Biological risk assessment is a process that includes the identification, the probability of occurrence and the severity of a potential negative effect on human health or the environment associated with a specific use of a GMO or a pathogen. A known risk will lead to the implementation of appropriate prevention measures. This section describes the basic principles and methodology of biological risk assessment.
Biosecurity exceeds the field of competence of public health and is not currently covered by the duties formally entrusted to the SBB by the Cooperation Agreement concerning biosafety. Nevertheless, this topic noticeably has many points in common with biosafety and as such, the scientific and technical expertise of the SBB can easily be developed in the field of biosecurity, particularly with regard to the contained use of pathogenic organisms (genetically modified or not). This informative page aims to tell how the biosecurity concept has emerged and has established naturally a closed link with biosafety.
Laboratory-acquired infections (LAIs) refer to all direct or indirect human infections, with or without the onset of symptoms, following exposure to pathogenic organisms (genetically modified or not) in the laboratory. This exposure can be the result of a bio-incident caused by irregularities that occur while handling these organisms such as technical failure or human errors. This section briefly introduces the concepts of LAIs and bio-incidents and provides a detailed list of LAIs case reports. It also provides detailed information on various initiatives taken by the SBB to identify and analyse bio-incidents and LAIs in biological laboratories in Belgium, in particular the results of a survey conducted for the period 2007-2012 and an online occupational bio-incident notification platform.
Genome editing techniques involving the use of Site Directed Nucleases such as Meganucleases, Zinc-Finger Nucleases, TALENs and the CRISPR/Cas system make it possible to induce genetic modifications in a pre-defined region and offer a more targeted and predictable approach than classical mutagenesis. Besides addressing the predictability and safety of the approach and the characteristics and the molecular mechanisms of the several nucleases and systems, this section also provides an overview of the regulatory considerations associated to the application of genome editing techniques.
In 1988, the World Health Organization (WHO) adopted a resolution calling for global eradication of poliomyelitis. In this context a Global Action Plan (GAP III) has been established to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of routine OPV use. This section provides information on the consequences of the implementation of GAP III and on the laboratory containment of wild poliovirus.
(Coming soon) Synthetic Biology (SB) can be summarized as the rational design and construction of new biological parts, devices and systems with predictable and reliable functional behavior that do not exist in nature, and the re-design of existing, natural biological systems for basic research and useful purposes. This section gives an overview of the biosafety considerations and regulatory challenges of SB in general, and of the 4 major SB approaches specifically.
The following guidelines provide an overview of the transport requirements within the country and across international borders for infectious substances including pathogens, GMOs and biological waste. They provide information for classifying these substances for transportation and ensuring their safe packaging and correct labelling.