KENYA – Just a month after Nigeria published regulations for genome editing in the country, Kenya has also made a bold step towards regulating the sector, becoming the second African country to do so.
Kenya’s National Biosafety Authority (NBA) has published gene editing guidelines to provide clarity on which genome-edited organisms and/or derived products will be regulated under Kenya’s Biosafety Act, and which products are regulated as conventional varieties or breeds.
“The Guidelines will lead applicants and reviewers on the approach to take while submitting and reviewing applications for consideration of projects at research, trials, and commercial release of products of this technology,” explained Dr. Roy Mugiira, NBA’s acting Chief Executive Officer.
The highlight of the regulations is the provision for early consultation to determine the regulatory pathway to be adopted in view of potential outcomes of genome editing procedures.
An applicant is required to submit an Early Consultation Form to the NBA providing data on their project experimental processes and end product to establish whether it should be regulated under the Biosafety Act or not.
“The decision on early consultation by the NBA will be communicated to the applicant within 30 working days. However, genome editing projects that do not have the required data will be regulated under the Biosafety (Contained Use) Regulations 2011,” reads part of the guidelines.
In addition, the guidelines outline considerations or scenarios for regulation of genome editing techniques and derived products either under the Biosafety Act or not.
Genome editing and derived products that will not be regulated under the Biosafety Act include modifications made by inserting genes from sexually compatible species and deletions/knockouts without foreign genetic material in the end-product.
Processed products whose inserted foreign genetic material cannot be detected will also bypass regulation.
However, in cases where research and developmental phase starts with a Genetically Modified Organism (GMO), NBA will regulate genome edited organisms up to the stage where GMO component is removed/segregated.
All in all, a decision will be made on a case-by-case basis.
Gene editing to help achieve Agenda 2063
The scope of these guidelines does not extend to detailing how risk assessment and risk management of genome-edited products will be conducted.
“Genome editing technology has been identified as a potential new option to augment existing interventions in pursuance of achieving the African Union Agenda 2063,” reads the guidelines document.
Agenda 2063 is Africa’s blueprint and master plan for transforming Africa into the global powerhouse of the future. It is the continent’s strategic framework that aims to deliver on its goal for inclusive and sustainable development.
Established in 2009, NBA has made great strides in creating a strong Biosafety regulatory framework in Kenya by developing and publishing the implementing Biosafety Regulations.
These include the Biosafety (Contained Use) Regulations, 2011; the Biosafety (Environmental Release) Regulations, 2011; the Biosafety (Import, Export and Transit) Regulations, 2011; and the Biosafety (Labeling) Regulations, 2012.
In order to achieve food security, several countries are looking in the direction of gene editing. Both China and the Philippines have recently amended their laws to shorten the lengthy approval times usually required for the GM products.
Following its exit from the European Union, the United Kingdom is also considering green-lighting gene editing in agriculture. In January this year, the UK parliament passed a law to help researchers carry out trials of gene-edited crops in England, a process which might take about 5 years before products hit the market.
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