Directive No. 02/2009 issued to determine Risk Assessment Parameters for 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|TmNG|TmNG|TmNG|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 h#lTmmRà h#lTmmRà h#lTmmRà h#lT DIRECTIVE TWO yyyyLW ?ÃêN LW ?ÃêN LW ?ÃêN LW ?ÃêN yyyy----NQ GMg¥ mSfRèCNQ GMg¥ mSfRèCNQ GMg¥ mSfRèCNQ GMg¥ mSfRèC RISK ASSESSMENT PARAMETERS FOR 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 2mm¶Ã q$ R 2mm¶Ã q$ R 2mm¶Ã q$ R 2 bLW bLW bLW bLW ?ÃêN §Y ?ÃêN §Y ?ÃêN §Y ?ÃêN §Y ����¸drG y¸drG y¸drG y¸drG y----NQ GMg¥NQ GMg¥NQ GMg¥NQ GMg¥ ���������������������������� mSmSmSmSfRèCN fRèCN fRèCN fRèCN lmwsN ywÈ mm¶Ã lmwsN ywÈ mm¶Ã lmwsN ywÈ mm¶Ã lmwsN ywÈ mm¶Ã bLW ?ÃêN y¸dr�W � � � XNQS”s@ ���� btgb!W y-NQ GMg¥ £dT ¥lF �lbT mçn#¿ ên¾ mSfRèC mlyT y-NQ GMg¥ |R›T b|‰ §Y b¸WLbT wQT bxg¶t$ bml# yxs‰R ���� � xND w nTN �¥rUg xSf§g! bmçn#¿ ���� bdHNnt ?YwT xêJ ��� xNq{ 22 m\rT YH mm¶� w aLÝÝ KFL xND KFL xND KFL xND KFL xND 1. |û 1. |û 1. |û 1. |û YH mm¶Ã «bLW ?ÃêN §Y �¸drG y-NQ GMg¥ ������� mSfRèC lmwsN ywÈ mm¶Ã q$ R 02¼2001´ tBlÖ l!-qS YC§LÝÝ 3 DIRECTIVE No. TWO DDIIRREECCTTIIVVEE OONN RRIISSKK AASSSSEESSSSMMEENNTT PPAARRAAMMEETTEERRSS FFOORR MMOODDIIFFIIEEDD OORRGGAANNIISSMMSS WHEREAS every transaction on modified organisms should be preceded by an appropriate risk assessment, WHEREAS, identifying the key parameters is essential to harmonize and standardize the application of a risk assessment procedure in the country; 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. 02/ 2009 issued to determine Risk Assessment Parameters for 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 ,-� .� wYM %/01 23 y¸ktL ÃL¬qd t}:ñN lmk§kL 4)� 5�6 7� �8��9 & � ��::�� �4� %8�0 � ��;, ;�) ��<� ��� 03/2001 A BCD) E (F 4.8 ;3� 4.9 A89K9K) �-L� �K #��L �2 D�KW LW ?ÃêN �s„½ XNÄ!ÃDg#½ XNÄ!k¥c$½ XNÄ!wgÇ wYM ��H��N� MRMR $�M N# l@§ � �� QM §Y XNÄ!Wl# ��K� nWÝÝ 9. «�8.# LqT´ ¥lT kGN²b@ bmn= SMMnT msrT LW ?ÃWN � ��O ���PO � ��D MGB½ xµÆb!N l¥}ÄT½ l¥St¥¶ÃnT½ lMRMR½ lmStêT b@T½ lW¦ WS XRƬ½ lXNSúT mñ½ lsW wYM lXNSúT HKM wYM ll@§ QM b¥êL ;A xµÆb! �Är� ��K� nWÝÝ 10. «-NQ´ ¥lT kyt$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@¬ ;3� %�<Q RST�O §Y l!ktL y¸CL xdU nWÝÝ 11. «ßéè÷L´ ¥lT %6U ��� 362/1995 �YA(W �P+/ 53;� S Z [n# yµR¬\ �A5 #8 53;� ]M^S4 #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 3333. dNb# tfɸ Sl¸çNÆcW XNQS”s@ãC . dNb# tfɸ Sl¸çNÆcW XNQS”s@ãC . dNb# tfɸ Sl¸çNÆcW XNQS”s@ãC . dNb# tfɸ Sl¸çNÆcW XNQS”s@ãC 3� ��<� � )� ��'` 23 8ab�#� 3TK64** �� 8�� � 7cde #&2 �8fg hNi� A�BCDj) Pk) � 3�� D�** 4444.... yLW yLW yLW yLW 5555ÃêN yxµÆb! t}:ñ GMg¥ mÃêN yxµÆb! t}:ñ GMg¥ mÃêN yxµÆb! t}:ñ GMg¥ mÃêN yxµÆb! t}:ñ GMg¥ mSSSSfRèC mm¶Ã fRèC mm¶Ã fRèC mm¶Ã fRèC mm¶Ã yLW 5ÃW \¶Â t-”¸ � W � ��'` kmjm‰cW bðT sW ;3� XNSúT -@NnT½ bBZh ?YwT½ b%/Æb!½ �� K,le SnMGƉêE `^e ;3� ÆH§êE ;3� RST��L BCDde½ XNdz!h#M bxg¶t$ x!÷ñ�ÃêE h#n@¬ l!ñR y¸ClWN m�� ����� �-NQ ���� �/n� xlÆcWÝÝ GMg¥W kz!H b¬C ytzrz„TN l@lÖC xGÆPnT çjW N#W �8�o� mSfRèC �/8� %� �ÝÝ x\‰R wQT xND wY� kxND b§3 xD‰[½ 038ê� zrmlÖp� ky›Ynt$ 1 BÒ wYM k1 b§Y ;A��;&W 5�W l!