Section A9: Health, attendance, wellbeing and safety:

Appendix A9.13i

Biosafety legislation

There is a significant quantity of UK legislation, ACOP's and guidance relevant to the Biosafety field and the following includes the main legislation relevant to Biosafety work but is not intended to be a complete list.

Control Of Substances Hazardous to Health (COSHH) Regulations and guidance define a biological agent and covers all work with human pathogens including containment and control measures. This is regulated by the HSE and requires the duty holder to notify work involving human pathogens.

Genetically Modified Organisms (GMO's) (contained use) Regulations and guidance define genetically modified organisms and covers all activities with GMO's in containment. This is regulated by HSE in consultation with Defra and requires the duty holder to register the site and notify GMO activities.

Genetically Modified Organisms (deliberate release) Regulations and guidance covers all activities with GMO's that are used outside of containment i.e. deliberate release. This is regulated by Defra and requires the duty holder to notify any activities.

Specified Animal Pathogens Order (SAPO) covers work with any of the animal pathogens on the specified pathogens list. These pathogens are generally exotic to the UK. This involves inspection by the HSE with the licence issued by Defra, it requires the duty holder to notify any activities with these pathogens.

Importation of Animal Pathogens Order (IAPO) regulates the importation of designated animal pathogens. Import licences are required for importation of these agents to the UK.

Anti Terrorism Crime and Security Act, schedule 5 of this Act covers activities with pathogens and toxins listed in the schedule. This is regulated by the Police service, specifically Counter Terrorism Security Advisors (CTSA's) and requires the duty holder to notify the Home Office of any activities with any of these substances.

Plant Health Order, this is in place to protect against the introduction of organisms harmful to plants or plant products and against their spread. It is regulated by Defra and requires the duty holder to notify any importation of plants and plant products.

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Last updated 03/11/10
Amendment 110 - November 2010