Directive No. 06/2009 issued to determine responses to accidental releases of modified organisms

1 yx!T×ùà ØÁ‰§êE Äyx!T×ùà ØÁ‰§êE Äyx!T×ùà ØÁ‰§êE Äyx!T×ùà ØÁ‰§êE Ä!äK‰s!ÃêE Êp$Bl!K !äK‰s!ÃêE Êp$Bl!K !äK‰s!ÃêE Êp$Bl!K !äK‰s!ÃêE Êp$Bl!K mNG|T mNG|T mNG|T mNG|T THE GOVERNMENT OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA yxµÆb! b” Æl|LÈNyxµÆb! b” Æl|LÈNyxµÆb! b” Æl|LÈNyxµÆb! b” Æl|LÈN ENVIRONMENTAL PROTECTION AUTHORITY mmRà mmRà mmRà mmRà SDSTSDSTSDSTSDST DIRECTIVE SIX yLW ?ÃêN ÃLtyLW ?ÃêN ÃLtyLW ?ÃêN ÃLtyLW ?ÃêN ÃLt----@n LqT mÌÌM@n LqT mÌÌM@n LqT mÌÌM@n LqT mÌÌM RESPONSES TO ACCIDENTAL RELEASE OF MODIFIED ORGANISM xÄ!S xbÆxÄ!S xbÆxÄ!S xbÆxÄ!S xbÆ R 2000 R 2000 R 2000 R 2000 ADDIS ABABA January 2008 2 mm¶Ã q$ R 6mm¶Ã q$ R 6mm¶Ã q$ R 6mm¶Ã q$ R 6 yLW yLW yLW yLW ����ÃÃÃÃ����NNNN ÃLÃLÃLÃL��� ��� ��� ��� LqT LqT LqT LqT ��� ��� ��� ��� lmwsN ywÈ mm¶ÃlmwsN ywÈ mm¶ÃlmwsN ywÈ mm¶ÃlmwsN ywÈ mm¶Ã LW �ÃêN bDNgT wd xµÆb! b!lqq$ fÈN q t¾ ���� � � � �W�� xSf§g! �mçn#½ Slz!H bdHNnt HYwT xêJ ��� ……. �Nq� 22222222 m\rT YH mm¶Ã w aLÝÝ KFL xND KFL xND KFL xND KFL xND 1. |û 1. |û 1. |û 1. |û YH mm¶Ã «yLW �ÃêN ����� LqT ��� lmwsN ywÈ mm¶Ã q$ R 06¼2001´ tBlÖ l!-qS YC§LÝÝ 3 DIRECTIVE No. SIX A DIRECTIVE ISSUED TO DETERMINE RESPONSES TO ACCIDENTAL RELEASES OF MODIFIED ORGANISM WHEREAS it is essential to give a prompt and direct response to any accidental release of modified organisms, THEREFORE, this directive is issued in accordance with Article 22 of the Biosafety Proclamation No. 1. Designation This directive may be cited as ‘Directive No. 06/ 2009’ issued to determine responses to accidental releases of modified organisms”. 4 2. TRÙ» 2. TRÙ» 2. TRÙ» 2. TRÙ» bz!H xêJ WS ½ 1. «lgbà ¥QrB´ ¥lT LW ?ÃWN lt-@n LqT l¥êL kGN²b@ ymn= SMMnTN ktqbl# b“§ bXRĬ MGBnT mS-TN =Mé lîSt¾ wgN b>Ã+½ bSõ¬ wYM bl@§ mNgD ¥St§lF nWÝÝ 2. «LW ?ÃW´ ¥lT sW \‰> yçn½ wYM kl@§ ?ÃW ytwsd Yh#N kQ¶T ytwsd wYM XNdxÄ!S ytqmm ÆYtêR zrmL wYM l@§ N r ngR SltkttbT yzrmlÖC Yzt$ wYM yÆ?R† KStT ytlw-bT ?ÃW nWÝÝ 3. «����´ ¥lT bzmÂêE ��� ?YwT LW ?ÃW ��� �r! nWÝÝ 4. #c¨<$ TKƒ ¾}ðØa c¨< ¨ÃU uQÓ ¾c¨<’ƒ Swƒ ¾}cÖ¨< ›"M ’¨<& 5. «Æl|LÈN´ ¥lT bxêJ q$ R 295¼1995 ytÌÌmW yx!T×ùà ØÁ‰§êE Ä!äK‰s!ÃêE ¶p$Bl!K yxµÆb! b” Æl|LÈN nWÝÝ 6. «�"##$´ %� �&' �� '()� ��*+ �,- �)# ./ & 01 )( ��$� �2� % 34�� �5�61 78 ����� � � �),� 9%��#: �;�)#/ ��$� �<3� ��=� �/ �/>> 7. «xmLµC´ ¥lT y¸-YqWN :NQS”s@ l¥µÿD 2! ?@ ���A SMMnT XNÄ!s-W lÆl|LÈn# Ãmlkt sW nWÝÝ 8. «XNQS”s@´ ¥lT LW ?ÃWN m|‰TN¿¿¿¿ wYM lTMHRT½ lMRMR½ lMRT½ wd xgR WS l¥SgÆT½ wd WÀ lm§K½ bT‰Nz!T l¥St§lF½ lt-@n LqT½ bZG �BCD l¥MrT½ l¥ÙÙZ½ lgbà l¥QrB½ lsW wYM lXNSú bmD`n!TnT lm-qM½ lMGBnT½ lmñnT wYM lÍB¶µ Ê :”nT ¥êL¿ ¿ ¿ ¿ �/>> 4 1. Definitions For the purpose of this Proclamation: 1. ‘Placing on the market’ means obtaining an advance informed agreement for deliberate release or making available to third parties a modified organism for any use by selling, giving away or in any other way, and includes giving as aid food. 2. ‘Modified organism’ means any biological entity which has been artificially synthesized, or in which the genetic material or the expression of any of its traits has been changed by the introduction of any foreign gene or any other chemical whether taken from another organism, from a fossil organism or artificially synthesized. 3. ‘Making’ means the development of a modified organism through modern biotechnology; 4. 