�q YC§l#ÝÝ ���� ��(��� mSfRèe ytzrz„T bn-§ hçNM yt/tt$T h#l# xD‰ëC ÆYtêR zrmlÖC �B� rse � ��'`W �tDde bÑl# bGMg¥W WS mµ8T xlÆcWÝÝ 8 3. Transactions subject to this Directive This Directive shall apply to any transaction. Any of the following provisions that is written in the singular shall also apply to the plural as the case may be. 4. Directive on risk assessment parameters for modified organisms The maker and the user of a modified organism shall respectively carry out a risk assessment prior to any transaction to evaluate the possible harm to human or animal health, biological diversity, the environment, ethical values or cultural or economic norms of local communities or the economic condition of the country. This assessment shall take the following parameters, including any others deemed relevant, into consideration. One or more vector and one or more of each of the kinds of transgene may go into making a genetically modified organism. Therefore, even when the parameters are written in the singular, all the vectors, transgenes and other aspects of the transaction must be included in the analysis. 9 4444.1 yLW .1 yLW .1 yLW .1 yLW 5555ÃÃÃÃuuuu sÀ tqÆY wYM w§sÀ tqÆY wYM w§sÀ tqÆY wYM w§sÀ tqÆY wYM w§UUUU ?ÃêN ÆHRÃT ?ÃêN ÆHRÃT ?ÃêN ÆHRÃT ?ÃêN ÆHRÃT h. úYN-êE� �8��v �we½ l. ��!�xjW l@lÖC ZRÃãC yZMDÂãÒcW QRbT½ y. bsÀ btqÆY ;3� ;2U ?ÃêN mµkL ÃlW ZMD �� �½ �. sÀ tqÆY ?Ãên# ytsbsb#ÆcW ï¬ãC½ y¸¬wq$ kçn½ z. X�xNDxNÇ w§J ?ÃW y¸‰ÆbTN zÁ½ ¼„µÆL ;3� x!„µÆL¼ ���0� ;#dt$ y¸fjWN g!z@½ xND TWLD b?YwT y¸öYbTN g!z@ X m { wQèCN %-4{ b?YwT lmöyT y¸-QÑÆcWN xµ§T y¸gLi# mr©ãC½ K. qDä ytdrg yLW nT ¬¶KO tqÆY wYM sÀ ?Ãên# LW HÃêN ynb„ SlmçÂcW wYM xlmçÂcW bMN zÁ LW XNdçn#½ ,. y¸t÷RÆcW xµ§L wYM zrm§êE MLKèC½ |. y?Ãên# MNnT mñR xlmñR �3^ ��;}� S4èC ��~#DjW ����½ (. y?Ãên# �4�E ���L SR+T ytf é ï¬ãÒcW½ ‘−‰†W ½ 8 ‘d�jW ½ �� d�jW O twÄĶãÒcW ½ tUUÎÒcW X t¹µ¸ãÒcWN $�M½ . ytf é lDãÒcW yxyR NBrT½ 8. LW ?Ãu �. ¸lqQbT wYM -3. l!lqQ ¸CLbT lD �;2U 5�6i b?YwT ymöyT� ��!�� ClÖ¬½ j. y?Ãên# zrm§êE mrUUT bmrUUt$ §Y t}:ñ y¸ÃúD„ h#n@¬ãC½ 10 4.1 Characteristics of donor and recipient or parental organisms a) Scientific and common names; b) Species they are related to and degrees of relatedness; c) The degree of relatedness between the donor and recipient or parental organisms; d) All sites from where the donor and recipient organisms were collected, if known; e) Information on the type of reproduction (sexual/ asexual) of both parental organisms and the length of reproductive cycle and generation time, as well as the formation of resting and survival stages; f) History of prior genetic manipulation, whether and how the donor or recipient organisms were already modified; g) Phenotypic and genetic markers of interest; h) The identification and detection techniques for the organisms, and the sensitivities of these techniques; i) Geographic distribution and natural habitats of the organisms including information on natural predators, preys, parasites, competitors, symbionts and hosts; j) Climatic characteristics of their original habitats; k) Ability of the organisms to survive and colonize the environment to which the release of the modified organism is intended or may accidentally occure; l) Genetic stability of the organisms, and factors affecting the stability; 11 #. bzrm§êE mrUU¬cW §Y t}:ñ l!