NATIONAL BIOSAFETY AUTHORITY STEPS INTO LIMELIGHT AS KENYA OKAYS GM FOODS

By Catherine Odhiambo

The National Biosafety Authority (NBA) was established by the Biosafety Act No. 2 of 2009 to exercise general supervision and control over the transfer, handling, and use of GMOs. GMOs are products of modern biotechnology that involve the manipulation of the genetic material of organisms through genetic engineering procedures.

“GMO is either a plant, an animal or a microorganism that has new genetic composition, or that has been altered through modern biotechnology,” elaborates Dr.Mugiira.

When GMOs initially gained notoriety, customers expressed concern about their safety. Additional elements like socioeconomic status, cultural practices, and religious convictions also impacted how people perceived these new breeds. Consequently, the international community negotiated a protocol called the Cartagena Protocol on Biosafety that is anchored under the Convention on Biological Diversity, to which Kenya is a party.

“We want to assure our consumers and particularly the Kenyan public that that which we have checked and put our seal of approval on is indeed safe,” he reiterates.

HIERARCHY OF LEADERSHIP

The Authority was founded with the goal of regulating the research and commercial use of genetically modified organisms in order to protect the environment and ensure human and animal health.

The Authority is governed by a Board of Directors comprising nine members. They include a Chairperson; representatives of four Principal Secretaries from the Ministries of Education (as the Ministry responsible for Science and Technology), The National Treasury, Ministry of Agriculture and Livestock Development, and the Ministry of Health; Two experts in the biological, environmental, and social sciences respectively, one member with financial expertise, and the Chief Executive Officer (CEO) who is an ex- officio member.

The CEO is backed by two Directors in the Technical area, one Director in Corporate Services, another Director in Planning and Strategy, and a Director in the Legal and Cooperation area, collectively known as the "Cooperation Secretary Office.”

In addition to an operational border post in Namanga, NBA also maintains outposts at the Jomo Kenyatta International Airport (JKIA), which is overseen from the Nairobi headquarters, one in Mombasa, and the final one in Busia. These outposts are used to monitor products entering the country and guarantee compliance.

“We hope to expand but we are limited by resources. The 10-year ban didn't see quite a bit of movement in this space. That is why you have seen after the lifting of the ban, it is like we have been taken out of the freezer. Now we are out there and we hope to fall back on track quickly enough so that we can pick up our mandate as is required,” notes the NBA boss.

Staff at the national Biosafety Authority Lab in Nairobi

ROBUST REGULATIONS TO MAN GMO SECTOR

Nonetheless, a number of stakeholders have expressed concern over whether the nation is prepared to end the embargo. According to Dr. Mugiira, Kenya laid down the groundwork for biotechnology way before the year 2000 when the Cartagena Protocol was signed into law by the late former President Daniel Arap Moi and later ratified in the year 2003. In 2006, Kenya published the National Biotechnology Development Policy followed by the enaction of the Biosafety act which now established the National Biosafety Authority.

In 2011, the country published three sets of regulations. One such regulation was the Contained Use Regulations published in August 2011 to guide activities involving GMOs under containment and confinement. These regulations are applied during research on GMOs while still in the laboratory, greenhouse, growth chamber, and confined field trials.

“We also published regulations for Environmental Release. If we are releasing a GM crop into the environment for cultivation, these regulations clarify the forms to be filled, any costs to be incurred, and safety evaluation procedures,” says Dr. Mugiira.

The third regulation was the Import, Export, and Transit Regulation which as the CEO points out is a hot topic of discussion currently. They give explicit protocols on importing, exporting, and transportation of GMOs and guidance on steps to undertake in case of unintended release of the items into the environment while in transit. Under the regulations, any person(s) involved in GMO import for consumption or research, GMO export to any country, and GMO transit from one country to another through Kenya is/are required to seek approval from the Authority.

Later in 2012, the Authority released the Biosafety Labeling Regulation to ensure that consumers are made aware that the food, feed, or product is genetically modified so they can make an informed decision. The regulation also facilitates product traceability to assist in the implementation of the necessary risk management strategies when necessary. The regulations aim to make it easier to accurately label products, monitor their impacts on the environment and, when necessary, human health, and put in place the necessary risk management strategies, such as pulling products off the market.

Subsequent to the release of the Biosafety Labeling Regulation, the government banned the importation and use of genetically modified crops, thanks to a publication publicized by a French scientist by the name Professor Séralini. This effectively put the NBA's regulatory system on ice.

“For 10 years, we have just been dealing with research work, except the approval of Bt cotton, which was approved in 2020 responding to the need to revitalize the cotton apparel value chain. So in essence, therefore, we have been ready way before 2000.

“We have the capacity, both in our research institutions, and also our regulatory framework, which includes eight other regulatory agencies,” echoed Dr. Mugiira.

