By Murimi Gitari
Dr. Roy Mugiira, the Acting CEO of Kenya’s National Biosafety Authority, converses with PanAfrican Agriculture the biotechnology regulator’s delicate balancing act enforcing policies meant to promote adoption of the modern science while keeping people and the environment safe from any harmful effects.
What is the role of the National Biosafety Authority?
The National Biosafety Authority (NBA) was established in 2010 with the mandate to exercise supervision and control over the development, transfer, handling and use of genetically modified organisms (GMOs) so as to ensure and assure safety of human and animal health and provide adequate protection of the environment. NBA is also the Focal Point for the Cartagena Protocol on Biosafety and regulates all activities involving GMO in food, feed, research, industry, trade and environmental release.
What are genetically modified organisms and GM foods?
A genetically modified organism (GMO) is a plant, animal or microorganism that possesses a novel or new combination of genetic material obtained through the use of modern biotechnology techniques. GM foods are foods derived from modern biotechnology.
Why produce GM foods?
GM technology is only one of the technologies for improving productivity in crops or animals. It is used to develop, for instance, insect-resistant crops, diseasetolerant crops, and weed-tolerant crops. GM foods have many attributes such as better nutritional value through bio-fortification.
What is the process and cost of registering a GMO product in Kenya?
The process starts with a developer or plant breeder who identifies a positive trait in one organism and wishes to introduce the same into another organism through modern biotechnology techniques.
Once the improvement has been done and safety assessments conducted, the developer/breeder makes an application to NBA for consideration. NBA will conduct an extensive safety assessment to ensure the GM product is safe to humans and animals as well as to the environment. A socio-economic impact assessment is also carried out before any release is allowed. Members of the public are also engaged through a structured public participation exercise.
A decision regarding the GMO application is then communicated to the applicant in 90-150 days. Members of the public are informed of NBA decision through the NBA website and internationally through a biosafety clearing house (BCH) platform.
The application fee for biosafety approval is Ksh. 850,000 (an average USD8,500), which covers for a period of 10 years without any further payment.
Are these application requirements the same for all the GMO products?
GMO applicants are required to submit fully filled application forms in prescribed format and payment of relevant applicable fees. One may apply for contained use research, environmental release and placing on the market of GMO or import, export and transit of GM products. The various application forms are available in the NBA website.
How long does it take to register a GM crop?
It takes 90 to 150 days to make a decision and communicate to applicant(s) regarding environmental release and/or placing on the market of genetically modified organisms.
Once NBA completes its process, other agencies involved in variety registration in Kenya take over the process.
Who can apply to register a GM crop?
Any Kenyan citizen can make a request for registration of a GM crop in Kenya
What are the requirements for exporting and importing a GMO product in the country?
The requirements for importation, exportation and transportation of GMOs are as per the Biosafety (Import, Export and Transit) Regulations, 2011.
Important information required includes evidence of approval of the GMO by a competent biosafety agency; identity and quantity of the genetically modified organism to be imported or exported; port of entry or exit into or out of Kenya; the intended purpose of importation, exportation or transit of the genetically modified organism; and for transit commodities, evidence of approval or no objection letter by the destination country.
Which GM crops are currently being grown in the country?
Bt cotton that has resistance to the cotton bollworm pest was approved for commercialisation in January 2020 and is now available to Kenyan farmers.
Other crops such as insect-resistant maize (Bt maize) and disease-resistant cassava are at national performance trials and final biosafety approval stages. A number of important crops such as sorghum, sweet potato, yams, banana, and Irish potato are still being experimented in the country.
Are GM foods assessed differently from traditional foods?
In practice, very few foods consumed today are subjected to any systematic safety assessment process, but they are rather generally accepted as safe to eat due to the history of safe use.
Safety assessment of GM foods is based on international standards (CODEX, OECD, Cartagena Protocol on Biosafety) and national laws, and aims to ensure that the GM food is as safe as its conventional counterpart.
Are there any issues of concern for human health with the GM products? If yes, explain.
The main concerns over GMOs focus on potential toxicity, allergenicity, and compositional analysis. The GM products currently available on the international market have undergone thorough safety assessment and have shown no adverse effects on human and animal health.
How is the risk assessment of the environment performed?
Environmental risk assessment of GMOs is done in accordance with provisions of the Cartagena Protocol on Biosafety (Annex III), Biosafety Act and Regulations and Environmental Risk Assessment Guidelines developed by NBA for this type of assessment.
We also consult independent experts and other government agencies on environmental matters before any decision is made. All assessments undertaken by the Authority are science-based, transparent and are carried out on a case by case basis.
How do you regulate GM foods and crops?
Regulation of GM foods in Kenya is carried out in line with the provisions of the Biosafety Act and biosafety regulations. Biosafety (Contained Use) Regulations, 2011 ensure that potential adverse effects of genetically modified organism are addressed to protect human health and the environment when conducting research of GMOs.
Biosafety (Environmental Release) Regulations, 2011 ensure that potential adverse effects of genetically modified organism are addressed to protect human health and the environment before commercialising any GMOs. Biosafety (Import, Export and Transit) Regulations, 2011 ensure safe movement of genetically modified organisms into and out of Kenya while protecting human health and the environment. Biosafety (Labeling) Regulations, 2011 ensure accurate consumer information regarding GM food, feed or products and traceability for implementation of risk management measures where necessary.
There are certain groups concerned with the growing influence of biotechnology, what’s your take on that?
As stated earlier, biotechnology is only one tool that is utilised to improve crops or animals among others. The role of NBA is to ensure that those who choose to use modern biotechnology do it in a responsible manner that guarantees safety of humans, animals and the environment.
At NBA, we recognise the possibilities of modern biotechnology in ensuring food security, fighting poverty and improving livelihoods. We also recognise the concerns of the public regarding the safety of GMOs. As an institution we are committed to ensuring that any application of modern biotechnology in Kenya is done in a safe and responsible manner.
We can assure the public that any GMOs approved by NBA will have undergone thorough scrutiny to ascertain that they are safe for human or animal consumption.
The biosafety laws also provide for a robust monitoring and evaluation framework for all commercialised GMOs which are monitored for 20 years for any unanticipated effects.
What future developments can Kenyans expect in the field of biotechnology?
It’s important to note that there are other emerging biotechnologies such as gene editing that have come up in recent years and some of the research projects in Kenya are already utilizing these technologies though at early stages of development. NBA will ensure that as new technologies evolve, so do the regulations to ensure safety of humans, animals and environment.
Do you think biotechnology will help solve the problem of food security in the country or something else needs to be done?
Low crop productivity is considered one of the main reasons for poverty and food insecurity in the world. Biotechnology has contributed to an increase in food production using different approaches such as introducing high-yielding varieties resistant to biotic and abiotic stresses, reducing pest-associated losses, and improving nutritional values of foods.
Biotechnology should therefore be considered among the key tools we need to meet the rising demand for food for our fast growing population as a country.
The Kenya Vision 2030 and Medium Term Plans (MTP) recognise the potential benefits of biotechnology while also cognizant of potential risks, hence the establishment of NBA as a competent body on these matters.
