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
Environmental risk assessment (ERA) guidelines for GM crops in Kenya
Modern biotechnology involving the use of recombinant DNA (rDNA) technologies has emerged as a powerful tool with many potential applications in healthcare, industries and agriculture. The Authority’s operations are guided by the Biosafety Act, Regulations and operational guidelines and/or Standard Operating Procedures (SOPs). The general framework for conducting environmental risk assessment is as illustrated in Annex III of the Cartagena Protocol on Biosafety and Fifth Schedule of Biosafety Act. This guideline is meant to provide general guidance on how environmental risk assessment of GM crops will be conducted in Kenya and is not for a specific crop. The guideline provides guidance to applicants/technology developers, expert reviewers, risk assessors and decision makers on the requirements for environmental risk assessment data required in GMO applications for environmental release, import, export and transit of viable GMOs; to provide a detailed stepwise process of assessing potential adverse effects of GM crops to the environment and natural ecosystems and how the identified risks shall be mitigated post release; to provide clarity on identification of potential hazards/adverse effects that are relevant for evaluation in the risk assessment of GM crops; and to provide clarity on the risk assessment and regulatory approach to be taken on stacked gene events meant for commercialization in Kenya
Environmental Risk Assessment Guidelines.
Food/Feed safety assessment guidelines for GM crops in Kenya
Modern biotechnology involving the use of recombinant DNA (rDNA) technologies has emerged as a powerful tool with many potential applications in healthcare, industries and agriculture. The Authority’s operations are guided by the Biosafety Act, Regulations and operational guidelines and/or Standard Operating Procedures (SOPs). The general framework for conducting food/feed safety assessment is as illustrated in Codex and OECD Guidelines and Fifth Schedule of Biosafety Act. The guidelines for the safety assessment of foods derived from genetically modified crops in Kenya has been developed to provide general guidance on how food and feed safety assessment of GM crops will be conducted in Kenya. Specifically, the guidelines guide applicants, expert reviewers, risk assessors and decision makers on the requirements for food/feed assessment data required in GMO applications for environmental release; to provide a detailed stepwise process of assessing safety of foods and feeds derived from GM crops; and to provide clarity on specific parameters analyzed in determination of food/feed safety of GM crops
Genome editing guidelines
Modern biotechnology, involving the use of recombinant-DNA (r-DNA) technologies, also known as genetic engineering, emerged as a powerful tool with many potential applications in agriculture and healthcare in the 1980s. Advancements in genome sequencing and comparative analysis, functional genomics, and the growing knowledge about function of various genes have motivated researchers to look at new ways to develop new traits by changing specific genes in the organism’s own DNA, or to insert new DNA in a targeted manner. Over the last decade, researchers have developed many new precise techniques to develop new traits in a targeted manner through genome editing. Genome editing differs from genetic modification in that the latter generates modifications in the genome via stable integration of DNA elements which does not occur naturally. Further, Genome editing utilizes natural DNA repair mechanisms to complete the process of reconstituting the fragment after the edit. As a result, the final outcome of Genome editing could either be a genetically modified organism (GMO) or a non-GMO depending on the pathway followed in the editing process. The former is regulated under the Biosafety Act 2009 in Kenya while the later falls outside the provisions of the Act. These guidelines have been developed to provide technical guidance to applicants and reviewers on which genome editing organisms and/or products are regulated under the Biosafety Act, 2009 or not.
Below find the Genome Editing Early Consultation Application Form.