Directive No. 03/2009 issued to determine the Procedures of a Risk Management Strategy for Dealing with Accidents Involving 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 îîîîSTSTSTST DIRECTIVE THREE kLW ?ÃêN U‰ ytÃÃz kLW ?ÃêN U‰ ytÃÃz kLW ?ÃêN U‰ ytÃÃz kLW ?ÃêN U‰ ytÃÃz ----NQN ymÌÌMNQN ymÌÌMNQN ymÌÌMNQN ymÌÌMà à à à SLT xtgÆbRSLT xtgÆbRSLT xtgÆbRSLT xtgÆbR PROCEDURES OF A RISK MANAGEMENT STRATEGY FOR DEALING WITH ACCIDENTS INVOLVING MODIFIED ORGANISMS 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 3 mm¶Ã q$ R 3 mm¶Ã q$ R 3 mm¶Ã q$ R 3 ��������W� ���� ���� � ���� ���� � ���� ���� � ���� ���� NQNQNQNQ���� ����mÌÌMà SLT xtgÆbRN mÌÌMà SLT xtgÆbRN mÌÌMà SLT xtgÆbRN mÌÌMà SLT xtgÆbRN lmwsN ywÈ mm¶ÃlmwsN ywÈ mm¶ÃlmwsN ywÈ mm¶ÃlmwsN ywÈ mm¶Ã kLW wYM ?YwT ktz‰ÆcW Q¶T ?ÃêN UR ytÃÃz XNQS”s@ kmµÿÇ bðT DNgt¾ h#n@¬ãC b!kst$ lm���� y¸ÃSCL y-NQ mÌÌM SLTN m�r{ xSf§g! bmçn#½ y-NQ mÌÌMà SLTN lmQr{ XNÄ!ÒL xns �ÆL l!àl# y¸gÆcWN GÁ¬ãC� tGƉT mwsN xSf§g! bmçn#¿ Slz!H bd~Nnt ?YwT xêJ q$ R........ bxNq{ 22 m\rT YH mm¶Ã w aLÝÝ KFL xNDKFL xNDKFL xNDKFL xND 1.1.1.1. |û |û |û |û YH mm¶Ã «��W� ���� ���� NQ� ������ ��� ������� lmwsN ywÈ mm¶Ã q$ R 03¼2001´ tBlÖ l!-qS YC§LÝÝ 3 DIRECTIVE NO. THREE A DIRECTIVE ISSUED TO DETERMINE THE PROCEDURES OF A RISK MANAGEMENT STRATEGY FOR DEALING WITH ACCIDENTS INVOLVING MODIFIED ORGANISMS WHEREAS it is essential to plan a risk management strategy to deal with emergency situations in any transaction involving modified organisms, WHEREAS it is essential to set the minimum requirements and actions to be fulfilled when designing a risk management strategy, 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. 03/ 2009’’ issued to determine the Procedures of a Risk Management Strategy for Dealing with Accidents Involving 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$Bl!K yxµÆb! b” Æl|LÈN nWÝÝ 6. «xmLµC´ ¥lT y¸-YqWN :NQS”s@ l¥µÿD �"�#$ ��%& SMMnT XNÄ!s-W lÆl|LÈn# Ãmlkt sW nWÝÝ 7. «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 �'()* 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. ‘Applicant’ means any person who submits an application to the Authority seeking an advance informed agreement to be engaged in a transaction. 7. '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 8. «-" �'()*´ ¥lT �.W wYM ���./� 0� wYM ��1�2 �3 y¸ktL ÃL¬qd t}:ñN lmk§kL ��+� ���� ���� '��� ����*� ��� ������� 4�5.� �56+ ��7� 8�� 03/2001 ��= >?@+ �A�)B 4.8 53* 4.9 ��=� G G+ �8/H� ���G %� H �4� @�GW LW ?ÃêN ���s„½ XNÄ!ÃDg#½ XNÄ!k¥c$½ XNÄ!wgÇ wYM �*H��N� MRMR� &*I �J% l@§ ���! � QM §Y XNÄ!Wl# !G" nWÝÝ 9. «��0% LqT´ ¥lT kGN²b@ bmn= SMMnT msrT LW ?ÃWN 4�"!K 4*"LK 4��M@ MGB½ xµÆb!N l¥}ÄT½ l¥St¥¶ÃnT½ lMRMR½ lmStêT b@T½ lW¦ WS XRƬ½ lXNSúT mñ½ lsW wYM lXNSúT HKM wYM ll@§ QM b¥êL 5= xµÆb! ���Är� !G" nWÝÝ 10. «-NQ´ ¥lT kyt$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@¬ 53* ���7N OPQ�K §Y l!ktL y¸CL xdU nWÝÝ 11. «ßéè÷L´ ¥lT ���R 8�� 362/1995 �V=)W �L-/ �35� P�W�Xn# yµR¬Y �=��%� �35� ZI[P� %W,, 6 8. "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. 