Directive No. 05/2009 issued to determine the storing and processing 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 xMSTmmRà xMSTmmRà xMSTmmRà xMST DIRECTIVE FIVE yLW ?ÃêN xkmÒcT bÍB¶µ Ê :”nT xyLW ?ÃêN xkmÒcT bÍB¶µ Ê :”nT xyLW ?ÃêN xkmÒcT bÍB¶µ Ê :”nT xyLW ?ÃêN xkmÒcT bÍB¶µ Ê :”nT x----”qM”qM”qM”qM THE STORING AND PROCESSING OF 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 5mm¶Ã q$ R 5mm¶Ã q$ R 5mm¶Ã q$ R 5 yLW yLW yLW yLW ?ÃêN xkmÒcTN bÍB¶µ Ê :”nT x?ÃêN xkmÒcTN bÍB¶µ Ê :”nT x?ÃêN xkmÒcTN bÍB¶µ Ê :”nT x?ÃêN xkmÒcTN bÍB¶µ Ê :”nT x----”qMN lmwsN ywÈ ”qMN lmwsN ywÈ ”qMN lmwsN ywÈ ”qMN lmwsN ywÈ mm¶Ã mm¶Ã mm¶Ã mm¶Ã yLW ?ÃêN xkmÒcT b Ê :”nT lÍB¶µ x-”qM bsW ��� bXNSúT -@ wYM bxµÆb! §Y g#ÄèCN ����� mçN §lÆcW½ Slz!H bdHNnt ?YwT xêJ q$ R ........ �� � 22 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 xkmÒcTN bÍB¶µ Ê :”nT x-”qMN lmwsN ywÈ mm¶Ã q$ R 05¼2001´ tBlÖ l!-qS YC§LÝÝ Ga0EP kPL 5 PADP AEP? AMEE EIT 140160 TG 6LP7E AML PP? AOA PON anand P PAD-P hEPD ANS ATG OF rk ARNE AML?” INO Weg AAT MF OLI° NADI, 12 RED POTPL CO GOUT DAAVEO-? AAU ALVITE HELO APE kPC ........ AIPA 22 WAAC Ly gavge oPka:: AGA AS 1. 9% LV MaDe, e LAMP HEPD ANF ELIT 14160 26 OPE AML PPS APONT PON a0, kTC 05/2001» bNhe AMPA LTAA:: 3 DIRECTIVE No. FIVE A DIRECTIVE ISSUED TO DETERMINE THE STORING AND PROCESSING OF MODIFIED ORGANISMS WHEREAS the storing and processing of modified organisms have to avoid any harm to human or animal health or the environment, 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. 05/ 2009 issued to determine the storing and processing 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$Bl!K yxµÆb! b” Æl|LÈN nWÝÝ 6. «�� !´ �"� ��#�$� #��� �%&' � ( �� ��)*� ��+, ��� ��!� �-�(� "�./�� �0�1, 23 �4��� ���5 ���� � 6"�7 8 �9�� * ��!� �:.� ��;� �* $*<< 7. «xmLµC´ ¥lT y¸-YqWN :NQS”s@ l¥µÿD -��=> ��$? 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 �@A � l¥MrT½ l¥ÙÙZ½ lgbà l¥QrB½ lsW wYM lXNSú bmD`n!TnT lm-qM½ lMGBnT½ lmñnT wYM lÍB¶µ Ê :”nT ¥êL¿ ¿ ¿ ¿ $*<< 2. TCAD ANU APL Wp? 1. KANE "LM> TWA AMP HEM? Atm) APT ACTTPA 17710 °9°%76R, APP? OEPAA 144A NACaZ PUNE PAM? BPC AAT O17 APR? NAM OLI NAA G71 PMTAAG WO: KAMP HEM» WA AD we PUT? DLI 104 HED P+TOAL. Bv-7 nee PTOAL OLY AILASA PPP 1E5FPC HCPA MOLI AA TPA 2G AATOETAE PHL CHE O29° PINCR hath PFAOMIT new: 5@::: KOO PPEby AT MPFR TAN ALO AMP HED AFSTH MLD WO: AD? Tb OTEPC AD OL Nh? PAD GN PTAMM ANA 10-: KNAPAN > WT NAPE &PC 295/1995 PrRRGOM PAAR 6.2.6-4P SPHEALP CENARD PANIA PAL VA2PAN? VO: «FPUNS» Ab PLVITE VZOF APE? NAG PON °17FO-" LING OZI? TIVE