E8

HIGH-CONTAINMENT LABORATORIES—UK CASE STUDY

Dr. Neil Davison, Science Policy Centre, the Royal Society
Dr. Filippa Lentzos, BIOS Centre, London School of Economics

Royal Society contribution to a project of the Committee on International Security and Arms Control (CISAC) and the Board of Life Sciences at the US National Academy of Sciences: “Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories”

What high-containment biological research facilities exist in your country?

The UK has both Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) laboratories. In the UK these are referred to as Containment Level 3 and 4 (CL3 & CL4). Most work with dangerous pathogens is carried out in Government and Research Council laboratories.1

There are approximately 600 laboratories around the UK that are built to operate at BSL-3. Of these around 150 are in research institutes and 150 at universities, although differentiating between research institutes and university laboratories is difficult. There are around 75 BSL-3 laboratories operated by private companies. A large proportion of BSL-3 capacity is held by a small number of universities and research institutes, e.g. two universities have 84 BSL-3 laboratories between them; and one institute has 60 BSL-3 laboratories. The National Health Service (NHS) has 170 BSL-3 laboratories mainly for diagnostics.2

Table E8-1 shows data collected by the Health and Safety Executive (HSE) for the number of organisations with BSL-3 laboratories and their operators as of December 2007. Note that an organisation is at the employer level (e.g. University of Oxford), and a given organisation may have multiple facilities.3

Table E8-1 Number of organisations with BSL-3 laboratories (December 2007)a

   Government Private Research Council University
BSL-3 202 98 7 40

SOURCE: Contains Parliamentary information licensed under the Open Parliament Licence v1.0.

a http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25 &
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 52

In December 2007, HSE figures showed ten sites in the UK with BSL-4 laboratories as shown in Table E8-2. These figures referred to seven government or government sponsored research institutes, one government clinical diagnostic site, and two commercial veterinary vaccine manufacturers.4 However, as of April 2009 there is only one privately operated BSL-4 site since the Intervet Schering-Plough laboratory in Middlesex, which previously carried out research on Newcastle disease, has now closed. This brings the total number of BSL-4 sites to nine.

images

1http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 160-162.

2http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf pp Ev 162.

3http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25 &
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 52.

4http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 162.



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E8 HIGH-CONTAINMENT LABORATORIES—UK CASE STUDY Dr. Neil Davison, Science Policy Centre, the Royal Society Dr. Filippa Lentzos, BIOS Centre, London School of Economics Royal Society contribution to a project of the Committee on International Security and Arms Control (CISAC) and the Board of Life Sciences at the US National Academy of Sciences: “Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories” What high-containment biological research facilities exist in your country? The UK has both Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) laboratories. In the UK these are referred to as Containment Level 3 and 4 (CL3 & CL4). Most work with dangerous pathogens is carried out in Government and Research Council laboratories.1 There are approximately 600 laboratories around the UK that are built to operate at BSL-3. Of these around 150 are in research institutes and 150 at universities, although differentiating between research institutes and university laboratories is difficult. There are around 75 BSL-3 laboratories operated by private companies. A large proportion of BSL-3 capacity is held by a small number of universities and research institutes, e.g. two universities have 84 BSL-3 laboratories between them; and one institute has 60 BSL-3 laboratories. The National Health Service (NHS) has 170 BSL-3 laboratories mainly for diagnostics.2 Table E8-1 shows data collected by the Health and Safety Executive (HSE) for the number of organisations with BSL-3 laboratories and their operators as of December 2007. Note that an organisation is at the employer level (e.g. University of Oxford), and a given organisation may have multiple facilities.3 Table E8-1 Number of organisations with BSL-3 laboratories (December 2007)a Government Private Research Council University BSL-3 202 98 7 40 SOURCE: Contains Parliamentary information licensed under the Open Parliament Licence v1.0. a http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25 & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 52 In December 2007, HSE figures showed ten sites in the UK with BSL-4 laboratories as shown in Table E8-2. These figures referred to seven government or government sponsored research institutes, one government clinical diagnostic site, and two commercial veterinary vaccine manufacturers.4 However, as of April 2009 there is only one privately operated BSL-4 site since the Intervet Schering-Plough laboratory in Middlesex, which previously carried out research on Newcastle disease, has now closed. This brings the total number of BSL-4 sites to nine. 1 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 160-162. 2 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf pp Ev 162. 3 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25 & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 52. 4 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 162. 175

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176 Biosecurity Challenges Table E8-2 Number of sites with BSL-4 laboratories (December 2007)a Government Private Research Council University BSL-4 5 2* (Now 1) 3 0 * There is now only one private BSL-4 site. SOURCE: Contains Parliamentary information licensed under the Open Parliament Licence v1.0. a http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25 & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 52 Of the eight government sites, five can operate at BSL-4 for human pathogens (ACDP4), although only four actually operate at this level, and three at BSL-4 for animal pathogens (SAPO4). Seven sites have facilities to work with infected animals.5 The facilities at each site vary in size from a single room to multiple suites or even individual buildings of BSL-4 laboratories.6 All BSL-4 facilities are located in the South East of England, ranging from rural settings to suburban areas and cities (there are three BSL-4 sites in or near London).7 In addition to these BSL-4 laboratories for research and diagnostics, there are also two High Security Disease Isolation Units (HSDUs) for the care of patients with viral haemorrhagic fevers, such as Ebola or Lassa. One is in Coppetts Wood, London, which would also be used for a post- mortem requiring BSL-4, and the other is under development at the Royal Victoria Infirmary, Newcastle.8 Details of eight of the UK BSL-4 sites are provided in the UK Government Confidence Building Measure (CBM) submission to the Biological and Toxin Weapons Convention (BTWC), as shown in Table E8-3.9 Table E8-3 Details of UK BSL-4 laboratories, covering data for 2010a Type Operator Funding Facilities Activities Government Defence science Ministry of Two BSL-4 laboratories R&D into protective measures 2 and technology Defence (335 m total) against biological weapons laboratory (Dstl), Porton Down, Wiltshire Government Centre for Department of Two BSL-4 units (59 Diagnosis and research on 2 2 Emergency Health m ; and 46 m ) viruses including Lassa, Ebola, Preparedness Marburg and other haemorrhagic and Response, fever viruses. Health Protection Agency (HPA), Porton Down, Wiltshire One BSL-4 unit (30 m2) Government Health Department of Applied diagnostic R&D, and Protection Health diagnostic services for Herpes B; Agency (HPA), viral haemorrhagic fever infections Colindale, (Lassa fever, Ebola, Marburg, London Congo-Crimean haemorrhagic fever); avian influenza; and SARS Government National Institute Department of Two BSL-4 units (each Activities related to development 59 m2) for Biological Health and of assays and testing of reagents 5 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev162. 6 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25 & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 162. 7 http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1227688128129. 8 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp 24-25. 9 UK BWC CBM 2009: http://www.unog.ch/80256EDD006B8954/(httpAssets)/5D42C16D75CA84D4C12575A0002A5A7A/$file/B WC_CBM_2009_UK.pdf.

