Department for Environment, Food and Rural Affairs
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Publication of reports into Foot and Mouth outbreak in Surrey
Defra has today published reports from the Health and Safety Executive and Professor Brian Spratt, of Imperial College London, into the recent outbreak of Foot and Mouth Disease in Surrey.
Alongside these reports, Defra has also published the Government's response which accepts, in full, the recommendations made in both reports.
In particular, Defra is taking the following steps:
* Put in place new requirements for IAH and Merial to ensure that all waste is sterilised within a high containment area;
* Establish improvement plans setting out the action which both IAH and Merial must take, which will be subject to inspections;
* Revise guidance and licence conditions on access to restricted sites;
* Require other relevant laboratories, through HSE and Defra safety alerts, to satisfy themselves that their own facilities and procedures address all the issues identified in these reports;
* Establish a review of the regulatory framework for animal pathogens led by Sir Bill Callaghan, which will also address the position of Defra as regulator, licensor and inspector of SAPO 4 regulation and as a major customer of animal pathogens research and diagnostics;
* A review of funding, governance and risk management at the Pirbright site.
Hilary Benn, Secretary of State for Environment, Food and Rural Affairs said:
"The thorough and detailed work carried out by the HSE and by Professor Spratt shows that there is no absolute certainty about how the outbreak occurred and no one single factor can account for it.
"Even in these extraordinary circumstances, this should not have happened and must not happen again. That is why we are taking every possible precaution to prevent this from happening again.
"Everyone who is involved - the management and staff of the IAH and Merial, Defra as the licensing authority and regulator, and the BBSRC as the owners of the Pirbright site and sponsors of IAH - must take careful note of the conclusions of these reports, and act swiftly to put right every weakness that has been identified."
A full summary of the Government's response to the recommendations from both reports can be found below.
Defra has today also published a further epidemiological report into the outbreak in Surrey.
The Chief Veterinary Officer, Debby Reynolds, today announced that she was satisfied that Foot and Mouth Disease had now been eradicated from Surrey.
Following the completion of the clinical inspection of livestock within the Surveillance Zone (SZ), and the results of the blood samples which have all proved negative, the 10km SZ around the Infected Premises in Surrey will be lifted at noon on Saturday 8 September. This is the earliest that this can be done under European disease legislation.
The restrictions outside the Surveillance Zone, will be lifted at the same time. This includes the 20-day standstill for livestock following movement and additional controls on livestock market and shows.
Notes to Editors:
1. The HSE report, the independent report from Professor Spratt of Imperial College, Defra's epidemiology report and the full Government response are available at: http://www.defra.gov.uk/animalh/diseases/fmd/investigations/
2. For further information on Foot and Mouth Disease and the current situation please visit: http://www.defra.gov.uk/footandmouth
3. The full Government response can be viewed here: http://www.defra.gov.uk/animalh/diseases/fmd/investigations/ A summary of the recommendations from the reports can be found below:
Recommendations Response/Action A) Spratt 1) If identifying the source of the There is uncertainty as to virus is considered a priority, an whether any further work independent consisting of international could conclusively experts in the molecular epidemiology of identify the source of the FMD, and in RNA virus molecular virus. At present we do evolution, should convene to consider not believe that it would whether additional virus sequencing, or add to our understanding the passage of candidate viruses through of the risk mitigation cattle, could establish with confidence measures that need to be which was the cause of the outbreak. put in place as a result of the Pirbright escape but we will keep that assessment under review. 2) Entry to any facility handling SAPO Accept. Improvement Category 4 pathogens should require all plansSafety Alert has been visitors to sign in, obtain a numbered issued to establishments visitor pass, be escorted into the handling hazard groups 3 & building and handed over to their host. 4 human and animal Visitors (including all contractors) pathogens drawing must be informed of the animal attention to issues quarantine requirements and sign (and be arising from HSE given a copy of) a form accepting that investigation. HSE/Defra these are understood. For all visitors, inspectors will inspect including contractors, requirements to all containment level 4 prevent inadvertent infection of facilities and level 3 livestock should be based on an facilities based on assessment of the risk of exposure to risk.Regulatory Review, pathogens. under independent chair (Sir Bill Callaghan) to examine ways of simplifying and strengthening the regulatory framework for animal pathogens. Will include consideration of appropriate enforcement standards. (See also HSE Rec 1). Membership of the review team will include a representative from the farming community. 3) IAH and Merial should erect secure Agree IAH and Merial have fencing to separate their two committed to implementing facilities, with swipe card entrances this. through the fencing between sites for those authorised to move between the facilities. 4) The responsibilities of the Site Agree.Merial is committed Director and Biological Safety Officer to implementing this. of Merial should be clearly separated. The BSO should not be subject to commercial pressures on matters of biosafety and biosecurity. 5) IAH should have a thorough review of Agree IAH to conduct the safety of all laboratory activities review of safety to ensure the procedures which could management procedures for release infectious FMDV into the all pathogens led by containment labs are eliminated. This is independent person with particularly important for BBSRC to assist in aerosol-producing procedures. undertaking the review and applying its findings. 6) Defra and the Veterinary Medicines Accept.Defra and VMD will Directorate (VMD) should work together ensure the exchange of all more closely and exchange information reports and information about inspections at Merial. One of the about Good Manufacturing two regulatory authorities should take Practice and SAPO the responsibility for ensuring that all Inspections is aspects of biocontainment and biosafety shared.Regulatory Review are thoroughly inspected. will include examination of how SAPO inspections are undertaken and how they relate to other inspection regimes including those undertaken by VMD. 7) The biological safety officers of IAH Agree.IAH and Merial have and Merial should institute regular committed to implementing meetings to improve communications and this. their understanding of the risks on the Pirbright site, particularly those that arise from the sharing of the effluent system. 