Inside Rwanda's biosafety law set to regulate GMOs

Rwanda, on February 21, promulgated a law governing biosafety, which seeks to ensure that genetically modified organisms (GMOs) are handled, transferred and used safely in the country. Its enactment comes when the Rwanda Agriculture and Animal Resources Development Board (RAB) is carrying out confined field trials on a variety resistant to cassava brown streak disease and cassava mosaic disease – two major viral diseases affecting the staple crop. A confined field trial (CFT) means an experimental release of a GMO into a specific place designated in the environment under physical and biological confinement conditions, which effectively limits its impact on a human being or environment, according to interpretation in the law. Also, information from RAB indicates that the institution got approval from the Rwanda Environment Management Authority (REMA) to conduct confined field trials on a GMO potato variety [resistant to late blight – a destructive potato disease mainly during the rainy season]. The move, it said, could ensure that farmers get good potato yields and save them the costs they were incurring on a lot of pesticide sprays in an attempt to mitigate disease-induced losses. ALSO READ: Genetically modified potatoes could address honey crisis – scientists As per the law, the authority in charge of environment management is designated as the national competent entity to ensure coordination of its enforcement. It is referred to as the authority throughout the law and serves as the national focal point for the Cartagena Protocol on Biosafety. The protocol seeks to create an enabling environment for environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that modern biotechnology has to offer, such as living modified organisms (LMOs) – also known as GMOs, while minimising the possible risks to the environment and human health. Common LMOs (or GMOs) include crops that have been genetically modified for greater productivity or resistance to pests or diseases, according to the Convention on Biological Diversity – an international treaty on biodiversity conservation. ALSO READ: How agricultural biotechnology could boost food security Below are 10 key provisions in the law: 1. Purpose of the law The law establishes an adequate level of protection in the field of the safe transfer and use of living modified organisms, resulting from modern biotechnology that may harm the conservation and sustainable use of biological diversity while taking into consideration the effect of this transfer and use on human health. 2. Scope of application The law applies to the transboundary movement, transit and use of all living-modified organisms through modern biotechnology, which may have adverse effects on the conservation and sustainable use of biological diversity and risks to human health. However, living modified organisms that are pharmaceuticals for human use are not governed by this law. 3. Activities subject to permit application The law provides that activities subject to the permit application; are contained use of a GMO, its confined field trials, intentional introduction of a GMO into the environment, placing a GMO on the market for direct use as food, feed or for processing, importing, transiting or exporting, and its handling, packaging, labelling, transporting or storage. An Order of the Minister in charge of the environment may determine other activities subject to permit application. It adds that a Ministerial Order determines modalities for permit application, its requirements and procedures. It also determines information contained in the application file for each type of activity. Meanwhile, the law provides that an applicant may withdraw his or her application at any time before the authority issues the final decision. 4. Decision-making on an application In deciding on an application regarding a GMO, the authority takes into account the information submitted by the applicant, a risk assessment report, the risk assessment review report submitted by the National Biosafety Committee, a risk management plan and strategy and post-release monitoring plan of a GMO, and a submission related to the application under consideration, submitted by a member of the public, if any. 5. Assessment of risks relating to a GMO A person who wishes to carry out any of the activities indicated above must first disclose the result of a mandatory risk assessment carried out as to the potential risks to the environment in general, or to human health in particular. A risk assessment report must be included in each application file. The authority establishes the guidelines to comply with in conducting a GMO risk assessment. 6. Management of risks relating to a GMO A person who carries out an activity relating to a GMO develops and maintains its risk management plan and strategy and post-release monitoring plan. The authority establishes the guidelines to comply with in conducting a GMO risk management plan. 7. Creation of National Biosafety Committee The law provides for the establishment of a National Biosafety Committee to assist and provide expertise in reviewing applications [regarding GMOs]. The committee also advises the authority (in charge of environment management). Based on a report submitted by the National Biosafety Committee, the authority may request the applicant in writing, to set up an Institutional Biosafety Committee within the prospective institution while stating in the same notice, directions for the Institutional Biosafety Committee. An Order of the Prime Minister determines the composition, responsibilities and functioning of the National Biosafety Committee as well as its term of office. The National Biosafety Committee carries out the risk assessment report review of a GMO. Following a report review of the risk assessment, it makes a report on its findings and indicates measures to be taken to ensure the safe use of the GMO. 8. Exemption of GMO from risk assessment and management The authority may exempt a GMO from some requirements of risk assessment and management where there exists sufficient experience or information to conclude that it, or its activity, does not pose a significant risk to the environment in general or to human health in particular. ALSO READ: Rwanda ready to harness GMOs tech, official tells EAC lawmakers 9. Cessation orders – for a licence holder to cease GMO activities When the authority finds that there is a danger posed to the conservation and sustainable use of biological diversity, it may suspend the authorised activity per the law, revoke the permit and permanently stop the authorised activity, or impose additional risk management measures concerning the authorised activity. Also, the authority may decide to revoke the permit and permanently stop the authorised activity when the permit holder fails to comply with the terms of the permit in accordance with this. 10. Offences and penalties Failure to label GMOs or misuse of label The law provides that a physical person who fails to label a GMO, packages or identifies a GMO in a manner that is false, misleading, deceptive or in its breach, commits an offence. Upon conviction, he or she is liable to a term of imprisonment not less than one year and not more than three years and a fine of not less than Rwf3 million and not more than Rwf10 million. Release into the environment, placing a GMO on market without permit According to the law, a physical person who releases into the environment, places on the market, transports, imports, transits or exports a GMO without a prior permit from the authority, commits an offence. Upon conviction, he or she is liable to a term of imprisonment not less than one year and not more than three years, and a fine of not less than Rwf3 million and not more than Rwf10 million, or one of these penalties. Using a GMO in a harmful way As per the law, a physical person who uses a GMO in a way that causes harm to the environment or human health commits an offence. Upon conviction, he or she is liable to a term of imprisonment not less than three years and not more than five years, and a fine of not less than Rwf3 million and not more than Rwf10 million or one of these penalties. Overall, when the offences mentioned above are committed by a legal person – a company, a cooperative, a national or international non-governmental organisation, a faith-based organisation with legal personality or any other entity with legal personality – a fine imposed on them is 10 times that provided for each of the offence.

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Inside Rwanda's biosafety law set to regulate GMOs