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177 Appendix E: Country and Region Overviews Standards and Home Office including: highly pathogenic Control (NIBSC), influenza virus – reagent Department of development; Bacillus anthracis – Health, Potters vaccine testing, reagent Bar, development, development of in Hertfordshire vitro assays; Yersinia pestis – molecular structural work; Botulinum toxins (serotypes A-G) – control, standardisation and assay development for vaccines and anti-toxins Government Veterinary Department for Specified Animal Diagnosis and applied research Laboratories Environment, Pathogens Order on livestock diseases and wild Agency, Food and Rural (SAPO) Level 4: Three animal reservoirs. Addlestone, Affairs (Defra) avian flu laboratories (each 50 m2); one Surrey classical swine fever 2 laboratory (15 m ); one Newcastle disease virus laboratory (50 2 m ); one rabies virus laboratory (45 m2); one suite of serology labs capable of increasing to SAPO level 4 (approximately 100 m2) Research National Institute Medical One BSL-4 unit (298 Research and diagnostics on 2 Council for Medical Research m) highly pathogenic avian influenza Research Council virus and pandemic influenza (NIMR), NIMR viruses. Containment 4 Building C, London Research National Institute Medical One BSL-4 unit (298 Research and diagnostics on m2 ) Council for Medical Research highly pathogenic avian influenza Research Council virus and pandemic influenza (NIMR), NIMR viruses. Containment 4 Building C, London Research Institute for Biotechnology SAPO Level 4 Research on exotic animal virus Council Animal Health, and Biological laboratory space and diseases: foot and mouth disease Pirbright Sciences plant areas (5,173.87 (FMD), bluetongue, swine m2); SAPO Level 4 Laboratory, Research vesicular disease, African horse Pirbright, Surrey Council animal accommodation sickness, capripox, African swine (BBSRC), EU, including plant (4,327 fever, peste des petits ruminants 2 Defra m) and rinderpest. Private Merial Animal Private One SAPO Level 4 Production of inactivated FMD Health Ltd, facility and bluetongue vaccines. Pirbright Laboratory, Pirbright Surrey SOURCE: UK BWC CBM 2011: United Kingdom of Great Britain and Northern Ireland: Confidence Building Measure Return for 2011 (covering data for 2010) for the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and their Destruction, 10 April 1972 (Submitted to the United Nations on 31 March 2011). a UK BWC CBM 2011: http://www.unog.ch/80256EDD006B8954/(httpAssets)/009540B24174AC38C12578930057FF00/$file/BWC_CBM_2011_United+Kin gdom.pdf

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178 Biosecurity Challenges A 2008 review of the UK’s BSL-4 laboratories, Chaired by Professor George Griffin and sponsored by the Health Protection Agency, the Medical Research Council, the Biotechnology and Biological Sciences Research Council, and the Department for Environment, Food and Rural Affairs, identified six building or renovation plans for BSL-4 facilities that were in planning or under consideration as of October 2008: “Two of these are in major universities, one involving the up-grading of a yet to be licensed SAPO3 facility to a SAPO4 level, the other, the construction of a completely new ACDP [Advisory Committee on Dangerous Pathogens] CL4 laboratory.”10 2 What government organizations are responsible for safety and security of high- containment biological (high BSL) laboratories? The Health and Safety Executive (HSE)11 is the main government authority that regulates standards and compliance relating to general health, safety and the environment including most matters relating to biological agents, biosafety, and genetic modification. HSE fulfils advisory, regulatory, and enforcement roles. HSE has sole responsibility for inspections and enforcement at facilities handling dangerous human and animal pathogens and Genetically Modified Microorganisms (GMMs) in the UK.12 Until 2008 the Department for Environment, Food and Rural Affairs (Defra) regulated standards and compliance for animal and plant diseases, and it continues to license premises for work with animal pathogens under the Specified Animal Pathogens Order (SAPO).13 The Home Office is responsible for standards and compliance relating to biosecurity.14 The Advisory Committee on Dangerous Pathogens (ACDP) provides independent scientific advice (see Section 3). The June 2008 report of a House of Commons inquiry on Biosecurity in UK research laboratories expressed concern that there was no ministerial oversight of biosecurity and recommended: “... that in view of the cross-cutting nature of these issues, the Government establish a ministerial group to meet periodically to discuss issues of biosecurity. A single Minister, for example the Minister for Science and Innovation, should take responsibility for co-ordinating biosecurity and the provision of high-containment laboratories and should act to convene this ministerial group and the inter-agency body we have recommended be set up.”15 The government response to this recommendation noted: “Where scientific and technical issues are involved, the Chief Scientific Advisers’ Committee is best placed to oversee cross-cutting issues and receive reports from the interagency group from time to time. We agree with the Select Committee that a collective Ministerial overview would be appropriate, at least until Ministers are confident that coordination by officials and Chief Scientific Advisers is working well. We will therefore establish a Ministerial group, to be convened when the need arises.”16 10 http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1227688128129. 11 http://www.hse.gov.uk/biosafety/. 12 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 20 & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 53 & http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1227688128129. 13 http://www.hse.gov.uk/biosafety/callaghan.htm. 14 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf & http://www.opbw.org/new_process/mx2008/BWC_2008_MX_Docs/BWC_MSP_2008_MX_WP.6_En.pdf. 15 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 31. 16 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/1111/1111.pdf p 9.

