Guidelines and checklists for the Risk Assessment and Certification of facilities dealing with Genetically Modified Organisms

Prior to conducting any work with genetically modified organisms, an application of such an activity must be made to the National Biosafety Authority as stipulated in the Biosafety Act, 2009. The applicant must submit the information stipulated in the third schedule of the Contained use Regulations, 2011. NBA afterwards conducts risk assessment to identify and evaluate the potential adverse effects of the genetically modified organisms on human health and the environment as stipulated in the fifth schedule of the Biosafety Act, 2009. Such an assessment is also intended to prevent laboratory acquired infections while dealing with biological agents, prevent escape of the GM organisms into the environment, classify biological agents according to risk and appropriate containment laboratories to ensure safety.

The classification into containment levels will be determined by the handling requirements of the work processes, or the degree of hazard to humans and environment. The containment requirements will provide the end user and the Biosafety inspector with a description of the minimum containment required for handling the genetically modified organism safely. The containment descriptions will include:
i) The facility design
ii) Regular and operational practices such as engineering, technical, administrative physical requirements
iii) Personnel competency and training
iv) Occupational health and safety

The scope of the risk assessment of experimental facilities manual will be limited to laboratory, greenhouses and animal houses handling genetically modified organisms. It will focus on containment requirements with emphasis on facility design elements, operational practices (engineering, technical, administrative and physical requirements), personnel competence, and occupational health requirements.
NB: Risk assessment of the genetically modified organisms that will be handled in every facility will be evaluated during the application process for contained use.

Objectives of the manual
The main purpose of this manual is to provide a guideline to Biosafety Inspectors and researchers on how to undertake risk assessment of experimental facilities handling genetically modified organisms and provide a checklist for use during certification inspections. The manual shall also serve as a guide to institutions undertaking work on genetically modified organism€™s in order to help them identify the areas of assessment and ensure that they comply. ++ Read More Guidelines and checklist for Risk assessment and certification of facilities


Guidelines for testing of genetically modified organisms in certified laboratories

These guidelines describe the procedures for the detection of specific GM DNA markers (CaMV35S promoter and Nos terminator) and endogenous markers (lectin and zein) found in raw materials derived from GM soya and maize. They are also suitable for screening some processed foods, animal feeds and ingredients. ++ Read More GMO Testing Guidelines



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