Genetically Modified Organisms (GMOs) research refers to scientific studies and experiments involving plants, animals, microorganisms and pharmaceutical research that has not received approval for human use. To conduct GMO research in Kenya, researchers and Institutions shall comply with the requirements of the Biosafety Act CAP 320 and supporting regulations, which include: having a functional Institutional Biosafety Committee (IBC) and Biosafety Level II (BSLII)certified facility or higher. Researchers through their IBCs submit formal applications to NBA in the prescribed formats.
Contained use activity (Laboratory, Greenhouse and Growth chambers
Contained use and Confined field trials (GMO Animals and Animal health inputs and micro-organisms)
An IBC is a multidisciplinary body established within a research institution, academia or organization to oversee and ensure the safe conduct of activities involving GMOs. It acts as a link between the researchers and NBA. To operationalize an IBC, an institution shall submit an application with payment of the applicable fees
GMO research in Kenya MUST be conducted in BSL II facility or higher; therefore, the facility has to be certified by NBA, prior to the start of research. The certification must be in good standing and as such annual inspection and recertification is required. Institutions are required to apply for Certification of New and Existing Facility.
This is a formal process established by NBA to guide applicants in determining the regulatory pathway of genome editing project or products. Early consultation on genome editing was necessitated by the fact that some genome editing techniques may lead to GMO products while others lead to products that are more similar to the products of mutational breeding. All genome editing products and processes are subject to varying levels of regulatory oversight. An applicant needs to submit an application on Early consultation on Genome Editing .