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179 Appendix E: Country and Region Overviews Regulations and associated responsibilities are currently undergoing significant changes. In the aftermath of the foot and mouth disease (FMD) outbreak in Surrey in 2007 (see Section 5), a single regulatory framework for human and animal pathogens will replace relevant elements of existing regulations.17 Consultations on the new regulations, termed The Biological Agents and Genetically Modified Organisms (Contained Use) Regulations, are now complete, and it is expected that the new regulations will be introduced in 2012.18 The Advisory Committee on Dangerous Pathogens (ACDP) (see Section 3) is producing guidance to accompany the new regulations that will encompass a common set of containment measures for human and animal pathogens.19 The guidance is currently in draft form.20 As of July 2011, and prior to the introduction of the new regulations, biosafety in UK laboratories is covered by three pieces of legislation:21 • The Control of Substances Hazardous to Health Regulations 2002 (COSHH)22 COSHH regulations come under the European Communities Act 1972 and the Health and Safety at Work etc Act 1974.23 COSHH regulations are wide-ranging and are not limited to regulation of dangerous pathogens. They are enforced by HSE.24 Under COSHH, pathogens are classified into Hazard Groups 1-4 based on the risk to human health as defined in The Approved List of Biological Agents.25 This list is produced in consultation with the Advisory Committee on Dangerous Pathogens (ACDP).26 Biosafety level categories under COSHH are often referred to as ACDP1-4. COSHH is primarily aimed at preventing exposure of workers to dangerous pathogens and places duties on employers to carry out risk assessments and ensure that exposure is prevented or controlled.27 • The Specified Animal Pathogens Order 2008 (SAPO)28 SAPO regulates the use of animal pathogens and until recently was administered by Defra. SAPO is aimed at preventing the escape of pathogens from the laboratory and not with the protection of laboratory workers. It is a licensing system that specifies conditions for handling animal pathogens following inspection of the laboratory and documentation. Licenses are usually valid for five years. Conditions cover: safe containment and disposal; the areas of the laboratory in which various types of work may be done; and the people responsible for the work.29 Following recommendations of the Callaghan Review,30 HSE is now responsible for inspection and enforcement across the UK while Defra remains responsible for licensing. SAPO was based on the ACDP 1-4 recommendations (animal pathogens are consequently classed in four categories: SAPO1-431) and the regulations covering work with animal pathogens was 17 http://www.hse.gov.uk/biosafety/callaghan.htm. 18 Consultative document http://consultations.hse.gov.uk/inovem/gf2.ti/f/11362/306085.1/pdf/-/cd230.pdf & draft regulations http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a- annex1.pdf. 19 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf pp13-15. 20 Draft CU2010: http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a- annex1.pdf. 21 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 51 & http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.7_En.pdf. 22 http://www.opsi.gov.uk/si/si2002/20022677.htm. 23 http://www.hse.gov.uk/legislation/hswa.htm. 24 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p10. 25 http://www.hse.gov.uk/pubns/misc208.pdf. 26 http://www.dh.gov.uk/ab/ACDP/index.htm. 27 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/callaghan- reviewreport071213.pdf. 28 http://www.opsi.gov.uk/si/si2008/uksi_20080944_en_1. 29 http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf p11. 30 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/callaghan- reviewreport071213.pdf. 31 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p.10.

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180 Biosecurity Challenges therefore interlined with those covering human pathogens even before the decision to develop a single regulatory framework. • The Genetically Modified Organisms (Contained Use) Regulations 2000 [GMO(CU)]32 GMO(CU) regulations33 come under the European Communities Act 1972 and the Health and Safety at Work etc Act 1974. GMO(CU) regulates genetically modified pathogens, categorising them in Class 1-4, according to an assessment of risks to both the worker and the environment (thereby differing from COSHH and SAPO). HSE and Defra are responsible for this regulation in England and Wales, and HSE and the Scottish Executive in Scotland.34 Table E8-4 below shows data from HSE for the number of organisations (for BSL-3) and number of sites (for BSL-4) working with dangerous pathogens and their regulation as of December 2007. (Note: These data were provided before HSE took on responsibility for SAPO). Table E8-4 Number of organisations (BSL-3) and sites (BSL-4) working with dangerous pathogens and their regulation in the UK. (December 2007)a BSL COSHH and/or GMO(CU) SAPO HSE & SAPO Total regulated only only combined Number of organisations 3 323 5 19 347 Number of sites 4 1 2 7 10 SOURCE: Contains Parliamentary information licensed under the Open Parliament Licence v1.0. a http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p10 & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev52 The Home Office is responsible for biosecurity in UK laboratories. The regulatory framework is Part 7 and Schedule 5 of the Anti-terrorism Crime and Security Act 2001 (ATCSA),35 which is implemented by the National Counter-Terrorism Security Office (NaCTSO),36 a police unit reporting to the Association of Chief Police Officers (ACPO). ATCSA allows the police to impose security measures in laboratories handling dangerous pathogens and toxins included on a list of just over 100 pathogens in Schedule 5, which was extended in 2007 to include animal pathogens.37 ATCSA covers around 400 laboratories including university and hospital laboratories.38 Guidelines governing these measures are provided in restricted circulation documents published jointly by the Home Office and NaCTSO: “Security Standards for Laboratories”; and “Personnel Security Measures for Laboratories.”39 ATCSA requires laboratories to: • Register with the Home Office their holdings of Schedule 5 substances. • Inform the police of the security measures in place and the personnel who have access to the Schedule 5 substances in certain circumstances. • Ensure that Schedule 5 substances and the premises in which they are kept, stored, worked on, and disposed of are secure. 32 http://www.opsi.gov.uk/si/si2000/20002831.htm. 33 http://www.hse.gov.uk/biosafety/gmo/law.htm. 34 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p.10. 35 http://www.opsi.gov.uk/acts/acts2001/ukpga_20010024_en_1. 36 http://www.nactso.gov.uk/. 37 http://www.nactso.gov.uk/SiteCollectionDocuments/AreasOfRisk/Implementation%20Guidance% 20for%20Labs.pdf. 38 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p11 &http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev52. 39 http://www.dh.gov.uk/prod_consum_dh/idcplg%3FIdcService%3DGET_FILE%26dID% 3D137088%26Rendition%3DWeb.

