Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories Summary of a Workshop (2012) / Chapter Skim
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E8: United Kingdom
E8: United Kingdom
Pages 175-192
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From page 175... ...
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?
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From page 176... ...
, although only four actually operate at this level, and three at BSL-4 for animal pathogens (SAPO4)
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From page 177... ...
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)
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From page 178... ...
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)
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From page 179... ...
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.
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From page 180... ...
. 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.
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From page 181... ...
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.
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From page 182... ...
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.
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From page 183... ...
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.
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From page 184... ...
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.
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From page 185... ...
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]
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From page 186... ...
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)
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From page 187... ...
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.
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From page 188... ...
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.
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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)
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From page 190... ...
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)
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From page 191... ...
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.
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From page 192... ...
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)
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