9. ‘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. 10. ‘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. 11. ‘Protocol’ means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity ratified through Proclamation No 362/2003. 7 2.2.2.2. ��7���7���7���7�W tfɸ y¸çNÆcW XNQS”tfɸ y¸çNÆcW XNQS”tfɸ y¸çNÆcW XNQS”tfɸ y¸çNÆcW XNQS”\\\\ãC ãC ãC ãC YH ��7� � �]+* ����(\ �3 �^ �%� 3QG��,, ����`� !� abc �%'� �� d �Je* ��=�>?@f+ Lg+�* 3�4�@`,, 3.3.3.3. yyyy----NQ mÌÌMà SLT xtgÆbRNQ mÌÌMà SLT xtgÆbRNQ mÌÌMà SLT xtgÆbRNQ mÌÌMà SLT xtgÆbR t-”¸W kz!H q lÖ ytmlktWN y-NQ ����� SLT �W� HÃWN lm|‰T k¸jMRbT g!z@ xNSè bh#l#M yÑk‰ dr©ãC ��h 4@.�4� ��* ���W� ��4�4�6n# �"�#$ ��%& �**%� ��������� ij !G� !G� !G� !G� mtGbR xlbTÝÝ �x\‰R wQT xND wY* kxND b§3 xD‰X½ ��3�5� zrmlÖk* ky›Ynt$ 1 BÒ wYM k1 b§Y 5=�45'W ��W l!�l YC§l#ÝÝ �4mn ��)�`� mSfRèc ytzrz„T bn-§ �çNM yt1tt$T h#l# xD‰ëC ÆYtêR zrmlÖC ���>* opc �����(\W �q@bc bÑl# bGMg¥W WS mµ�T xlÆcWÝÝ 4.14.14.14.1 ysWN wYM yXNSúTN ysWN wYM yXNSúTN ysWN wYM yXNSúTN ysWN wYM yXNSúTN ----@NnT lm@NnT lm@NnT lm@NnT lm----bQ wYM ll@§ QM bQ wYM ll@§ QM bQ wYM ll@§ QM bQ wYM ll@§ QM ((((mD`n!T mD`n!T mD`n!T mD`n!T çRäN½ Çq&T½ zçRäN½ Çq&T½ zçRäN½ Çq&T½ zçRäN½ Çq&T½ zYT wzt.YT wzt.YT wzt.YT wzt.)))) kWÀ xgR y¸gb# yLW HÃêN kWÀ xgR y¸gb# yLW HÃêN kWÀ xgR y¸gb# yLW HÃêN kWÀ xgR y¸gb# yLW HÃêN tê{åãCtê{åãCtê{åãCtê{åãC½½½½ 8 3. Transactions subject to this Directive This Directive shall apply to any transaction. Any of the following provisions that is written in the singular shall also apply to the plural as the case may be. 4. Procedures of a risk management strategy The user shall employ the following risk management strategy starting from the making, through all stages of experimentation to getting the advance informed agreement from the Authority for the intended use of the modified organism. One or more vector and one or more of each of the kinds of transgene may go into making a genetically modified organism. Therefore, even when the parameters are written in the singular, all the vectors, transgenes and other aspects of transaction must be included in the analysis. 4.1 Imported products of modified organisms to be used for human or animal health or for other applications (e.g. drugs, hormones, flour, oil, etc. ): 9 bt�qrW �3 �Ws t�Ic ��1uv �w� bc� ��'()xc ��bc ��4��6e ���)� 3��� `,, �"*� W 5�� w� bk� �'()xk 4��.Gy�fW �zc �{ �|G� 3.6�,, �"*� W ��%/� �4��6e ��^�ibk w� bc �A�)q 4.5 �� G }� ���Qc ��y]W ��=�~*} 35���,, 4444.2.2.2.2 lsW wYM lXNSúT lsW wYM lXNSúT lsW wYM lXNSúT lsW wYM lXNSúT ----@ b” kWÀ y¸m@ b” kWÀ y¸m@ b” kWÀ y¸m@ b” kWÀ y¸m----# LW dqEQ xµ§T# LW dqEQ xµ§T# LW dqEQ xµ§T# LW dqEQ xµ§T½½½½ bLW dqEQ xµl# �3 �Ws t�Ic ��1uv �w� bc� ��'()xc ��bc ��4��6e ���)� 3��� `,, �"*� W 5�� w� bk� lsW wYM lXNSúT -@ b” �'()xk 4��.Gy�fW �zc �{ �|G� 3.6�,, �"*� W ��%/� �4��6e ��^�ibk w� bc �A�)q 4.6 �� G }� ���Qc ��y]W ��=�~*} 35���,, 4.4.4.4.3333 4�0%4�0%4�0%4�0% LqT kWÀ ygLqT kWÀ ygLqT kWÀ ygLqT kWÀ ygb# LW b# LW b# LW b# LW ::::VVVVêT wYM dqEQ xµ§T½êT wYM dqEQ xµ§T½êT wYM dqEQ xµ§T½êT wYM dqEQ xµ§T½ bLW :i# wYM dqEQ xµl# �3 �Ws t�Ic ��1uv �w� bc� yLqèC ��bc ��4��6e ���)� 3��� `,, �"*� W 5�� w� bk� Lqèc$ 4��.Gy�fW �zc �{ �|G� 3.6�,, �"*� W ��%/� �4��6e ��^�ibk w� bc �A�)q 4.8 �� G }� ���Qc ��y]W ��=�~*} 35���,, 10 Reports on experiments and uses outside Ethiopia on the product of the modified organism shall be thoroughly evaluated by the Authority. Special emphasis shall be given to the adequacy of the laws governing the experiments and uses reported. Based on this, the Authority shall decide at which steps in Article 4.5 experiments shall start. 4.2 Modified microbial organisms imported for human or animal health: Reports on experiments and uses outside of Ethiopia on the modified microbial organism shall be thoroughly evaluated by the Authority. Special emphasis shall be given to the adequacy of the laws governing the experiments and uses for human or animal health reported. Based on this, the Authority shall decide at which steps in Article 4.6 experiments shall start. 4.3 Modified plant or microbial organisms imported for deliberate release: Reports from experiments and releases of the modified plant or microbial organism in countries outside of Ethiopia shall be thoroughly evaluated by the Authority. Special emphasis shall be given to the adequacy of the laws governing the experiments and releases reported. Based on this, the Authority shall decide at which step in Article 4.8 experiments shall start. 11 4444....4 4 4 4 4�0%4�0%4�0%4�0% LqT kxgR WÀ y¸gb# LW XNSúTLqT kxgR WÀ y¸gb# LW XNSúTLqT kxgR WÀ y¸gb# LW XNSúTLqT kxgR WÀ y¸gb# LW XNSúT½½½½ bLW XNSúW �3 �Ws t�Ic ��1uv �w� bc� ��'()xc ��bc ��4��6e ���)� 3��� `,, �"*� W 5�� w� bk� Lqèc$ 4��.Gy�fW �zc �{ �|G� 3.6�,, �"*� W ��%/� �4��6e ��^�ibk w� bc �A�)q 4.9 �� G }� ���Qc ��y]W ��=�~*} 35���,, 4444....5555 bxgR WS yts‰ yLW ?ÃbxgR WS yts‰ yLW ?ÃbxgR WS yts‰ yLW ?ÃbxgR WS yts‰ yLW ?ÃWWWW tê{åtê{åtê{åtê{å½½½½ h. yLW �Ã� tê{å lsãC xgLGlÖT y¸WL kçn ��3��� G�pc� �opc ���73 ���� %� ��G %�Ic ����7� �|� 5= opc ���� ����4� '��� &*I mjm¶Ã b›Nq{ 4.9 btzrzrW ZG h#n@¬ bXNSúT �3 mäkR xlbTÝÝ YH Ñk‰ ytúµ s!çN Ñl# mr© xG"tW f”d¾ bçn# sãC �3 mäkR xlbTÝÝ l. ksW bStqR ll@lÖC ?ÃêN b¬q= yLW ?ÃW tê{å Ñk‰ y¸µÿdW ��3��� G�pc� �opc ���73 ���� %� ��G %�Ic ����7� �|� 5= opc ���� ����4� '��� &*I bz!ÃW l!-qMbT b¬qd�T ZRà b›Nq{ 4.9 btzrzrW ZG h#n@¬ mçN xlbTÝÝ /. ��&G�* �4��6e �w� bk W0[c ��%/� �"�#$ ��%& �**%y� yLW ?ÃW ��qrW 4@.�4� ��* ���W� 3.6�K 53* 3�4���,, 12 4.4 Modified animals imported for deliberate release: Reports from experiments and releases of the modified animal in countries outside of Ethiopia shall be thoroughly evaluated by the Authority. Special emphasis shall be given to the adequacy of the laws governing the experiments and uses reported. Based on this, the Authority shall decide at which step in Article 4.9 experiments shall start. 