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The full report, published December 13th 2007 can be viewed here as a pdf file

A summary of the recommendations of the Callaghan Review and DEFRA's responses:


Government Response

We recommend that consideration is given to extending the duty to co-operate in any new regulatory framework for handling dangerous pathogens.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.