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

Memorandum 1

Submission from the Government, submitted by the Department for Innovation, Universities and Skills


  1.1  Work with dangerous pathogens enables us to understand better how infectious diseases of human and animals develop and spread, which is essential if we are to develop effective treatments and vaccines against them. In addition to protection against naturally-occurring disease outbreaks, research involving dangerous pathogens provides the UK and its Armed Forces with safe and effective protection against the hazards of exposure to biological warfare agents.

  1.2  The UK university and research sectors are very strong, and have a good international reputation. For example the Health Protection Agency (HPA) is a world leading contributor to research on human pathogens and the National Institute of Biological Standards and Control (NIBSC) is the world leader in many areas of biological standardisation. Both organisations play a crucial role in frontline defence against future threats such as pandemic influenza. Their work maintains UK capabilities in a vital area for national security.

  1.3  Research on animal pathogens has also made a positive contribution to our ability to diagnose and understand disease occurrence, spread and future disease threats:

    —    Research has developed methods using full genome sequencing of Foot and Mouth Disease (FMD) viruses that have facilitated the tracking of the spread of FMD and identication of the order in which farms become infected within a complex outbreak.

    —    A simple molecular test to detect FMD virus has been developed, which can be used as the basis of a rapid and disposable device for field diagnosis.

    —    Work on the transmission dynamics of avian influenza virus will add to the evidence base on suitable control measures and risks to commercial poultry production from wild birds.

  1.4  UK industry has built on this work by developing commercially successful vaccines against diseases such as anthrax and smallpox.

  1.5  As Sir Bill Callaghan noted in his Review of the Regulatory Framework for Handling Animal Pathogens:[1]

    "The ability to handle animal pathogens in laboratories is essential if we are to fully understand infectious diseases and to develop effective vaccines against them. The [...] research carried out in UK laboratories plays an important role in the international fight against existing and emerging diseases. Without this research, there would be a significant adverse impact on the well being of both people and animals around the world."

  This point also applies to the ability to handle human pathogens.

  1.6  It is thus imperative that we continue to maintain the capacity for research on dangerous pathogens in the UK. But we also need to minimise the risks from that work. This was highlighted in August 2007, when an outbreak of FMD was traced to a site at Pirbright in Surrey where the virus was being used in research and vaccine production.

  1.7  Following this incident, two reviews have been published which bear on the containment of dangerous pathogens in UK research facilities. Both the Independent Review of the safety of UK facilities handling foot-and-mouth disease virus by Professor Brian Spratt[2] and A Review of the Regulatory Framework for Handling Animal Pathogens1 chaired by Sir Bill Callaghan made recommendations to improve containment and biosecurity. The Government has fully accepted all recommendations applicable to Government, most recently in a written statement[3] to the House on 13 December, when Sir Bill Callaghan's report was published. In particular, the Government has agreed that the role of the regulator of laboratories handling animal pathogens should move from Defra to the Health and Safety Executive. In addition, relevant Government Departments and Agencies are working together to establish a single regulatory framework to rationalise the control of human and animal pathogens.

  1.8  This memorandum explains controls that apply in research laboratories. It covers the situation in Great Britain. Where relevant, it explains the changes being made in response to the recent recommendations.

  1.9  The legislation described in this memorandum is concerned only with ensuring the biosafety and biosecurity of research facilities. Such facilities will additionally have to comply with any other relevant legislation, for example the Animal (Scientific) Procedures Act 1986 for research involving animals protected by the Act.

  1.10  This memorandum represents the contributions of the following Government departments and agencies:

    —    Home Office;

    —    Department for Transport;

    —    The Health and Safety Executive (HSE);

    —    Department of Health;

    —    Department for Innovation Universities and Skills;

    —    The Foreign and Commonwealth Office (FCO);

    —    Department for the Environment, Food and Rural Affairs (Defra); and

    —    Ministry of Defence (MoD)

  1.11  The FCO's Science and Innovation Network will be responding to the Committee separately, as will the Devolved Administrations and RCUK (a partnership of seven UK Research Councils).

2.   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

  2.1  The sector working with dangerous pathogens includes a workforce of approximately 250,000 scientists working in a range of laboratory premises in healthcare, academia and industry. The UK has a large network of research facilities and diagnostic laboratories where work is undertaken with dangerous pathogens. Details are given below of the number of facilities which hold licences or are regulated to allow them to work on dangerous pathogens.

  2.2  We will describe separately laboratory biosafety and laboratory biosecurity. Biosafety will be used to refer to the appropriate containment of pathogens in the laboratory environment, both to prevent exposure of workers within the laboratory, and exposure of people, animals and other vulnerable organisms in the external environment. Biosecurity will be used to refer to the secure storage, use and transport of dangerous pathogens and toxins to reduce the risk of malicious use.

2.3  Biosafety

  2.3.1  Biosafety in laboratories is covered by three separate pieces of legislation:

    —    Control of Substances Hazardous to Health Regulations 2002 (COSHH)—regulated by HSE;

    —    Specified Animal Pathogens Order 1998 (SAPO)—currently regulated by Defra, Scottish Executive and National Assembly for Wales; and

    —    Genetically Modified Organisms (Contained Use) Regulations 2000 (GMO(CU)). There is a joint Competent Authority—HSE and Defra in England and Wales, and HSE and the Scottish Executive in Scotland. HSE acts as the lead Competent Authority, and enforces the legislation in Great Britain.

