Directive Issued to Establish Procedures for the Management of Risks from any Transaction Involving Modified Organisms No. 06/2018”

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L 8.7 2010 9.9° ( AN £IC e s &t\,@?i PANNN, PRTT PAPC TNLT a0 910EC “LL0TC DIRECTIVE NOWZOIS DIRECTIVE TO ESTABLISH PROCEDURES FOR MANAGEMENT OF RISKS FROM ANY TRANSACTION INVOLVINGMODIFIED ORGANISMS Whereas, it is essential to set a risk management procedure dealing with risks arising from any transaction involving modified organisms, NOW THEREFORE, this directive is issued by the Ministry of Environment, Forest and Climate Change in accordance with Article 25 of the Biosafety Proclamation No. 655/2009 (as amended by Proclamation No. 896/2015): PART ONE GENERAL 1. Short Title This directive may be cited as *“Directive Issued to Establish Procedures for the Management of Risks from any Transaction Involving Modified Organisms No2é&/2018” 2. Scope of this Directive (1) This Directive shall apply to manage any unforeseen risk arising from deliberate and unintentional release during making, use in teaching, research, import, export, transit, contained production, transport, storage, processing and putting in the market of any modified organisms. (2) In this directive, unless the context otherwise requires, the Risk arising from unintentional release includes, inter alia; a. Spillage from storage or transportation, b. release out of Human error c. Release out of force majeure. PART TWO 3. Response Measures To Risks Arising From Any Transaction (1) The ministry shall, before recommending an application for approval for any transaction, ensure that the application contains; a. An emergency plan which includes information on safety measures and procedures to be adopted and, b. Mechanisms through which the information shall be made available to the persons likely to be affected by the transaction. 4. Emergency Response Group (1) The Minister shall establish an Emergency Response Group in order to respond to any emergency cases related to the transaction of modified organism. (2) The Minister shall appoint the Chairperson, the Secretary and the members of the Emergency Response Group to comprise representatives of institutions capable of undertaking risk management measures. (3) The duties and responsibilities of the Emergency Response Group shall be to: a. Develop, implement when needed and keep updating a national risk management plan; b. Develop appropriate systems for the detection and reporting of emergencies in any transaction involving modified organisms; c. Ensure that there is a constant readiness to respond to any emergency of any modified organism to prevent damage to human and animal health, and the environment. d. Ensure that there is a constant readiness for the disposal of modified organisms recovered after accidents without any harm to humans, animals or the environment; e. Ensure that complete and accurate records of expenditures incurred in responding to emergencies are maintained to facilitate cost recovery and the payment of compensation; f. Ensure prompt and efficient mobilization of manpower, financial resources and equipment to deal with any emergency; (4) The Emergency Response Group shall be responsible to coordinate any accident at national level involving modified organisms and it shall direct the activities of institutions and individuals that may offer assistance. (5) The Emergency Response Group shall meet at such times and with such frequency as may be necessary to fulfill its duties and responsibilities which, in any event, shall not be less than every six months. (6) In cases of emergencies such as accidental release of modified organisms, the Emergency Response Group shall closely work with the authorized person and other relevant stakeholders to take rapid action to minimize or prevent possible risks (7) Without prejudice to the provision of this article, the Emergency Response Group may adopt its own rules of procedures. 5. Duties of the Permit Holder (1) Where there is an emergency related to transaction of modified organisms, the applicant or any person to whom approval was given shall, within twenty-four hours, inform the Emergency Response Group about the emergency providing the following information The circumstances of the accident, b. The identity and quantity of the modified organism involved in the emergency. c. Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, d. The mitigation measures taken, and e. Any other relevant information. 6. Risk management measures to be taken by the applicant (1) The applicant or any person to whom approval was given shall use the following Risk Management approaches in the event of emergency a. Report to the Emergency Response Group. b. Inform and involve the local leadership to take charge of the area and create awareness to the population. c. Isolate the area and provide adequate security to cordon off the affected place, if needed. d. When appropriate, evacuate humans and animals that are within reach by the exposure case by case. e. In the event where there are residual materials arising from modified organisms, they have to be collected and, when applicable, be destroyed by appropriate means. 7. Effective Date This directive shall enter into force as of thejé/”day of 2018. Done at Addis Ababa, this -'-é- day ofJM‘Zolx Dr. Gemedo Dalle MINISTER OF MINSTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE A\ J