ÃdRs# y¸Cl# yxµL WS tNqú”> yŠYrS 9K�2L ��e mñR½ �. (�D� N# A}� %/2� �4 ?Ãên# kl@lÖC ?ÃêN UR l!ñ‰cW y¸CL zrmse ���82�� ;3� ���6;� :DL½ %. sWN wYM XNSúTN b>¬ y¥SÃZ Æ?RY½ µ§cW½ . b>¬ y¸ÃSYz# kçn y¥ ”�½ ymLkF ymmrZ esDjW� ymt§lFà mNgìÒcW½ �. yxlR©!½ y>L xµLN y¥g#dL½ çRäNN ymMsL ;3� �mR²¥nT 0���� ��j)0���� ��j)0���� ��j)0���� ��j) y?YwT WSÈêE wYM y¸wgÇ yx••R W-@èe yçn# �K #�M�jW½ ;. lb>¬ xMÀn¬cW½ lxlR©! qS”>n¬cWO lmR²¥n¬cW X çRäNN lmMs§jW HKM �� mTR½ 4444.2 b QM §Y Slê.2 b QM §Y Slê.2 b QM §Y Slê.2 b QM §Y Slê���� xD‰xD‰xD‰xD‰[[[[ kúC½ kLµY X mlà kúC½ kLµY X mlà kúC½ kLµY X mlà kúC½ kLµY X mlà 9K�se9K�se9K�se9K�se ÆÆÆÆHRÃT HRÃT HRÃT HRÃT mr©ãC mr©ãC mr©ãC mr©ãC h. yxD‰¹# tf é MN+½ l. yxD‰¹# zrm§êE NDF½ ytkttW 0386� zrmL½ �05�3 KStTN l!nk# y¸Cl# ¥N¾cWM yn#KlYK xs!D sNslèCO ymlà zrmL½ ykúC zrmL½ ykLµY zrmL � �� jW� l@lÖC �05�3 ��8� #� �K #�Me xq¥m ½ 12 m) The presence of endogenous mobile genetic elements of viruses likely to affect the genetic stability; n) The potential of the organisms to transfer to or exchange genes with other organisms, either vertically or horizontally; o) Pathogenicity to humans or animals, if any; p) If pathogenic, their virulence, infectivity, toxicity and modes of transmission; q) Allergenicity, teratogenecity, the mimicking of hormones, toxicity of biochemical or metabolic products; r) Availability of appropriate therapies for their pathogenicity, allergenicity, toxicity and mimicking of hormones. 4.2 Characteristics of the vector and the promoter, terminator and marker genes a) Nature and source of the vector; b) Genetic map of the vector, position of the transgene inserted, other nucliec acid sequences that may affect the expression of traits, marker gene, promoter, termintator and any other chemicals that affect trait expression; 13 /. yxD‰¹# kl@lÖC zrmlÖC wYM kl@lÖC yÆ?RY KStT nK N r ngéC UR tqÂJè y¥NqúqS zrmlÖc$N y¥St§lF Cl֬ XNÄ!h#M yxD‰�N mñR wY� xlmñR ¥wqEà zÁ½ m. qDä ytdrg zrmlÖCN wYM l@lÖC yÆ?RY KStT nK N r ngéCN ymnµµT ¬‰K½ sÀ wYM tqÆY ?Ãên# LW ynb„ SlmçÂcW s§lmçÂcW½ LW knb„M ytlw-#ÆcW zÁãC½ \. sWN wYM XNSúTN b>¬ y¥SÃZ X � [DW KBd�½ xlR©! ymqSqS½ y>LN xµL y¥g#dL X lsW wYM lXNSúT çRäNN ymMsL ClÖ¬½ r. yxD‰¹# tf éxêE x¥‰+ t¹µ¸ãC B²T½ s. yxD‰¹# t¹µ¸ãC t¹µ¸ l!çn# YCl# YçÂL tBlW y¸gmt$ ZRÃãC tf éxêE ï¬ãC �4�E ���L SR+T½ ¹. xD‰¹# wYM kxSgÆcW ÆYtêR zrmlÖC wYM tf éxêEM Yh#n# sW \‰> l@lÖC yÆ?RY KStT nK N r ngéC %/01 23 l!ñ„ y¸Cl# t{:ñãC½ q. y¥Yflg# t}:ñãC lmk§kL y¸ÃSCl# XRM©ãC½ b. bxµÆb!W bHYwT lmöyT lm‰ÆT XNÄ!h#M zrm§êE wYM l@§ yÆ?RY KStT nK N r ng‰êE �(��� lmF-R ��TKW :DL½ t. yt¹µ¸W SnÆH¶ÃêE XRU¬½ lMúr bkFt¾ F nT y�qÃyR ÆHRY½ 4444.3 .3 .3 .3 yLW yLW yLW yLW ?Ã?Ã?Ã?