On the publishing of the reports into the Surrey outbreak of FMD in August 2007
The reports
.................
September 11 ~ "IAH and its Governing Body are reassured that the investigations found no evidence that the Institute's laboratories are the source of the leak or that virus escaped from the Institute's laboratories, - and considered both to be unlikely."
IAH's brief statement in response to the recent reports can be found at www.iah.bbsrc.ac.uk. Extract:
" In the scenario suggested by the investigators to be the most likely cause of the outbreak, live virus has somehow entered the drains. This clearly means that all future biosecurity measures must take greater account of the integrity of the drains than hitherto. Following agreement with Defra and Merial, work on the Pirbright site has already begun to address this, including the completion of protective lining to the drains including the one implicated in the reports, and sealing of manhole covers. .."
Merial, on the other hand, after saying that no biosecurity breach was found by the reports at its own more modern and well equipped site, makes no mention of the problems with virus disposal. The statement concentrates, not surprisingly, on the following:"Merial's FMD and bluetongue work at its Pirbright centre enables governments and farmers around the world to combat these potentially devastating diseases. As such, in consultation with the appropriate authorities, we look forward to returning to full production."
See Merial statement . There were undoubtedly minor breaches of biosecurity at the IAH site as a result of years of underfunding. Merial's facilities were found to be good and the work done there is vital and urgently needed - but leakage of virus because of an unsatisfactory system of disposal almost certainly originated at Merial rather than at the IAH site. However, problems at the IAH site have, at last, been brought under the spotlight. Adequate funding for Pirbright must surely be forthcoming now so that the concerns mentioned in the reports can be properly addressed. It is vital that any level 4 containment lab should be the opposite of shabby, that morale should be high and that the best and most competent minds should be attracted there. The fact that IAH Pirbright deals with animal rather than human disease makes it no less important in its job of protecting the country and we need the very best expertise there that the country can afford.September 10 ~ Defra also comes in for heavy criticism in its role as regulator, licenser and inspector
Alistair Driver in the Farmers Guardian ....."HSE chief executive Geoffrey Podger said inspectors found the IAH had been 'complacent' about biosecurity on the site. The Spratt report referred to the 'poor state' of the IAH facilities and suggested adequate funding had not been made available for to improve safety work at the 'ageing facility'.
Defra also comes in for heavy criticism in its role as regulator, licenser and inspector of the Pirbright site. Questions it now faces include why it allowed live virus to be deposited into drains, how it allowed the dispute between Merial and IAH to prevent necessary improvements to the drainage system taking place for four years and how its inspectors failed to spot the problems with the drainage system. ..."September 9/10 2007 ~ What was the work being done by Stabilitech at the time of the escaped 01 BFS1860 strain of foot and mouth virus?
(Warmwell paragraph on Stabilitech here) We read in the HSE report:
"Two Stabilitech researchers were involved in freeze-drying cultures of the O1 BFS strain in a laboratory within the main IAH facility. Freeze-driers are a known source of aerosol...the equipment did not have an in-line filter for vented gases, however, the line did pass through an oil sump before discharge into the room. ."
Although the reports found no evidence of possible aerosol release in July they do not absoutely rule it out. In the 1960 outbreak at Pirbright, one farm 1.5Km away was infected by aerosol release via the ventilation system from infected animals in the Pirbright animal house. No exhaust air filtration system had been in place in 1960 but after that incident filtration units were installed in the vaccine production unit and animal compounds and later in all buildings where live virus was handled. The HSE report said,"We have concerns about the suitability of continued use of the upper south wing of the IAH laboratory, which is also used by Stabilitech for high containment work. In our view, it does not meet the requirement for SAPO 4( Category 4 Specified Animal Pathogens Order 1998) and we recommend that remedial work be carried out at the facility.
We have concerns about filter arrangements throughout the IAH/Stabilitech facility where banks of HEPA filters are tested as a single unit leading to possible undetected failures..."September 9th 2007 ~"Gordon Brown is the person ultimately responsible for the FMD outbreak."
writes Roger Sainsbury, ex DVO (bTb), Animal Health, Truro
"As the Chancellor, it was himself who restricted the cash available to all government departments, and that included the wholly government owned subsidiary of the IAH at Pirbright. So, the priorities changed. Instead of looking after the public interest first, control of the budget took priority.