4.5 Product of a modified organism made locally: a) Trials on animals under contained conditions as specified in Article 4.9, including for evaluating the risks of the horizontal transfer of transgenes and other chemcials that affect trait expressin into other organisms, shall be made when the product of the modified organism is intended to be used on humans; when these are all successful, trials on fully informed volunteers shall be carried out. b) When intended for use on organisms other than humans, trials under contained conditions as specified in Article 4.9 with any product of a modified organism shall be made on the species for which the product has been designed, including for evaluating the risks of horizontal transfer of transgenes and other chemcials that affect trait expression into other organisms. c) Finally based on the outcomes of the experiments, the Authority shall give or deny an advance informed agreement for the use of the product of the modified organism for the intended purpose. 13 4444....6666 lsW wYM lXNSúT mD`n!TnT bxgR WS ytlsW wYM lXNSúT mD`n!TnT bxgR WS ytlsW wYM lXNSúT mD`n!TnT bxgR WS ytlsW wYM lXNSúT mD`n!TnT bxgR WS yt\\\\‰ LW ‰ LW ‰ LW ‰ LW =�� =�� =�� =�� �1��1��1��1�½½½½ h. ymjm¶Ã yN r ng‰êE½ ytE¹# µLcR½ yX™Â l@lÖC t²¥J Ñk‰ãC b›Nq{ 4.8 XNdtgl[W bZG �'()* bb@tÑk‰ WS mµÿD xlÆcWÝÝ l. q lÖ b›Nq{ 4.9 XNdtzrzrW bZG �'()* bXNSúT Ñk‰ mµÿD xlbTÝÝ /. q lÖ bn#KlYK xs!ìC wYM bßétEñC wYM bl@lÖC yÆ?RY KStT nK N r ngéC y¸ñR N r ng‰êE lW N yxD‰¹# wYM l@lÖC ÆYtêR zrmlÖC wYM ßétEñC wYM l@lÖC yÆ?RY KStT nK N r ngéC wd l@lÖC ZRÃãC½ btlYM wd b@� XNSúT½ ymt§lFN £dT l¥wQ b›Nq{ 4.9 XNdtzrzrW bZG �'()* btqm� XNSúT Ñk‰ãC YdrUl#ÝÝ m. )�p* mD`n!t$ ytdrgÆcW XNSút$ l@lÖC xÒãÒcW �¸ñ„bT h#n@¬ b›Nq{ 4.9 XNdtzrzrW bZG �'()* y¸ö†bT lS¬tEStEµêE Sl@T y¸Ãb” Ñk‰ mµÿD xlbTÝÝ �. ��&G�* �4��6e �w� bk W0[c ��%/� �"�#$ ��%& �**%y� LW dqEQ xµl# 4@.�4� ��* ���W� 3.6�K 53* 3�4���,, 14 4.6 Modified micro-organism made locally to be used as a pharmaceutical for humans or animals: a) Initial chemical, tissue culture, serological and other related experiments shall be made in the laboratory in contained use as specified in Article 4.8. b) Then experiments shall be made with animals in contained use as specifed in Article 4.9. c) Then experiments shall be carried out on animals in contained use as specified in Article 4.9 to evaluate the extent of chemical change in nucleic acids or protiens or other chemicals that affect trait expression and the possibilities of the transfer of genes or other chemicals that affect trait expression from the vector or from the other transgenes to other species, especially to domestic animals. d) Statistically valid trials in contained use as specified in Article 4.9 will be carried out in which the animals that have the pharmaceutical used on them live in conditions that are the same as their non-modified counterparts. e) Finally based on the outcomes of the experiments, the Authority shall give or deny an advance informed agreement for the use of the modified micro-organism for the intended purpose. 