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181 Appendix E: Country and Region Overviews Ensure that access to said substances is authorised and controlled.40 • If there are BSL laboratories in your country, are there established criteria for deciding: a. Whether or not to establish such facilities? Establishment of new BSL-3 and BSL-4 facilities is at the discretion of the relevant organisation, company, or government department. Consulting HSE at an early stage is considered advisable when building new BSL-3 and BSL-4 facilities. For BSL-3 facilities, the organisation is encouraged to contact HSE, and for BSL-4 HSE is always consulted. HSE has the power to prevent the construction of a BSL-4 laboratory if it considers the plans for its construction, operation, or maintenance to be unsafe.41 The 2008 House of Commons inquiry recommended that “...HSE be a statutory consultee in any planning application for a CL3 or CL4 laboratory.”42 The report also urged “...HSE to engage as early as possible with those building and operating high-containment facilities to avoid resorting to enforcement action.”43 The UK government has stated that it does not intend to amend current requirements for planning permission but that, in the development of the new single regulatory framework (SRF), consideration will be given to the information that should be provided to HSE and the extent of consultation required for a new facility or change of use of an existing facility.44 What criteria are used to select the placement of such facilities? There are no universal criteria used to select the placement of high-containment facilities. The location of BSL-3 and BSL-4 laboratories is part of an overall risk assessment that would consider other factors including the availability of scientific and maintenance staff and proximity to emergency services.45 The 2008 House of Commons inquiry concluded “there is no reason in principle why CL4 laboratories should not be built in urban areas, provided that the correct risk assessment is undertaken and biorisk is managed appropriately. As each case will be unique, we recommend that such applications be treated on an individual basis.”46 As regards the highest level of containment, an October 2008 independent review of UK BSL-4 facilities Chaired by Professor George Griffin concluded: “The geographical locations of the existing high-containment facilities have arisen for historic operational reasons and few opportunities exist to alter this situation. When such opportunities do arise then decisions on their location should be based on a robust, multi-faceted risk assessment in which microbiological science and all aspects of security, safety, and public opinion are considered and on the existence of good links to academic centres of excellence.”47 The review emphasised the importance on taking into account public opinion when locating or renovating high-containment facilities. HSE’s guidance, Biological agents: The principles, design and operation of Containment Level 4 facilities, notes that local authorities are responsible for adequate planning and public consent and that those designing the BSL-4 laboratory may want to consider conducting a local public consultation.48 HSE provides more specific guidance on factors that influence the positioning of a BSL-4 building at a given location including: headroom; access; daylight and visibility; utilities; and air handling.49 The guidance also notes: 40 http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a-annex1.pdf. 41 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdfp34. 42 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdfp35. 43 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p22. 44 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/1111/1111.pdf p11. 45 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p34. 46 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p35. 47 http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1227688128129 p17. 48 http://www.hse.gov.uk/pubns/web09.pdf p9.

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182 Biosecurity Challenges “The CL4 [BSL-4] facility will consist of either a separate building or a clearly demarcated and isolated zone within a building. Activities can be separated by locating the laboratory away from main public thoroughfares of the building. The rooms in the unit should be arranged to ensure passage through the changing and decontamination area before entering rooms where work is done with HG4 [Hazard Group 4] agents.”50 b. What criteria are used to decide what research will be done in such facilities? Decisions on research to be undertaken are taken by the organisation, company, or government department that is responsible for the laboratory. There are specific requirements for containment measures for BSL-3 and 4 laboratories, as detailed in Section 4. ACDP guidance, Biological agents: Managing the risks in laboratories and healthcare premises,51 provides criteria for selecting appropriate control measures for different types of research and different pathogens. c. What scientific, technical, and management advice is available to governments when making their decisions. Advice and guidance is provided to the UK government by the Biological Agents Unit at HSE.52 Independent scientific and technical advice is provided by the Advisory Committee on Dangerous Pathogens (ACDP), a non-departmental public body with a Chairman and up to 17 members comprising scientific experts, employer representatives, and employee representatives. ACDP’s terms of reference are: "To advise the Health and Safety Executive, and Ministers for the Department of Health and the Department for Environment, Food and Rural Affairs, 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."53 ACDP’s two main areas of work are: “Production of guidance relating to safety at work and protection of public health; and Provision of advice to Government on the formulation and implementation of policy and legislation, relating to specific pathogen risks and their impact.” 54 There are three main guidance documents in current use, which were produced by ACDP and published by HSE: The management, design and operation of microbiological containment laboratories (2001),55 aimed • at those responsible for the management and operation of BSL2 and BSL-3 laboratories. Biological agents: Managing the risks in laboratories and healthcare premises (2005),56 aimed at the • healthcare sector; and Biological agents: The principles, design and operation of Containment Level 4 facilities (2006),57 • which is aimed at high-hazard containment facilities, mainly those that present a risk to human health under COSHH. Genetically modified and animal pathogens are discussed only in the context of human health. 49 http://www.hse.gov.uk/pubns/web09.pdf p33. 50 http://www.hse.gov.uk/pubns/web09.pdf p41. 51 http://www.hse.gov.uk/biosafety/biologagents.pdf 52 http://www.hse.gov.uk/biosafety/infection.htm 53 http://www.dh.gov.uk/ab/ACDP/index.htm 54 http://www.dh.gov.uk/ab/ACDP/index.htm 55 http://www.hse.gov.uk/pubns/books/microbio-cont.htm 56 http://www.hse.gov.uk/biosafety/biologagents.pdf 57 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_ 4135258