Ãuuuu ÆHRÃTÆHRÃTÆHRÃTÆHRÃT h. LW 5Ãu XNÁT XNdts‰ wYM XNdtlw- y¸ÃmlKT ZRZR mGlŽ l. yLW nt$ 8�0�O yyxNDxNÇ ytkttW ÆYtêR zrmL tGÆRN =Mé½ 14 c) Ability of the vector to mobilize and transfer other genes or other chemicals that affect trait expression by integration and methods for determining the presence of the vector; d) History of prior genetic or other trait affecting chemical manipulation, whether and how the donor or recipient organisms are already modified; e) Potential for human or animal pathogenicity and virulence, allergenecity; teratogenecity and the mimicking of hormones in humans or animals; f) Natural host range of vector; g) Natural habitat and geographic distribution of natural and potential hosts of the vector; h) Potential impacts of the vector or the inserted transgenes or other molecules that affect trait expresion, whether natural or synthetic, on the environment; i) Measures for counteracting adverse impacts; j) Potential to survive and multiply in the environment, or to form genetic; recombinants or other molecules that affect trait expression; k) Genetic stability of vector, such as hypermutability; 4.3 Characteristics of modified organism a) The description of the synthesis or modifications; b) The function of the modifications including that of each of the transgenes and other trait affecting chemicals inserted; 15 /. yÆHRY lW� wYM KStt$ xSf§g!nT½ m. �8�;& � wYM yt-ÂqrbT 9�½ btlYM Æ3têR zrmL ygÆbT ?ÃW kçnO yKStT NQ„N lm|‰T wd tqÆY ?Ãý lmKtT b QM §Y yêl# zÁãC½ \. ;d tqÆY ?Ãu ytkttW Æ3têR tf éxêE wYM sW \‰> zKmL ;3� dGä r2 �05<3 ��8� nK �K #�� 5�ý y9K�L yPse 7� Slm6�Ç ;3� bW+ �(K Slmçn#½ r. XNÄ!gb# ytdrg#� yÆ?RY KStT nK N�éC btqƆ yzrmL SR›T WS yÃz#6jW ï¬de XNdz!h#M QR��jW½ lMúr yyKStT NQ„ tdUU¸nT bq$ R½ bQdM tktL mgÈ-M wY r2 %3#� mdUgM½ s. wd LW ?�u ygb#� Æ3têR zrmlÖC ;3� r2 �05<3 ��8� n� �K #�� W.^e½ btlYM �05<3 ��8� E3#�� �& O ���8� ��~� 9�de½ ¹. bÆHRÃT lWõC b!kst$M ÆYkst$M XNÄ!gb# ytdrg#T Æ3têR zrmlÖC ;3� rse �K #�Me XRU¬½ ytlw-#ÆcW wYM ytê¦Ç0cW QRÛC ï¬ãC½ q. 4W� 5Ãu LW µlçn#T %�dc$ UR s!nÉiR y?Yw¬êE £dèC � r ngéC L†nèC½ b. wd l@lÖC 5�6 bq ¬M çn bdqEQ xµ§T bk#L l!ñR y¸ClW yzrmlÖC ;3� �rse �05<3 KStT nK �K #�Me mt§lF½ 16 c) Need for the expression or modification of the trait; d) Method of synthesis or modification, and in the case of a transgenic organism, the methods for constructing the expression cassette and for introducing it into the recipient organism; e) Whether the introduced natural or synthesized transgene or other trait affecting chemical has been integrated or is extrachromosomal; f) Number of expression cassettes inserted and their positions in the host genome, and their structures, for example the copy number and whether in tandem or other types of repeats; g) Products of the introduced transgenes or other trait affecting chemical, and in prticular induced trait and levels of expression and methods for measuring experssion; h) Stability of the introduced transgenes or other chemicals whether they are expressed or not, structures and sites of modification or integration; i) Biochemical and metabolic differences of the modified organism compared with its unmodified counterpart; j) Probability of vertical or horizontal gene or other trait affecting chemical transfer to other species; 17 t. XNÄ!lw-# ytdrg#T yn#KlYK xs!D N r ngéC wYM XNÄ!gb# ytdrg#T Æ3têR zrmlÖC ;3� rse �05<3 KStT nK �K #�Me b?