(Dr Sainsbury is a founder member of the Society of Veterinary Epidemiologists, with over 30 years experience within the State Veterinary Service , now rebranded Animal Health. Read in full)
Now, public interest is really important - it's a phrase that seems to have gone out of fashion. It is readily forgotten that the food supply to the people of the UK is actually really important... and it is only available if other countries have surpluses to export - which could be a problem waiting in the wings.
... When I visited Pirbright a few years ago - to learn about notifiable disease - the whole culture of the place was biosecurity. It is so sad that they will get the blame when they are not really the real villains of the piece. They are totally committed to dealing with these dreadful diseases whever they are found in the world. Can't we place the blame where it should really be?"September 8th 2007 ~ Journalism turns speculation into "confirmation"
Although both the HSE and Spratt reports were careful to use words such as "likely", "could have" and "might have", and to avoid apportioning blame, for some journalists doubt must never be allowed to weaken dramatic impact. At least the BBC uses single quotation marks around its headline Leaking drains 'caused outbreak' but, in their official looking map, wrongly call Hunts Hill farm the "second infected farm" , whereas actually it was the SOS farm whose 362 animals were slaughtered even though all were healthy - to the grief of their owner.
The Scotsman appears to be in no doubt about its 'facts': "... the outbreak was caused by cracked pipes belonging to the Institute for Animal Health (IAH) in Pirbright, Surrey. The original source of the virus was Merial Animal Health..... nearby building work had allowed it to spread."
We read in the Telegraph that " It has been confirmed that the virus spilled from leaky pipes at the Defra facility at Pirbright." This is London talks of a "drain - which carries virus-contaminated waste".
The Daily Mail finds much to dramatise:"....Unforgivably, the Government knew about problems with the pipe and drains but did nothing about them, even though the risks were glaringly obvious. And why not? The answer is truly breathtaking. It all comes down to a petty dispute between the IAH and the American firm Merial, which shares the site, over who should pay."
The Guardian, in its snipe at DEFRA today, talks of "an invisible curse that can scythe through the rural economy on a building worker's boot" - but it does at least refrain from assuming guilt at Merial:"Fault, it seems, does not necessarily lie with the pharmaceutical company Merial, which has a plant at Pirbright, the source of the outbreak, and was initially seen as the most likely culprit. There is a chance that the crucial errors were instead made by the Department for Environment, Food and Rural Affairs' own Institute of Animal Health - where there was found to be less appreciation of risk, and where investments deemed necessary by a 2002 review had received only a slow drip of funding. The conclusions make it harder for ministers to convince when they pledge, as they did yesterday, to make sure the same sort of thing will not happen again."
And one can only hope that one good thing to come from this accident - the source of which has not been definitively explained - may be that the 'slow drip of funding' for animal health soon becomes the urgently needed flow. The UK's "wait and hope" approach to animal disease control needs the input of experts who actually understand how disease is best controlled and who can deliver the tools. Zoonoses threaten everyone and a joined-up approach to disease control is vitally needed even when diseases like FMD and Bluetongue seem not to affect human health. We are all, in various ways, affected.September 7 2007 ~ "exact origin of virus" - a further "critical experiment" would involve infecting a number of cows at Pirbright with foot and mouth.
The HSE report: "..due to very small differences in the strains used at all three organisations at Pirbright, it has not been possible to pinpoint precisely through sequencing the exact origin of virus found in the infected animals at Normandy."
However, the Spratt report ( Annex 4 Analysis of the sequences of the O1 BFS viruses) points out that the Merial virus (MER) that was sequenced was from their vaccine seed stock. But if the farms were infected because of Merial, it was most likely to have been virus from one of the 6,000 litre batches - not the seed stock virus that was sequenced. And " virus samples from the 6,000 litre batches were not available for sequencing as inactivation with BEI had taken place".