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183 Appendix E: Country and Region Overviews As discussed in Section 2, ACDP and HSE are currently developing guidance to accompany the new single regulatory framework to be introduced during 2012.58 4 What standards exist for BSL laboratories? In the UK there are legal requirements under COSHH, SAPO, GMO(CU), and ATCSA (see Section 2). These are supported by guidance from ACDP (see Section 3 (d)). A new single regulatory framework for biosafety, which will replace GMO(CU) and elements of COSHH and SAPO, is under development for introduction during 2012. ATCSA related standards for biosecurity regulated by the Home Office will remain the same. a) For engineering and construction? The minimum containment requirements under COSHH regulations for BSL-3 and BSL-4 laboratories are summarised in Table E8-5, which is taken from the ACDP guidance Biological agents: Managing the risks in laboratories and healthcare premises.59 Table E8-5 Minimum containment requirements under COSHH for work in BSL-3 and BSL-4 laboratories.a Containment Level BSL-3 BSL-4 Air Handling The workplace is to be maintained at air pressure Yes Yes negative to atmosphere Input air and extract air to the workplace are to be Yes, on extract air Yes, on input and double filtered using high efficiency particulate absorption on extract air (HEPA) filters or equivalent Security and Access The workplace is to be separated from any other Yes Yes activities in the same building Access is to be restricted to authorised persons only Yes Yes, via air-lock key procedure Efficient vector control, e.g. rodents and insects Yes, for animal containment Yes Safe storage of a biological agent Yes Yes, secure storage An observation window, or alternative, is to be present, Yes Yes so that occupants can be seen A laboratory is to contain its own equipment Yes, so far as is reasonably Yes practicable Disinfection and Disposal Procedures The workplace is to be sealable to permit disinfection Yes Yes Specified disinfection procedure Yes Yes Surfaces impervious to water and easy to clean Yes, for bench and floor (and Yes, for bench, floor, walls walls for animal containment) and ceiling Surfaces resistant to acids, alkalis, solvents, Yes, for bench and floor (and Yes, for bench, floor, walls disinfectants walls for animal containment) and ceiling Incinerator for the disposal of animal carcasses Accessible Yes, on site 58 http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a-annex1.pdf 59 http://www.hse.gov.uk/biosafety/biologagents.pdf

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184 Biosecurity Challenges Protective Equipment and Procedures Infected material, including any animal, is to be Yes, where aerosol Yes handled in a safety cabinet or isolator or other suitable produced equipment SOURCE: © Crown copyright: Health and Safety Executive. a http://www.hse.gov.uk/biosafety/biologagents.pdf The minimum containment requirements under COSHH, SAPO and GMO(CU) regulations for work in BSL-4 laboratories are shown in Table E8.6, which is taken from the ACDP guidance The Principles, Design and Operation of Containment Level 4 Facilities. 60 Table E8-6 Containment requirements under COSHH, SAPO and GMO(CU) regulations for work in BSL- 4 laboratories.a Containment Measures COSHH SAPO GMO(CU)* The workplace is to be separated Yes Yes Yes from any other activities in the same building Input air and extract air to the Yes, on input and double Yes, single on input and Yes, extra workplace are to be filtered using on extract air double on extract air requirements for HEPA or equivalent viruses Access is to be restricted to Yes, via airlock key Yes, restricted and entry Yes, via airlock key authorised people only procedure through an airlock, clean/dirty area. Shower on exit The workplace is to be sealable to Yes Yes Yes, sealable for permit disinfection fumigation Specified disinfection procedure Yes Yes Yes The workplace is to be Yes Yes, pressure to be Yes maintained at air pressure maintained at not less negative to atmosphere than -75 Pa Efficient vector control, e.g. Yes Yes, and proofed Yes rodents and insects against entry or exit of animals and insects Surfaces impervious to water and Yes, for bench, floor, Yes, for working Yes, for bench, floor, easy to clean walls and ceiling surfaces, walls and walls and ceiling ceiling Surfaces resistant to acids, Yes, for bench, floor, Yes, for working Yes, for bench, floor, alkalis, solvents, disinfectants walls and ceiling surfaces, walls and walls and ceiling ceiling Safe storage of a biological agent Yes, secure storage Yes, secure storage in Yes, secure storage the laboratory suite. Inventory to be maintained An observation window, or Yes Yes Yes alternative, is to be present, so that occupants can be seen A laboratory is to contain its own Yes Yes Yes equipment Infected material, including any Yes Yes Class III cabinet animal, is to be handled in a required safety cabinet or isolator or other suitable containment Incinerator for the disposal of Yes, on site Yes, or some other Yes, on site animal carcasses validated means of pathogen inactivation and 60 http://www.hse.gov.uk/pubns/web09.pdf pp 14-16.

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185 Appendix E: Country and Region Overviews safe carcass disposal Treatment of liquid and solid All waste should be made All wastes to be sterilised Inactivation by wastes safe or safe to handle by a procedure known to validated means before leaving the inactivate the laboratory pathogen(s). For solids this requires autoclaving followed by incineration Laboratory security Laboratory and animal rooms to be kept secure and locked. Intruder alarm system to be fitted SOURCE: © Crown copyright: Health and Safety Executive. a http://www.hse.gov.uk/pubns/web09.pdf pp 14-16. *Note: GMO(CU) Regulations specify additional control measures for work with genetically modified micro-organisms in animal units, plant growth facilities and for large-scale work. These two ACDP guidance documents provide further guidance for the design, construction, and operation of BSL-3 and BSL-4 laboratories. They also refer to publications that provide more detailed information on laboratory construction: Richmond, J Y (ed) (2000) Anthology of Biosafety II – BSL 2 Facility design considerations. American Biological Safety Association; and Richmond, J Y (ed) (2002) Anthology of Biosafety V – BSL 4 Laboratories. American Biological Safety Association. The ACDP note that: “...it must be remembered that each CL4 [BSL-4] laboratory will be unique and that the number of publications and people (e.g. architects, designers and engineers) with experience of building a CL4 facility will be limited. Consequently, extensive liaison and consultation between all parties, including regulators, at a very early stage is highly recommended for a successful build – the aim being to eliminate problems at the design stage rather than rectifying problems once the facility is built.”61 b) For licensing? (Also see Section 2) SAPO is a licensing regime, work covered by COSHH requires notification and, work under GMO (CU) requires permission.62 Laboratory work covered by ATCSA requires notification. There is no formal licensing system under COSHH regulations, which are enforced by HSE. However, there is a requirement for those wishing to work on dangerous pathogens in the laboratory to notify and receive acknowledgement from HSE.63 Evidence submitted by the government to the 2008 House of Commons inquiry noted: “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 HG [hazard group] 2, HG3 and HG4 are used for the first time, at particular premises. Notification is also required of the subsequent use of certain organisms (i.e. 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). 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.”64 61 http://www.hse.gov.uk/pubns/web09.pdf p 31 62 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 13 63 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/callaghan- reviewreport071213.pdf p 8 64 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 55

