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

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

  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


(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.


  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

  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.

    —  Prion Unit, London.

    —  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.

Containment levelNo of labs Pathogens held, and under what regulations

NIMR4—SAPO and HSE 1Avian Influenza Virus


Mycobacterium tuberculosis

Plasmodium falciparum

3—HSE1 HepB





Human Immunology
3—HSE 2HIV-1



Dengue virus

Molecular Haematology
3—HSE 1Recombinant lentiviruses

3 (HSE)1 HIV

3 (HSE)1 HIV


  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

    —  Rothamsted Research:

    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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