IMPORT PROTOCOLS AND SAFETY TESTS

Following the lifting of the ban, the NBA updated some facets of the Export, Import, and Transit Regulation including digitizing the application process. They also updated a platform known as KenTrade and identified a seven-step procedure to be followed by potential GM food importers. All import procedures begin with the completion of an Import Declaration Form (IDF), which details the products the importer plans to bring in, who the products are from, where they are coming from, and what components of the products are GM or non-GM. Dr. Mugiira claims that when that is indicated, it raises a flag for NBA inspection.

“So within the KenTrade platform, as KEPHIS is looking at the potential for insect pests and diseases, as KEBs is looking at moisture and aflatoxin among other things, we are looking at what GM is in that commodity,” he informs.

Subsequent to clearance from the partner organizations, NBA doesn’t conduct repeat tests owing to the large costs and a potential delay to trade. Instead, they only verify the approval of the specific gene in the commodity for use as food, feed, and processing in its country. Once verified, the findings are posted in the Biosafety Clearing House, a virtual Clearing House, where state parties to the Cartagena Protocol post all decisions. This then paves way for the release of the product for use in the country.

“However, if the product is coming as a seed which will be required to germinate in our environment, it will be required to have been approved here for environmental release,” he points out.

GENOME EDITING UNPACKED

Last year, Kenya joined its Nigerian counterpart in establishing guidelines for the Genome Editing (GE) technology, a more recent innovation that does not involve the transfer of genetic material from one organism to another. Nonetheless, one can question the need for GE regulations given the existence of GM ones. What defines the difference between these two?

Dr. Roy clarifies that in GE, instead of bringing a gene fragment from another source, the scientists go into the organism, identify the genome of interest and edit it either by removing it or modifying it constitutively.

“Hence the crops are not classical GMOs as they don’t have the novel gene from another source and should not be regulated in a similar manner,” he explains.

The guidelines were developed to provide technical guidance to applicants and reviewers on which genome editing organisms and/or products are regulated under the Biosafety Act 2009 or not, as genome editing can result in either a GMO or non-GMO depending on the pathway followed in the editing process. The applicants are supposed to consult with the Authority early enough for them to assess their research and issue a verdict on the product category.

The other feature of the GE regulations is the three pathways where if the researcher ends up with GMO it becomes the NBA’s interest, if not, it becomes the interest of other regulatory agencies.

“Where there are transient stages that are GM, we regulate up to the point where it has exited the GMO component. That approach resonates well with several other jurisdictions including Argentina, Nigeria, India, and Malawi.

“It is an approach that is universally agreed upon. And that has made us reasonably popular. We are now being invited to share our experiences with that approach,” says Dr. Mugiira.

NBA works hand in hand with several regulatory agencies as stipulated in the first schedule of the Biosafety Act. Key among them is the Kenya Plant Health Inspectorate Service (KEPHIS) which also deals in crops. Others include the Department of Public Health, Department of Veterinary Services (DVS), Kenya Bureau of Standards (KEBS), Pest Control Products Board (PCPB), National Environmental Management Authority (NEMA), Kenya Wildlife Service (KWS), and Kenya Industrial Property Institute (KIPI).

Internationally, the Authority has partnered with the African Union Development Agency NEPAD (AUDANEPAD) which manages a program called the African Biotechnology Network of Expertise (ABNE).

“This program helps African countries to develop regulatory frameworks. They’re supporting us a lot in developing our regulations around genome editing and also in the rollout of biotechnology,” he says.

They also work with an institution called the Program for Biosafety Systems, a program under the International Food Policy Research Institute (IFPRI) of the U.S., in the development of frameworks and especially in the coordination framework for the regulatory agencies. In terms of food safety assessment, they work with the Food and Agriculture Organization (FAO) of the United Nations, the World Health Organization, and the Codex Alimentarius Commission. Debunking the myths through public education

Besides the NBA’s regulatory role, the Authority is also mandated to provide public education and awareness. A lot of myths and misconceptions have flooded the internet with no voice of authority to set the record straight, an issue Dr. Mugiira attributes to the 10year silence occasioned by the ban on GM foods.

“You cannot tell a story if you have nothing to tell. We are now able to tell a story because we can talk about Bt cotton, which is already with farmers. Farmers can come out themselves and even tell us their experiences generally.

“And the best way of communicating is people sharing experiences. So the 10 years, have been really quiet. And that is one of the reasons why our role in public education, public awareness, and Public Communications has been low,” he says.

In a bid to up that game, NBA is mulling on revitalizing a program launched by His Excellency, President William Ruto, when he was serving as Minister for Agriculture in 2008, known as the ‘Bio Aware program’.

“Hence, public education and awareness have long been recognized as being necessary. I have already requested financial facilitation from the government so that we can roll out a structured, coordinated public education, public engagement, public communication program,” Dr. Mugiira revealed noting that the Authority currently only engages in ad hoc modes of awareness creation, an initiative that has earned him the title, ‘GMO man’.

Dr. Roy underscored the need for the public to be made aware that GM farming is not the opposite of organic farming since one can grow GM crops that are also organic. Just like farmers utilize organic chemicals/fertilizers on their nonGM crops, the same can be adapted to their GM counterparts. To avoid cross-pollination with nonGM crops, the Authority recommends distancing. In the event that cross-breeding actually happens, the transgene is lost in the second generation.

“Where we want to maintain purity is at the seed production level. At the crop cultivation level, we are saying this is safe, it can go to the cultivation and we will progressively see it not appearing in the non-GM crop production system after generations of cultivation,” he explains.

REGULATORY OVERLAP AND LIMITED RESOURCES STILL A CHALLENGE

While NBA jubilates the country’s move to open its doors to GMOs, the Authority is still left to grapple with the impacts of staying underground for over a decade. Making do with a 2010-2011 budget is no mean feat given the current economic status not only of the country but of the global community at large. This has restricted the NBA’s capacity to carry out public education and awareness and in turn, limited the potential uptake of the technology.

“Today, if you ask somebody, ‘if I made ugali from GM corn, would you partake of that meal?’ Somebody would want to run away. So it means therefore even the acceptance of the technology is low,” Dr. Mugiira says.

The Authority also has to battle with an overlap in the regulatory framework that hinders the seamless coordination among partner institutions.

“For example, within the Environmental Management Act (EMCA), there is a provision for subjecting projects of biotechnology, particularly testing of GM commodities or crops to environmental impact assessment, while we have already conducted environmental risk assessment. So it becomes like a duplication, or even an unnecessary kind of undertaking,” comments the CEO adding that there are a number of other gap areas in legal provisions that NBA intends to address with the country’s legislature.

CONTINUOUS LEARNING TO STAY ON THE RADAR OF TECHNOLOGICAL ADVANCES

To continuously keep up with the rapidly evolving scientific and technological innovations, NBA takes its staff through incessant training sessions that also encompass short courses. These training sessions are backed by partner organizations like the AUDA-NEPAD. The UN has also come in handy in facilitating the Authority’s human technical capacity building. NBA has thus far held two training sessions on genome editing and the proposed regulatory framework for the Board and top policymakers in the government.

“We are also embracing IT in our operations so that we step out of the paper and file processes. Our clients who need us to clear them for GMO-free certificates can access our services virtually. This has enabled us to enhance our service delivery. So it is training, training, and some more training and also setting up the infrastructure for ICT,” informs the NBA Head.

DELICATE BALANCE BETWEEN INNOVATION AND SAFETY

As new technologies emerge, there is a risk that they could fall into the wrong hands and end up being utilized as bioweapons. Dr. Mugiira informs of the existence of a sister institution called, the ‘National Commission for Science Technology and Innovation (NACOSTI) established to specifically regulate science research and innovation. NACOSTI implements the requirements of the Biological Weapons Convention (BWC) which prohibits the development, production, acquisition, transfer, stockpiling, and use of biological and toxin weapons.

However, he affirms that there is a delicate balance between innovation and safety, and regulations alone cannot bridge that gap. As a result, he urges scientific professionals to self-regulate. Just as food safety is everyone’s business, responsible innovation should also be everyone’s business.

“Our role, therefore, is to ensure that this technology doesn't find itself in the wrong hands and be used for purposes of enhancing the virulence of a disease-causing pathogen for example, for use in biological warfare, or even in hostile activities of terrorists and groups like those,” he says.

SOLDIERING ON DESPITE THE HURDLES

According to Dr.Mugiira, NBA has been able to put in place a robust science-based regulatory system that has been tested and tried over time. It is on account of this robust framework, that the former CEO, Professor Dorington Ogoyi shepherded the approval of Bt cotton amidst a very hostile environment.

“By demonstrating how Bt cotton can contribute to socioeconomic development, the Authority was able to take it through all the phases up to the doorstep of the farmer, which is a major achievement, and it has been a big test for our regulatory system,” he highlights when asked some of their achievements.

The Authority has also been able to oversee the National Performance Trials for Bt maize and was almost releasing it to farmers were it not for the obstruction by the court. Moreover, it has 32 GMO projects for contained use and 12 for confined field trials in various research facilities in the country, to date.

With an eye toward the future, NBA seeks to control and direct new bioscience fields including synthetic biology and the militarization of biotechnology. In the medium term, the authority has a strategic plan running through 2025 and an upto-the-task management team which Dr. Roy is confident will ensure it remains relevant in an ever-changing technology and regulatory landscape.