The National Biosafety Authority (NBA) has officially released its updated fee structure for a wide array of services related to the handling and regulation of genetically modified organisms (GMOs) and other biosafety-related matters. The new charges, effective from 1st October 2024, encompass a range of services aimed at ensuring the safe use and management of GMOs in Kenya, aligning with the country’s regulatory framework under the Biosafety Act, 2009.
This updated schedule includes fees for the approval of genetically modified applications, the handling of genetically modified material, genome editing applications, and the issuance of biosafety certificates. The NBA plays a critical role in maintaining public and environmental safety by overseeing the use, import, and production of GMOs.
New Fee Schedule Highlights
The NBA’s fee structure introduces specific charges for various types of applications and services, providing clarity and transparency for all stakeholders involved in the biosafety and GMO sectors.
- Genetically Modified Organism (GMO) Applications:
- A fee of KES 60,000 per each additional facility is required when applying for approval of GMOs for confined field trials.
- Applications for GMO environmental release or placing in the market will incur a cost of KES 170,000.
- Those seeking public notification for environmental release or placing on the market will need to cover the actual cost of publication.
- Genome Editing Applications:
- The NBA charges KES 30,000 for changes or modifications of research protocols where no field trials or additional risk assessments are required.
- Early consultation services on genome editing applications are available for KES 850,000.
- Approval fees for genome editing applications are also pegged at KES 850,000.
- Low-Level Presence Situations:
- For consignment approval involving low-level GMO presence, a fee of KES 20,000 per consignment is charged for shipments up to 40 metric tonnes.
- Additional fees include KES 5,000 per consignment for consignment notifications, as well as KES 30,000 for inspections related to GMOs in consignment shipments.
- Molecular Laboratory and Biosafety:
- The NBA charges KES 25,000 per sample for GMO screening and KES 5,000 per sample for GMO event identification.
- Outsourced GMO detection services come at a cost of KES 10,000.
- Licensing and Inspection Fees:
- Annual licensing fees for operators handling GMOs, such as handlers and processors, begin at KES 30,000.
- Clearance and inspection of cargo at points of entry incur fees ranging from KES 2,000 to KES 3,500 per consignment.
- Training and Registration Services:
- Biosafety training for institutional biosafety committee members, along with the issuance of non-objection letters, are part of the NBA’s service offerings. Fees for such services start from KES 30,000 per entity.
Ensuring Public Safety and Regulatory Compliance
The National Biosafety Authority, as a state corporation established to regulate GMO use and ensure the protection of human, animal, and environmental health, plays a key role in providing oversight on the introduction of GMOs into the Kenyan ecosystem. The fees associated with NBA services are geared toward enhancing operational efficiency while ensuring that all GMO-related activities comply with Kenya’s biosafety regulations.
The updated fee schedule aligns with international best practices in GMO regulation, ensuring that Kenya remains at the forefront of biosafety oversight in Africa. By introducing these fees, the NBA ensures that it has the resources necessary to rigorously monitor GMO usage and enforce compliance with biosafety laws.
Striking a Balance Between Innovation and Safety
The growing use of genetically modified organisms in agriculture, medicine, and research makes NBA’s role more critical than ever. With Kenya’s agricultural sector facing multiple challenges, including food security and the need for sustainable farming practices, the regulated use of GMOs could offer solutions. However, safeguarding public health and the environment remains a priority.
The NBA’s introduction of these fees ensures that research institutions, biotech companies, and other GMO handlers have a clear framework for applying for approvals, conducting trials, and commercializing genetically modified products. This regulatory clarity is expected to encourage more innovation while ensuring that public and environmental safety is not compromised.
Supporting Kenya’s Biosafety Ecosystem
In addition to the updated fee structure, the NBA has also expanded its services in biosafety management, including the issuance of biosafety certificates, handling non-GMO products, and maintaining oversight on GMO labeling. The agency has implemented systems to ensure that the fees collected are used to support Kenya’s biosafety ecosystem, including building institutional capacity, conducting more inspections, and enhancing monitoring systems.
Conclusion
The new fee structure introduced by the National Biosafety Authority marks a pivotal moment for the regulation of GMOs and biosafety in Kenya. With these fees set to take effect from 1st October 2024, stakeholders across the biotech and agricultural industries will be better equipped to navigate the regulatory landscape while ensuring that all GMO-related activities adhere to stringent safety standards.
Kenya’s commitment to biosafety is evident in this updated fee schedule, which not only provides transparency but also emphasizes the country’s dedication to ensuring that genetically modified products are handled in a way that safeguards the environment and the public. As more companies and research institutions delve into GMO technologies, the NBA’s role will continue to be essential in promoting innovation while protecting Kenya’s natural resources.