15 4444.7.7.7.7 bZG l¸drG xbZG l¸drG xbZG l¸drG xbZG l¸drG x----”qM kxgR WÀ y¸gb# ”qM kxgR WÀ y¸gb# ”qM kxgR WÀ y¸gb# ”qM kxgR WÀ y¸gb# 53* ���� 53* ���� 53* ���� 53* ���� WWWW�� ��.}�� ��.}�� ��.}�� ��.} LW HÃêN LW HÃêN LW HÃêN LW HÃêN )�p �� G }�� >?@bc lmlyT XNdh#n@¬W b›Nq{ 4.8 wYM 4.9 btzrzrW ZG �'()* w� bc 31uM`,, t. 5= $t w� W� 5= �1�2W ��@.� �)� 2^'� �W� ��� ��35� ���3�� ij �'�½ 4. �e�43� ���c 53* �opc y�n�Y KStT nK ��G %�Ic 5= opc =�� �1�� 53* 5= opc ���� ���4�� �.W 53* ���./� 0�%� 53* ="x ��1�2 �3 �����l#T ��cl#T '��K �. ���0% �)� �^'� ��c4W� gÖ©! t{:ñ 4���* ��c�` Lp ���1k � �fW �bc L(�K �. yZG x-”qÑ Ñk‰½ \. ��&G�* �w� bk W0[c ��%/� �4��6e �"�#$ ��%& �**%y� �W� ��� 4@)=4� ��* ���W� 3.6� 53* 3�4���,, 16 4.7 Modified organisms imported or made locally for contained use: Experiments shall be carried out in contained use as specified in Articles 4.8 or 4.9, as the case may be to determine the following conditions: a) Longevity of the modified organism in case of unintended release into the premises and into the surrounding environment, b) Transfer of nucleic acides or other chemicals that have impacts on traits into micro-organisms or other organisms and implications thereof on risks to human or animal health or the environment; c) The efficacy of methods specified by the applicant for counteracting adverse impacts that might result from unintended releases. d) Trial of the contained use; e) Finally based on the outcomes of the experiments, the Authority shall give or deny an advance informed agreement for the use of the modified organism for the intended purpose. 17 4444.8.8.8.8 4�0% �)�4�0% �)�4�0% �)�4�0% �)� bxgR bxgR bxgR bxgR WS ytWS ytWS ytWS yt\\\\„ LW „ LW „ LW „ LW �V�V�V�VêT dqEQ xµ§T¿ êT dqEQ xµ§T¿ êT dqEQ xµ§T¿ êT dqEQ xµ§T¿ h. dqEQ xµ§T bZG h#n@¬ tÃg y¸ÆlW b¥'Rà q$S N r ng‰êE zÁãC kxµÆb!W tlYtW bfú> WS kçn# Yzt$ �500 �.�. (�" X ���) ÃLbl-½ b-ÈR §Y tl fW kçn# dGä SÍt$ k2500 ú». µÊ ÃLbl- s!çn# nWÝÝ :VêT bZG h#n@¬ tÃz# y¸ÆlW b¥-R� q$S bN r ng‰êE zÁãC kxµÆb!W y¸l†bT ï¬ SÍT �Vêt$ µdg# b“§ k¸ñ‰cW !*� SÍT UR s!nÉiR k10 : F ÃLbl-� *� ij* 2J� �1000 1� ��� ���4' s!çN nWÝÝ l. bn#Kl3K xs!ìC½ yÆ?RY ���� nK bçn# l@lÖC N r ngéC X tÃÙnT �§cW ßétEñC wYM XNdh#n@¬W LW ?ÃêN� bm|‰T wYM y NT Q¶èC ?YwT XNÄ!z„ b¥DrG �3 y¸µÿÇ ?Yw¬êE N r ngR nK w� bc h#l# b-" �'()* ���5� xlÆcWÝÝ /. LW HÃ�N l¥údG y�� µLcR Ñk‰ y¸µÿdW bZG �'()* mçN xlbTÝÝ m. LW HÃ�N xSqMõ ¥öyTN =*é tf éWN lmrÄT y¸drg# Ñk‰ãC bZG �'()* mµÿD xlÆcWÝÝ \. ��0% LqT �fiM b¬qdbT ï¬ ÆlW xfR½ yxfR dqEQ xµ��½ y:VêT yXNSST zWG X bLW ?