7 Sep 2007 01:08 PM
Publication of reports into Foot and Mouth outbreak in Surrey

DEPARTMENT FOR ENVIRONMENT, FOOD AND RURAL AFFAIRS News Release (News Release ref : 289/07) issued by The Government News Network on 7 September 2007

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
                                                - All level 4 premises
                                                will be inspected and 3s
                                                on risk basisSAPO licences
                                                - amended to make clear
                                                Review (including
                                                technical support) - will
                                                include consideration of
                                                appropriate enforcement
                                                standards for animal
       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
       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
       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
       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
       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

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