Source – allAfrica / The Star (Kenya)
By Agatha Ngotho
Date – 6 May 2013
Website – allafrica.com
Dr Willy Kiprotich Tonui is the chief executive officer (CEO) of the National Biosafety Authority (NBA). He is one of the leading scientists in Africa and the only Registered Biosafety Professional (RBP). Prior to his appointment, he served as a Principal Research Officer and Environment Coordinator (Immunology), Health and Safety at the Kenya Medical Research Institute (KEMRI). He spoke to Star Reporter Agatha Ngotho about his role in the NBA.
Briefly tell us about the mandate of the National Biosafety Authority (NBA).
The National Biosafety Authority (NBA) was established pursuant to the provisions of the Biosafety Act No 2 of 2009. The overarching mandate of NBA is to exercise general supervision and control over development, transfer, handling and use of genetically modified organisms (GMOs) so as to ensure human safety and animal health and provide adequate protection to the environment.
Genetically Modified Organisms (GMOs) are defined as those organisms in which the genetic material (DNA) has been altered through genetic engineering in a way that is not possible through traditional breeding or natural selection methods. The genetic engineering (GE) technology often referred to as biotechnology, allows carefully selected individual genes to be transferred from one organism into another and also between non-related species.
In Agriculture, for example, GE technologies have been used to create genetically modified (GM) plants that are then grown and cultivated to produce GM food crops. The main GM crops currently approved and on the international market have been modified to acquire the ability to protect themselves against destructive plant pests, diseases, viruses and for tolerance to certain herbicides.
Do we have commercially available GM food or feed in Kenya approved by NBA?
We would like to inform the public that NBA has not yet approved any GMO for commercial use in Kenya and so far we have not received an application for GM commercialisation. The Kenya Agricultural Research Institute (KARI) is experimenting on GM cotton (Bt cotton) and when they are finally ready they may come to us for commercialisation and there is a possibility that we may receive an application this year.
But even when this comes to us, it will take four to six months or so to approve as provided by the law. The Environmental Regulations 2011 that is going to guide the process of application demands that we seek public opinion and we will do this through the press for 21 days.
If the application is approved, the organisation seeking the application is given a permit for a period not exceeding 10 years. We are ready for any application that will come our way and we will do it with the public safety and interest in mind.
The authority has approved genetically modified products for importation into Kenya for humanitarian assistance and relief supplies during drought seasons. These include: corn-soya blend and maize meal. These approvals were granted after a food safety assessment by expert reviewers concluded that the food products are as safe as the conventional counterparts.
What is the status of transit products through Kenya?
The Authority has so far approved 27 applications of GM products for importation and trans-boundary movement some to Uganda and neighbouring countries through Kenya.
How do you ensure that GM foods on transit are not planted in Kenya?
GM food that enters Kenya on transit or for humanitarian assistance must be milled before being allowed to come into the country. The Authority ensures that a person transiting genetically modified organisms shall ensure that the genetically modified organisms are appropriately packaged and transported in accordance with the Biosafety (import, export and transit) regulations and other applicable international standards. A person transiting genetically modified organisms shall provide a copy of the approval granted by the Authority or clearance at the port of entry and exit.
How does NBA ensure GMO products on transit do not end up in the country and do you have adequate manpower for enforcement or you heavily rely on other regulators?
NBA currently has adequate manpower to enforce our mandate. We have highly trained personnel in Mombasa, Namanga, Busia borders and the Jomo Kenyatta International Airport to assess what comes and goes out of Kenya with specific attention to GMO products.
What are some of the approved GM activities currently going on in Kenya?
In general, the current research in laboratories, greenhouses and at confined field trials has largely concentrated on constraints that are economically important to Kenya’s agricultural patterns that include pests, drought, diseases and nutritional deficiencies.
Some of the approved genetically modified research projects in Kenya include: Bt cotton resistant to bollworms, drought tolerant maize, virus resistant cassava, nutritionally enhanced cassava and nutritionally enhanced sorghum. These crops are still being assessed under restricted field trials and have not been approved for commercial release, that is, for use in Kenya as foodstuff.
What is risk assessment?
Risk assessment refers to the evaluation of potential risks to human, animals and the environment, whether direct or indirect, immediate or delayed, which the environmental release or placing on the market of genetically modified organisms may pose.
It is imperative to carry out risk assessment in order to determine whether the GM products being released, transported are safe to humans, animals and environment. As a regulator, NBA wishes to inform the public that the authority exists to assure and ensure the safety of GMOs in the country by implementing the best internationally agreed practices in its risk assessment of GM foods before release into the market and also post-market surveillance. In doing so, the Authority has established a scientific basis for making its decisions on GM foods and products, a process that ensures transparency, excellence and independence in decision making.
Are these International guidelines on risk assessment applicable to Kenya?
The risk assessment guidelines as specified by Codex Alimentarius Commission and European Union’s Organisation for Economic Corporation and Development (OECD) consensus documents are considered by NBA and other international regulatory authorities to be adequate for assessment of safety of GM foods currently in the international market.
How does NBA approve applications?