Ãý WS k¸gß# ŠYrîC½ P§Z¸ìC wYM Æ��¶ÃãC UR tqÂJtW b>¬ xMÀ dqEQ xµ§TN �f „ y¸ñrW :DL½ c. xlR©! ymqSqS½ mR²¥nT½ b>¬ y¥MÈT½ çRäNN ymMsL wYM l@lÖC �L¬sb# W-@èC½ ^. %/01 7� 02ju GNß#nT LW ?Ãu LW µLçnW xÒW UR Ã�W N{{R½ n. LW 5Ãu LW µLçnW xÒW UR s!nÚ[R lb>¬Â ltÆY ymUl� h#n@¬½ �. yLW 5Ãu qdM s!L b QM §3 ��64 mr©½ �8.# 4(� � �� qdM PlW ytdrg#T Ñk‰ãC W-@èCN =Mé½ 4444.4.4.4.4 ?YwT ytz‰?YwT ytz‰?YwT ytz‰?YwT ytz‰ � � � � �<�<�<�<T T T T wYM sW wYM sW wYM sW wYM sW \\\\‰> ‰> ‰> ‰> ?Ã?Ã?Ã?ÃWWWW½ Q¶T½ Q¶T½ Q¶T½ Q¶T wYM sW wYM sW wYM sW wYM sW \\\\‰>‰>‰>‰> zrmzrmzrmzrm4444    rserserserse Q¶T wYM sW Q¶T wYM sW Q¶T wYM sW Q¶T wYM sW \\\\‰> ‰> ‰> ‰> yn#Klyn#Klyn#Klyn#KlYK xs!D YK xs!D YK xs!D YK xs!D r ngéC r ngéC r ngéC r ngéC 4444.4.1 ?.4.1 ?.4.1 ?.4.1 ?YwT ytz‰YwT ytz‰YwT ytz‰YwT ytz‰ � � � � �<��<��<��<� wYM sW wYM sW wYM sW wYM sW \\\\‰>‰>‰>‰> ?ÃW?ÃW?ÃW?ÃW h. úYNúêE ��½ µlW½ l. b?YwT Ãl# ¼ÃLfls#¼ t²¥J ZRÃãC ZRZR� k¬sbW QM xNÚR s!”ß# ÆHR×ÒcW½ /. ytg�bT ﬽ m. ?YwT XNÄ!z‰bT wYM XNÄ!\‰ ytdrgbT zÁ½ 18 k) Probability of the inserted nucleic acids, transgenes or other chemicals that have modified nucleic acides or other trait affecting chemcials of the recepient organism generating pathogenic recombinants with endogenous viruses, plasmids or bacteria; l) Allergenicities, toxicities, pathogenicities, mimicking hormones and other unintended effects; m) Autecology of the modified organism compared with that of its unmodified counterpart; n) Susceptibility of the modified organism to diseases and pests compared with its unmodified counterpart; o) Detailed information on past uses including results of all experiments leading to previous releases. 4.4 Characteristics of resuscitated fossil or synthesized organism, fossil or synthesized gene and other fossil or synthesized nucleic acid molecules 4.4.1. Resuscitated fossil or synthetic organism a) Scientific name if any; b) Identity of nearest living (i.e. non-extinct) species and their characteristics which are of relevance to the intended use; c) Site at which it was found; d) Method used for resuscitation or for its synthesis; 19 \. ?YwT XNÄ!z‰bT wYM sW XNÄ!\‰W ytdrgbT MKNÃT Yg¾L tBlÖ y¬sb QM µl½ r. bsW ;3� bXNSúT -@½ ;3� A�w bxµÆb! §Y l!ÃúDrW y¸ClW t}:ñ½ s. ¯©! t{:ñãC lmÌÌM ����a4m ���de½ ¹. ?Ãý b QM §Y yöybT g!z@ m-N½ q. zrm§êE XRU¬W½ b. k?Ãu wd l@lÖC ?ÃêN yzrmlÖC mt§lF :DL½ t. B�� � �& yzR QRbT çcW l@lÖC Q¶èC wYM sW \‰> ?ÃêN ZRZR½ c. b?YwT µl# t²¥J ZRÃãC UR ÃlW Sn ?Yw¬êE r #g‰êE tlÃYnT½ n. ?YwT ktz‰bT wYM sW k\‰W wÄ!H b QM §Y ���6� mr©½ 4444.4.2 .4.2 .4.2 .4.2 � � � � WWWW� �<� � �<� � �<� � �<� wYM ?YwT ktz‰wYM ?YwT ktz‰wYM ?YwT ktz‰wYM ?YwT ktz‰ � � � � �<��<��<��<� ?Ã?Ã?Ã?