Biosafety regulatory framework

The assessment of biological risks associated with the use of pathogens and/or recombinant DNA techniques has taken shape through different periods in 
This framework relies on a biological risk assessment system common to the Federal State and to the Regions and is composed of two bodies: The Biosafety 

How do biosafety and biosecurity regulations work?

In countries with regulatory systems for biosafety and biosecurity already in place, regulations tend to be based on the more conventional approach to hazard assessment, whereby risk mitigation and containment measures are selected (and mandated) according to the pathogen categorization or risk group.

How should a national biosafety and biosecurity framework (NBBF) be implemented?

A comprehensive evaluation of existing regulatory arrangements, including:

  • the identification of any gaps
  • forms part of the recommended step-wise approach to implementing a national biosafety and biosecurity framework (NBBF) and is described in more detail later in this document (see Section 3:
  • STEP 2).

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