  2.3.2  With minor differences, each piece of legislation indicates the appropriate Containment Level (CL) for each facility, the level being dependent on the nature of the micro-organisms in use:

    —    CL 1—appropriate for micro-organisms posing no or negligible risk;

    —    CL 2—appropriate for micro-organisms posing low risk;

    —    CL 3—appropriate for micro-organisms posing moderate risk; and

    —    CL 4—appropriate for micro-organisms posing high risk.

  The legislation specifies which micro-organisms require which levels of containment. This is covered in more detail in section 4.

  Effectively, work with dangerous pathogens is restricted to CL 2, 3 & 4 laboratories, and the following information applies to only these.

  2.3.3  Pathogens for which CL1 is appropriate are not considered to pose a risk to human health or the wider environment, and the regulatory framework is minimal under COSHH and SAPO. The Importation of Animal Pathogens Order 1980 as amended (IAPO) prohibits the importation into Great Britain from third countries of all risk groups of animal pathogens or carriers except under the authority of a valid licence issued by Defra, the Scottish Executive or Welsh Assembly. Under the GMO(CU) Regulations, all centres working with genetically modified organisms (GMOs) must notify the Competent Authority before commencing work for the first time, including work at CL1. However, once a centre is notified, no further notification is required for work requiring only CL1.

  2.4  In this memorandum, the term "dangerous pathogens" will be used throughout, and covers human and animal pathogens as well as genetically modified micro-organisms (GMMs) which require CLs 2, 3 and 4.

2.5  Organisations working with dangerous pathogens at containment level 2, 3 and 4 under regulation by HSE and/or SAPO

  2.5.1  As Table 1 below shows, most work with dangerous pathogens is done in Government and Research Council laboratories, and is regulated by HSE only.

  2.5.2  Similar work is carried out in 70 different universities (those working at level 3 are also included in the 70 listed at level 2—ie all that handle CL3 pathogens also handle CL2 pathogens).

Table 1

Containment level GovernmentPrivate Research CouncilUniversity
2212230 1770
320298 740
452 30

  2.5.3  The numbers of organisations working with dangerous pathogens in Great Britain are presented in Table 2 below. The term "organisation" is used at the employer level, eg The University of Oxford. Organisations may have multiple facilities for work with dangerous pathogens. For example, one university has over 50 containment level 3 laboratories located on different sites. The term "site" is used for the different departments/locations/campuses where the laboratories are housed.

Table 2

Containment levelCOSHH and/or GMO(CU) regulated only SAPO regulated onlyHSE & SAPO combined Total
24947 28529
33235 19347
Number of sites
4[6] 127 10

  These data represent the situation at December 2007 and cover a dynamic sector with frequent changes to organisations, facilities and projects. As such, these figures may be subject to change.

2.6  Biosecurity

  2.6.1  Biosecurity is covered by measures set out in the Anti-terrorism Crime and Security Act 2001 (ATCSA), which are implemented by the National Counter-Terrorism Security Office (NaCTSO). Part 7 of the ATCSA provides the police with powers to impose security measures at laboratories in the UK that hold certain dangerous pathogens and toxins (as listed in Schedule 5 of the Act).

  2.6.2  There are just over 100 pathogens and toxins caught by Part 7 and Schedule 5 of ATCSA. Approximately 400 laboratories in the UK are required to register under the legislation. This includes university and hospital laboratories but not necessarily diagnostic laboratories (which are an exception under the Security of Pathogens and Toxins (Exceptions to Dangerous Substances) Regulations 2002 (Statutory Instrument 1281).

2.7  Emerging diseases

  2.7.1  Many of these licensed facilities are involved in work on diseases that may emerge at a future time, such as NIBSC's work on pandemic influenza. There is a significant amount of work carried out by the HPA, Medical Research Council and universities on pathogens which may pose a threat to the UK in the future, for example due to climate change or population movement.

  2.7.2  Horizon scanning to identify existing and emerging infectious disease threats to public health in the UK is undertaken by the HPA's Microbial Risk Assessment team, supported by specialist diagnostic expertise in the Special Pathogens Reference Laboratory.

  2.7.3  The HPA is a key player in the European Commission's public health infectious disease networks and provides consistent UK surveillance data for many diseases, based on its specialist microbiological services. It is the UK portal for the European Union Early Warnings and Alerts and for Assistance Calls, and its Centre for Emergency Preparedness and Response (CEPR) works closely with other centres, particularly in Europe, North America and Australasia.

  2.7.4  Many staff at the CEPR are internationally renowned experts in their field and often provide advice and consultancy for the World Health Organization (WHO) and other international agencies. The HPA also houses many WHO Collaborating Centres and WHO Reference Laboratories for various infections (including polio and SARS).

  2.7.5  On behalf of the MoD and the Government, the Defence Science and Technology Laboratory has the capability to safely undertake both in vivo and in vitro research with dangerous pathogens. The scope of the research programme is to provide effective protective measures against the range of potential biological and toxin agents which may be used aggressively by terrorists or in times of conflict.

  2.7.6  Horizon scanning for future animal disease threats is conducted in different ways. Outbreaks of disease in the member countries of the Office Internationale des Epizooties (OIE) are reported through a notification system and this gives valuable information to allow global tracking of infectious diseases of significance. An additional system, placing obligations on the Member States to report outbreaks, is operated via the European Commission.

  2.7.7  In addition, both the Veterinary Laboratories Agency (VLA) and the Biotechnology and Biological Sciences Research Council sponsored Institute for Animal Health at Pirbright act as World Reference Laboratories. In this capacity, they have regular dialogue with the veterinary authorities and diagnostic laboratories in many countries which, when pieced together with the consultancy advice they provide, enable emerging trends to be identified. The VLA has a well established programme of scanning surveillance covering farmed livestock and wildlife disease diagnosis, to provide baseline data on disease occurrence and assessment of potential emerging diseases or infections.