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186 Biosecurity Challenges Defra remains responsible for licensing under SAPO (although HSE is now responsible for oversight). SAPO prohibits the possession or introduction of any animal pathogens listed in Part I of the Schedule, or any carrier of that pathogen, except under license. These are primarily exotic diseases that can affect farmed livestock and poultry. No license is needed to possess a pathogen listed in Part II of the schedule but its introduction to any animal is prohibited except under license. Conditions in licenses also place restrictions on domestic transfer of animal pathogens.65 Government evidence to the House of Commons inquiry provides more details on SAPO licensing: “The SAPO licensing process includes inspection of the applicants’ laboratories and review of supporting documentation (i.e. 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 license conditions and the Order.”66 GMO (CU) regulations require anyone carrying out genetic modification to conduct a risk assessment for human health and the environment and assign containment accordingly. Activities are assigned a risk class equating to the containment level (1-4). Prior to Class 2, 3 or 4 activities commencing, a notification must be submitted including an assessment of the hazards and planned containment measures. HSE and Defra review these notifications and request additional information where necessary. Written consent from HSE is required before work in class 3 or 4 begins.67 Under ATCSA, laboratories are required to register their holding of Schedule 5 substances with the Home Office and provide information to the police on their security measures and, in certain conditions, personnel. Liaison with laboratories is carried out by police Counter Terrorism Security Advisors (CTSAs) from the National Counter-Terrorism Security Office (NaCTSO). Security requirements are dependent on the organism(s) being handled. BSL-4 laboratories have extensive security measures with extremely limited access and all staff must have security clearances. Access to pathogens is restricted at BSL-3 laboratories, which are also subject to security measures and are provided with advice on staff security checking.68 c) For safety and security? There are regulatory requirements for biosafety, covered by COSHH, SAPO and GMO(CU), and biosecurity, covered by ATCSA (see Section 2) and supporting guidance from ACDP (see Section 3 (d)). Minimum containment requirements are outlined in Section 4 (a). In addition there are relevant standards and guidance around staffing and training. ACDP highlights the important role of Biological Safety Officers/Advisors (BSOs/BSAs): “The recruitment of a biological safety advisor (BSA) is pivotal in ensuring management are provided with sufficient information and advice to ensure risks related to biological agents are either controlled or prevented.”69 The 2008 House of Commons inquiry on biosecurity noted that there was “...widespread support for a more high profile role for BSOs and for giving them professional status.”70 Training is essential for work at high containment and employers are required to provide this under health and safety law and specific regulations such as COSHH. The House of Commons inquiry found that 65 http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.7_En.pdf 66 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 57 67 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/callaghan- reviewreport071213.pdf, http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 56 68 http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.6_En.pdf 69 http://www.hse.gov.uk/pubns/web09.pdf p 22 70 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 18

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187 Appendix E: Country and Region Overviews training could be better coordinated71 and, following the Griffin review, the government’s inter-agency group that is reviewing staffing of high-containment laboratories will also address training issues.72 The House of Commons inquiry also reviewed the issue of vetting staff, noting that: “...security clearance for scientists working with dangerous pathogens is still not harmonised in the UK and for Home and EU staff or students security-vetting is not always a prerequisite for work with dangerous pathogens.”73 Those working in government laboratories are subject to government vetting programmes but standards in universities, Research Council institutes, and the private sector vary.74 The National Counter-Terrorism Security Office (NaCTSO) liaises with laboratories on security checks under ATCSA. The Foreign and Commonwealth Office (FCO) administers the Academic Technology Approval Scheme (ATAS),75 which was introduced November 2007 as a replacement for the Voluntary Vetting Scheme. It requires all non European Union (EU) students applying for certain postgraduate programmes at UK universities to receive an ATAS certificate specific to their course and place of study before they apply to enter the UK or extend their stay. ATAS covers a wide range of science and engineering Masters and Doctorate research programmes and a more limited number of taught Masters courses.76 According to Nature, the FCO had rejected 100 applications in the period up to November 2008, representing 0.5 percent of around 20,000 applications.77 There is limited publicly available information about the operation of ATAS. An internal FCO review concluded that ATAS is a useful contribution to security at modest cost but noted concerns that handling times for applications are taking significantly longer than the planned ten working day processing time. The review recommended that the FCO ATAS Unit should conduct a biannual review of subject coverage to coincide with UK universities’ own review.78 d) For regular oversight and re-certification? The requirement for notifying HSE under COSHH regulations does not automatically lead to an inspection but the information is used to inform inspections and HSE expect to inspect BSL-4 laboratories once a year and BSL-3 laboratories at least once every three years.79 However, the House of Commons inquiry observed that: “...we received evidence that inspections are often infrequent unless problems are reported and that the frequency should increase. Concerns have also been expressed that the HSE may not have sufficient resources, especially with the new burden envisaged by the Callaghan Review, to inspect sufficiently,...”80 Under SAPO, inspections may be carried out at any time to ensure compliance with the licence conditions. In April 2008 HSE took over from Defra as the lead inspector and regulator.81 Under GMO (CU) all activities in Class 4 or novel genetic modification activities are brought to the attention of the Scientific Advisory Committee for Genetic Modification (SACGM), which provides advice to HSE on the risk assessment that has been submitted. Site inspection may be required if novel 71 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 46 72 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/1111/1111.pdf p 15 73 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 46 74 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 47 75 http://www.fco.gov.uk/en/about-us/what-we-do/services-we-deliver/atas/. 76 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 61-62. 77 http://www.nature.com/news/2008/081107/full/news.2008.1211.html. 78 Communication with ATAS Unit, FCO, August 2009. 79 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 55. 80 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 20. 81 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 56.

