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Implementing Sir Bill Callaghan’s recommendations for a single regulatory framework for handling human and animal pathogens

Following the outbreaks of Foot and Mouth Disease (FMD) which began in Surrey in August 2007, Sir Bill Callaghan led a Review of the Regulatory Framework for Handling Animal Pathogens.

This site provides information on progress with the recommendations of the review. It is aimed at duty holders and others with an interest in the regulation of work involving human and animal pathogens.

What are the recommendations of the review?

The review contained a number of recommendations, two key ones being:

that there should be a single regulatory framework to govern work with human and animal pathogens; and

that HSE become the single regulatory body for both human and animal pathogens, with responsibility for inspection and enforcement functions.

The regulatory frameworks for handling those animal pathogens not covered by SAPO and for handling wild-type (non-GM) pathogens of plants, fishes and bees was not in the scope of the review (section 2, paragraph 6 of the review). Currently these areas of work are not being considered, but that is not to say they have been precluded and will not be considered in the future.

Where are we now?

Progress to transfer inspection and enforcement functions for animal pathogens to HSE is well underway. Transferring this function to HSE is done through a legal process that requires changes to the Specified Animal Pathogens Order (SAPO). SAPO is implemented separately in England, Wales, Scotland and Northern Ireland. Because of this, current responsibilities for inspecting SAPO licensed premises and issuing licences may differ between England, Scotland, Wales and Northern Ireland.

What’s next?

Work has begun to implement the review’s recommendations to develop a single regulatory framework to govern work with animal and human pathogens. HSE is working with other Government Departments and other interested parties to take this forward.

The first stage has been to establish the legal basis for a single framework. This in itself is a complex process, resolution of which has now been reached. This means that more detailed work to shape the regulatory framework can begin. HSE will be seeking dialogue and involvement with stakeholders as part of the process of developing the framework. We try to make our consultation process as thorough and open as possible, and as well as our informal consultation with stakeholders during the development stage, emerging proposals for any new legislation and its associated guidance will be open to formal public consultation via our website. Any proposal for new legislation will also be subject to a Regulatory Impact Assessment. This is an assessment of the impact, in terms of costs, benefits and risks, of any proposed regulation, on businesses, charities or voluntary bodies.

There are several predetermined procedures that have to be followed to implement new legislation and, based on past experience, it is likely that the new regulations will be in place in early 2010.

Further information and progress updates will be provided via these pages.