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NEWS RELEASE

Ref: 465/07
Date: 13 December 2007

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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: www.defra.gov.uk/animalh/diseases/fmd/investigations/

Media contacts for the Callaghan Review:
Jessica Terrell: 020 7261 8644 / Jessica.Terrell@gnn.gsi.gov.uk
Katherine Ellery: 020 7261 8652 /  Katherine.Ellery@gnn.gsi.gov.uk

2. For further information on Foot and Mouth Disease and the current situation please visit: www.defra.gov.uk/footandmouth

3. TheHSE report, the independent report from Professor Spratt of Imperial College and the full Government response to these reports can be found here:
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 is given to extending the duty to co-operate in any new regulatory framework for handling dangerous pathogens.

Accept
The requirement for a duty to co-operate, between different occupiers on the same site, will be extended to all sites, including those which use animal pathogens, under the proposed single regulatory framework (stage 3).

We recommend that Defra, DH, HSE and other interested parties work together to develop a single regulatory framework to govern work with human and animal pathogens. 

Accept
Defra agree that this is in keeping with the Hampton principles of inspection and enforcement, and is in line with Government policy to simplify regulation.  Work has started to analyse how this will be taken forward.

We recommend that Defra, DH, HSE and other interested parties work towards the introduction of cost recovery in any new regulatory framework.

Accept
Government policy is to recover costs for services wherever possible.  Defra will work with DH, HSE and other interested parties to recover costs in this area.

We recommend that risk assessment be a key element of the regulatory framework for handling animal pathogens, as it currently is for human pathogens and genetically modified organisms.

Accept
The containment level currently sets the main risk level.  Under phase 3 of the proposed approach to the changes, Risk Assessment will be the fundamental principle that governs 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 tasked with formulating a common set of containment measures to apply to both animal and human pathogens.

Accept
Defra agree that there should be one set of guidance as the overriding priority is containment of dangerous pathogens, whether animal or human. 

We recommend that the regulator under the single regulatory framework be given discretion to agree with operators departures from the containment measures drawn up by ACDP, on the basis of risk assessments.

Accept
We acknowledge that it is not always appropriate for all measures that apply to work with human pathogens to apply to those sites solely working with animal pathogens.

We recommend that there be a single independent regulator for both animal and human pathogens, with the resources, expertise and legal powers to carry out its function effectively.

Accept
Defra agree that this will give greater clarity, and better regulation and enforcement.

We recommend that HSE become the single regulatory body for both animal and human pathogens.

Accept
Although there are other Agencies which could be considered, Defra believes that 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 to these changes.

Accept.
Defra agrees with the principle of the phased approach.

We envisage that the regulatory role will ultimately pass to HSE.  In the interim we recommend that inspections 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.

Accept
Defra are already conducting joint inspections with HSE and are in discussions with HSE about the proposed changes.

We recommend that the ACDP is asked to begin work now on 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.

Accept
We will ask ACDP to do this.

We recommend that changes be made to the SAPO, by April 2008, to designate HSE as the inspection and enforcement body.

Accept
Defra will discuss with HSE and aim to make changes to SAPO as rapidly as possible, in line with best practice for introducing new 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.

 

End

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Page published: 13 December 2007 11:00

Department for Environment, Food and Rural Affairs