Ã� y¸drg#T Ñk‰ãC bZG �'()* mµÿD xlÆcWÝÝ 18 4.8 Modified plant or microbial organisms made locally for deliberate release: a) The maximum volume of any solution which is a medium of any microorganisms that are physically and chemically isolated shall be 500 ml if it is to be accepted as being under contained use. The maximum area of solid meduim on which any microorganisms have been plated shall be 2500cm 2 if it is to be accepted as being under contained use. The maximum area that has been physically and chemically isolated for growing modified plants shall be a maximum of 10 times that of the basal areas of all the individual plants when fully grown added together, but not exceeding 1000 square meters if it is to be accepted as being under contained use. b) Laboratory biomolecular experiments on chemical changes to nucleic acids, other molecules that affect trait expression and associated protiens or, as the case may be, on transformation or resuscitation shall be carried out in contained use. c) Tissue culture to grow the modified organism shall be carried out in contained use. d) Experiments, including storage, aimed at understanding the nature of the modified organism shall be carried out under contained use. e) Experiments with the modified organisms in the soil type, soil organisms and plant and animal communities found in the environmental conditions of the area of intended deliberate release shall be carried out in contained use. 19 r. bLW �Ã� bxµÆb!W (bxfR� �W�� �`� ?ÃêN½ bsBlÖC bl@lÖC :VêT½ bb@T bÇR XNSúT) mµkL y¸ñrW� GNß#nT l¥wQ Ñl# bÑl# �-" �'()* ��J% ngR GN bx R btkll ¥ú yn#KlYK xs!ìC yl@lÖC yÆ?RY KStT nK N r ngéC mt§lFN mgMgMN =Mé Ñk‰ãC mµÿD xlÆcWÝÝ xND Ñk‰ s!-ÂqQ yLW HÃý MRèC lqÈY MRMR BÒ l!Wl# YC§l#¿ µLçn GN � ��K 53* Æl|LÈn# �^)=W o� ���! w` �w` ����K �4�fWÝÝ s. yLW �Ã� tê{å ���)B 4.5 btzrzrW £dT ¥lF xlbTÝÝ >. bm=ršM kÑk‰ãc$ W-@èC bmnúT Æl|LÈn# LW ?Ãý l¬sblT xgLGlÖT XNÄ!WL kGN²b@ ymn= SMMMnt$N wYM YsÈL½ wYM YklK§LÝÝ q. t-!nW ytlqq$ LW #hc m²mT ÆHRY KTTL l150 ›mT½ Ñl# bÑl# dRqW by›mt$ y¸bQl# �W� �VêT 53* �W� dqEQ xµ§T KTTL l30 ›mTK k²æC b¬C :D» çcW ̸ �W� �VêT �Je dGä KTTl# kh#lt$ mµkL bÆl|LÈn# l¸wsn# ›m¬T mµÿD xlbTÝÝ �%mn A�@� W�� LW ?ÃýN �4))W .W wYM yXRs# w‰> 4ÆlSLÈn# ��A�y �� ¥QrB xlbTÝÝ 20 f) Complete observations of the interactions of the modified organism with the environment (soil including micro-organisms, plants including crops and animals including domestic species), including on the transfer of nucleic acids and other trait affecting chemicals, shall be made in enclosed fields but not in fully contained use. At the end of an experiment, the products of the modified organism may be used for further research. Otherwise they shall be incinerated or completely destroyed through other methods approved by the Authority. g) The product from the modified or resuscitated fossil organism shall be subjected to the procedure in Article 4.5. h) Finally based on the outcomes of the experiments, the Authority shall give or deny an advance informed