als ATNLITE PREAT AN PREPC ACPS ATVE.OAS W7PANT N°7EOND: goad? ower Ptfiao Ad 1-:: PAT» "IAT PFLNLPOHD H1TPALA ACTHLS: NIA Paria, APPT ATAAMD AIAZPAN: PPA AD 70-:: KATPAL A> AT ADP AEOD 979677! O27 ATPVCTE APCIPCE APCT? Of AIC ON AMINA OF Men, AMAR Whe THT APMTAAGE Aba APT AND ANLPP ACIP AEE ACTA AML AP7TPLNE AND OL9° AATNA NLD LTE APMEPE APVTEE APT OLI ANC PG bOLPTE IPAE 1M: 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. «B� �@A �´ ¥lT ��W wYM ����C� D, wYM ��E6F 3� y¸ktL ÃL¬qd t}:ñN lmk§kL -7*� G�%� /� ����H @�I� ��JJ�� 7� ���6��� "���� �� * ��!� 4�� 03/2001 ��� NOP* �Q� � 4.8 ��� 4.9 ����H.H.* �4CV, ���. $��V -"3 P�.W LW ?ÃêN ���s„½ XNÄ!ÃDg#½ XNÄ!k¥c$½ XNÄ!wgÇ wYM ��H��N, MRMR� ?�W �X$ l@§ ���� � QM §Y XNÄ!Wl# ��.� nWÝÝ 10. «��D$ LqT´ ¥lT kGN²b@ bmn= SMMnT msrT LW ?ÃWN "���' "��+' "��YP 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 ��.� 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 [\]9' §Y l!ktL y¸CL xdU nWÝÝ 12. «ßéè÷L´ ¥lT ��%& 4�� 362/1995 �a� W �+B/ G��� \�b�cn# yµR¬d ��G�$� G��� eWf\7 $W<< 9. 10. 11. 12. «KH? ANLPM» MT NAO O29 NATE MF OL9I° NAAN, AL PeLOrA LADPL F087 AZSNADA NAD-T HEP Id. PTLLU MIPD PaVKLIPL AA ATIC? Aco NON goarde KFC 03/2001 AIR U-'4D-O NGIPO 4.8 OLI’ 4.9 ALAND NEARS NITPS 116-2 NAA ARLO- AO-T DEPT ATA ALR ATA TET AAO. O29 FPVUCTHIS PCPCT OPC NUT AA GTI NEPP AL ATO A: CILLD Oe: PEM Ath Wh AIHA 127 APPT PACH ADP Mew? AFIS? APWNE AACS PINE ANAT ACVWVEE ACTINIC LTE APCPCE APATP TE Wh? ADY OAT ACA? AAV FP? AND O29° AAT VAPT OLI AAA PHP? NPTIPA DES ANAND ATEACA [127 10-2: KNTP> WAT 1ERFOP ATVPALPA IPRA O29 ATHPPSE F971k? NASECE Azehnnay wer ALE Lh AN® WL9° NADA MF? ANNh AEOT? AAnIN = ACMWVACANE 9WNE-PF ADPELER? O29 AAP V-AF OLI7° NAIC ANT? AS ATA POVEFA ALD WO: KICTHA> "Mbt NAPE &PC 362/1995 POLPO PNUHh ALO 1777 PHC TDG PLATE ALOT TCH 10: 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 3333. . . . ��!�*��!�*��!�*��!�* tfɸ Sl¸çNÆcW XNQS”s@ãC tfɸ Sl¸çNÆcW XNQS”s@ãC tfɸ Sl¸çNÆcW XNQS”s@ãC tfɸ Sl¸çNÆcW XNQS”s@ãC yz!H mmRà tfɸ$� "�D$ 7 � -6"�7 n# -��=> y$�? ��$� Ã7��@6gW LW ?ÃêN xkmÒcTN bÍB¶µ Ê :”nT x-”qMN Ymlk¬LÝÝ 4444. yLW . yLW . yLW . yLW GGGGÃêN xkmÒcT bÍB¶µ Ê :”nT xÃêN xkmÒcT bÍB¶µ Ê :”nT xÃêN xkmÒcT bÍB¶µ Ê :”nT xÃêN xkmÒcT bÍB¶µ Ê :”nT x----”qM ”qM ”qM ”qM 4.1 LW ?ÃWN l¥k¥cT wYM bÍB¶µ Ê :”nT lm-qM y¸ÒlW "hN ��6� btmzgb# f”D btsÈcW tÌ¥T WS BÒ nWÝÝ 4.2 ÆlSLÈn# y-@Â, y\‰t®C g#Ä×C k¸mlkZcW |LÈN ktsÈcW f”D sÀ m|Rà b@èC UR bmmµkR LW GÃêN l¸k¥c$ÆcW X bÍB¶µ Ê :”nT l¸Wl#ÆcW tÌ¥T f”D YsÈL¿ YmzGÆLÝÝ YHN l¥Sf[MM y¸ktl#TN tGƉT õiÄLÝÝ h. LW ?ÃêNN l¥k¥cT bÍB¶µ Ê :”nT lm-qM y¸ÃSfLg# dr©ãCN ÃwÈL½ l. lKMCT lÍB¶µ ï¬ãC f”D MZgÆ y¸ÃSfLg# x\‰éCN GÁ¬ãCN Y�SÂL½ /. SlLW GÃêN xÃÃZ l\‰t®C SL- lmS-T mà§T ÃlÆcWN GÁ¬ãC YwSÂL½ 4.3 bz!h# mm¶Ã �� � 4.2 m\rT f”D s!s� MZgÆ s!õiÇ tÌ¥t$ bsW wYM bXNSúT -@NnT wYM bxµÆb! 3� g#Ä� b!ÃdRs# �¸ÃµKS bqE yêST >ÍN çcW mçn#N ÆlSLÈn# ¥rUg xlbTÝÝ 3. goad PD 14.997, NATLU VED ATPALOAP FT PHY Moce F297 AEM APE NIAZLAN?: NIFH P1a0EDL APP PATANVFO: ADP HEP? ANE EIG 14-160 6 OL TE ANL PPT BPADZA:: 4. PADP DEPT ANPFEES NEN TE OPT AMP OP? 4.1 4.2 4.3 AMP hey ANTE O29 1416 T6 OF1kK APMP? POLFAD: ALU: FIG AHS BPR ATAVEO: tke OAT MF 7-3: NANAN?: PMETG PHOERET 18 PLANE TO: YAN DTAVFO: 222 Ach, 7°02 UE DEC Nera AMT HEP? APLOTVENTO: AG 14-160 TE OP TE ACLOAVEO FRO BP LANA! BCOPHINA:: BUF ATINEAPLT? PPLObAT FING PULAA:: UV. ADP HEP ACTIVES 140160 86 OPT ANGMEI? P°LLNEAL LCEP ED PONAE AL ANP EET ANCA ODP PF BPI PUM PPLPALAT APEC TIT WISP EY LONTAT ah. MAA PE HEP ALPEN ALETE ER AAME AVANT 714-4 LAVEOF 12, 5-P7 LOATAT QU: 220022 APO 4.2 PoE BPR AATT 2110 Hen'Ls. TROVE NNO O29 NAINA MI O29 NAHI AR +-4b Pech PeZehna Ab PPA 4 PVFO cour AANA IIE AAT: 8 3. Transactions subject to this Directive A transaction subject to this directive shall include any storing or processing of modified organisms that have not been given advance informed agreements by the Authority for deliberate release. 4. Procedures for storing and processing modified organisms 4.1 Only licensed and registered facilities shall store or process any modified organism. 4.2 The Authority, in consultation with the competent licensing agencies for health and labour affairs, will undertake licensing and registration of premises for the storage and processing of modified organisms and for this purpose shall establish. (a) Standards pertaining to the storage and processing of modified organisms. (b) Procedures and requirements for the licensing and registration of storage and processing premises. (c) Requirements for the training of employees in the safe handling of modified organisms. 4.3 In undertaking the licensing and registration of premises under Article 4.2 of this Directive, the Authority shall require the premises to carry adequate insurance to cover liability for harm to human or animal health or the environment. 9 4.4 yLW GÃêN ¥k¥Ò wYM bÍB¶µ Ê :”nT m-qMà tÌM `§ð yçn sW tÌÑN lz!H xgLGlÖT l¥êL -��=> ��$? ��$� XNÄ!Ãg" y¸ÃSClWN ¥mLkÒ "ÆlSLÈn# b}h#F ¥QrB xlbTÝÝ 4.5 LW ?ÃWN l¥k¥cT wYM bÍB¶µ Ê :”nT lm-qM y¸qRB ¥mLkÒ q lÖ ytmlk�WN B�B� mÃZ �"��ÝÝ h. lKMCT wYM lÍB¶µ Ê :”nT y¬sbW LW ?