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FMD: Recommendations from the reports

A summary of the recommendations from the reports into the outbreak can be found below:

Recommendations Response/Action
A) Spratt
1) If identifying the source of the virus is considered a priority, an independent consisting of international experts in the molecular epidemiology of FMD, and in RNA virus molecular evolution, should convene to consider whether additional virus sequencing, or the passage of candidate viruses through cattle, could establish with confidence which was the cause of the outbreak. There is uncertainty as to whether any further work could conclusively identify the source of the virus. At present we do not believe that it would add to our understanding of the risk mitigation measures that need to be 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 Category 4 pathogens should require all visitors to sign in, obtain a numbered visitor pass, be escorted into the building and handed over to their host. Visitors (including all contractors) must be informed of the animal quarantine requirements and sign (and be given a copy of) a form accepting that these are understood. For all visitors, including contractors, requirements to prevent inadvertent infection of livestock should be based on an assessment of the risk of exposure to pathogens. Accept.

Improvement plans

Safety Alert has been issued to establishments handling hazard groups 3 & 4 human and animal pathogens drawing attention to issues arising from HSE investigation. HSE/Defra inspectors will inspect all containment level 4 facilities and level 3 facilities based on risk.

Regulatory Review, 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 fencing to separate their two facilities, with swipe card entrances through the fencing between sites for those authorised to move between the facilities. Agree

IAH and Merial have committed to implementing this.
4) The responsibilities of the Site Director and Biological Safety Officer of Merial should be clearly separated. The BSO should not be subject to commercial pressures on matters of biosafety and biosecurity. Agree.

Merial is committed to implementing this.
5) IAH should have a thorough review of the safety of all laboratory activities to ensure the procedures which could release infectious FMDV into the containment labs are eliminated. This is particularly important for aerosol-producing procedures. Agree.

IAH to conduct review of safety management procedures for all pathogens led by independent person with BBSRC to assist in undertaking the review and applying its findings.
6) Defra and the Veterinary Medicines Directorate (VMD) should work together more closely and exchange information about inspections at Merial. One of the two regulatory authorities should take the responsibility for ensuring that all aspects of biocontainment and biosafety are thoroughly inspected. Accept.

Defra and VMD will ensure the exchange of all reports and information about Good Manufacturing Practice and SAPO Inspections is shared.

Regulatory Review 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 and Merial should institute regular meetings to improve communications and their understanding of the risks on the Pirbright site, particularly those that arise from the sharing of the effluent system. Agree.

IAH and Merial have committed to implementing this.
8) As a matter of urgency, Defra should require that actions are taken to ensure the effluent drainage system at the Pirbright facility is fully contained and its continuing integrity confirmed by regular inspections. In the interim, we advise that work with infectious virus should only be allowed if effluent released into the pipes has first been completely inactivated. Accept: existing drain has been relined and manhole covers sealed pending construction of the new effluent system

Improvement plan.

Safety Alert – issued jointly with HSE to all level 3 & 4 and SAPO 3&4 licence holders reminding them of their responsibilities.

Inspection – All level 4 premises will be inspected and 3s on risk basis

SAPO licenses – 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 it plans to modify its procedures to minimise the possibility of release of infectious FMDV virus into the effluent pipe. Any new process should be validated. Accept.

Merial will not be able to work with live virus until they can ensure that all waste potentially containing live virus is sterilised within a high containment area.
10) The plans for future development of the Pirbright site should be reviewed to ensure that all safety critical issues have been addressed. This should be carried out with the help of the full of relevant experts and regulatory bodies. Accept.

BBSRC will review all aspects of the Pirbright site so as to ensure that all safety critical issues have been addressed
11) The construction of the new high containment laboratories at IAH should go ahead as a matter of urgency. Such facilities are expensive to construct and maintain and Government must ensure that adequate funds continue to be available to enable the highest standards of biological safety for dealing with FMDV and other high risk viruses. In the meantime, investment to ensure safety and public trust in the existing laboratories and the effluent system is needed. Accept.

Government already committed to funding new laboratory at Pirbright: have spent £31m out of estimated total of £121m. At all stages of design, biosecurity aspects have been given the highest priority.
12) Biosecurity of laboratories that work with FMDV is of paramount importance. Therefore there should be a review of funding, governance and risk management at IAH Pirbright to ensure an appropriate focus on biosafety and biosecurity in the future. Agree.

A review body lead by BBSRC in conjunction with the IAH Governing Body, supported by Defra and with a representative of the farming community will review funding governance and risk management at Pirbright.
13) There should be shared governance for the management of risks to biosecurity and biosafety involving both IAH and Merial. The two facilities should ensure complete clarity of responsibility and liability for the biosafety and biosecurity of the whole site. Agree.

IAH and Merial have committed to implementing this.
14) There should be a review of systems for regulation, inspection and enforcement of biosecurity for work on animal and human pathogens at containment level 4. This should consider whether there should be a common regulatory inspection framework overseen by an arm's length body such as the HSE. Accept.

The terms of reference for the review of the regulatory framework (see HSE 1) will address issue about position of Defra as regulator, licensor and inspector of SAPO 4 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 standards of containment for animal pathogens should be clearly documented to facilitate the regulatory process and that a review is completed to contrast the actual regulatory position for animal pathogens with human pathogens to make sure the position is justified Accept.

Defra is commissioning Regulatory Review, under Bill Callaghan, of the current regulatory framework which will include comparison of regulation of animal and 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 for setting and monitoring safe operating practices where work is subcontracted under a single operating SAPO licence with responsibilities clearly defined between the licence holder and the subcontractor. Accept.

To be examined as part of the regulatory review (see above).

ACDP will advise on this matter as part of the Regulatory Review.
3) We have concerns about the suitability of the 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 and we recommend remedial work be carried out at this facility Accept.

Defra amended IAH’s SAPO licence on 21 August to stop all live virus work in the main laboratory in the upper south wing. IAH to undertake necessary remedial work to be inspected by Defra before the suspension will be lifted.
4) We have concerns about the filter arrangements throughout the IAH/Stabilitech facility where banks of HEPA filters are tested as a single unit leading to possible undetected failures. We recommend consideration be given to changing the citing and testing arrangements. Accept.

Defra has discussed with HSE.

The filter arrangement provides double HEPA filtration as required and so meets the standard – though it is difficult to validate. The 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 appropriateness of chemical treatment for sterilising liquid waste containing SAPO category 4 pathogens. It is our experience that chemical treatments, while reducing the amount of pathogen in the liquid, may not render the liquid completely pathogen-free. Accept.

Defra will require IAH and Merial to make arrangements which ensure that all such waste is sterilised within a high containment area.
6) We recommend the effluent drainage system on the Pirbright site is improved to ensure high level SAPO requirements are met. In addition we also recommend better record keeping, maintenance and monitoring regimes in relation to the effluent drainage system. Accept.

Existing drain has been relined and manhole covers sealed pending construction of the new effluent system.

Merial will not be able to work 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 vehicle and human movement on the IAH site. Accept.

Improvement Plan will prescribe action to be taken on this, which will be subject to inspections involving HSE input.

 

Page last modified: 14 January, 2008 13:15

Department for Environment, Food and Rural Affairs