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

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, including those that have been genetically modified; 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 the Specified Animal Pathogens Order (SAPO) and for handling wild-type (non-Genetically Modified) 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?

Defra continue to licence premises for work with animal pathogens under the Specified Animal Pathogens Order (SAPO), but HSE undertake the inspection and enforcement functions for animal pathogens under Agency agreements with England, Wales and Scotland.

What’s next?

Work has begun to implement the review’s recommendations to develop a single regulatory framework to govern contained use work with animal and human pathogens, including GMOs. HSE is working with Defra, other Government Departments, the Scottish Government and the National Assembly for Wales and other interested parties to take this forward. The intention is that this will align regulatory requirements for all work with human and animal pathogens and genetically modified organisms (GMOs) in containment, such as research laboratories or biotechnology production facilities.

Stakeholders in the sector have been extremely helpful to HSE in developing options for the necessary legislative changes. We anticipate that these will not occur until 2012.

Do you want to know more?

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