Ãý ytà§Â TKKl¾ ZRZR mGlŽ XNÄ!h#M úYNúêE ytlMì jk, ytlw-bT KNên@½ l. lKMCT wYM lÍB¶µ Ê :”nT xgLGlÖT y¸WlW LW ?Ã* m-N bKMCT wY bÍB¶µ Ê :”nT y¸öYbT yg!z@ gdB½ /. yLW ?Ãl ¥k¥Ò wYM lÍB¶µ Ê :”nT m-qMÃ ï¬ SM xD‰š½ m. LW ?Ãl b Ê :”nT l!-QM y¬sbbT x\‰R ZRZR½ \. btÌÑ WS Sl¸ñ„T y-NQ mk§kà zÁãC bDNgt¾ xdU g!z@ Sl¸w�Ç XRM©ãC xtgÆbR ZRZR½ 4.6 LW ?ÃlN l¥k¥cT wYM bÍB¶µ Ê :”nT lm-qM y¸ Y W� ¥mLkÒ ktqbl b“§ ÆlSLÈn# q lÖ ytmlkt$TN g#Ä×C lmwsN btÌÑ Ftš ¥µÿD xlbTÝÝ 4.4 4.5 4.6 PADP hEPT MDF O29 14-0160 76 OPE MMO" L TRY Dé PUT AO bP AV AIAMET ACTIPA NIM Poot, APP ATL POLENFAD? "IOADF ANAAAN? Nov-% °7hEN AAT: ADP hAEOD ATV O29 14-16 76 OPT AMM? P°LPCN IPADF bthe PLANO? TICIC MLN AAMT: VU. ANP FE O29? ANE PG OLE PZANM AMP HEM. PLAT TnhAAG ACUC F7A,F AFAVIP ALTIAPT PFAPR AVES PTAOMIT NIP2F A. ANP Er O27 ANC) TE OPT AAMT PPLO-AD ADP ALD PMNIT ANP RE OL 14-0160 7G OPE PPLFLAT PN 12.1? hh. PAOD AED. MIF OL9 ANC 6 OP rr MMO" L N APT AGA DAMP HED. APS OLE AMEP PAANVH AWw?-C WUC Ww VER OAT ANTLEEE PMI HANDE WLP FS AIT ALD LI, AAPTLOAS. ACP ELF AIG WUC? AO? AED? ACTH O29 14-0161 86 6L7E APMPP” P7LM LPO-> JoAnF ATPNA 174 VANANY PPA® PLOPADEET 14°07 APON? AtLor Gra °TNLR: AAT:: 10 4.4 The person in charge of any premise that is to be used for the storage or processing of any modified organism shall apply in writing to the Authority for an advance informed agreement to use the premise for the purpose. 4.5 Any application for an advance informed agreement to store or process a modified organism shall contain: (a) A full and accurate description of the modified organism that is to be stored or processed, including scientific and common names and transformation event; (b) A statement of the quantity of the modified organism to be stored or processed and the duration of the storage or processing; (c) The name and location of the place where the modified organism is to be stored or processed; (d) A description of the processing that is to be undertaken on the modified organism; (e) A description of the risk management strategy and emergency measures that operate within the facility. 4.6 Upon receipt of any application to store or process any modified organism, the Authority shall inspect the premise to determine if: 11 h. yLW GÃýN dHNnT -Bö l¥k¥cT wYM bÍB¶µ Ê :”nT lm-qM mPW +A� �"W �X8½ l. ��Jn bqE b” "�f ���B, dHNnTN ym-bQ ›QM mñ„½ /. yLW ?ÃêN b”N btmlkt l\‰t®C SL- ms-t$½ 4.7 ÆlSLÈn# xSf§g!WN Ftš µ-Âqq b“§ k¸ktl#T xNÇN YwSÂL½ h. �o X] E�pW µlMNM QDm h#n@¬ -��=> ��$? ��$q� �� 7½ l. �?