  2.7.8  Defra carries out veterinary risk assessments of outbreaks overseas to inform their policies, and publishes Quarterly International Disease Surveillance reports.

3.   The state of biological containment facilities in the UK

3.1  Assessment by HSE

  3.1.1  HSE is responsible for inspection and enforcement at facilities in Great Britain where work is undertaken with dangerous pathogens and GMOs. The work is carried out by staff from Staff from HSE's Biological Agents Unit.

  3.1.2  The standard of compliance with regulations in the UK is generally good. The standard of laboratories has improved in recent years, and there is clear evidence of investment in infrastructure.

  3.1.3  Table 3 below shows that 514 inspections were carried out by HSE between 2004 and September 2007. A small number of improvement notices was served in that period, reflecting the generally high standards of containment and management control at biological containment facilities.

Table 3

CategoryType Detail2002-03 2003-042004-05 2005-062006-07 Mid Year 2007-08Grand Total
EnforcementProhibition Notice 1 1
Crown Censure 1 1
Improvement Notice 435 282
Notice Count 445 2822
Enforcement Total 455 2823
InterventionInspection Inspection Count 179121145 69514
InvestigationRIDDOR[7]Accident 13 329
Complaint 11
RIDDOR Disease 22
RIDDOR Dangerous Occurrence 57 12428
GMO Accident 22
GMO Report of Disease 11
RIDDOR Count 610 21643
Intervention Total 185 13116675 557

3.2  Assessment of biological containment facilities by National Counter-Terrorism Security Office (NaCTSO

  3.2.1  NaCTSO assesses all laboratories required to register under ATCSA using a "Traffic Light" system. Currently, no laboratories are rated as "red" (of concern). There are many new laboratories being built in the UK which will be incorporating the "gold standard" of security measures in their design, as defined in the Home Office document Security Standards for Laboratories. This ensures a continuing improvement in laboratory security across the UK.

3.3  Compliance with the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2007

  3.3.1  The HSE is the enforcement authority for these safety regulations, aided by the Vehicle Operators and Services Agency and the police at the roadside. HSE inspectors undertake inspections at premises often in conjunction with other enforcement activities. Generally, there is no evidence of non-compliance with these requirements.

3.4  Inspection activity since the accidental release of FMD Virus from Pirbright

  3.4.1  Following the publication of the investigation report following the 2007 outbreak of FMD, HSE and Defra released a Safety Alert on 7 September 2007. This was aimed at all high containment laboratories, to draw attention to the issues arising from the investigation. In addition, HSE and Defra committed to undertake a programme of inspections.

  3.4.2  The first phase of the Safety Alert inspection programme focussed on CL4 facilities where work is undertaken with Hazard Group (HG) four dangerous pathogens, including both human and animal pathogens.

  3.4.3  The inspections revealed no breaches of the legislation and no formal enforcement action was taken. This process has provided both the regulatory bodies and the operators of the laboratories with the assurance that their facilities are well managed. The inspections have also provided a useful opportunity to provide advice and guidance on good practice. HSE will continue this series of Safety Alert inspections to consider CL3 facilities based on risk. The inspections will begin in January 2008 and will be completed by the end of the year.

4.   Laboratory inspection regimes and the rationale and practicalities of the licensing system

4.1  Regulation and Licensing of work with dangerous pathogens

  4.1.1  There is currently a complex regulatory framework for work with dangerous pathogens with different regimes for different types of pathogens, and the individual regimes are covered below. However, the Callaghan review recommended that a single regulatory framework should be developed to govern work with human and animal pathogens. Work is in progress to establish how this can be achieved in the recommended timescale. The following gives details of the current systems.

4.2  Human Pathogens: Control of Substance Hazardous to Health 2002 (COSHH)

  4.2.1  HSE is responsible for COSHH, and regulates compliance in respect of deliberate work with human pathogens. Deliberate work means carrying out activities such as propagation, for example, as would occur in bacteriology, virology, mycology and parasitology laboratories. HSE develops policy in consultation with other Government Departments, including the Department of Health and Defra.

  4.2.2  The COSHH regulations are wide ranging, covering all workplace exposure to substances that are hazardous to health. These include carcinogens, chemicals and other substances, such as microorganisms and toxins. Specific requirements relating to microorganisms are covered in Schedule 3 of the regulations, which apply, primarily, to laboratory and large-scale work with dangerous pathogens. The choice of control measures in laboratories is largely based on the HG of the pathogen that is being used (or that may be present). Pathogens are classified into one of four hazard groups from HG1 (the lowest) to HG4 (highest, eg Ebola virus) based on their ability to infect healthy adults. The classification is set out in the Approved List of Biological Agents, which is published on the HSE Website at

  4.2.3  The HGs equate to the CLs—containment level 4 is required for hazard group four pathogens, etc. The list is updated when new pathogens emerge, or when new evidence accrues on the pathogenicity of individual strains.

  4.2.4  In addition to using specific control measures, those working with dangerous pathogens need to notify HSE at least 20 days in advance of any planned work where HG2, HG3 and HG4 are used for the first time, at particular premises. Notification is also required of the subsequent use of certain organisms (ie those in HG3 and HG4 and those in HG2 that are listed in Part V of Schedule 3 of COSHH are used for the first time).

