Health and Safety Executive Developing measures to prevent, prepare for and respond to deliberate misuse and accidental release of biological agents Dr Paul Logan Head of Policy Hazardous Installations Directorate UK Health and Safety Executive (HSE) Biological Weapons Convention: meeting of Experts 23 – 27 August 2010
Biological Agents Unit, HSE • National inspection programme – 14 inspectors plus other specialists (e.g. C&I, process engineering) • Inspection of facilities – CL4 annually – CL3 every 3 years – CL2 risk-based • High Security Infectious Disease Units • National Network of Laboratories • Investigating incidents • Statutory notification schemes - review
Engagement with others Other Government Departments • NaCTSO – Counter Terrorism Security Advisers • Lightfoot Review – Schedule 5 ATCSA
Pirbright FMD outbreak • Outbreak of foot and mouth disease in Surrey declared on 3 August 2007 • Early indications that the source was a release from the nearby Pirbright site • Government asked HSE to lead an investigation into potential breaches of biosecurity • Established a cross-Government team, with input from key agencies • Focused investigation on outbreak strain O-1 BFS and narrow time-period identified by Defra epidemiologists
Pirbright FMD outbreak
Foot and Mouth Disease Virus • Exceptionally infectious • Affects cloven hoofed animals - cattle, pigs, deer • Inactivated by UV, desiccation below 60% RH, and pH < 6 or >9 • Transmission by aerosol or oral routes • Transmission through food, animal-to-animal contact, mechanical transmission
Foot and Mouth Outbreak 2001
Years Foot-and-Mouth Virus Is Known or Believed to Have Been Released from Laboratories • • 1960 United Kingdom 1978 United States • 1979 Spain • 1968 Denmark • 1987 Germany • 1969 Czechoslovakia • 1988 Germany • 1972 Hungary • 1993 Russia • 1974 Germany • 2007 United Kingdom • 1975 Czechoslovakia • 1976 Germany • 1977 Germany
Pirbright Site • Merial Animal Health Ltd – Manufacture FMDV vaccine, Blue Tongue Virus vaccine • Institute for Animal Health (IAH) – World Reference Centre for FMDV, BTV, RPV and ASFV – Research on FMDV and other exotic viruses – RPV, BTV, SVDV, ASFV, AHSV, etc.
Lines of Inquiry • Team began work on 5 August • Initial report published within 48 hours confirmed outbreak strain was in use at Pirbright by both IAH and Merial • Identified the following key lines of inquiry: – sequencing to pinpoint precise origin of virus – release by the airborne route – release by the human route – release by the waste route
Results of investigation • Unable to pinpoint precise origin, but definitely from the Pirbright site • No evidence of airborne release – No evidence of release within premises – Air filtration systems all tested • No evidence of human release • Main concern focussed on waste streams • Identified serious breaches in biosecurity
Key Breaches in Biosecurity • FMDV likely to have leaked into surrounding soil on site through damage to drainage pipes and unsealed manhole covers. The pipes were a key component of the containment level 4 facilities. The leakage and spread of virus is likely to have been exacerbated by heavy rain • Building work and movement of soil from around the drainage pipes was not adequately controlled • Inadequate records were kept of the movement of vehicles on and off the site, and biosecurity measures, such as wheel washing was not routinely used
Other contributing issues? • Historical lack of investment • Poor safety culture – no personal risk as organisms used on site were not human pathogens • Confusion over the appropriate level of containment • Insufficient validation procedures • Poor communication • Inappropriate regulatory system
Government response • Accepted all recommendations in HSE report http://www.hse.gov.uk/news/archive/07aug/finalreport.pdf • Carried out a review of the regulatory system – report December 2007 • Accepted the recommendations – development of a single regulatory framework (SRF) to cover work with human and animal pathogens and GM organisms • Risk-based approach • Site being redeveloped to provide new containment facilities
Take home messages • Valuable lessons learned in 2007 • Even in highly regulated states things can go awry • Preparation for a deliberate release event • Need for continual review of procedures
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