Kiribati Draft Biosafety Regulation and Environment Act 2021

The draft Biosafety Regulation is currently in the finalization stage, in consultation with key stakeholders, to ensure alignment with existing biosafety-related legislation enforced by other sectors and to avoid duplication of roles, responsibilities, and regulatory actions.

Kiribati complies with Article 5 (Pharmaceuticals) of the Cartagena Protocol on Biosafety, which excludes living modified organisms intended for human pharmaceuticals from the scope of biosafety regulatory procedures. Such products are regulated under national health and pharmaceutical legislation through the Ministry of Health and Medical Services. The national biosafety framework currently under development focuses on the regulation of LMOs that may affect biodiversity, agriculture, and the environment, in accordance with the requirements of the Protocol.

The transboundary movement of living modified organisms (LMOs) is addressed in national legislation. The draft Biosafety Regulation includes provisions governing transboundary movement; however, it has not yet been formally endorsed. The draft Regulation also requires amendment to ensure full alignment with the Environment Act 2021.

Kiribati has taken initial steps toward implementing Articles 7–10 of the Cartagena Protocol on Biosafety relating to the Advance Informed Agreement (AIA) procedure. The Environment Act 2021 provides overarching legal authority for environmental protection, and the draft Biosafety Regulation includes provisions to regulate the transboundary movement and import of living modified organisms. However, the draft Biosafety Regulation has not yet been formally endorsed, and the full operational procedures for notification, acknowledgement, and decision-making under the AIA procedure are still under development. Institutional arrangements and regulatory mechanisms are currently being strengthened to ensure full compliance with the requirements of the Protocol.

Kiribati has taken initial steps toward implementing Article 11 of the Cartagena Protocol on Biosafety concerning living modified organisms intended for direct use as food, feed, or for processing. The Environment Act 2021 provides general legal authority for environmental protection, and the draft Biosafety Regulation includes provisions to regulate the import and management of LMOs, including LMO-FFPs. However, the draft Biosafety Regulation has not yet been formally endorsed, and specific procedures for risk assessment, decision-making, and notification through the Biosafety Clearing-House are still under development. Institutional and regulatory frameworks are being strengthened to ensure full compliance with the requirements of the Protocol.

Kiribati is in the process of strengthening its biosafety regulatory framework to implement Article 12 of the Cartagena Protocol on Biosafety concerning the review of decisions on living modified organism imports. While the Environment Act 2021 provides general authority for environmental protection, specific procedures for reviewing and revising biosafety decisions are being developed under the draft Biosafety Regulation, which has not yet been formally endorsed. To date, no import decisions regarding LMOs have been made that require review. Kiribati continues to strengthen its institutional and regulatory arrangements to ensure full compliance with the requirements of the Protocol.

Kiribati is in the process of strengthening its biosafety regulatory framework to implement Article 13 of the Cartagena Protocol on Biosafety concerning simplified procedures for the import of living modified organisms. While the Environment Act 2021 provides general legal authority for environmental protection, specific provisions establishing simplified import procedures are being developed under the draft Biosafety Regulation, which has not yet been formally endorsed. Kiribati has not yet adopted or applied simplified procedures for LMO imports. Institutional and regulatory arrangements are currently being strengthened to ensure future compliance with the requirements of the Protocol.

Kiribati has not yet established specific bilateral, regional, or multilateral agreements governing the transboundary movement of living modified organisms in accordance with Article 14 of the Cartagena Protocol on Biosafety. Kiribati currently relies on national legislation, including the Environment Act 2021 and draft Biosafety Regulation, to regulate LMOs. Kiribati participates in regional environmental and biosecurity cooperation initiatives that support biosafety capacity-building. Institutional and regulatory arrangements are being strengthened to support future development and notification of biosafety agreements, as required under the Protocol.

Kiribati has initiated steps to implement Articles 15 and 16 of the Cartagena Protocol on Biosafety, addressing risk assessment and risk management. The National Biosafety Framework and draft regulations include provisions for these mechanisms; however, full implementation is constrained by limited technical and scientific capacity to conduct risk assessments, insufficient financial and institutional resources to operationalize risk management infrastructure, and the limited occurrence of LMOs at the national level.

Currently, Kiribati lacks the institutional, technical, and financial capacity to support the implementation of Article 17.

Kiribati has taken important initial steps toward implementing Article 18 of the Cartagena Protocol, including the development of a National Biosafety Framework. Nevertheless, implementation remains at an early stage due to the absence of enacted biosafety legislation, limited border control capacity, the lack of LMO detection and testing infrastructure, and limited engagement with the Biosafety Clearing-House. Strengthening the legal and regulatory framework, enhancing institutional coordination, building technical and operational capacity, and improving information management systems remain key priorities for the effective implementation of Article 18.

Kiribati has begun implementing Article 19 of the Cartagena Protocol by designating a National Focal Point and developing a National Biosafety Framework that identifies potential competent authorities. However, the formal designation and full operationalization of Competent National Authorities are still underway. The lack of enacted biosafety legislation, limited institutional and technical capacity, and minimal engagement with the Biosafety Clearing-House continue to hinder full implementation. Strengthening the legal and regulatory framework, clarifying institutional roles, and building national capacity remain key priorities for effective implementation of Article 19.

The contact details for the national competent authority and the relevant decision-making process are included in the draft biosafety regulation. This regulation is awaiting endorsement. Once finalized, the information will be uploaded to the Biosafety Clearing House (BCH).

Kiribati remains committed to updating and uploading all necessary information to the Biosafety Clearing-House (BCH). Acknowledging the high staff turnover within the Environment & Conservation Division (ECD) of the Ministry of Environment, Lands, and Agricultural Development (MELAD), Kiribati will ensure the BCH Secretariat is continually informed regarding the updated details, including the full name, of the new Secretary of MELAD, who also serves as the National Focal Point for the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

Kiribati is currently developing the Kiribati Environment Management Information System (KEMIS) to establish mechanisms for safeguarding confidential information, which is already a consideration in its regulations.

Kiribati requires both capacity building and financial assistance to develop a strategy and action plan for the protocol's implementation. Furthermore, once the strategy and action plan are developed, additional funding will be necessary to execute them.

A major obstacle to the advancement of this protocol in Kiribati is the limited funding available for awareness campaigns and related activities. Furthermore, raising awareness and providing education, including the development of educational materials, is a costly endeavour in Kiribati. Therefore, both financial and technical assistance are essential to address these challenges.

Kiribati will update the BCH with information relevant to this article, as the need arises.

Since becoming a Party to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Kiribati has not yet become aware of any illegal transboundary movement of Living Modified Organisms (LMOs)

Kiribati faces significant human resource, technical, and institutional capacity deficits, which hinder the effective implementation of this Article within the country.

The Environment and Conservation Division (ECD), under the Ministry of Environment, Lands and Agricultural Development (MELAD), serves as the implementing agency for Biosafety. To support the on-the-ground implementation of the Cartagena Protocol, MELAD, through ECD, collaborates with key government sectors via consultations and bilateral meetings. To further support and strengthen this implementation, there is a need to establish a dedicated National Biosafety Coordination Committee.

There is existing legislation, National Research Administration ACT 2023 and regulation which are Environment Act 2021 and Biosafety Regulation (draft version but will finalize this year).

The Draft Biosafety Regulation is currently being reviewed and updated. This revision will incorporate key considerations related to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress.