Department for Environment, Food and Rural Affairs
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Publication of Callaghan Review
Sir Bill Callaghan has today published his review of the regulatory framework for handling of animal pathogens in the United Kingdom.
The Review, commissioned by the Secretary of State Hilary Benn, was asked to take forward recommendations made by the Health and Safety Executive (HSE) in their report on biosecurity at the Pirbright site in 2007, and Professor Spratt's review of safety of UK facilities handling FMD virus. In particular Sir Bill Callaghan was asked to consider:
* Any changes needed to clarify and strengthen the regulatory
framework for animal pathogens, to bring it in line with those for
human pathogens;
* Any steps needed to ensure independence and
clarity on the separate roles and responsibilities of funders,
regulators, customers and the institutions themselves; and
*
Any steps needed to provide clearer lines of accountability,
inspection protocols and responses to non compliance.
The Callaghan Review recommends a three-phased approach to implement a number of changes to strengthen this regulatory framework in the UK.
The main change would be to move to a model where use of both animal and human pathogens is governed by a single regulatory framework, with Defra passing the responsibility for regulation of these pathogens to the HSE, as a single, independent body with the appropriate expertise and experience in the field.
Secretary of State for the Environment, Hilary Benn, said:
"I fully accept all the recommendations made by Sir Bill Callaghan in this review. In particular, I agree that Defra should not continue as regulator of laboratories handling of animal pathogens. This is because of the clear need to have a single independent regulatory body.
"I very much welcome this report and am grateful to Sir Bill for this thorough investigation."
Hilary Benn has made a Written Ministerial Statement to the House
today on the Callaghan Review and this can be viewed in full here:
http://www.defra.gov.uk/corporate/ministers/statements/
Notes to editors
1. The Callaghan Review is available at: http://www.defra.gov.ukanimal/diseases/fmd/investigation
2. For further information on Foot and Mouth Disease and the current situation please visit: http://www.defra.gov.uk/footandmouth
3. The HSE report, the independent report from Professor Spratt
of Imperial College and the full Government response to these
reports can be found here:
http://www.defra.gov.uk/animalh/diseases/fmd/investigations
4. A summary of the recommendations from this Review can be found below:
Recommendation Government Response
We recommend that consideration Accept-The requirement for a duty
is given to extending the duty to co-operate, between different
to co-operate in any new occupiers on the same site, will
regulatory framework for be extended to all sites,
handling dangerous pathogens. including those which use animal
pathogens, under the proposed
single regulatory framework (stage
3).
We recommend that Defra, DH, Accept-Defra agree that this is in
HSE and other interested keeping with the Hampton
parties work together to principles of inspection and
develop a single regulatory enforcement, and is in line with
framework to govern work with Government policy to simplify
human and animal pathogens. regulation. Work has started to
analyse how this will be taken
forward.
We recommend that Defra, DH, Accept-Government policy is to
HSE and other interested recover costs for services
parties work towards the wherever possible. Defra will work
introduction of cost recovery with DH, HSE and other interested
in any new regulatory parties to recover costs in this
framework. area.
We recommend that risk Accept-The containment level
assessment be a key element of currently sets the main risk
the regulatory framework for level. Under phase 3 of the
handling animal pathogens, as proposed approach to the changes,
it currently is for human Risk Assessment will be the
pathogens and genetically fundamental principle that governs
modified organisms. the new single regulatory
framework. We acknowledge that it
puts an onus on the person
applying to do work to make a full
assessment of the risks and
present to the regulator any
mitigation measures. This would
also provide flexibility to
reconsider the risk assessment as
new evidence or other factors
emerge.
We recommend that ACDP be Accept-Defra agree that there
tasked with formulating a should be one set of guidance as
common set of containment the overriding priority is
measures to apply to both containment of dangerous
animal and human pathogens. pathogens, whether animal or
human.
We recommend that the regulator Accept-We acknowledge that it is
under the single regulatory not always appropriate for all
framework be given discretion measures that apply to work with
to agree with operators human pathogens to apply to those
departures from the containment sites solely working with animal
measures drawn up by ACDP, on pathogens.
the basis of risk assessments.
We recommend that there be a Accept-Defra agree that this will
single independent regulator give greater clarity, and better
for both animal and human regulation and enforcement.
pathogens, with the resources, expertise and legal powers to
carry out its function effectively.
We recommend that HSE become Accept-Although there are other
the single regulatory body for Agencies which could be
both animal and human considered, Defra believes that
pathogens. HSE has the expertise and critical
mass and since it works in the
related field, is the most
appropriate body to take this on.
HSE have accepted in principle,
and are in discussions with Defra.
We recommend a phased approach Accept-Defra agrees with the
to these changes. principle of the phased approach.
We envisage that the regulatory Accept-Defra are already
role will ultimately pass to conducting joint inspections with
HSE. In the interim we HSE and are in discussions with
recommend that inspections HSE about the proposed changes.
under SAPO continue to be conducted by Defra, but with
support from HSE. We recommend that Defra enter into immediate
discussions with HSE to formalise HSE's support of SAPO
inspections by 1 January 2008.
We recommend that the ACDP is Accept-We will ask ACDP to do
asked to begin work now on this.
drawing up guidance on a single set of containment requirements
for human and animal pathogens, to complement the single
regulatory framework when it is introduced.
We recommend that changes be Accept-Defra will discuss with HSE
made to the SAPO, by April and aim to make changes to SAPO as
2008, to designate HSE as the rapidly as possible, in line with
inspection and enforcement best practice for introducing new
body. statutory instruments. We have
already started considering legal
issues, Defra and HSE lawyers are
working together to effect these
changes within the shortest
possible legislative timetable.
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