  4.2.5  Although this is not an approval system, HSE requires the notification to include sufficient information to demonstrate that duty holders have identified hazards associated with the organism which might arise from carrying out the work. This includes circumstances where staff (and others) could be exposed to a source of infection during the work, and the measures that will be applied to prevent or control exposure. The supporting documentation can include a risk assessment, a local code of practice or standard operating procedures/protocols. Where sufficient information is not provided, it may be requested.

  4.2.6  Where necessary, technical advice can be obtained from the Advisory Committee for Dangerous Pathogens (ACDP), whose remit is to advise on risks to workers and others from exposure to pathogens. The ACDP is an independent committee which advises the Health and Safety Commission, HSE, Health and Agriculture Ministers and their counterparts under devolution in Scotland, Wales and Northern Ireland, as required, on all aspects of hazards and risks to workers and others from exposure to pathogens. The committee is made up from experts in microbiology and infectious diseases recruited from academia, the health service, industry and trade unions. It is serviced by a joint secretariat (HSE, Defra, and the HPA).

  4.2.7  Inspection under COSHH.  Although notification does not automatically entail an inspection, the notification is used to inform inspection activities. The expectation is that CL4 laboratories are inspected annually and CL3 laboratories are inspected at least once every three years.

4.3  Animal Pathogens: Specified Animal Pathogens Order 1998 (SAPO)

  4.3.1  The containment and transport of animal pathogens is controlled by SAPO in Great Britain. Responsibility for the Order rests with Defra in England and the devolved administrations in Scotland and Wales (although there are no SAPO-approved laboratories in Wales).

  4.3.2  The purpose of SAPO is to prevent animals and poultry in Great Britain being exposed to specified animal pathogens which could cause serious disease and economic loss to the British livestock and poultry industries. The Order does not apply to any animal pathogen or carrier contained in licensed veterinary or human medicines.

  4.3.3  SAPO requires those working with any specified animal pathogen (listed in the Schedule to the Order) to apply for and obtain a licence. This stipulates the way in which the specified animal pathogens must be handled to ensure their safe containment and disposal, the areas of the laboratory in which various types of work may be done and the persons responsible for supervising the work.

  4.3.4  Under SAPO, "specified animal pathogen" means an animal pathogen listed in the schedule to SAPO, including:

    (a)  intact pathogens;

    (b)  pathogens which have been attenuated or genetically modified by any means, and

    (c)  any nucleic acid derived from an animal pathogen listed in the Schedule which could produce that pathogen when introduced into a biological system in which the nucleic acid is capable of replicating.

  4.3.5  Defra classifies animal pathogens for the purpose of operating IAPO and SAPO. The classification is made for the purpose of protecting animal health from escapes of organisms from a laboratory. (IAPO is described in section 6.2.)

  4.3.6  Specified animal pathogens are classified into four categories:

    —    Group 1—Disease-producing organisms which are enzootic (ie already present in the livestock population at a low or stable level) and do not produce notifiable disease.

    —    Group 2—Disease producing organisms which are either exotic (ie not present in the UK livestock population) or produce notifiable disease, but have a low risk of spread from the laboratory.

    —    Group 3—Disease producing organisms which are either exotic or produce notifiable disease and have a moderate risk of spread from the laboratory.

    —    Group 4—Disease producing organisms which are either exotic or produce notifiable disease and have a high risk of spread from the laboratory.

    —    Rabies—Special containment conditions exist for Rabies and Rabies related viruses.

  4.3.7  The animal pathogens in Groups 2, 3 and 4 and containment requirements for Groups 2, 3 and 4 are described on the Defra website ( htm, They are based on those described in the COSHH regulations, with additional measures and procedures added to cover biosafety.

  4.3.8  These containment requirements are intended only as a guide, as decisions on the facilities and procedures required to contain specified animal pathogens safely at individual establishments are made on a case-by-case basis.

  4.3.9  Licensing and Inspection under SAPO:  The SAPO licensing process includes inspection of the applicants' laboratories and review of supporting documentation (ie the operating procedures for work, risk assessment and appropriate containment measures) prior to the licence being issued. Licences are usually valid for five years. Inspections of laboratories licensed under SAPO may be carried out at any time to ensure full compliance with licence conditions and the Order.  These inspections are currently carried out by Defra, the VLA and HSE. However, from April 2008, HSE becomes lead inspector and will assume these functions, under new regulatory powers which are currently being developed. This will apply across Great Britain, with separate arrangements being developed for Northern Ireland.

4.4  Genetically Modified Organisms (Contained Use) Regulations 2000 (as amended 2002, 2005)

  4.4.1  Genetic modification of pathogens (human, animal or plant) where barriers are necessary to prevent their release is subject to compliance with the GMO(CU). GMO(CU) applies across Great Britain, with parallel regulations in Northern Ireland. The key requirement of GMO(CU) is that such pathogens may not be created or brought into the laboratory until the regulator is satisfied that the operator has assessed the risks of all activities and made sure that any necessary controls are put in place. There is a high priority given to the hazard identification of potentially novel GMMs.

  4.4.2  The containment levels and criteria are defined in the European Directive 90/219/EC, and the amending Directive 98/81. These are detailed in the GMO(CU) Regulations. They differ from COSHH in a number of areas, primarily because the GM regulations are intended to protect both human health and the environment, whereas COSHH only covers human health.

  4.4.3  Responsiblity for the GMO(CU) has not been devolved to Wales, although it has been devolved to Scotland. Thus in England and Wales the Competent Authority is Defra and the HSE acting jointly, while in Scotland it is the Scottish Ministers and the HSE acting jointly. HSE acts as the lead competent authority on risks to human health, and Defra/Scottish Executive on environmental issues. HSE is responsible for inspecting and enforcing on all aspects of GMO(CU).

