Kenya has published science-based guidelines to facilitate the development of gene-edited research and products, which will be reviewed on a case-by-case basis.
“Genome editing technology has been identified as a potential new option to augment existing interventions in pursuance of achieving the African Union Agenda 2063 and it is expected that proposed applications for genome editing technology for basic research, conservation, agriculture, public health and other purposes will likely continue to expand as genome editing tools become more refined,” states the foreward to the guidelines, which are published on the NBA website.
The guidelines are intended to guide product developers and reviewers through the process of submitting and reviewing applications for research projects and trials involving gene editing and the commercial release of products developed through this technology.
Kenya has a number of agricultural gene editing research projects under way involving sorghum, maize, bananas, pigs and cattle. They include building resistance in the sorghum plant against the parasitic striga weed, controlling maize lethal necrosis disease, disease-resistant varieties of banana, drought-tolerance in maize and developing vaccines against African Swine Fever Virus (ASFV) and East Coast fever (ECF), two dangerous diseases affecting pigs and cattle, respectively.
Kenyan scientists welcomed the news as they had been urging regulators to adopt guidelines specific to gene editing. They said deployment of gene-edited products to farmers could be delayed if gene-edited products are regulated the same as GMOs.
An important feature of the guidelines is a provision for early consultation to determine the regulatory pathway to be followed depending on one of three potential outcomes of genome editing procedures. The country’s National Biotechnology Authority (NBA) the process.
“These guidelines provide clarity on which genome edited organisms and/or derived products should be regulated under the Biosafety Act and which products would be exempted and managed as conventional varieties or breeds,” the document states. “The guidelines apply to genome -dited plants, animals and microorganisms. Determination of genome-edited organisms and/or products for possible regulation will be conducted on a case-by-case basis.”
Kenya, which only recently approved its first genetically modified (GMO) crop, now joins Nigeria as the only two countries on the continent to have developed regulatory guidelines specific to the process of genome editing.
“A growing number of countries have developed or are currently developing regulatory policy/guidance for what genome editing products may be exempted from existing GMO regulatory frameworks, considering that genome editing can result in a variety of outcomes: from outcomes comparable to those achieved by conventional breeding or found in nature, to outcomes comparable to transgenesis,” the guidelines state.
“Genome editing techniques may alter the genome of organisms resulting in either a GMO or organisms that are not distinguishable from those developed from conventional breeding or natural selection. Those techniques that result to a GMO would be subject to the provisions of the Protocol and the Biosafety Act.”
Image: Gene editing research is under way on a vaccine that could help protect cattle, such as these in Masai Mara, Kenya, from East Coast fever. Photo: Shutterstock: Marion Smith – Byers