ÃWWWW y¸wy¸wy¸wy¸wssssÇ Ç Ç Ç wY wY wY wY dGä sW dGä sW dGä sW dGä sW \\\\‰> yçn# ‰> yçn# ‰> yçn# ‰> yçn# n#Kn#Kn#Kn#KllllYK xs!ìC wYM l@lÖC yÆHRY YK xs!ìC wYM l@lÖC yÆHRY YK xs!ìC wYM l@lÖC yÆHRY YK xs!ìC wYM l@lÖC yÆHRY ��8���8���8���8� nK nK nK nK N r ngéC N r ngéC N r ngéC N r ngéC h. ?YwT ytz‰bT �<� 5�W� Yh#N Q¶T wYM sW \‰> ?ÃW úYNúêE SM½ l. Q¶� ;3� 53;� �89� � Q¶T ?Ãý ytgßbT ï¬ wYM dGä sW \‰> ?Ãý yt-ÂqrbT "t Ñk‰½ /. zrml# wYM yÆ?RY KStT nK N r ng„ ?YwT btz‰bT Q¶T ?Ãý WS ½ y¸¬wQ kçnM bQ¶t$ wYM bsW \‰> ?Ãý WS ½ y¸g"bT ﬽ �. kl@§ ?ÃW ytwsdW wYM sW \‰> yçnW zrmL yn#KlYK xs!D r ngéC QdM tktL wYM yl@§ ›YnT yÆHRY KStT nK N r ng„ MNnT½ \. zrml#O n#KlYK xs!�O wY� yÆHRY KStT nK yçnW l@§ N�K ng„ tn lÖ XNÄ!wÈ wYM XNÄ!\‰ ytdrgbT zÁ½ 20 e) Purpose of resuscitation or synthesis of the organism and intended benefits, if any; f) Possible impacts on human or animal health or the environment; g) Measures for counteracting adverse impacts; h) Length of time the organism has been in use; i) Genetic stability; j) Likelihood of gene transfer to other organisms; k) Nearest relative fossil or synthesized species; l) Biological and biochemical differences from related living species; m) Information on previous uses since resuscitation or synthesis. 4.4.2. Nucleic acids or other chemicals that affect trait expression taken from any fossil or from any resuscitated fossil organism or synthesized a) Scientific name of the species whether resuscitated, a fossil or synthesized; b) Site of origin of the fossil or resuscitated fossil organism or laboratory where the orgnzisim was synthesized; c) Site of the gene or other trait affecting chemical in the genome of the resuscitated fossil organism, in the fossil genome or in the synthesized organism, if known; d) Nuclic acid sequences of the extracted or synthesized gene or composition of the trait affecting other chemcial; e) Method used in extracting or synthesizing the gene, the nucliec acid or trait affecting other molecule; 21 r. yzmrl#½ yn#KlYK xs!� wYM �l@§ N r ng„ y?YwT tL:÷½ s. lMN |‰ 23 XNdêl YsÈL tBlÖ y¬sbW QM /�½ ¹. Q¶T kmçn# bðT YñRbT ynbrW xµÆb!½ (. 9K��½ yn#�l3� %h� �K #�� ;3� r2 �K #�� ktwsdbT Q¶T ZRà UR y¸²mÇ l@lÖC Q¶T ZRÃãC½ b. zrm�½ n#K�YK xs!� wYM l@§W N r ngR ktwsdbT Q¶T ZRà UR y¸²m� wYM dGä ksW \‰> zrml#½ n#KlYK xs!ǽ wYM l@§ yÆ?RY KStT N r ng„ U‰ tmúúY YzT çcW ?ÃêN ZRÃãC½ t. ksW \�> zrml# wYM yÆ?RY KStT nK N r ng„ U‰ xBé wYM t-ÂQé y¸g" k?ÃW wYM kQ¶T ytwsd zrmL wYM l@§ yÆ?RY KStT nK N r ngR½ 4444.5 ysW yXNSúT .5 ysW yXNSúT .5 ysW yXNSúT .5 ysW yXNSúT ----@@@@ dHNnTN btmlkt dHNnTN btmlkt dHNnTN btmlkt dHNnTN btmlkt SlLW ?Ãu mr©O LW HÃý bzrmL MHNDS yt\‰ kçn ��sÀ ��tqÆY ZRÃãC XNÄ!h#M ��xD‰¹# mr©½ %��� XNd¥Y¯Ä �AKm bðT ynbrbTN h#n@¬ =Mé ��mlÃW½ ��kúc$ ��kLµ† zrmlÖC mr©ãC½ h. ym²mT ClÖD½ l. 4�W 5Ãu sWN wYM XNSúTN b>¬ y¸ÃSYz kçn kz!H q lÖ ytmlkt$T mr©ãC ÃSfLUl#½ 1. yb>¬dp xYnèe� b>¬ãc$ -NQ y¸çn#ÆcW mNgìC½ y ”T m-NN =Mé½ 2. t§§ðnT½ 3. b>¬ �ÃSYZ y¸ClW m-N½ 4. b>DW y¸Y²cW ZRÃãC P!