agreement for the use of the modified organism for the intended purpose. i) The monitoring of spread and behaviour of any deliberately released modified trees shall continue for at least 150 years, the monitoring shall continue for at least 30 years in the case of modified annuals and micro organisms, and the duration of the monitoring of modified perennials which live shorter than trees shall be determined by the Authority to be inbetween. The user who was responsible for releasing the modified organism or his heir shall provide annual reports to the Authority for the duration of these time preiods. 21 4444.9.9.9.9 4�0% 4�0% 4�0% 4�0% LqT bxgR WS ytLqT bxgR WS ytLqT bxgR WS ytLqT bxgR WS yt\\\\„ LW XNSúT„ LW XNSúT„ LW XNSúT„ LW XNSúT h. LW XNSú bZG �'()* tà y¸ÆlW b¥-¶Ã q$S bN r ng‰êE zÁãC kxµÆb!W tlYè y¸ñRbT ï¬ XNSúW � =* k¸YzW SÍT k100 : F ÃLbl- s!çN nWÝÝ ytlÆ XNSúT bxND §Y tq§QlW y¸gß# kçn GN ï¬W TLq$ yXNSú ZRà � =* ��3 W SÍT k500 g!z@ ÃLbl- mçN xlbTÝÝ �-" �'()* ���/� ���g�� �@ ��� *�ij* 2J� �1000 1� ��� ���� �3^)!4�*,, l. bn#K43� xs!ìC½ yÆHRY KStT nK bçn# l@lÖC N r ngéC X tÃÙnT �§cW ßétEñC XNdz!h#M LW XNSúTN bm|‰T §Y y¸µÿÇ ?Yw¬êE N r ngR nK Ñk‰ãC bZG �'()* m��5� xlÆcWÝÝ /. k?êS jMé y¸ÃDG LW XNSú y¸qm-W bZG �'()* mçN xlbTÝÝ m. LW XNSú y¸ÃD�W� MRMR y¸drGbT �ZG �'()*�'()*�'()*�'()* mçN xlbTÝÝ 22 4.9 Modified animals made locally for deliberate release: a) The maximum area in which the modified animal is living physically and chemically isolated shall not exceed 100 times the area it occupies when it is lying down if it is to be accepted to be under contained use. In the case of a mixtures of animal species, the maximum area shall not exceed 500 times that of the area occupied by the largest species when it is lying down. The total area shall not exceed 1000 m 2 if the animals are to be said to be in contained use. b) Laboratory biomolecular experiments on chemical changes to nucleic acids, other chemicals that affect trait expression and associated protiens as well as on making modified animals shall be carried out in contained use. c) Methods of incubating the transformed generative cell shall be carried out in contained use. d) The rearing of and observations on any modified animal shall be carried out in contained use. 23 \. bLW XNSú §Y MRMR y¸µÿdW ZG �'()*� ��0% �)� �^�*�� �@)=�� �1�2 � bxyR NBrT½ bdqEQ xµ§TK sBlÖCN &MI b�VêT yb@TN =Mé bXNSúT zW¯C xND ›YnT bçn ï¬ mçN xlbT,, �MRM„ y¸sbsbWM mr© yLW XNSúW ydqEQ xµ§t$ h#n@¬½ btlYM bn#K43K xs!ìCK bPétEñC bl@lÖC yÆ?RY ���� nK N r ngéC mt§lF N r ng‰êE lW Ãt÷r mçN xlbTÝÝ G. )�p* ��2 �J% ��= ij ��(� ���^)= �)� '��� 4���* ����c� ��� �=�z�� W�� �)� 31uM�,, ��.�.�W �G�* ��W� ���/W� �=�� �1�y >?@�K ��43* �e�43� ���cK yPétEñC yl@lÖC �n�3 ���� %� ��G %�Ic ��G %� H 4W��� 5= opc n��� ���4�� �'(44 �J� �4��,, s. LW XNSúW tê{åN ����� �@.