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188 Biosecurity Challenges containment requirements are proposed. HSE issues consent for work to proceed once satisfied with the risk assessment and proposed containment measures.82 Under ATCSA, laboratories working with Schedule 5 agents must notify the Home Office and will then be visited by Counter Terrorism Security Advisors (CTSAs). Visits are used to assess physical security and make recommendations. CTSAs produce a written assessment including security advice, which is then provided to the laboratory. Any security improvements required are specific to the laboratory. Often advice is focused on personnel security and procedures with information about security checks and monitoring of staff. (Police can request the details of those with access to Schedule 5 materials if they have specific intelligence.) CTSAs visit registered laboratories once a year or more often if security improvements are required. As of July 2008 there had been issues at two sites, both related to a shortage of funds to improve security at university facilities.83 5 Have there been any BSL accidents in your country? a) If yes, how and why did accidents at high-containment facilities occur? Foot and mouth disease outbreak in Surrey, UK in August 2007 Pirbright is the site of an Institute for Animal Health (IAH) laboratory and the vaccine manufacturer Merial Animal Health Ltd. A company called Stabilitech that carried out work with FMDV in a laboratory within the IAH facility left the Pirbright site in 2008. The preliminary investigation of an outbreak of FMD in August 2007 indicated that the Pirbright site was the likely source.84 The Health and Safety Executive (HSE) was then tasked with investigating: “potential breaches of biosecurity at the Pirbright site; whether such breaches may have led to a release of any specified animal pathogen; whether any such breaches had been rectified to prevent future incidents.”85 The December 2007 report of the investigation concluded that wastewater containing live virus leaked out from the drainage pipes and contaminated the surrounding soil. The investigation found evidence of long term damage and leakage from the waste system, including cracked pipes, tree branches breaching pipes, and unsealed manholes. The virus is thought to have spread by vehicles and been exacerbated by mud and slurry due to heavy rainfall in July 2007.86 Merial were engaged in large-scale FMDV vaccine production and the waste from this process containing live virus was passed into the site drainage system along with smaller quantities from IAH and Stablitech operations, as permitted under the Defra licence. However, the investigators found that the condition of the site drainage system breached biosecurity for the site as a whole and did not meet requirements for BSL-4 containment. Ownership of the drainage system rests with IAH but the investigators found a difference in opinion between IAH and Merial over responsibility for maintenance of a key section of pipe. (Detailed information about the investigation can be found in the December 2007 report by the HSE, Final report on potential breaches of biosecurity at the Pirbright site 2007.)87 In addition to recommending a review of the regulatory framework for animal pathogens (see Section 2 and Section 5 (e)), HSE made specific recommendations to the site operators on: whether a high- containment laboratory could be sealed for fumigation; the testing of filters; the need to investigate whether liquid waste could be effectively sterilized; and improvements to the effluent drainage system.88 82 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 56. 83 http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.6_En.pdf & http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 56-57. 84 http://www.hse.gov.uk/news/archive/07aug/pirbright.pdf. 85 http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf. 86 http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf & http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.7_En.pdf. 87 http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf. 88 http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf & http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.7_En.pdf.

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189 Appendix E: Country and Region Overviews Another well-documented example from the UK is the Birmingham University Medical School smallpox outbreak in 1978. b) How, to whom and when are they reported? The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR)89 requires laboratories to report to HSE certain accidents and near misses involving high hazard biological agents90 that pose a risk to human health. It covers wild-type human pathogens, zoonotic pathogens, and genetically modified versions of these. RIDDOR requires reporting of infections due to work with live or dead humans or animals, exposure to body fluids, or any potentially infected material derived for any of these. A separate report is required for any release or escape of a biological agent likely to cause severe human disease (i.e., hazard group 3 or 4 biological agents or Class 3 or 4 GMMs). Infections that could have been acquired outside work are not reportable. The following types of accidents require reporting: • Accidents where the person dies, suffers major injury, or is absent or unable to work for more than three days; • Accidents where a person not at work suffers an injury and is taken to hospital; • A person suffering one of the specified work-related diseases; and • A “dangerous occurrence”, which may not necessarily result in injury but has potential to cause significant harm. These encompass any accident or incident that causes or could have caused the release of a biological agent that could cause severe human disease (i.e., hazard group 3 and 4 agents and certain hazard group 2 agents).91 Guidance on RIDDOR last updated in 2008 is provided by HSE: A guide to the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995.92 In addition to RIDDOR requirements for a given accident, there are requirements under GMO(CU)93 regulations to report certain accidents involving Genetically Modified Organisms (GMOs) to HSE, described as “... an accident involving a significant and unintended release of genetically modified organisms in the course of an activity involving genetic modification which presents an immediate or delayed hazard to human health or the environment.”94 Such accidents might include: • “the spillage of any Class 3 GMM outside of a microbiological safety cabinet (MSC) or other primary container; • a major spillage of a Class 3 GMM within a MSC; • the spillage of any Class 2 GMM outside of a MSC or other primary container, where it is thought likely that an individual or the environment could have been exposed during the spill or during decontamination; • the release or escape of a GMO, other than a GMM that could cause harm to human health, for example, by acting as a novel disease reservoir; • infection (classical) of a person with a (replication competent) GMM, as this constitutes a significant and unintended release.”95 After an accident notification, HSE is required to investigate and provide a report to the European Commission.96 89 http://www.hse.gov.uk/riddor/. 90 http://www.opsi.gov.uk/SI/si1995/Uksi_19953163_en_5.htm#sdiv3. 91 http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a-annex1.pdf. 92 http://www.hse.gov.uk/pubns/priced/l73.pdf . 93 https://www.hse.gov.uk/forms/genetic/index.htm. 94 https://www.hse.gov.uk/forms/genetic/cu3.pdf . 95 https://www.hse.gov.uk/forms/genetic/cu3.pdf. 96 http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a-annex1.pdf.