'Person' includes any natural or juridical person. 5. 'Authority' means the Environmental Protection Authority of the Federal Democratic Republic of Ethiopia established pursuant to Proclamation No. 295/2002. 6. ‘Inspector’ means a person appointed pursuant to the directives issued by the Authority to undertake examination and any other control measures to ensure compliance with the proclamation on biosafety regulations or directives issued under it. 7. ‘Applicant’ means any person who submits an application to the Authority seeking an advance informed agreement to be engaged in a transaction. 8. 'Transaction' means any making or use of any modified organism in teaching, research, production, import, export, transit, deliberate release, production under contained use, transport, placing on the market, or use as a pharmaceutical, as food, as feed or for processing. 5 9. «E! �BCD ´ ¥lT ��W wYM � �F� �1 wYM ��G9H 8( y¸ktL ÃL¬qd t}:ñN lmk§kL 2�/� ��� 4� ����I B J ���� � ,�� ���9�� %�)� �)#/ ��$� ��� 03/2001 & OPQ/ �R D� 4.8 )( 4.9 &�I3I3/ ��FV1 � �3 ���V 2%8 Q�3W LW ?ÃêN �s„½ XNÄ!ÃDg#½ XNÄ!k¥c$½ XNÄ!wgÇ wYM � H��N1 MRMR A W �X� l@§ � �� � QM §Y XNÄ!Wl# �3! nWÝÝ 10. «���� LqT´ ¥lT kGN²b@ bmn= SMMnT msrT LW ?ÃWN % !�+ % !0+ % �YQ MGB½ xµÆb!N l¥}ÄT½ l¥St¥¶ÃnT½ lMRMR½ lmStêT b@T½ lW¦ WS XRƬ½ lXNSúT mñ½ lsW wYM lXNSúT HKM wYM ll@§ QM b¥êL )& xµÆb! �Är, �3! nWÝÝ 11. «-NQ´ ¥lT kyt$¾WM XNQS”s@ bq ¬ wYM btzêê¶ mNgD½ bx+R½ bmµkl¾ wYM brJM g!z@ bsW wYM bXNSú -@½ bBZ/ ?YwT½ bxµÆb!½ b¥HbrsïC ¥Hb‰êE½ x!÷ñ¸ÃêE½ wYM ÆH§êE h#n@¬ )( ���$Z [\];+ §Y l!ktL y¸CL xdU nWÝÝ 12. «ßéè÷L´ ¥lT ���* ��� 362/1995 �a&DW �0E/ �()� \ b cn# yµR¬d �&� �� �()� eWf\� �W>> 6 9. ‘Contained use’ means any operation in which modified organisms are made, grown, stored, destroyed or used in any other way including for teaching and research isolated by physical and chemical barriers as specified in Articles 4.8 or 4.9 of Directive no. 03/2009 issued to determine the procedures of a risk management strategy for dealing with accidents involving modified organisms, as the case may be, with a view to effectively preventing their contact with, and their unintended impact on, humans, animals or the external environment. 10. ‘Deliberate release’ means any introduction into the environment of a modified organism based on an advance informed agreement and includes, inter alia, any use in commerce, food, aid food, remediation, teaching, research, greenhouses, aqua-culture, animal feed or other inputs for animals, medicines for humans or animals, or disposal. 11. ‘Risk’ means direct or indirect, short, medium or long-term danger that may befall human or animal health, biological diversity, the environment, socio-economic or cultural conditions of local communities or the economic condition of the country from any transaction. 12. ‘Protocol’ means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity ratified through Proclamation No 362/2003. 7 3. mmRÃW tfɸ Sl¸çNÆcW XNQS”s@ãC 3. mmRÃW tfɸ Sl¸çNÆcW XNQS”s@ãC 3. mmRÃW tfɸ Sl¸çNÆcW XNQS”s@ãC 3. mmRÃW tfɸ Sl¸çNÆcW XNQS”s@ãC YH mm�à %��� �D� �9%��#: 2! ?@ ���A , �� 9���B�� � ./ LW ?ÃW ./ J,Cg hGi�hGi�hGi�hGi� b¸g M ����� LqT btÃÃz# xdUãC §Y tfɸnT YñrêLÝÝ 4. 4. 4. 4. ����xdU g!z@ xdU g!z@ xdU g!z@ xdU g!z@ �)���)���)���)�� �%9j�%9j�%9j�%9jW XRM©ãCW XRM©ãCW XRM©ãCW XRM©ãC 4.1 .W �LW ��W DNgt¾ LqT %��� XNÄ!ÒL ����� LqT ���;� b#DN ��( %� 9%,�#: ��G9H k� @� �0FHW (B(C�ÝÝ 4.2 ��G9H k� @� �0FHW ����� LqT ��� � b#Dn# lD� �� 1 �98� DNgt¾ xdUN ymÌÌM XRM© ymWsD xQM 9§cW tÌ¥T 2;�- 9%m�no �G2� (�( �ÝÝ 4.3 ÆlSLÈ: 8���� LqT ��� � b#Dn# apq (��0%Q�ÝÝ 8 3. Transactions subject to this Directive This Directive shall apply to any unintended release or any related accident during any transaction. 4. Emergency measures 4.1 The Authority shall, in order to be ready to respond to any accidental release of any modified organism, request the Chairperson of the Environmental Council to establish an Accidental Release Response Group. 4.2 The Chairperson of the Environmental Council shall appoint the Chairperson and the members of the Accidental Release Response Group to comprise representatives of institutions capable of undertaking risk management measures. 4.3 The Authority shall appoint a secretary for the Accidental Release Response Group. 9 4.4 ����� LqT ��� � b#D: tGƉT `§ðnfo kz!H b¬C ytzrz„T 1jW½ h. B/@‰êE yxdU mÌÌMà XQDN ¥zUjT½ h�,r�! mtGbR byg!z@W ¥ššL½ l. Æl|LÈn# lt-@n LqT kGN²b@ ymn= SMMnT ÆLs-ÆcW LW �ÃêN �;Gis J,Cgno )J� ����� �D� 1 7to xdUno lmk¬tL lmzgB y¸ÃSCl# tgb! SR›èCN mzRUT½ /. kLW �Ã� ����� LqT lmÈ y¸ClWN bBZh ?YwT½ bxµÆb! bsW bXNSúT -@NnT y¸dRS xdU lmk§kL y¸ySCL fÈN ���� � SLT MN g!z@M ZG° mçn#N 34��½ �. ��W� ��W ����� �D� ��B� &X� �G9H (O ��W )( � �F� �1 & (uY % �3! �v E!*� wx �] 34��½ <. )yno % ,�%,1 GF % ,2r� ��!E ��&4 ��� � � � �;)���� wx �;&�z )yno ��{81 ��kk%. � �� ��E�9jW 34��½ r. ÃL��� LqT %��� �;�,o� ysW `YL½ gNzB mœRà E!| �X: ¥rUg ½ 4.5 ¥N¾jW M LW ?ÃêNN y¸mlkT xdU s!ÃU M l��� �;�!} DRJèCN GlsïCN ymM‰T `§ðnT ����� LqT ��� � b#Dn# BÒ nWÝÝ 10 4.4 The duties and responsibilities of the Accidental Release 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 accidental releases and other incidents that happen during any transaction involving any modified organisms that have not been cleared for deliberate release through an advanced informed agreement issued by the Authority; c) Ensure that there is a constant readiness to respond to any accidental release of any modified organism to prevent damage to biodiversity, the environment or human or animal health d) Ensure that there is a constant readiness for the disposal of modified organisms recovered after accidents without any harm to humans, animals and the environment; e) Ensure that complete and accurate records of expenditures incurred in responding to any accidental release are maintained so as to facilitate cost recovery and the payment of compensation; f) Ensure the prompt availability of manpower, financial resources and equipment to deal with any accidental release; 4.5 The Accidental Release Response Group shall be the sole authority responsible for response to any accident involving modified organisms and it shall direct the activities of institutions and individuals that may offer assistance. 11 4.6 ����� LqT ��� � b#D: yts-#TN �!9�� `§ðnèC lmwÈT XNdxSf§g!nt$½ çñM xns b!ÆL by6 w„+ ,BsÆ ÃdRULÝÝ 5555. y¸iÂbT g!z@ . y¸iÂbT g!z@ . y¸iÂbT g!z@ . y¸iÂbT g!z@ YH mm¶Ã k qN ›.M. jMé yi YçÂLÝÝ xÄ!S xbÆ qN ›.M. yxµÆb!W MKR b@T sBúb! 12 4.6 The Accidental Release 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. 2. Effective Date This directive shall enter into force as of the day of 200 Done at Addis Ababa, this day of 200 Chairperson of the Environmental Council