�� xÄ!S Z�ÃN y¥úm� :DL½ 22 f) Function of the gene, the nucleic acid or other molecule; g) Purpose of use and intended benefits, if any; h) Environment in which it lived before fossilization; i) Fossil species related to the species from which the gene, the nucliec acid or other molecule was taken; j) Living species related to the species from which the gene, the nucliec acid or other molecule was taken or with similarity to the synthesized gene, nucleic acid or trait affecting other chemcial; k) Any gene or any other chemical that affects trait expression taken from any living, fossil or resuscitated fossil organism that is now mixed with the synthesized gene or other trait affecting synthesized chemcial. 4.5 Safety considerations for human and animal health Information on the modified organism and when it is genetically engineered using recombinant DNA technology, information on the donor and recipient organisms as well as the vector including before it was disarmed, marker genes, promoters and terminators regarding: a) Capacity for colonization; b) If the modified organism is pathogenic to humans or animals the following information is required: 1) diseases caused and mechanism of pathogenicity, including virulence; 2) communicability; 3) infective dose; 4) host range and possibilities of using new hosts; 23 5. ksW wYM kXNSúT sWnT WÀ bHYwT ymöyT xQM½ 6. yb¹¬W xSt§§ð HÃêN mñR x¥‰+ ymt§lðà mNgìC½ 7. Sn HYw¬êE XRU¬½ 8. xlR©! ymqSqS½ ymR²¥nT½ b>D y¥SÃZ½ çRäNN ymMsL l@lÖC t}:ñãC½ 9. tgb! yçn# HKMÂãC �T�½ 4444.6. xµÆb!N bt.6. xµÆb!N bt.6. xµÆb!N bt.6. xµÆb!N btmlkt mlkt mlkt mlkt SlLW ?Ãu mr©O LW 5Ãu bzrmL MHNDS yt\‰ kçn A�w ��sÀ ��tqÆY ZRÃãC XNÄ!h#M ��xD‰¹# mr©½ XNd¥Y¯Ä çñ kmlw-# bðT ynbrbTN h#n@¬N =Mé½ �� mlÃW½ �� kúc$ �� kLµ† zrmlÖC mr©ãC½ h. LW ?Ãý bHYwT XNÄ!öY½ XNÄ!‰Æ XNÄ!s‰+ t}:ñ y¸ÃúD„ h#n@¬ãC½ l. �4W� 5�u �T� ;3� xlmñRN l¥wQ½ ¥Nnt$N lmlyT KTTL �¥DrG y¸ÃSCl# zÁãC ZRZR½ /. LW 5Ãu kl@lÖC HÃêN UR y¸�dRgW yzrmL LWW N l¥wQ y¸ÃSCl# zÁãC ZRZR½ m. y¸¬wq$ wYM y¸gmt$ lLW 5Ãu y¸mc$ ï¬ãC½ \. 048.# LqT l!nk# y¸Cl#T SRxt �HDéC mGlŽ K. LW 5Ãu 048.# LqT �� �� l@lÖC HÃêN UR l!ñKW y¸ClW GNß#nT½ 24 5) ability to survive outside of the human or animal host; 6) the existence of vectors or other means of transmission; 7) biological stability; 8) allergenicity, toxicity, phatogenecity, mimicking hormones and other impacts 9) availability of appropriate therapies. 4.6 Environmental considerations Information on the modified or resuscitated fossil organism, and when it is genetically engineered, information on the donor and recipient organisms as well as on the vector including before it was disarmed and on the marker, promoter and terminator genes regarding: a) Factors affecting the survival, reproduction and spread of the modified organism in the environment; b) Techniques for detection, identification and monitoring of the modified organism; c) Techniques for detecting the transfer of genes to and from the modified organism; d) Known and predicted habitats of the modified organism; e) Description of the ecosystems which could be affected by accidental release; f) Possible interactions of the modified organism with other organisms following its accidental release into the environment; 25 ,. y¬wq$ wY� y¸gmt$ kLW 5Ãu YêTO bXNSúT ;3� A}� %/2� §Y l!dRs# y¸Cl# ymLkF½ y¥úmM½ ymmrZ½ y¥�”TO yb>¬ xSt§§ð �mçN½ xlR©! ymqSqS½ ym²mT ;3� l@lÖC t}:ñãCO ¹. b?Yw¬êE yN r ngéC ;#dT y¸ñrW ¸Â½ q. ÃL8.