Written Ministerial Statement by Hilary Benn on publication of the Callaghan review of the regulatory framework for handling animal pathogens - 13 December 2007
The Secretary of State for Environment, Food and Rural Affairs (Hilary Benn)
I announced on 7 September that I had asked Sir Bill Callaghan to lead a review of the regulatory framework for handling animal pathogens.
The purpose of the review was to take forward recommendations of the HSE’s report on potential breaches of biosecurity at the Pirbright site in 2007 and Professor Spratt’s review of the safety of UK facilities handling FMD virus; in particular to consider:
- Any changes needed to clarify and strengthen the regulatory framework for animal pathogens, in the light of that 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 clear lines of accountability, inspection protocols and responses to non compliance.
Sir Bill Callaghan was assisted in his work by representatives from HSE, HPA, Defra, the farming community and Professor George Griffin (Chairman of the Advisory Committee on Dangerous Pathogens). I am very grateful to Sir Bill and his team for the swift and thorough way in which they have completed their task.
I am accepting all of the recommendations set out in the report and I am determined to ensure that Defra works quickly with the other Departments and Agencies involved to take forward the necessary changes. I set out in more detail below the position in respect of each recommendation
The regulatory framework for Specified Animal Pathogens was first introduced in 1993, and there have been limited changes since then . The report recognises that there are in fact three overlapping but separate sets of legislation which apply to the handling of human and animal pathogens. This does not reflect the spirit or the substance of Hampton principles and making changes here will also be of benefit to the industry in making the rules that they must work to clearer and more coherent.
I agree with the recommendation that Defra should not continue as regulator of laboratories handling of animal pathogens because the report finds there was a conflict of interest. This was an area where I was particularly keen to have an independent view, as I felt that this was an issue that needed addressing. I acknowledge the comments that Defra’s weaknesses as a regulator in this context were as a result of the regulatory system, rather than because of failings on the part of individual inspectors and because of the level of expertise within Defra and the resource allocated to this work.
I also note the report’s comments that the primary responsibility for managing risks must lie with the top management of any facility where work on dangerous pathogens is carried out. Any regulatory system is only as good as the people being regulated. The regulator’s role , whoever that regulator may be, is to provide assurance that the systems in place will deliver the desired objective.
The UK has a very important science base , which has built an enviable international reputation. The research carried out in this country including at Pirbright, plays an important part, not only in supporting our response to disease outbreaks, but also in the international fight against existing and emerging diseases. This position inevitably means that there is a need to handle dangerous pathogens in UK laboratories. The public, farming community and others have a right to expect that all possible measures will be taken to protect them and the environment. That risk can never be zero, but ,as the report points out , the regulatory outcome we must seek to achieve is one that provides an assurance that the risk of accidental release is as close to zero as possible.
I am depositing copies of their report in the libraries of both Houses today. The report is also available at
www.defra.gov.uk/animalh/diseases/fmd/investigations/bill-callaghan.htm
I will keep the House informed of developments.
Page published: 13 December 2007