A GM breeding stack refers to a GMO that contains two or more separate transgenic events that have been combined through conventional breeding. If the single events and the highest order stacks have already been approved by NBA, any other sub-combinations of those same events will require a notification to the Authority for approval for commercialization. If any of the single events have not been approved, an application for full risk assessment will be required. For the highest order stack, the applicant will be required to demonstrate that there are no gene interactions that introduce new risks.

In Kenya, GM breeding stacks must undergo different levels of assessment before approval for commercialization or environmental release. An applicant needs to submit an application  in the prescribed format and pay the applicable fees for GM Breeding Stacks  .

National Performance Trials (NPTs) are scientifically designed evaluations conducted to assess performance, adaptability and value for use of GMOs under localized conditions. These trials are mandatory before any GMO can be considered for commercialization. Approvals for NPTs are granted by NBA. In Kenya, NPTs are an integral part of commercialization decision making process, conducted in collaboration with other relevant regulatory agencies under local conditions.  

An applicant can submit an application for placing on the market for agricultural purposes, importation for food, feed or processing, industrial applications and environmental remediation. NBA evaluates the application based on relevant data for environmental and food safety assessment as well as history of use on a case-by-case basis. If granted approval, the applicant is required to provide a monitoring plan including stewardship program. An applicant needs to submit an application in the prescribed format and pay the applicable fees for Environmental Release and Placing on the Market.

Post Release Monitoring (PRM) is done after environmental release in order to assess the impact of any unidentified or unanticipated risks of a GMO to human and animal health and the environment. PRM is the primary responsibility of the applicant who has been granted approval by NBA and is required to submit monitoring reports periodically. The Authority also conducts independent monitoring through general surveillance and/or case specific monitoring to assess socio-economic impact in addition to safety issues and also to check the efficiency of stewardship programs undertaken by the applicant. Moreover, NBA uses regulatory data from relevant agencies in the monitoring process.

Market surveillance involves the routine or scheduled inspection, monitoring and sampling of products in the market. NBA conducts market surveillance:

1. To ensure that no unapproved GMOs have been placed on the market;
2. To ensure that approved GMO products are correctly labelled according to the Biosafety Labelling regulations;
3. To ensure that products do not have misleading labels regarding their GMO status;
4. To ensure that all GM-free labelling claims are verified and approved by NBA; and
5. For sampling and testing to confirm the presence or absence of genetically modified (GM) material.

In Kenya, labelling of GM and GM-free products is regulated by the Biosafety (labelling) regulations, 2012. Labelling is done to ensure transparency, consumer choice, traceability and safety in the handling and marketing of GMOs and their derived products. Labelling of GMOs is mandatory whereas GM-Free labelling is voluntary but requires mandatory verification and approval by NBA. An applicant needs to submit an application in the prescribed format and pay the applicable fees for GM and GM-Free Labels .

Annual registration and licensing is a regulatory requirement for any entity involved in trade, processing, packaging, storage, handling and transportation of GMOs, already approved for use, to ensure that it is done safely and transparently in compliance with approval conditions.

NBA conducts regular inspections to ensure that all license holders adhere to the given approval conditions. An applicant needs to submit an application in the prescribed format and pay the applicable fees for Annual Registration and Licensing of Handlers, Operators and Facilities of GMOs .