# LqT b!ÃU M ï¬WN ��t�� y¸ÃSCl# zÁãC ZRZRO b. �P�� §Y l!ñR y¸CL t}:ñ½ 4444.7 ¥Hb‰êE x!÷ñ¸ÃêE g#Ä×CN btmlkt .7 ¥Hb‰êE x!÷ñ¸ÃêE g#Ä×CN btmlkt .7 ¥Hb‰êE x!÷ñ¸ÃêE g#Ä×CN btmlkt .7 ¥Hb‰êE x!÷ñ¸ÃêE g#Ä×CN btmlkt ��'`W MKNÃT YmÈl# tBlW y¸gmt$ ¥Hb‰êEO x!÷ñ¸ÃêE wYM ÆH§êE lWõCN y¸Ãú† mr©ãC½ h. bBZ¦ HYwT½ #0� xZR:T wYM l@lÖC MRèC½ btlYM bgbÊãC ZRÃãC� bz§qE GBR §Y l!f-„ y¸Cl# xdUãC½ l. #0� xZR:T ;3� xgR bqL 9ÁãC ��'`W bmtµ¬cW MKNÃT �#� y¸Cl# & �C½ /. P+y 53;� mmÂmN½ b|‰ ����½ bgbà ¥ÈT½ Æ-”§†� �� K,le n#é 23 l!dRs# y¸Cl# ¥Hb‰êE x!÷ñ¸ÃêE t{:ñãC½ 26 g) Known or predicted effects of the modified organism on plants or animals or microorganisms including infectivity, pathogenicity, toxicity, virulence, being a vector of pathogens, allergenicity, colonization or other impacts; h) Possible involvement in biogeochemical cycles; i) Methods for decontamination of the area in case of accidental release; j) Impacts on agriculture; 4.7 Socio-economic considerations Anticipated changes in the existing social or economic conditions or cultural norms resulting from the transaction; a) Possible threats to biological diversity, traditional crops or other products and, in particular, farmers' varieties and sustainable agriculture; b) Risks likely to be posed by the possibility of substituting traditional crops, products or indigenous technologies with the transaction; c) Anticipated socio-economic impacts on loss of genetic diversity, employment, market opportunities and, in general, means of livelihood of the communities likely to be affected; 27 �. +��de 53;DL �K #�Me 23 �A�� ��e�W �W�� �W� �� �� �+��dp &'�#� ��A4� �-� O ,Pse ;3� ��T �Y6� 0���� � �0�W 9� ���y�^e� �rse �K #�Me ��K� �P</de ��K�� 0�<�jW 8!�^ 8�3� �� �de ;3� � P� %�1de �� K,le �# �jW &'�#� �(#� $�M½ z. l!dRS b¸ClW ¥Hb‰êE wYM x!÷ñ¸ÃêE qWS MKNÃT l!-q$ y¸Cl# kx!T×ùà W+ Ãl# xgéC wYM ¥HbrsïC½ K. bx!T×ùà ;3� bx¯‰ÆC xgéC �� K,le 23 l!dRS y¸CL ¥�b‰êE½ ÆH§êE½ SnMGƉêE wYM ¦Y¥ñ¬êE Xs@èeN y¸ÚrR t{:ñ½ 5. y¸iÂbT g!z@ YH mm¶Ã k qN ›.M. jMé yi YçÂL xÄ!S xbÆ qN ›.M. yxµÆb! ��� "� ,P-1 28 d) Changes to the biochemistry and usefulness of the species, including biopharming with animals, crops or forage plants to produce medicines or other chemicals and the spread of the changed trait and the consequent reduction of the usefulness of the species, especially to local farming or pastoralist communities; e) Possible countries or communities outside of Ethiopia likely to be affected by disruptions to their social or economic welfare; f) Possible effects within Ethiopia or in neighbouring countries which are contrary to the social, cultural, ethical or religious values of communities. 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