  4.4.4  The GMO(CU) Regulations require users to assign containment on the basis of risk assessment. Once the containment required to minimise human and environmental exposure has been determined, the activity is assigned a "risk class" based on that containment. The four risk classes essentially equate to the containment level—CL1 is required for Class 1 activities, CL2 for Class 2, etc.

  4.4.5  Prior to Class 2, 3 or 4 activities commencing, the notifier must submit a notification, including an assessment of the hazardous properties of the GMMs and the proposed containment for the planned activity. Specialist Inspectors at HSE and Defra review these notifications for technical content and compliance with the legislation placing an emphasis on the adequacy of the risk assessment and requesting additional information where necessary.

  4.4.6  For high hazard organisms (Class 3 and 4) the operator may not proceed without the written consent of the Competent Authority.

  4.4.7  Inspection under GMO(CU):  All Class 4 or novel genetic modification activities are brought to the attention of the Scientific Advisory Committee for Genetic Modification (SACGM), to provide independent scientific advice to the Competent Authority on the adequacy and scientific content of the hazard assessment. Where necessary, site inspection may be required where novel containment requirements are proposed. Once satisfied with the assessment of the hazard properties of the proposed GMM and proposed containment, the Competent Authority issues consent for the work to proceed.

4.5  Anti-Terrorism Crime and Security Act 2001 (ATCSA)

  4.5.1  The secure storage and use of dangerous pathogens and toxins to reduce the risk of malicious use is regulated by ATCSA. Part 7 of ATCSA applies across the UK and provides the police with powers to impose security measures at laboratories that hold certain dangerous pathogens and toxins (as listed in Schedule 5 of the Act). The ATCSA list does not correspond directly to the classifications used in COSHH, SAPO or GMO(CU), as it has been drawn up specifically with malicious use in mind. These powers were introduced to improve the security of dangerous substances that may be targeted or used by terrorists. Schedule 5 has recently been updated to include further pathogens and toxins that could cause serous harm to human health or damage, disruption and alarm regarding animal pathogens (Part 7 of ATCSA (Extension to Animal Pathogens) Order 2007 and Schedule 5 to the ATCSA 2001 (Modification) Order 2007).

  4.5.2  The list of registered laboratories, implementation policy and training for the police has been provided by NaCTSO. This is a national police unit co-located with the Centre for the Protection of the National Infrastructure.

  4.5.3  Security procedures for laboratories differ according to containment level:

    —    CL 4 laboratories are subject to extensive security measures with extremely limited access. All staff granted access must undergo security clearance.

    —    CL 3 laboratories are subject to security measures required by ATCSA and receive bespoke advice regarding staff security checking.

    —    CL 2 laboratories are provided with bespoke advice regarding physical and personnel security by Counter-Terrorism Security Advisers (CTSAs).

  4.5.4  Personnel Security Measures for Laboratories:  The document "Personnel Security Standards for Laboratories" was published by the Association of Chief Police Officers and the Home Office in April 2005. Since then it has been circulated to laboratories subject to Part 7 and Schedule 5 of ATCSA. The document delivers detailed personnel security advice to laboratories regarding new staff, existing staff, visitors and contractors.  The document delivers specific guidance on good practice relating to security checking of new staff, existing staff, contractors, visitors and students/short term appointments. The advice details how to check identities, checking references, checking qualifications, employment history and criminal convictions. It also provides guidance on what to do if concerns arise during the process.  This document was designed to deliver practical guidance without the false sense of security that can arise from a criminal records check alone. Managers are advised to maintain personnel security by way of good human resource management and reporting, the wearing of security passes and the creation of a "security aware" environment.

  4.5.5  Inspection under ATSCA:  Since 2002 the legislation has been enforced by police CTSAs. Premises working with Schedule five agents need to notify the Home Office and will be visited by CTSAs. The CTSAs assess the security of the laboratories and have powers under part 7 of ATCSA to serve directions requiring security improvements. Failure to comply with these directions is a criminal offence.

  4.5.6  Home Office review of Hazardous Substances:  As the Prime Minister announced on 14 November 2007, the Home Office is carrying out further work to look at what more might be needed to strengthen protection against the use of hazardous substances for terrorist purposes. This review is being led by Lord West and will report to the Prime Minister later this year.

4.6  Inspection regimes

  4.6.1  Regulatory activities in the sector.  HSE, Defra and the Scottish Executive currently regulate work with dangerous pathogens in Great Britain. HSE is responsible for the regulation and manages the statutory notifications and permissioning schemes for work with human pathogens and GMMs under GMO(CU) and COSHH, whilst Defra and the Scottish Executive license work with animal pathogens under SAPO.  HSE provides technical and regulatory advice to other government departments, agencies and the bioscience and healthcare communities about working with dangerous pathogens. HSE also develops standards and guidance at national and international level on the control of dangerous pathogens, often based on advice from the SACGM and ACDP.

  4.6.2  Inspection by under COSHH and GMO(CU):  HSE inspectors undertake inspection and enforcement activities at premises where work is undertaken with dangerous pathogens under GMO(CU) and COSHH. The inspection unit is made up of a team of specialists in the fields of microbiology and biotechnology with a broad collective experience in the research, clinical and industrial biosciences sectors.  Inspection of the physical containment of the laboratories is supplemented by review of documentation and interviewing staff to assess compliance with safety management systems. Where significant breaches of legislation are identified, Specialist Inspectors can use a full range of enforcement powers conferred by the Health and Safety at Work Act 1974, which include stopping work activities, issuing notices requiring specific improvements by specific dates and prosecution.  For larger sites involving extensive work with dangerous pathogens, an "Inspection Plan" is developed. In essence this is a summary of the different interactions that HSE will utilise to engage a particular duty holder over a particular time period. The overall intention of the intervention plan is to facilitate a partnership approach to raising standards of biological safety. This approach can involve a range of activities including traditional inspections, topic-specific or all-encompassing biosafety audits, participation in training courses, and involvement in biosafety committee meetings and providing presentations.

