Parliament approved the relevance of a draft law governing biosafety, which aims to address the potential risks associated with genetically modified organisms (GMOs), protect biodiversity, and preserve the integrity of the environment, according to the government.

The relevance of the bill which was approved on August 2, will later be scrutinised by a responsible parliamentary committee, and later be put to a vote by the Lower House’s Plenary Sitting.

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GMOs include crops and other living organisms such as livestock animals.

According to the UN Food and Agriculture Organization (FAO). GMO crops are those that have genes inserted from the same or unrelated organism using genetic engineering methods.

These genes confer beneficial traits such as pest resistance, ability to grow in extreme and unfavourable conditions such as drought and increased nutrient levels among others.

Rwanda’s Vision 2050, according to an explanatory note of the bill, aims at ensuring high quality standards of living for all Rwandans while targeting attainment of upper middle-income country status by 2035 and high-income status by 2050. In view to achieve this vision, there is progression of the development and application of biotechnology.

Currently, it added, the trend is in genetic engineering for the production of pharmaceuticals, industrial materials and agriculture.

Despite advancements in the development and application of biotechnology, the explanatory note indicated, there are broad concerns about the potential risks resulting from modern biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity and human health.

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The draft law, through which the government seeks to address identified issues, is composed of five chapters and 34 articles.

The following are 10 key provisions of the bill.

1. Scope of application

This law applies to the transboundary movement, transit and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity and risks to human health, according to an explanatory note of the bill.

It added that it does not apply to living modified organisms that are pharmaceuticals for human use addressed by other laws.

2. National Biosafety Committee

The bill provides that a National Biosafety Committee is established for the purpose of assisting and providing expertise in reviewing applications (related to GMOs). The Committee also advises the authority in charge of management of the environment – which is referred to in the bill as the Authority.

The Committee may require a sub-committee for technical assistance, if necessary.

A Ministerial Order determines the composition, responsibilities and functioning of the National Biosafety Committee, according to the bill.

3. Institutional Biosafety Committees

A person who wishes to carry out contained use and confined field trials operates under requirements set up by the Institutional Biosafety Committee.

Contained use means an operation undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with and their impact on the external environment, according to the bill.

The Institutional Biosafety Committee assesses and approves works classified as minimal risk and low risk approved and provides a copy to the Authority.

The Authority assesses and approves works involving a higher level of risk.

A Ministerial Order determines the composition, certification and responsibilities of the Institutional Biosafety Committee.

4. Activities subject to permit application

Activities are subject to the permit application are contained use of a living modified organism; confined field trials of a living modified organism; intentional introduction of a living modified organism into the environment; to place on the market a living modified organism for direct use as food, feed or for processing; to import, transit or export a living modified organism; and to handle, package, label, transport or store a living modified organism.

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A person who wishes to carry out any of the cited activities must apply for a permit issued by the Authority in charge of management of the environment.

The Authority consults the Ministry in charge of health before issuing a permit for use or place on the market the living modified organism to be used for food or feed for human or animal consumption.

A Ministerial Order determines modalities for permit application, its requirements and procedures. It also determines the information contained in the application file for each type of activity.

5. Assessment of risks relating to living modified organism

A person who wishes to carry out any of the abovementioned activities must make a mandatory assessment of the potential risk to human health or environment.

A risk assessment report must be included in each application file.

The Authority establishes the guidelines to comply with in conducting the living modified organism risk assessment.

6. Management of risks relating to a living modified organism

A person that carries out an activity relating to a living modified organism develops and maintains a risk management plan and strategy and post-release monitoring plan of a living modified organism.

The Authority establishes the guidelines to comply with in conducting the living modified organism risk management plan.

7. Living modified organism risk assessment report review

The National Biosafety Committee carries out the risk assessment report review of a living modified organism.

Following the report review of the risk assessment, the National Biosafety Committee makes a report on its findings and indicates measures to be taken to ensure the safe use of the living modified organism as recommendations to inform the decision by the Authority. The National Biosafety Committee may as well recommend additional risk assessment.

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8. Exemption of a living modified organism

The Authority may exempt a living modified organism from some requirements of risk assessment and management where there exists sufficient experience or information to conclude that the living modified organism or its activity does not pose a significant risk to human health or the environment.

9. Faults and sanctions

A person who – violates the terms and requirements of a permit issued under this Law; does not handle, label, package or identify a living modified organism in accordance with the provisions of this Law and regulations in force; handles, labels, packages or identifies a living modified organism in a manner that is false, misleading and deceptive or in contravention of this Law; commits a fault and is liable to an administrative fine of not less than Rwf1 million but not more than Rwf5 million.

10. Offences and penalties

A person who does the following acts commits an offence, and upon conviction, he or she is liable to imprisonment for a term of not less than three years but not more than five years, and a fine of not less than Rwf10 million but not more than Rwf20 million, the bill has proposed.

The acts in question are making confined field trials or contained use, releasing into the environment, placing on market, importing or exporting a living modified organism without authorisation from the Authority; withholding information that has become available to the applicant after the approval of his or her application and that could change the evaluation of the risk posed by the project of the implicated person.

Others are providing false, misleading or deceptive information intentionally in order to secure an approval or a permit under this Law; using a living modified organism for mischievous or unethical purposes; and obstructing the Authority or its officers in performance of a function under this Law.