biosafety Flashcards
CARTAGENA PROTOCOL ON BIOSAFETY TO THE CONVENTION ON BIOLOGICAL DIVERSITY
Objective of CBP: To contribute to ensuring an adequate level of protection in the field of the safe transfer, handling, and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on trans-boundary movements.
CONVENTION ON BIOLOGICAL DIVERSITY
CBD is an international agreement adopted at the Earth Summit, in Rio de Janeiro, in 1992. It has three main objectives: to conserve biological diversity; to use its components in a sustainable way; to share fairly and equitably the benefits arising from the use of genetic resources.
Article 11: Procedure For Living Modified Organisms Intended For Direct Use As Food Or Feed, Or For Processing
A Party that makes a final decision regarding domestic use, including placing on the market, of a living modified organism that may be subject to transboundary movement for direct use as food or feed, or for processing shall, within fifteen days of making that decision, inform the Parties through the Biosafety Clearing-House. A Party may take a decision on the import of living modified organisms intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of this Protocol. Each Party shall make available to the BCH copies of any national laws, regulations, and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing, if available. A developing country Party or a Party may, in the absence of the domestic regulatory framework referred to in paragraph 4 above, and in exercise of its domestic jurisdiction, declare through the BCH that its decision prior to the first import of an LMO intended for direct use as food or feed, or for processing, on which information has been provided under paragraph 1 above, will be taken according to the following: A risk assessment undertaken in accordance with Annex III; and a decision made within a predictable timeframe, not exceeding two hundred and seventy days. A Party may indicate its needs for financial and technical assistance and capacity-building with respect to LMOs intended for direct use as food or feed, or for processing.
Article 15: RISK ASSESSMENT
Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
Article 16: RISK MANAGEMENT
The Parties shall, taking into account Article 8 (g) of the Convention, establish and maintain appropriate mechanisms, measures, and strategies to regulate, manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling, and transboundary movement of LMOs. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the LMO on the conservation and sustainable use of biological diversity, taking also into account risks to human health, within the territory of the Party of import.
Article 22: CAPACITY BUILDING
The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in Parties with economies in transition, including through existing global, regional, subregional, and national institutions and organizations and, as appropriate, through facilitating private sector involvement.
Article 23: PUBLIC AWARENESS AND PARTICIPATION
Promote and facilitate public awareness, education, and participation concerning the safe transfer, handling, and use of LMOs in relation to the conservation and sustainable use of biological diversity, taking also into account risks to human health. Endeavour to ensure that public awareness and education encompass access to information on LMOs identified in accordance with this Protocol that may be imported.
Article 31: SECRETARIAT
The Secretariat established by Article 24 of the Convention shall serve as the secretariat to this Protocol. To the extent that they are distinct, the costs of the secretariat services for this Protocol shall be met by the Parties hereto. Secretariat in Montreal, Canada.
The Biosafety Clearing-House (BCH)
BCH is a mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on LMOs and assist the Parties to better comply with their obligations under the Protocol.
BIOSAFETY ACT OF BHUTAN 2015
Objective: To protect the rich domestic and wild biodiversity of Bhutan, promote the nation’s food and nutrition security, and safeguard the animal and human health.
ORGANIZATION OF BIOSAFETY ADMINISTRATION
National Biosafety Board: This Act hereby establishes a Board, to be known as the National Biosafety Board which shall consist of the following members: Minister, MoAF (chairperson), Head of Depts and agencies in Agri, Public Health, Trade, Finance, Home, Rep from NEC, BCCI. The Board shall: Periodically review and recommend to the Royal Government on the national biosafety policy; Endorse rules and regulations pertaining to the implementation of this Act; Approve overall plans and programs of the agencies involved in the administration of the biosafety related activities.
Bhutan Agriculture and Food Regulatory Authority
The Bhutan Agriculture and Food Regulatory Authority is the national competent authority for the implementation and enforcement of this Act and all other biosafety related activities in the Kingdom. The Authority shall: Develop and review periodically the rules and regulations for effective implementation of this Act; Develop and adopt standards, forms, codes of practice, and other tools as necessary for the administrative processes required to implement this Act; Establish technical working groups from relevant agencies to advise on technical and scientific aspects of issues related to biosafety.
Prohibitions
Import of any genetically modified organism capable of reproducing; Import of any genetically modified biological material capable of reproducing; Transit of genetically modified organisms capable of reproducing; Intentional introduction into the environment of genetically modified organisms capable of reproducing.
RISK ASSESSMENT, MANAGEMENT AND COMMUNICATION
Genetically modified organisms and products derived from genetically modified organisms for introduction into the Kingdom shall be subject to risk analysis, which comprises risk assessment, management, and communication. Risk assessment, management, and communication shall be conducted according to the standards, procedures, and guidelines for risk analysis as prescribed in the Rules and Regulations. Public consultation, as a component under risk communication, may be conducted as deemed appropriate by the Authority.
LABELING AND COMPLIANCE MONITORING
Labeling: The labeling requirements of all approved commercial products derived from genetically modified organisms placed in the market shall be regulated according to the threshold level as prescribed in the Rules and Regulations. Public Awareness: The Authority and all relevant stakeholders may ensure public, school, institute, and college participation in awareness programs on issues related to genetically modified organisms and products derived from genetically modified organisms. Access to Information: The Authority shall ensure public access to information relevant to genetically modified organisms and to the regulation and use of products derived from genetically modified organisms in the Kingdom.
