High Court Told Kenya GMO Approval Process Aligns With Global Standards

The National Biosafety Authority (NBA) has defended the legal and regulatory framework governing genetically modified organisms (GMOs) in Kenya. The state agency told the High Court that the country has established comprehensive safeguards designed to protect human health, animal health, and the environment.

In a replying affidavit filed in response to a petition challenging the regulation of these products, NBA Acting Director of Biosafety Research and Compliance Josphat Njogo Muchiri stated that the local oversight regime remains anchored on international agreements, national legislation, and detailed regulatory guidelines.

According to the submission, Kenya ratified the Cartagena Protocol on Biosafety in 2003, before enacting the National Biotechnology Development Policy in 2006. These steps culminated in the Biosafety Act, which formally established the NBA as the lead agency responsible for regulating genetically modified products.

The authority argued that before any GMO product is approved for use, importation, cultivation, or commercialisation, it must undergo a rigorous scientific assessment involving multiple government agencies, independent experts, and public participation processes.

The court heard that applications are subjected to extensive risk assessments by the NBA. These requests are subsequently reviewed by several state agencies, including the Kenya Plant Health Inspectorate Service (KEPHIS), the National Environment Management Authority (NEMA), the Kenya Bureau of Standards (KEBS), the Kenya Wildlife Service (KWS), the Directorate of Veterinary Services, and the Department of Public Health.

The NBA further stated that all applications are publicised in national newspapers. This measure allows members of the public to submit comments and voice concerns before any final regulatory decision is made by the board.

Muchiri noted that genetically modified crops undergo environmental impact assessments, national performance trials, and distinctness, uniformity, and stability tests before final approval is granted. The authority maintained that its previous approval decisions remain the prevailing legal position, given that they have not been overturned on appeal.

Addressing claims that county governments were excluded from the decision-making process, the NBA argued that the regulation of genetically modified organisms remains a national function. This is because biotechnology cuts across several key sectors, including health, environment, wildlife conservation, and industrial development.

The authority maintained that GMO regulation is not expressly assigned to devolved units under the Constitution, meaning it falls within the mandate of the national government. The NBA added that even where a function has devolved aspects, there is no constitutional requirement that it must be implemented directly by county governments, citing national agencies that operate countrywide while exercising oversight over devolved sectors.