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190 Biosecurity Challenges HSE must also be notified of any accident while working with specified animal pathogens, which has or may have caused the release of a specified animal pathogen that could cause serious disease in susceptible animals. For any release into the environment, Defra should also be notified.97 c) Who has authority to investigate accidents? HSE has authority for investigating accidents. d) What disciplinary or legal actions can be taken? Under COSHH and GMO(CU) where significant breaches are identified, HSE, “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.”98 Under SAPO, if HSE inspectors identify non-compliance under the licence conditions they can recommend the license is amended, suspended, or revoked by Defra. Any prosecution would be undertaken by the relevant local authority, when alerted to non-compliance by inspectors.99 Under ATCSA, the police CTSAs can demand security requirements, and failure to comply with these is a criminal offence.100 e) Have any steps been taken to minimize BSL laboratory accidents? Following the HSE investigation of the Pirbright FMD outbreak,101 the government instigated a review of the safety of facilities handling FMDV, carried out by Professor Brian Spratt and published in August 2007, which highlighted a potential conflict of interest for Defra as regulator, licensor, and inspector of the facilities and also their major customer.102 Subsequently, the government asked Sir Bill Callaghan to carry out a “...review of the regulatory framework for handling animal pathogens and to make recommendations to Government for changes that would strengthen the regulation of animal pathogens.”103 In addition, the Prime Minster commissioned Dr Iain Anderson to lead an independent review of the lessons learned from the response to the 2007 outbreak.104 The Callaghan Review – accepted in full by the government – recommended a three-phase approach to changes leading towards a single regulatory framework (SRF) for human and animal pathogens.105 The recent status of the changes is summarised in a June 2009 HSE paper: “Phase 1, for HSE to formalise support to Defra and the Devolved Administrations for SAPO inspections, is now complete; Phase 2 saw changes made to the Specified Animal Pathogens Order (SAPO) to designate HSE as the inspection and enforcement body by means of Agency Agreements with Defra and the Devolved Administrations. These arrangements were implemented successfully and are working well. 97 http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a-annex1.pdf. 98 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 58. 99 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 58. 100 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 57. 101 http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf. 102 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/spratt_final.pdf. 103 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/callaghan- reviewreport071213.pdf. 104 http://webarchive.nationalarchives.gov.uk/20100807034701/http://archive.cabinetoffice.gov.uk/ fmdreview/. 105 http://archive.defra.gov.uk/foodfarm/farmanimal/diseases/atoz/fmd/documents/callaghan- reviewreport071213.pdf.

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191 Appendix E: Country and Region Overviews We are now working on the third and most complex phase of the project that will deliver: a. the SRF comprising a single set of regulations to govern work with human and animal pathogens based on a Legislative Reform Order (LRO) to provide HSE with the viruses to make regulations in relation to animal pathogens; b. a common set of containment measures based on advice from ACDP (HSE is leading the work); c. appropriate cost recovery and integrated notification systems.”106 These new regulations, to be introduced in 2012, are termed The Biological Agents and Genetically Modified Organisms (Contained Use) Regulations.107 They will replace will replace GMO(CU) and elements of COSHH and SAPO, and will be accompanied by guidance from ACDP, which is currently in draft form.108 Government evidence to the 2008 House of Commons inquiry provided some information on the inspection activity that followed the 2007 FMD outbreak: “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. The first phase of the Safety Alert inspection programme focused on CL4 facilities where work is undertaken with Hazard Group (HG) four dangerous pathogens, including both human and animal pathogens. 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 practices. 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.”109 Another issue raised in the 2008 House of Commons inquiry was a concern over under-investment in certain UK high-containment laboratories, noting: “We have observed at first hand the extent to which the quality of facilities can vary, even those designated CL4. Some of the UK’s facilities are world-class; for example the state- of-the-art facilities at the DSTL, Porton Down. In contrast, we found other facilities, at IAH Pirbright and at the HPA in Porton Down, to be in need of significant investment given their age...”110 In July 2009 the BBSRC and the government announced £100 million in funding to be allocated to the redevelopment of the IAH facilities at Pirbright.111 106 http://www.hse.gov.uk/aboutus/meetings/hseboard/2009/230609/p-jun-b09-57.pdf. 107 http://www.hse.gov.uk/aboutus/meetings/hseboard/2009/230609/p-jun-b09-57.pdf. 108 Draft CU2010: http://www.hse.gov.uk/aboutus/meetings/committees/acdp/080609/acdp-92-p13a- annex1.pdf. 109 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360ii.pdf Ev 54. 110 http://www.publications.parliament.uk/pa/cm200708/cmselect/cmdius/360/360i.pdf p 25. 111 http://www.bbsrc.ac.uk/news/archive/2009/090727-pr-100-million-boost-for-animal-health- research.aspx.

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192 Biosecurity Challenges f) Have any steps been taken to increase security at BSL facilities? In 2007 Schedule 5 of ATCSA was updated to include animal pathogens.112 In July 2008, the government noted plans to review Schedule 5 of ATCSA every two years to update the list of agents covered, and also to review whether any further changes should be made to primary and secondary legislation.113 Acknowledgements The Royal Society would like to thank the Advisory Group for reviewing this document: • Professor Keith Gull FRS, Wellcome Trust Principal Research Fellow, Sir William Dunn School of Pathology, University of Oxford • Dr John McCauley, Division of Virology, National Institute of Medical Research, Medical Research Council • Sir John Skehel FRS • Professor Geoffrey Smith FRS (Chair), Wellcome Principal Research Fellow and Head, Department of Virology, Imperial College London; and Chair, Royal Society Advisory Group on the Scientific Aspects of International Security (SAIS). • Professor Robin Weiss FRS, Professor of Viral Oncology, University College London. We would also like to thank Katie Wookey, intern at the Science Policy Centre in 2009, for conducting background research. Please send any comments to: Dr Filippa Lentzos, BIOS Centre, London School of Economics, Houghton Street, London WC2A 2AE, UK; e-mail: f.lentzos@lse.ac.uk. 112 http://www.opsi.gov.uk/si/si2007/uksi_20070926_en_1. 113 http://www.opbw.org/new_process/mx2008/BWC_MSP_2008_MX_WP.6_En.pdf.