Molecular Biology,
Cambridge.
— Virology Unit, Glasgow.
— Human Immunology Unit, Oxford.
— Molecular Haematology Unit, Oxford.
— MRC/UVRI Uganda Research Unit on
AIDS, Entebbe.
— MRC Gambia Unit, Fajara.
All have CL3 facilities, except NIMR which has
both CL3 and CL4.
Institute/Unit
| Containment level | No of labs
| Pathogens held, and under what regulations
|
| | |
HSE/ACDP | SAPO |
ATCSA |
| NIMR | 4—SAPO and HSE |
1 | | Avian Influenza Virus
| |
| 3—HSE | 9
| HIV
Mycobacterium tuberculosis
Plasmodium falciparum
| | |
LMB | 3—HSE | 1
| HepB | | |
Virology | 3—SAPO and HSE
| 4 | HIV
HepB
HepC |
| |
Prion | |
| | | |
Human Immunology | 3—HSE
| 2 | HIV-1
HIV-2
SIV
Dengue virus
| | |
Molecular Haematology | 3—HSE
| 1 | Recombinant lentiviruses
| | |
Uganda | 3 (HSE) | 1
| HIV | | |
Gambia | 3 (HSE) | 1
| HIV
Tuberculosis | |
|
From the MRC's perspective, the current capacity is adequate.
However, the HPA Review referred to above may come to a different
conclusion concerning overall UK capacity.
Most of the UK's capability to work in high containment on
animal and plant pathogens resides in BBSRC institutes. In particular:
Animal Pathogens
— Institute for Animal Health (IAH)—Compton
site: endemic disease, (eg TB, Salmonella); unique resources for
immunology in cattle (MHC herd) and chicken (for avian flu work).
— IAH—Pirbright site: exotic viral diseases
(eg foot and mouth, bluetongue).
— Roslin—Neuropathogenesis Unit : prion diseases
(scrapie and BSE).
— Institute for Food Research: food-borne zoonoses
(including food poisoning).
Plant Pathogens
IAH, Roslin (including Neuropathogenesis Unit), and IFR all
have CL3 facilities, except IAH—Pirbright site, which has
CL4.
NERC's Centre for Ecology and Hydrology has two category
3 facilities, at CEH Lancaster and Oxford. The Oxford laboratory
has the most comprehensive facilities, and has equipment in place
to sterilise liquid effluent and solid waste.
Using these facilities, CEH has conducted extensive research
into the molecular biology of human pathogens and their modes
of action. It is now focussing more on the environmental distribution
and transport of certain pathogens, the ecology of selected invertebrate
vectors and the distribution and role of pathogens in the population
biology of natural (non-human, non-livestock) hosts in the environment.
Surveillance of the presence of (potential) disease-causing
organisms in (potential) vector populations, and the prevalence
of the (potential) vectors themselves, is an area which could
sensibly be developed to provide greater advance warning of the
transport of pathogens and the likelihood of disease outbreaks,
especially in view of the implications of climate change for vector
movement. A routine screen of many wildlife species could yield
important data on environmental disease reservoirs, alerting us
to the presence in the UK of certain disease-causing organisms
(some viruses for example) that might suddenly become a problem
even though they are not a problem at the moment.
4. The state of biological containment facilities in the
UK
This section should be read in association with the separate
submission from BBSRC.
The Containment Level 3 facilities for which the MRC is responsible
all meet HSE requirements, and the CL 4 facility for which the
MRC is responsible meets DEFRA and HSE requirements.
The MRC is advised by the National Counter-Terrorism Security
Office (NaCTSO) on the physical security standards of its containment
facilities. Local counter-terrorism advisors advise the MRC on
the interpretation of the national guidelines for individual facilities.
NERC's CEH adheres to all the proscribed procedures for category
3 work.
5. Laboratory inspection regimes and the rationale and
practicalities of the licensing system
This section should be read in association with the separate
submission from BBSRC.
Laboratory inspection regimes are currently the responsibility
of HSE and DEFRA, but this may change if the recommendations of
the Callaghan Report are implemented. [In addition, the MRC is
currently updating its audit process for its own CL 3 and 4 facilities.
MRC inspections of these are planned to be undertaken every year
for CL 4, and every three years for CL 3]. (In terms of the rationale
and practicalities of the licensing system, the MRC has nothing
to add to the recommendations of the Callaghan Report).
6. Biosafety training provision for staff working in containment
facilities
Training is key to the safe operation and management of containment
labs. There are three groups of staff who require training:
(i) biological safety officers who have responsibilities
for all aspects of biological safety but may have limited practical
experience of CL3 and CL4;
(ii) containment laboratory managers or supervisors who
should ideally be both practically trained and have a comprehensive
understanding of the regulations and be able to train and assess
other staff; and
(iii) users who need practical training to work in the
laboratory, but who only need to have a limited knowledge of the
regulations.
The MRC provides the only training course in the UK for biological
safety officers (though the MRC and other organisations provide
training for other staff working in Containment 3 laboratories).
Other institutions (public and private) send their staff on these
courses. In the public sector, it is difficult to recruit such
officers; currently there are a small number of competent practitioners
in the market place.