The Spratt report, noting that the sequencing gave inconclusive results, recommends that "several further studies are needed to try and increase the confidence in conclusions that might be drawn from them" The report suggests that the most critical experiment would be to use IAH-M (the Institute strain sequenced) virus to infect a number of cattle" If the unique non-synonymous substitution present in IAH-M is never seen to revert to the consensus in cattle it indicates that there is not strong selection for this to occur. This would considerably strengthen the view that the reversion of this residue (which is required for IAH-M to be the outbreak virus) is a very unlikely event, and would make the Merial virus more likely to be the source of the outbreak. ..."
There may be those who question whether such an experiment involving infected cattle is desirable - particularly before improved "funding, governance and risk management" take place at the Pirbright site - and especially since "given the near identity of the IAH-M and MER viruses, even with additional studies it may well not be possible to identify the source of the outbreak with a high degree of certainty". Ruth Watkins says, "I rather hope they will not do experiments on cows that will result in their death when the answer is only relevant to a court of law and probably won't be incontrovertible and unequivocal proof. There is no intrinsic scientific merit on the experiment." We agree.
Responsibility for safety, in the future, should be clearly delineated between the research and the commercial parts of the site and with decent funding we hope never to hear again of such things as " critical state-of-the art diagnostics undertaken by PhD students at the very beginning of their research training - and not by experienced technical staff."September 7 2007 ~ "..potential loss of public trust in a government laboratory due to incidents that are beyond their control "
" It is not for the Review Group to apportion blame for the accidental release of FMDV"says the Spratt report, "but the relationship between IAH and Merial brings risks to both parties. These include the responsibility of what is essentially a government laboratory for elements of the biocontainment risks of a commercial company, the impact of a safety breakdown at one facility preventing work at the other, and the potential loss of public trust in a government laboratory due to incidents that are beyond their control. In future we believe that these risks should be avoided by each facility at Pirbright being entirely responsible for all aspects of their own safety."
September 7 2007 ~"...adequate funding has not been available to ensure the highest standards of safety for the work on FMDV" Spratt report
"A review of funding, governance and risk management at the Pirbright site" is the sixth and last step that DEFRA says it will undertake as a response to the reports. (See news release) DEFRA's response to the reommendations can be seen here. Professor Spratt's investigation revealed that
"The poor state of the IAH laboratories, and the effluent pipes, indicates that adequate funding has not been available to ensure the highest standards of safety for the work on FMDV carried out at this ageing facility.
Adequate funding to ensure the safety of the important work on FMDV at IAH must be put in place until the new high containment laboratories are completed around 2012.
...There was evidence of a lack of urgency and ownership of risk at all levels, resulting in the failure to take appropriate decisions on the funding for essential improvements in safety critical infrastructure. This was particularly documented in the series of letters and reports from the biological safety officer of IAH in his attempts over four years to get agreement on funding for the replacement of the effluent pipes....Biosecurity of laboratories that work with FMDV is of paramount importance..."September 7 2007 ~ HSE final report on 'potential breaches of biosecurity at the Pirbright site' No definite evidence but...
From the HSE report:
"....We judge it likely that waste water containing the live virus strain, having entered the drainage pipework, then leaked out and contaminated the surrounding soil. We also believe that excessive rainfall may have exacerbated the potential release from the drain..."
As we thought, no trace of live virus was definitively taken from the suspect pipe - and our questions below remain - for the time being at least - unanswered.
".......We worked with the Environment Agency to devise a strategy for taking soil samples from around manhole covers around the effluent drainage system and commissioned scientists from CSL to undertake testing to see whether traces of FMDV could be detected in the soil samples. ...... The work was carried out in a laboratory at IAH. The results were inconclusive......We have no direct evidence that there was an overflow from manhole FM1 releasing the O1 BFS strain over the period covered by our investigation... We found no evidence that the procedures and processes for undertaking preliminary chemical treatment at Merial were not undertaken according to Defra requirements........We consider it unlikely that aerosols containing the O1 BFS strain were released from the site's effluent drainage system during the period covered by our investigation.."September 7 2007 ~ The reports published today
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