Burkina Faso publishes latest gene edited crop regulations
Burkina Faso have published their Guide Technique pour la Réglementation de la Biotechnologie Moderne : Édition Génomique (Technical Guide for the Regulation of Modern Biotechnology: Genome Editing), by the Agence Nationale de Biosécurité (ANB).
The document issued by Burkina Faso's ANB under the Ministry of Higher Education, Research and Innovation, providing secondary interpretive instrument to build upon the existing primary biosafety legislation (Law 064-2012/AN of 20 December 2012 on biosafety in biotechnology and its implementing decrees).
This law defines a genetically modified organism as any organism whose genetic material has been modified other than by natural multiplication or recombination. The new secondary framework states that organisms and products derived from genome editing do not always fall within the GMO definition.
Burkina Faso uses transgene presence / absence as its primary trigger, with a secondary criterion around novel genetic combinations from sexually incompatible species.
The ANB will exempt genome-edited organisms and their derivatives from the biosafety law when:
- Absence of a transgene in the final product
- Absence of a novel combination of genetic material from sexually non-compatible species resulting from the use of modern biotechnology.
The standard GMO decision-making procedure applies in all other cases. The decision on whether a product is GMO or non-GMO rests with the ANB.
The process involves pre-submission consultation with the ANB, completion of a determination form, physical and electronic submission of the dossier, and payment of examination fees. A decision is taken within 21 days of receipt of the completed application. The ANB may request supplementary information during review.
flow chart guides applicants through the three-question logic: (1) Is there a transgene or novel genetic combination? (2) Is it used only temporarily? (3) Is it present in the final product?
The national biosafety institutional framework under Law 064-2012/AN comprises the ANB as the competent authority, supported by two advisory bodies: the Comité Scientifique National de Biosécurité (CSNB), which conducts technical risk assessment, and the Observatoire National de Biosécurité (ONB), responsible for public surveillance and education. Institutional Biosafety Committees (CIBs) are also established within higher education and research institutions.
The CSNB's evaluates applications, proposes corrective measures, validates risk management plans, assesses economic profitability and ethical compliance, and makes recommendations to the ANB.