�! B�&� y�Jn� +A� r�s3 �9k7 X] -P�W btgdb h#n@¬ -��=> ��$? ��$q� �� 7½ /. @�IN � ��� ���t7 X] -P�W -��=> ��$? ��$q� �-"u37½ 4.8 y¸s-W -��=> ��$? ��$� q lÖ ytmlkt$TN mr©ãC mÃZ xlbT½ h. yLW ?Ãl ¥k¥Ò wYM b Ê :”nT y¸ÃglGLbT tÌM SM xD‰š½ l. lKMCT wYM lÍB¶µ Ê :”nT l!WL y¬sbW LW ?Ãl Ñl# TKKl¾ ZRZR mGlŽ úYNúêE ytlMì jk�, ytlw-bT Knên@� ?�W½ II 2DoabW L4b4U -LUWOV-Ld Sh-babY SabVS SbVLEIY 2:VGao JUIN VUE 5°V-a0 WIV LOV OU-FS V-OV L469 Pb YPUCOV o6TO Lk abUV © 22-54 bab ob bE LUVLVLS hod L4G? PLU obdTO Lbobo WSV LOWS 2EUVY Ndao Lbx2a0 LlelUVaal+d Vbd bhabo6Y Whars VhLGU -oWV%od sVU4uUud LthobabY Whavs VhALGU -o0d-FU SN VEDhodS SLOVYLo LbLw 2VYWUS Lhabob6Y Whars VALGY -F 40 USL-LU OeFU SN Wkhod Viod V LF L:00b4S -LAbIL Pho WL * 2VWVUd Lbhob6ob6Y Whar VALGU -F FO aoSh ob6b06VGU -OLLU SN PU a :V45U00 L944 AVAUSY VEU bb bWY kb LOL PUY 4 YUVD EWWan SWYY Lobel? --UVaa--+U LeUL Ldd'v b-OWd “WY 2b 50D bbe bUWard L-E4408 SUS09S FOV SEUL PU -09h-+U | shar -OVS -LFU -O-FU abbWanV -L4g'? Ph YPUCDD o6TO -LebkboUboY PUW -LALOS Lod b-ovd a 8'V LY 12 (a) Adequate facilities exist for the safe storage or processing of the specified modified organism. (b) Adequate security, segregation and safety measures exist at the premise; (c) Employee training in the management of modified organisms has been undertaken. 4.7 Upon the completion of the inspection, the Authority shall decide on one of the following: a) Issue an advance informed agreement without conditions if it is satisfied. b) Issue an advance informed agreement which may specify conditions if some additional work will make the premise adequate. c) Refuse an advance informed agreement if it decides that a significant risk cannot be avoided. 4.8 The advance informed agreement issued shall contain information regarding: (a) The name and location of the place where the modified organism is to be stored or processed; (b) Full and accurate description of the modified organism that is to be stored or processed, including scientific and common names and the transformation event; 13 /. lKMCT wYM lÍB¶µ Ê :”nT xgLGlÖT y¸W"W m-N bKMCT ��� �v+!E b Ê :”nT y¸öYbT yg!z@ gdB½ m. yxdU �-3-� XRM©ãC ZGJT½ 4.9 ÆlSLÈn# LW ?ÃýN "¥k¥cT wYM bÍB¶µ Ê :”nT lm-qM lxmLµc$ bs-W -��=> ��$? ��$� ytzrzr ¥N¾WM GÁ¬ btgb!W XytৠÆLçnbT b¥N¾WM g!z@ ��$q� l!\RZ |‰WN l!ÃSöM YC§LÝÝ 4.10 bz!H mm¶Ã m\rT -��=> ��$? ��$� kts- b“§ bsÆT qN WS ÆlSLÈn# I&W� bB/@‰êEW ydHNn� ?YwT ymr© |R›T WS ¥Sqm xlbTÝÝ 4.11 ¥N¾WNM LW ?ÃWN l¥k¥cT wYM bÍB¶µ Ê :”nT lm-qM -��=> y�$? ��$� yts-W ¥N¾WM DRJT Ê :”W yÍB¶µW W-@T h#l# ¬>¯½ MNnt$N y¸gL{ {/#F tl æbT tlYè mqm-#N ¥rUg xlbTÝÝ YHM y¸çnW yd?Nnt ?YwT ?g#N xNq{ 7 X ymm¶Ã q$ R 1� ›Nq{ 9.2 lmtGbR nWÝÝ 4.12 LW ?