UK research facility fined by regulator for biohazard failings
02 May 2014
A world-renowned animal disease research facility in Surrey has been fined for shortcomings in the management of safety during experiments with cattle infected with the foot-and-mouth disease virus (FMDV). This follows two incidents at the Pirbright Institute in November 2012 and January 2013 in parts of a contained facility housing infected animals.
Neither incident resulted in the release of the livestock disease to the external environment, however, the shortcomings in control and non-compliance with licence conditions were considered serious enough to warrant legal action.
The Institute, which receives strategic funding from the Biotechnology and Biological Sciences Research Council, is regulated by the Health and Safety Executive (HSE) on behalf of Defra. It was prosecuted today (30 April) by HSE for breaching the Specified Animal Pathogens Order (SAPO) 2008 – the first time the legislation has ever been used.
City of London Magistrates’ Court heard the two incidents occurred when a ventilation system designed to create a negative pressure was operated in a different configuration from normal.
Ordinarily such a facility would be maintained at differential negative pressures to ensure that air containing FMDV would be drawn from clean areas into dirty ones before being filter-cleaned. FMDV could not escape airborne from the facility whilst the system was operated in this way.
Any changes to operating procedures at a facility of this kind have to be properly planned, assessed and agreed in advance with HSE and Defra, but that didn’t happen and protective measures were compromised. As a consequence, on both occasions the required level of negative air pressure was not maintained.
Crucially, on the first occasion there was no effective alarm system to warn staff working in the animal room about the loss of negative air pressure. This meant the existence of the November incident did not emerge until during the course of an investigation into the later January incident.
The court was told that the shortcomings did not result in the detected release of FMDV to the outside world, and that remaining safeguards were sufficient to ensure the risk of a serious event was avoided. However, the decision to prosecute had to be seen in the context that the Institute is required to maintain high levels of controls at all times because of the highly contagious nature of FMDV if released.
The Pirbright Institute, of Ash Road, Pirbright, Surrey, was fined a total of £22,350 and ordered to pay a further £50,000 in costs after pleading guilty to eight breaches of the Specified Animals Pathogens Order (SAPO) 2008.
Speaking after the hearing Dr Simon Warne, a Principal Specialist Inspector from HSE’s Biological Agents Unit, commented:
“At facilities where research is undertaken with foot-and-mouth disease virus it is imperative that control measures are applied in a rigorous way. In common with other sites that pose major or significant hazards, either to people or the environment, there needs to be protection in depth. This involves having a number of protective measures, with each one providing some degree of assurance in the event of other failures.
“Our investigation identified failings with the Pirbright Institute’s management arrangements and controls for undertaking a series of experiments with foot and mouth disease virus. Whilst the foot and mouth disease virus was not on these occasions released to the outside world because of the multiple levels of protective measures in place, the failings were still significant.
‘’The fact that the Pirbright Institute has today pleaded guilty to all eight offences demonstrates that they recognise the failings in their controls that existed at that time. HSE has and will continue to work closely with the Institute to ensure appropriate management arrangements and controls are in place to support its important research work.”
The Health and Safety Executive is Britain’s national regulator for workplace health and safety. It aims to reduce work-related death, injury and ill health. It does so through research, information and advice; promoting training; new or revised regulations and codes of practice; and working with local authority partners by inspection, investigation and enforcement. www.hse.gov.uk
The Pirbright Institute receives strategic funding from the Biotechnology and Biological Sciences Research Council. Animal pathogens are regulated by the Health and Safety Executive (HSE) on behalf of Defra. So in relation to SAPO 2008, HSE acts as Defra’s enforcement agent.
The eight SAPO 2008 breaches are outlined as follows:
When important adaptations were made to the mode of operation of the animal facility in order to undertake the experiment in November 2012, the risks were not properly reassessed and the new procedures not formally agreed and documented. (Breach of paragraph 9 of the ‘FMDV Minimum Standards’).
Prior to the experiment in November 2012, the Institute failed to prepare a standard operating procedure (SOP) to provide clear instructions to the engineers as to how they should manually control the ventilation system in the absence of the normal automated control. (Breach of paragraph 4 of the ‘FMDV Minimum Standards’).
During the experiment in November 2012, there was no alarm system to inform staff working in the animal room of a significant loss of negative air pressure. (Breach of paragraph 46 of the ‘FMDV Minimum Standards’).
A differential negative pressure of not less than 50 Pascals was not maintained during the experiment in November 2012. (Breach of licence condition 5.1.5).
Despite the problems that arose during the first experiment in November 2012, there was a further failure to undertake an adequate formal change control process prior to the second experiment in January 2013. (The breach of paragraph 9 of the ‘FMDV Minimum standards’ was repeated).
Prior to the experiment in January 2013, there was a failure to prepare an adequate SOP covering the procedures for operation of the ventilation system. (Repeat breach of paragraph 4 of the ‘FMDV Minimum Standards’).
An inadequate document regarding procedure for operation of the ventilation system was compiled in advance of the experiment in January 2013, but it was not sent to regulators (HSE and Defra) as it should have been 14 days in advance, and so the January experiment, like the November one, went ahead without notification to regulators of the fact of the experiment or of the inadequacy of the arrangements for it. (Breach of licence condition 6.2.3).
A differential negative pressure of not less than 50 Pascals was not maintained during the experiment in January 2013. (Repeat breach of licence condition 5.1.5 again).
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