By Prof. Dorington O. Ogoyi

Kenya has recorded remarkable progress in agricultural biotechnology research and development over the last one decade. Research into genetically modified (GM) crops and animal vaccines is currently underway in various research and academic institutions in the country. The National Biosafety Authority (NBA) has approved 29 laboratory and 14 confined field trial GMO projects so far.

NBA is a biosafety regulatory body established by an Act of Parliament to provide supervision and control over development, transfer, handling and use of Genetically Modified Organisms (GMOs) to ensure safety of human and animal health and provide adequate protection of the environment.  

Among the biotech crops that have reached field experimentation include cotton, maize, sorghum, cassava, sweet potato, banana and gypsophila flowers. More recently, the Authority approved Bt maize and Bt cotton for limited environmental release and conducting of National Performance Trials (NPTs), a key step before any release of new crop varieties in Kenya. 

Bt cotton, a crop commercialized in a number of countries, has gone through rigorous evaluation in seven NPT sites that represent different agro-ecological zones in the country where conventional varieties are normally grown. The purpose of NPT tests is to generate agronomic performance data such as yield potential and insect resistance under farmer conditions, and to assess value for cultivation before the new varieties are finally released to farmers. 

Whereas the benefits of biotechnology are recognised, a number of food/feed and environmental concerns needs to be addressed to assure safety of these products. Among the food safety concerns of GM-crops include safety of inserted genetic elements, short and long-term direct health effects (toxicity), and a tendency to provoke allergic reactions as well as alterations in food nutritional and compositional properties. 

Kenya has in place the Biosafety Act principally enacted to provide a legal framework for ensuring safety to humans, animals and the environment in all dealings of GMOs. The Act has specific provisions that directly address human health. Specifically, one object of the Act is to  ensure an adequate level of protection for the safe transfer, handling and use of genetically modified organisms that may have an adverse effect on the health of the people and the environment

To assess safety of GM foods, NBA has established a transparent, science-based and predictable risk assessment (food and environmental safety assessment) and decision-making process. This risk assessment process is anchored on internationally recognised agreements and standards which Kenya is a signatory. The agreements include the Codex Alimentarius Commission (CAC), World Health Organisation (WHO), Cartagena Protocol on Biosafety (CPB), Food and Agricultural Organisation (FAO) and Organisation for Economic Development and Corporation (OECD). These standards and guidelines are considered adequate for assessment of safety of GM foods currently in the international market. 

The objective of conducting risk assessment is to identify and evaluate the potential adverse effects of GMOs on human, animal health and the environment.

The safety assessment process of GM crops at the NBA is a rigorous exercise. The process involves screening for the application’s completeness and acknowledgement of receipt, and engagement of independent biosafety experts to review food/feed safety, environmental and ecological safety as well as socio-economic data on the application. The application is then reviewed by other relevant Government bodies before being subjected to public participation. The application is also reviewed by a technical team of the NBA Board before finally making a decision. 

The GM products once approved by the Authority are clearly labeled as “Approved GM Product” for consumer information and ease of traceability. Once in the market, the Biosafety Act provides for post commercialisation monitoring and general surveillance for twenty years by the Authority. If any intended effect attributed to the released GMO is noted during the monitoring period and at any stage of use, the product shall be recalled from the market immediately.  It should be noted that NBA assesses the safety of the GM ingredient and once this is done, the product is subjected to existing assessment as any other conventional product. 

GMOs cut across a broad spectrum of disciplines. In view of this, the Biosafety Act stipulates that the biosafety Authority may consult with other regulatory agencies on need basis before making a decision. These agencies include Kenya Plant Health Inspectorate Service (KEPHIS), Kenya Bureau of Standards (KEBS), National Environment Management Authority (NEMA) and the Department of Public. Others are Health Directorate of Veterinary Services (DVS), Pests Control Products Board (PCPB), Kenya Wildlife Service (KWS), and Kenya Industrial Property Institute (KIPI). 

Five of these agencies – KEPHIS, DVS, KEBS, NEMA and Department of Public Health – also sit in the NBA Board and participate fully in the decision-making process.  

During the review process, the initial GMO application is sent to all relevant regulatory agencies for their review and comments.  Any concerns raised by the Regulatory Agencies are addressed before the NBA Board makes a final decision.

Overall, the safety assessment of GM crops is geared towards establishing whether the modified crop is “as safe as the conventional crop”, normally referred to as the “substantial equivalence principle” 

The country has made significant strides towards commercialisation of bollworm resistant Bt cotton varieties. Cotton is principally grown for lint. Besides lint, the cotton seed is routinely processed to make cooking oil and cotton seed cake as animal feed.

As such, NBA conducted food safety assessment of the Bt cotton as would be for any food/feed crop. On the basis of all available evidence to-date, including detailed studies provided by the applicant, available literature, it was concluded that Bt cotton was as safe as the conventional cotton and its environmental release for the purpose of conducting National Performance Trials (NPTs) pose no risk to humans, animals and the environment. 

The Authority therefore assures the public that with regards to the Bt-cotton, the safety of the cotton fibre, cotton cooking oil and derived animal feed cake is as safe as products derived from the conventional cotton based on the safety assessment carried out by the Authority. However, the Bt cotton, has to undergo the due process before it can be availed to the farmers for cultivation and placement in the market.

Prof. Dorington O. Ogoyi is Chief Executive Officer of the National Biosafety Authority