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UK to change animal pathogen regulation post Pirbright FMD
Jamie Day, Editor, Animal Pharm
19 December 2007

Members of the press outside the Institute of Animal Health, Pirbright, during the height of the FMD crisis. In his review, Professor Callaghan recommends that DEFRA should lose its role as the regulator of research facilities handling animal pathogens in favor of a single, independent body
Photo: Salina Christmas
A review of the regulatory framework for handling animal pathogens in the UK, commissioned in the wake of the foot and mouth disease outbreak in the late summer, has recommended that a single body oversee the use of human and animal pathogens.

The government's Department of Food, Environment and Rural Affairs (DEFRA) asked Sir Bill Callaghan to review the way animal pathogens are handled in laboratories. This followed the accidental release of the FMD virus from the Pirbright laboratory complex shared by the Institute of Animal Health and Merial Animal Health in August 2007.

The key recommendations of the report include the establishment of a single regulatory framework to govern the use of both human and animal pathogens, with a common set of containment procedures. Professor Callaghan identified a conflict of interest between DEFRA's role as the regulator, licensor and inspector of the Specified Animal Pathogens Order (SAPO 4), and it being a major customer of the animal pathogen research and diagnostics emanating from the Pirbright facility. He recommends that DEFRA should lose its role as the regulator of research facilities handling animal pathogens in favor of a single, independent body, the Health and Safety Executive (HSE). The HSE already oversees research and commercial activities using human pathogens. The changes should be phased in by the end of 2008.

Professor Callaghan also called for better leadership and a stronger safety culture at Pirbright, encompassing all full time and contract employees on the site, so that the risk of accidental releases is close to zero. In addition, there must be a clear and transparent infrastructure controlling biosecurity which is agreed between the various organizations working on the site. The report found that the existing regulatory framework was complex and disjointed, leading to unnecessary inspections, overlapping areas of responsibility, duplication between different regulators and a less than comprehensive risk assessment process.

DEFRA secretary of state Hilary Benn has accepted all the report's recommendations, especially that DEFRA should lose its role in regulating those laboratories working with animal pathogens in favor of a single, independent regulator.

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