  4.6.3  Inspection under SAPO:  In England up to March 2008, inspections of laboratories working with SAPO Group four pathogens are carried out by a senior veterinary official at Defra and HSE. From 2008, all other inspections are being carried out by the VLA and HSE. It is planned that HSE will take over sole responsibility for all inspections from April 2008. In Scotland, where there are no laboratories working with SAPO Category 4 pathogens, inspections are carried out by a Veterinary Advisor working in the Scottish Executive, assisted by veterinarians from Animal Health.  If, during an inspection, an inspector identifies non-compliance with the Order or the licence conditions, they may recommend that Defra or the Scottish Executive amend, suspend or revoke the licence. Any prosecution would be undertaken by the relevant local authority (usually the trading standards department) as local authorities are responsible for enforcement under SAPO. Since Local Authorities do not inspect laboratories, they will only become involved when the inspectors alert them to non-compliance that might warrant a prosecution.

5.   Biosafety training provision for staff working in containment facilities

  5.1  The only specific requirements for biosafety training are made under the GMO(CU) regulations. However, there are general duties placed on employers to provide appropriate staff training and instruction.

  5.2 All employers are bound under the Health and Safety at Work Act 1974 " . . . to provide such information, instruction, training and supervision as is necessary to ensure, so far as is reasonably practicable, the health and safety at work of his employees". This requirement is a general one, demanding training but not specifying content.

  5.3  The Management of Health and Safety at Work Regulations 1999, whilst not dictating content other than that it must be "adequate", reinforce the general requirement specified in the Act, and extend this by specifying the regime for training (for example, on recruitment or on exposure to new or increased risk).

  5.4  COSHH extend the general requirements to provide suitable and sufficient training with guidelines as to the content of this training. Training and information provided must provide the employee with details of the biological agent, including the risk presented to health; the significant findings of any relevant risk assessments; the appropriate precautions and actions to be taken by the employee to safeguard himself and other employees; results of any monitoring of exposure, and the collective results of any health surveillance. Furthermore, the training provided in the case of a HG4 pathogen or material which may contain such an organism, must provide for written instruction and procedures for the handling of such an agent specified in Regulation 12(2).

  5.5  The above requirements for training are embedded further in:

    5.5.1  COSHH 2002 (as amended) Regulation 7(7) where it is indicated that, where there is exposure to a substance hazardous to health, control of that exposure will only be adequate if the principles of good practice (set out in Schedule 2A) are applied. This includes a necessity to inform and train all employees on the hazards and risk from the substances with which they work and the use of control measures developed to minimise the risks.

    5.5.2  The GMO(CU) Regulations 2000 which require that written training records are kept for work at CLs 3 and 4. Inspections will cover training and instruction of staff, and involve a review of records. The lack of enforcement action in this area highlights a good level of compliance with the training requirements.

6.   The maintenance and recording practices surrounding the storage and transportation of dangerous pathogens

6.1  Storage

  6.1.1  Safe storage of dangerous pathogens is a requirement of all the current regulatory systems. The degree of security of storage required depends on the nature of the organisms being used. For the high hazard organisms, the legislation stipulates "secure storage". Accompanying guidance on what is expected is provided. At CL 4, organisms must only be stored within the CL 4 laboratory. Fridges, freezers and storage containers should be kept locked when not in use.

  6.1.2  NaCTSO, through the CTSAs, have for some time been carrying out their own security audits at sites that handle infectious substances. Advice that has been given by CTSAs on these visits is in line with the requirements for storage and use at premises (Schedule 5 to ATCSA).

6.2  Transportation: under SAPO and the Importation of Animal Pathogens Order 1980 (IAPO)

  6.2.1  Licences under SAPO stipulate the way in which the specified animal pathogens covered by the licence must be handled to ensure their safe transport, containment and disposal. SAPO applies to the specified animal pathogens, regardless of their origin (Great Britain, European Union (EU) or third country)

  6.2.2  IAPO prohibits the importation into Great Britain from a third country (ie a country that is not a Member State of the EU) of any animal pathogen or carrier except under the authority of a licence and in accordance with the conditions of that licence.

  6.2.3  Licences issued under IAPO contain conditions prohibiting any transfer of the imported animal pathogen and/or carrier and its derivatives to any other person or laboratory without the prior authority of the licensing authority.

  6.2.4  Licences under IAPO usually stipulate the manner in which the animal pathogen or carrier must be prepared, treated and packed prior to importation, the containment conditions under which it must be handled and the method by which it and its derivatives must be disposed of, if it is not re-exported. The purpose of imposing these conditions is to protect animals and poultry from infection by animal pathogens imported into Great Britain from outside the EU. Licences are normally valid for two years, to provide for the importation of the material and the completion of work on the material in the laboratory, following importation.

  6.2.5  The Order also requires anyone who has in his possession an animal pathogen or carrier which he knows to have been imported in contravention of the provisions of the Order to report the fact to a veterinary inspector as quickly as possible. The Order does not apply to any animal pathogen or carrier contained in a licensed medicinal product, the importation of which is permitted under the Medicines Act 1968, or to importations made from other Member States of the European Communities.

