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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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