8) As a matter of urgency, Defra should Accept: existing drain has require that actions are taken to ensure been relined and manhole the effluent drainage system at the covers sealed pending Pirbright facility is fully contained construction of the new and its continuing integrity confirmed effluent systemImprovement by regular inspections. In the interim, plan.Safety Alert - issued we advise that work with infectious jointly with HSE to all virus should only be allowed if effluent level 3 & 4 and SAPO 3&4 released into the pipes has first been licence holders reminding completely inactivated. them of their responsibilities.Inspection - All level 4 premises will be inspected and 3s on risk basisSAPO licences - amended to make clear responsibilities.Regulatory Review (including technical support) - will include consideration of appropriate enforcement standards for animal pathogens 9) Merial should discuss with Defra how Accept.Merial will not be it plans to modify its procedures to able to work with live minimise the possibility of release of virus until they can infectious FMDV virus into the effluent ensure that all waste pipe. Any new process should be potentially containing validated. live virus is sterilised within a high containment area. 10) The plans for future development of Accept.BBSRC will review the Pirbright site should be reviewed to all aspects of the ensure that all safety critical issues Pirbright site so as to have been addressed. This should be ensure that all safety carried out with the help of the full of critical issues have been relevant experts and regulatory bodies. addressed 11) The construction of the new high Accept.Government already containment laboratories at IAH should committed to funding new go ahead as a matter of urgency. Such laboratory at Pirbright: facilities are expensive to construct have spent £31m out of and maintain and Government must ensure estimated total of £121m. that adequate funds continue to be At all stages of design, available to enable the highest biosecurity aspects have standards of biological safety for been given the highest dealing with FMDV and other high risk priority. viruses. In the meantime, investment to ensure safety and public trust in the existing laboratories and the effluent system is needed. 12) Biosecurity of laboratories that Agree.A review body lead work with FMDV is of paramount by BBSRC in conjunction importance. Therefore there should be a with the IAH Governing review of funding, governance and risk Body, supported by Defra management at IAH Pirbright to ensure an and with a representative appropriate focus on biosafety and of the farming community biosecurity in the future. will review funding governance and risk management at Pirbright. 13) There should be shared governance Agree.IAH and Merial have for the management of risks to committed to implementing biosecurity and biosafety involving both this. IAH and Merial. The two facilities should ensure complete clarity of responsibility and liability for the biosafety and biosecurity of the whole site. 14) There should be a review of systems Accept.The terms of for regulation, inspection and reference for the review enforcement of biosecurity for work on of the regulatory animal and human pathogens at framework (see HSE 1) will containment level 4. This should address issue about consider whether there should be a position of Defra as common regulatory inspection framework regulator, licensor and overseen by an arm's length body such as inspector of SAPO 4 the HSE. regulation and as a major customer of animal pathogens research and diagnostics. B) HSE (para 18 pages 7- 8 of Report) 1) We recommend that the required Accept.Defra is standards of containment for animal commissioning Regulatory pathogens should be clearly documented Review, under Bill to facilitate the regulatory process and Callaghan, of the current that a review is completed to contrast regulatory framework which the actual regulatory position for will include comparison of animal pathogens with human pathogens to regulation of animal and make sure the position is justified human pathogens and consider whether the differences are justified and what improvements might be made. Review team to include Defra and HSE and a member of the farming community. ACDP to advise the review team on technical matters. 2) We recommend review of arrangements Accept.To be examined as for setting and monitoring safe part of the regulatory operating practices where work is review (see above). ACDP subcontracted under a single operating will advise on this matter SAPO licence with responsibilities as part of the Regulatory clearly defined between the licence Review. holder and the subcontractor. 3) We have concerns about the Accept. Defra amended suitability of the continued use of the IAH's SAPO licence on 21 upper south wing of the IAH laboratory August to stop all live which is also used by Stabilitech for virus work in the main high containment work. In our view, it laboratory in the upper does not meet the requirement for SAPO 4 south wing. IAH to and we recommend remedial work be undertake necessary carried out at this facility remedial work to be inspected by Defra before the suspension will be lifted. 4) We have concerns about the filter Accept.Defra has discussed arrangements throughout the with HSE. The filter IAH/Stabilitech facility where banks of arrangement provides HEPA filters are tested as a single unit double HEPA filtration as leading to possible undetected failures. required and so meets the We recommend consideration be given to standard - though it is changing the citing and testing difficult to validate. The arrangements. HSE report says (para 105) Despite the factors outlined above, there is no indication that the building lost negative pressure. And/or that there was a failure in the air filtering system. "HSE have confirmed that they are content that live virus work continues in the main laboratory but have suggested that frequency of testing should be increased as an interim measure while IAH investigates what arrangements can be made to allow independent testing of the filters. Defra is taking forward with IAH 5) We recommend review of the Accept.Defra will require appropriateness of chemical treatment IAH and Merial to make for sterilising liquid waste containing arrangements which ensure SAPO category 4 pathogens. It is our that all such waste is experience that chemical treatments, sterilised within a high while reducing the amount of pathogen in containment area. the liquid, may not render the liquid completely pathogen-free. 6) We recommend the effluent drainage Accept.Existing drain has system on the Pirbright site is improved been relined and manhole to ensure high level SAPO requirements covers sealed pending are met. In addition we also recommend construction of the new better record keeping, maintenance and effluent system.Merial monitoring regimes in relation to the will not be able to work effluent drainage system. with live virus until they can ensure that all waste potentially containing live virus is sterilised within a high containment area. 7) We recommend tighter controls of Accept.Improvement Plan vehicle and human movement on the IAH will prescribe action to site. be taken on this, which will be subject to inspections involving HSE input.
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