To realize its mandate, NBA has established a transparent, science-based and predictable process for reviewing and making decisions on the development, transfer, handling and use of GMOs and related activities. This is based on risk assessment process anchored on internationally recognised agreements and standards such as Codex Alimentarius Commission Principles (CAC), World Health Organization (WHO), Cartagena Protocol on Biosafety (CPB) and Food and Agricultural Organization (FAO). It is important to note that because various GMOs have different genes engineered in them, the WHO and other internationally agreed standards and guidelines such as CODEX requires that individual GM foods and their safety should be assessed on a case-by-case basis and not on a generalized basis of all GMOs.
In a nutshell the Codex Alimentarius Commission guidelines and codes of practice dictates that a pre-market assessment be performed on a case-by-case basis with emphasis on evaluation of both direct effects and unintended effects of GM foods. Areas that are looked into during GM food safety assessment include direct health effects (toxicity), tendency to provoke allergic reactions and specific components that may have effects on nutritional or have toxic properties.
As I said, the public must participate in the process of approving commercialization of GMOs in Kenya and now we must also seek the approval of the county governments.
What are some of the structures that the Government of Kenya put in place to protect the public for potential risks from GMOs?
As evidenced in the Biosafety Regulations, the Government of Kenya has put in place control measures to assure and ensure that all GM activities or products approved in Kenya are safe. These regulations include Regulations for Labelling, Environmental Release, Contained Use and Import, Export and Transit. The regulations for handling, packaging and transportation are underway.
This is also done through the provision of the Biosafety Act that prohibits anyone dealing with GMO without the approval of NBA.
Tell us a little bit about labelling regulations, have you implemented these regulations?
Yes, the latest regulations on labelling came into force as from May 2012 and are in force.
Labelling is intended to ensure that consumers are made aware that the food, feed or product is genetically modified so that they make informed choices and also to facilitate the traceability (make possible to follow up) of products to assist in the implementation of appropriate risk management measures where necessary. Anybody that imports or transits GM food/feed into Kenya should label them.
Why has the labeling regulation elicited a negative response from the stakeholders?
Indeed this is a question that NBA is also asking them? NBA welcomes any concerns on labeling and we are prepared to work with them to address them.
It is about giving information to consumers to make informed choices and not a punitive measure to hurt business. It is our mandate to inform the consumers.
Does the labeling requirement for GMO products still stand or are there plans to review it given that some traders are equally concerned that labeling would see the final products available in shops at higher prices than the non-GMO ones besides discouraging consumers from the products due to safety concerns?
The law still stands and we are also coming up with a generic label but it’s still under in-house discussion, however, we hope to engage our stakeholders so that they can know what products they are buying and who is dealing with them.
The reviews were done in consideration to public concerns and we are still receiving feedback from people. There have been concerns from the Cereal Millers Association on market and cost and we responded to them as required in the labeling regulations. Any product above one per cent GMO content should be labeled but below that it may not be labeled.
Concerns have been raised that the GMO debate is still a complex issue even within the NBA circles. What is the level of your capacity to test GMOs?
The National Biosafety Authority was established in 2009. The Board was inaugurated in May 2010 and in the last two years, the Authority has made deliberate steps to recruit its staff including top management. These recruitments were done in competitive basis; hence we achieved the best talents for the positions that were being filled.
The Biosafety Act of 2009 requires NBA to collaborate and regularly consult with 8 other Regulatory Agencies that have specific mandates on biosafety. These include; Department of Public Health (DPH), Department of Veterinary Services (DVS), Kenya Bureau of Standards (KEBS), Kenya Plant Health Inspectorate Services (KEPHIS), Kenya Industrial Property Institute (KIPI), Kenya Wildlife Service (KWS), Pest Control Products Board (PCPB) and National Environment Management Authority (NEMA).
Biotechnology is understood by few people and even scientists themselves. Most information has been from policy makers of NGOs who are either for or against and the few scientists that understand it have not come out strongly as required and this may be the missing link. However, I can authoritatively report that NBA is now available at all border points to test all GMOs.
Any pertinent challenges NBA is facing as the lead regulator of GMOs?
There is a lot of misinformation out there and NBA is fully mandated to create awareness and involve the public. That is why we declared this as the Year of National Biosafety Advocacy where we are engaging all stakeholders from secondary school students to the scientists’ level. We also hope to develop a curriculum to help scale up biosafety advocacy in the country. The idea behind this is to promote awareness and seek support from stakeholders towards promoting bio-safety.
The youth are better placed to take up this technology if you engage them when young. This could also help in reducing myths behind genetically modified organism (GMO). We are also looking for ambassadors who can spread the message on the safety of GMOs approved by the Authority.
As for the ban on GM food, we hope the new cabinet will lift the ban. No doubt there are still concerns on safety of GMO as evidenced by the recent ban on all GM food in Kenya by the Cabinet until such a time when there is sufficient information and knowledge stating that they are not a danger to the public. NBA has already addressed all the safety concerns raised to confirm safety of GMO foods.
We would like to inform the nation that any GM food that has been approved for use or transit in Kenya is safe and the public should rest assured that NBA exists to protect them and to take care of consumer interests. The Authority is the gatekeeper on all GMO products in Kenya and for any queries or more information, the public should contact us through phone numbers: 020 2678667 or 0713854132, website: www.biosafetykenya.go.ke, email: email@example.com, Facebook: National Biosafety Authority, Kenya or twitter: @biosafetykenya.