The containment managers and supervisors, who have day to
day management responsibilities, are key as they usually train
the much larger user population and so set the work standards.
Again, they are difficult to recruit and retain, and training
courses would help secure the supply of such staff.
The training of managers and supervisors clearly has to translate
into very thorough training of the laboratory staff. It is good
practice to maintain records of training in order to demonstrate
competence.
7. The maintenance and recording practices surrounding
the storage and transportation of dangerous pathogens
The maintenance and recording practices required by the legislation
vary depending on the pathogen worked with and the legislation.
Health and safety legislation is primarily concerned with safety
and does not dictate maintenance (other than that storage should
be safe), or recording procedures or labelling of material. Good
laboratory practice, however, does require keeping detailed inventories
of material and monitoring storage facilities, but it is not a
legal requirement. The GM regulations are more concerned with
control of material and preventing release into the environment,
and so require all material to be accounted for but do not specify
how. Transport legislation requires clear identification of pathogens
being transported, the quantities, appropriate packaging and safety
labelling.
A single nationally accepted system for logging information
on the storage of dangerous pathogens could be advantageous, provided
it were inexpensive and simple to operate. Such a system could
be used to log details of all pathogens, even those of accepted
low virulence, and would allow easy exchange of data when samples
are moved between laboratories.
SAPO licences are specific to the work and require storage
details to be held of locations, quantities of material and records
of disposal. DEFRA prefers SAPO material to be stored separately
from other material as they are particularly concerned about accidental
transmission of infection through physical contact with other
materials. Disposal has to be recorded. Transportation is also
closely controlled. DEFRA does not specify labelling requirements.
ATCSA has introduced a new level of storage and inventory
security for a limited list of pathogens. It specifies labelling
which must be unidentifiable to unauthorised persons a detailed
inventory and an audit system which allows tracking of all material
from cradle to grave. It also requires completely secure storage.
BBSRC, MRC and NERC abide by the requirements for storage
laid down by HSE and DEFRA, and by the transportation requirements
laid down for example by IATA, and by the European Agreement concerning
the International Carriage of Dangerous Goods by Road ("ADR").
The implementation of the ATCSA requirements is in progress at
a local level following advice from local counter terrorism security
advisors.
Consideration should be given to introducing a coding system
for all dangerous pathogens similar to that used for chemicals
or dangerous goods. This would facilitate the identification of
dangerous pathogens and assist in management and inventory control.
It would also assist in the recovery of any missing material and
assist in the response to finding material outside the appropriate
containment facility. More detail is given in the next section.
8. Measures implemented when pathogenic material cannot
be accounted for
All MRC units and BBSRC and NERC Institutes handling pathogens
have Standard Operating Procedures for storage, record keeping,
receipting incoming samples and audit/procedure for missing samples.
There is no formal requirement, as for example for radioactive
material, to account for missing pathogens In HSE legislation,
though, if there were thought to be health/safety implications
in an MRC establishment, the Head of Health, Safety and Security
would be alerted and appropriate investigations pursued. For BBSRC
Institutes, the Institutes Health and Safety Officer is responsible
in liaison with the Biological Safety Advisor. If the recommendation
of the Callaghan Report is implemented to transfer responsibility
for inspection and enforcement functions in respect of animal
pathogens to the HSE, the HSE would be well placed to provide
guidance covering both human and animal pathogens.
A standard labelling system would greatly facilitate management
of material and could help prevent accidental loss and assist
the response to missing material and improve the chances of recovery.
Such a system would need to be simple as label surfaces are often
small. This could involve use of a specific colour vial or vial
insert or label which signifies the material is a hazard group
3 or 4 pathogen. The system could also use a code letter indicating
the same information. This could be linked to a series of standard
instructions to be followed by emergency service or other trained
personnel, on finding material in an inappropriate context. For
example this material requires inactivation by autoclaving. It
could also indicate, for example, whether exposure to contents
requires medical attention. A second letter or number code could
identify the source laboratory. Such a system would not specifically
identify the material and so would meet the ATCSA requirement.
9. The role of universities in overseeing security clearance
for research students working with dangerous pathogens
The process of security clearance for foreign research students
who propose working with dangerous pathogens is undertaken by
the Foreign and Commonwealth Office. The scheme, "The Academic
Technology Approval Scheme" replaced the "The Voluntary
Vetting Scheme" on 1 November 2007. Potential students (if
non-EU/EEA (including Switzerland) nationals and proposing to
work in certain designated disciplines) are referred to the FCO
by the University to which the student has applied. None of the
three Councils referred to here is aware of any cases where this
process has not appeared effective for its students.
At present all overseas staff and students who are successful
applicants for posts in all BBSRC Institutes are subject to vetting
by the institute HR department. All successful applicants for
posts or visiting research workers are vetted before they are
allowed to work at Babraham Institute or IAH. A similar approach
is taken at NERC's CEH. The MRC has introduced the Government's
recruitment Baseline Security Standard, which applies to all staff.
25 January 2008
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www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6/en/ Back
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www.DEFRA/SEERAD.gov.uk/animalh/diseases/fmd/investigations/bill-callaghan.htm Back
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