6.3  Transport: The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2007

  6.3.1  Infectious substances transported in Great Britain are subject to these Regulations, which transpose international regulations originating in the UN and cover both safety and security measures. The Regulations apply throughout Great Britain.

6.3.2  Classification of dangerous goods, including infectious substances:  These Regulations set out nine classes of dangerous good. Infectious substances are Class 6, division 6.2. The regulations for infectious substances were developed by the UN Sub-Committee of Experts on the Transport of Dangerous Goods with input from specialised agencies including the WHO and the OIE.  Class 6.2 infectious substances are subdivided into Category A, the more dangerous pathogens, and Category B. Category A includes infectious agents which are capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals. This category includes all the pathogens listed in the COSHH HG4 and SAPO Group 4, and many of those in HG3 and Group 3.  Category A substances are divided into those infectious substances affecting humans, and those affecting animals only. The Regulations give an indicative list of infectious substances for both humans and animals. For example, the list for humans includes Ebola virus and Lassa virus, while the list for animals includes FMD virus cultures, and Rinderpest virus cultures. Category B substances would typically include diagnostic specimens from doctors' surgeries or veterinary surgeons where the consignor is confident the samples do not contain Category A substances.  The Regulations make it clear that the indicative lists are not exhaustive. New or emerging pathogens not on the list but meeting the criteria for Category A must be assigned to that category. Other infectious substances can be treated as Category B.

6.3.3  Safety requirements for dangerous goods:  All Category A substances, regardless of quantity, have to be packaged, labelled and marked according to the rigorous safety requirements in the regulations and have the appropriate documentation, and for road transport, the driver needs to hold a vocational training certificate for Division 6.2.  The regulations for Category B substances recognise the reduced risk posed by these substances, and provided they are packaged in accordance with the regulations, most other provisions are dis-applied. Category B substances are accepted by Royal Mail for transport.  For road and rail transport the vehicle or rail wagon transporting Category A pathogens has in most cases to carry warning plates. All involved in the transport chain have to receive safety training appropriate to their responsibilities. For road transport, the driver has to have specific driver training when carrying any Category A substances or other dangerous goods in quantities above certain thresholds.

6.3.4  Security requirements for dangerous goods  The aim of the security elements of the Dangerous Goods Regulations is to seek to prevent dangerous goods from being stolen and misused by terrorists. The security measures apply to all dangerous goods, except those that are nuclear and are split into two levels:

(i)  a general level applicable to the carriage of all dangerous goods; and

(ii)  a higher level for the carriage of high consequence dangerous goods.  High consequence dangerous goods are defined as those that, if misused, can cause a large loss of life or serious damage to the economy or environment, and include Category A substances as defined in section 6.3.2 above.  The security requirements apply to all those involved in the transport "chain": consignors, loaders, carriers and unloaders. Anyone involved in the transport of dangerous goods must:

—    Only offer dangerous goods to people, companies or organisations that have been properly identified;

—    Ensure temporary storage sites are secure;

—    Implement a security awareness training programme for staff;

—    Create and put in place a detailed security plan (if carrying high consequence dangerous goods) which includes the need to maintain records of the specific goods carried and the quantities. In addition to the requirement that records are kept, it is recommended that they are retained for four years.  The Regulations are supported by comprehensive guidance which has been the product of a close working relationship between Government, Police and representatives of those who have some part to play in the transport chain of dangerous goods. Various Government departments are also represented where applicable. The Department for Transport continues to cooperate with this group (called the Industry Advisory Group) and holds regular liaison meetings with them. Further information on supporting guidance can be obtained from the Department for Transport's website at

6.4  Review of Dangerous Goods Security

  6.4.1  The Department for Transport is currently reviewing its Dangerous Goods Security regime to ensure the requirements remain effective and proportionate.

  6.4.2  As part of this review, the Department has met with the other regulators of pathogen work and confirmed that their existing regulation and inspection regimes adequately cover the security requirements for pathogens and toxins stored in transit.

  6.4.3  However, within the category of high consequence dangerous goods there are some substances which have greater potential for misuse in a terrorist attack (termed "Very High Consequence Dangerous Goods" or VHCDGs). The Department for Transport is currently working with the Centre for Protection of National Infrastructure, Home Office and others to identify a list of VHCDGs, to assess the security measures currently in place to protect them in transit, and to consider the case for more stringent security requirements for these substances. This work will include pathogens and toxins within its scope and thus there is the potential for pathogens to be classified as VHCDGs and subject to enhanced containment levels accordingly.

6.5  Regulation of transport under COSHH

  6.5.1  Notification to HSE is required under COSHH where HG4 pathogens are being moved from one site to another. Notification needs to be made at least 30 days in advance of any planned movement of the agent, although in practice, shorter times are often agreed to allow clinical diagnostic work to be carried out.

7.   Measures implemented when pathogenic material cannot be accounted for

  7.1  There are reporting systems in place under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) and the GMO(CU) Regulations which would apply in cases where material could not be accounted for.

  7.2  The GMO(CU) Regulations require that accidents that "involve a significant and unintended release . . . which presents an immediate or delayed hazard to human health or to the environment" are reported to the Competent Authority. This would include any situation where material could not be accounted for.

  7.3  RIDDOR similarly requires notification to HSE as a "dangerous occurrence", which would cover situations where samples containing HG 3 or 4 micro-organisms were lost or accidentally released. However, there is no specific requirement to keep an inventory of organisms held, although it would be expected as good practice. The requirement to ensure safe storage can only be effectively met by knowing what is held, and ensuring that it is kept safe.