� kçn½ �*�y �3 ��=G�W q$ R b��)B 4.5 §Y btgliW xµÿD ¥lF xlbTÝÝ �. btlqqW LW XNSú m²mT l@§ yÆHRY lW y¸drgW KTTL 2��� l30 ›m¬T mq-L xlbTÝÝ 24 e) Experiments on modified animals shall be carried out in contained use in an environment which simulates the intended area of release in climatic, microbial, animal including domestic and plant including crop communities. The information collected shall include the condition of the modified animal and other organisms, especially those of its micro-organisms, in the context of changes to and transfer of nucleic acids, proteins and other trait affecting chemicals. f) Following this a limited release will be carried out in an area with appropriate enclosure and emergency measures put in place to prevent escape. Observations will include on the condition of the modified animal, its micro organisms focusing on chemical changes to nucleic acids, proteins and other chemicals that affect trait expression and on thier transfer to other organisms. g) If the modified animal is intended to yield a product, the regulation of the product shall follow the procedures described in Article 4.5. h) The monitoring of the spread and behaviour of any released modified animal shall continue for at least 30 years. 25 4444.10.10.10.10 xxxx----”§Y GÁ¬ãC ”§Y GÁ¬ãC ”§Y GÁ¬ãC ”§Y GÁ¬ãC h. ���)B 4.1 X�� 4.9 ytzrz„T Ñk‰ãC byRXs# |R kmjmRÃW XRkN tnSè bQdM tktL XDgT XSk m=ršW XRkN DrS 3��5�`ÝÝ byXRkn# y¸drg#T Ñk‰ãC h#l# kyXRkn# wd qȆ y¥lF Ãq&ãC h#l# �Æl|LÈn# �"�#$ ��%& �**%� ¥GßT xlÆcWÝÝ l. bm=ršW XRkN y¸µÿdW ym=ršW Ñk‰ �4 �^�w ÆlSLÈn# �"�#$ ��%& �**%y� �.' b“§ LW HÃ� ltflgW xgLGlÖT l!WL YC§LÝÝ /. Ñk‰ s!µÿDbT ynbrW LW ?ÃW kXRs# ymn= öšš s!wgD Ñl# bÑl# b¥UyT wYM Æl|LÈn# btS¥¥ÆcW l@lÖC ��* y¥ ðà mNgìC �J� xlbTÝÝ m. yLW ?ÃW yt-@n LqT KTTL bxmLµc$ wYM bw‰¹# mdrG xlbTÝÝ xmLµc$ wYM w‰¹# yKTTl#N zgÆ by›mt$ lÆl|LÈn# ¥QrB xlbT½ ÃL¬sb h#n@¬ s!f-R GN Ãn@Wn# zgÆ ¥QrB xlbTÝÝ 5.5.5.5. mm¶ÃW y¸iÂbT g!z@mm¶ÃW y¸iÂbT g!z@mm¶ÃW y¸iÂbT g!z@mm¶ÃW y¸iÂbT g!z@ YH mm¶Ã k qN ›.M. jMé yi YçÂLÝÝ xÄ!S xbÆ qN ›.M. ��1�2 MKR b@T sBúb! 26 4.10 General Requirements: a) All the necessary experiments specified under each heading in Paragraph 4.1 – 4.9 have been specified in sequence and they progress from the beginning to the highest level. Each experiment and progress after each step shall be subjected to approval by the Authority. b) Once an advance informed agreement from the Authority has been obtained at the completion of the final experiment in the final stage, the modified organism can be put to its intended use. c) The modified organism and any waste from it shall, upon the completion of any experiment, be disposed of by incineration or through other methods of complete destruction approved by the Authority. d) The release of any modified organisms shall be monitored by the applicant or his heir. The applicant or his heir shall submit annually reports of the monitoring, and immediately if any unforseen occurance is observed.. 5. 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