  7.4  HSE undertakes investigations of RIDDOR or GMO(CU) reportable incidents involving dangerous pathogens. Incidents range from dangerous occurrences which have the potential to expose employees to pathogens, such as laboratory spillages, to cases of laboratory acquired infections, via accidents such as needlestick injuries. The incidents are investigated in accordance with HSE's enforcement policy and operational investigation policy and procedures.

  7.5  Licence holders under SAPO CL4 have agreed procedures to notify the licensing authority (currently Defra) of either the accidental release of pathogenic material (as defined within SAPO) or of a "near miss". Defra would expect to be notified immediately by telephone, with a written report to follow within 24 hours. The responsibility for reporting rests with the Biological Safety Officer (where one has been appointed) or other competent individual at the licensed premises, who is required to make an assessment of the risk and formulate Standard Operating Procedures which set out the action to be taken. All such reports are assessed by senior veterinary officials in Defra and further action considered. For all relevant laboratories, provision for handling general and biological agents is contained in the COSHH, and for GM organisms in GMO(CU).

8.   The role of universities in overseeing security clearance for research students working with dangerous pathogens

  8.1  In common with other Governments around the world, the British Government is working hard to stop the spread of knowledge and skills that could be used in the proliferation of weapons of mass destruction (WMD) and their means of delivery. The Academic Technology Approval Scheme (ATAS) is designed to ensure that people who are applying to study certain sensitive subjects in the UK do not have links to WMD programmes. The ATAS is administered by the FCO and was introduced on 1 November 2007.

  8.2  Non-European Economic Area nationals who require leave to enter or remain in order to study in the UK and who are seeking to undertake postgraduate study in the UK in specific, limited subjects must hold an ATAS certificate before they can apply for an entry clearance or extension of stay. The Immigration Rules were amended on 30 November to make the possession of an ATAS certificate a mandatory requirement. Students seeking leave to enter or remain who require an ATAS certificate and who do not hold one will be refused leave to enter/remain.

  8.3  The MoD provided technical advice on which subjects to include in fields such as engineering, technology, and the sciences; a full list is available at The scheme is focussed on those conducting postgraduate research (at both Doctoral and Masters level) although students taking taught Masters in the specific areas of Materials Science, Materials Technology, Physics, Mechanical Engineering and Aerospace Engineering also come within its remit.

  8.4  An ATAS certificate can be applied for via a free, on-line form resembling a CV. No supporting documentation is required. The FCO aims to take decisions on the vast majority of applications within 10 working days. Applicants are notified by email of the decision and issued with a certificate if their clearance is confirmed. At the same time Higher Education Institutions (HEIs) are informed of decisions affecting their applicants.

  8.5  The ATAS certificate is specific to both the programme of study that the student intends to undertake and the HEI.

  8.6  HEIs have a fairly limited involvement in this process. They provide in their offer letters to students the relevant code for the programme of study the student is to follow, which enables the FCO to determine whether the programme of study is one which is covered by the ATAS arrangements. For those students undertaking postgraduate research the HEI also provides an agreed research proposal of what area of research is anticipated.

  8.7  Prior to the introduction of mandatory screening through ATAS, there was a voluntary screening system known as the Voluntary Vetting Scheme in place since 1994, also administered by the FCO. HEIs were invited to refer any applicants to the FCO for vetting. A recommendation was made to the HEI although they did not have to accept that advice. The scheme was voluntary, adherence to it by HEIs was patchy and it placed an undue burden on those who did participate. A lengthy review led to the introduction of the ATAS and the subsequent amendment of the Immigration Rules, which gives the scheme proper effect.

January 2008

Annex A

ACDPAdvisory Committee for Dangerous Pathogens
ATASAcademic Technology Approval Scheme
ATCSAAnti-terrorism Crime and Security Act 2001
CEPRHealth Protection Agency's Centre for Emergency Preparedness and Response
CLContainment Level
COSHHControl of Substances Hazardous to Health Regulations 2002
CTSACounter-terrorism Security Advisers
DefraDepartment for the Environment, Food and Rural Affairs
EUEuropean Union
FCOForeign and Commonwealth Office
FMDFoot and Mouth Disease
GMMGenetically Modified Micro-organism
GMOGenetically Modified Organism
GMO(CU)Genetically Modified Organisms (Contained Use) Regulations 2000
HEIHigher Education Institutions
HGHazard Group
HPAHealth Protection Agency
HSEHealth and Safety Executive
IAPOThe Importation of Animal Pathogens Order 1980
MoDMinistry of Defence
NaCTSONational Counter-Terrorism Security Office
NIBSCNational Institute of Biological Standards and Control
OIEOffice Internationale des Epizooties
RIDDORReporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995
SACGMScientific Advisory Committee for Genetic Modification
SAPOSpecified Animal Pathogens Order 1998
VHCDGsVery High Consequence Dangerous Goods
VLAVeterinary Laboratories Agency
WHOWorld Health Organization
WMDWeapons of mass destruction

1 Back

2 Back

3   Government statement: http://defraweb/corporate/ministers/statements/hb071213.htm Back

4   For containment level 4, category of sites is given; for containment level 2 and 3, the category of organisations is given. Back

5   This was difficult to assign with a high degree of confidence, particularly separating out Government and Research Council (plus others eg charities[0]). Back

6   For organisations with capacity to work at containment level 4, the number of sites is given; for organisations with capacity to work at containment level 2 and 3, the number of organisations is given.[0] Back

7   Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995. Back

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