ÃWN l¥k¥cT ��� bÍB¶µ Ê :”nT lm-qM `§ð yçnW GlsB kz!H b¬C ytzrz„TN tGƉT mfiM xlbTÝÝ el SaEUVY a60°2a0 Le? Ulel Le SUIS LEU CHU UUVG 040d PUG abbWanV LAGI Ph UPUDU o6TO -LekbolboV 4-08? b-OW TIP 704 JUG-b-aoV C6 BbL5 LI Db SPava0d SY L ¥BPLY CUP LOO -4LV9d OLNivd 6A -LUVY bLCPko LWarhan FIV 5-LUILVE SPY YVhod Litho the VO EW. .wk2Uebs 50g Dh bXIS ab-ObLbo OWLS habobY WLS UAL abbWarV Lg Ph UPVC a6TO bekboUboV 4-00 LOW o64-0%4h0 IP LUVY baobUbo LU-0 +b Jef K2a0d LOT? A4L08S ObPVUU Losh 4WVUVE LU.0 Lb LUVU VEU WU-LU Lhabob6QY Whars VRLGU +L 2map SPapan WH OP ENVVED abPUIV £-0°2e/ SLIMY LhobobY HL ab-OS4600 -LULAVU VeobdY OULU Sb 06-0 L bo AUAUS bhob6a6Y Whars VhtELU -oWUU EYWaoYV a6bWaoV Lag Q@ Pb YUU c6TO -bekhboboY Lod? bOV 4WYUVL 61 ELV LbeabIY SUA C'SYS ‘av USL ULS LUSH hod L4G PLU YPUOSU abTO LL aU 54Wap -OV-W'hod “LVL 4g Ph YPUCEV TO bk obUV 14 (c) The quantity to be stored or processed, and the duration of the storage or processing; (d) Risk management measures put in place. 4.9 The Authority may, at any time that it may consider appropriate, cancel the advance informed agreement that has been issued if any requirement contained therein is not strictly complied with and order the immediate cessation of the storage or processing of the modified organism. 4.10 Within seven days of issuing any advance informed agreement under this Directive the Authority shall lodge its copy in the National Biosafety Clearing House. 4.11 Any premise used for the storage or processing of a modified organism must ensure that all the stored material, whether processed or not, is packed, labeled and segregated as provided for in Article 7 of the Biosafety Proclamation and Article 9.2 of Directive One. 4.12. The person in charge of any premise used for the storage or processing of any modified organism shall: 15 h. LW ?Ãl lKMCT wYM lÍB¶µ Ê :”nT QM ��¸WL�� ï¬ ÃLtfqdlT ��� sW XNÄYdRS m-b4� ¥rUg ½ l. bKMCT wYM bÍB¶µ Ê :”nT l¸WlW LW ?ÃW mr© mÃZ �� ! wx7�W �I.+½ /. �7�D$ LqT wYM 23 xdU b!ÃU M lmÌÌM y¸ÃSCl# yx\‰R £dèC ZGJT bh#l#M g!z@ÃT mñ‰cWN ¥rUg ½ m. � 7�D$ LqT XNYÃU M bKMCT §Y Æl b¥N¾WM LW ?ÃW byqn# q$ R ¥DrG½ 5555. y¸[ÂbT g!z@ . y¸[ÂbT g!z@ . y¸[ÂbT g!z@ . y¸[ÂbT g!z@ YH mm¶Ã k qN ›.M. jMé yi YçÂLÝÝ xÄ!S xbÆ qN ›.M. yxµÆb!W MKR b@T sBúb! Sl VLU EV DUc6 -O'UDUYS ‘ab Lb DUY Voy EW5ND 5O3 Dab ‘a6 Lb U d?avan 1S WL -LUSVhod *S 8b7-Sho Dbbt 4bdU -Od b-OY ab-O2L600 VE OV -bkbkabY bLOTXLY “LOY LW San 2blO Pho L-Ole? bap -LIWL obVOU Lol Lesh DPMS VLUSh0d abfpaV abbOSV CSNY VV c6dO -LbY WHYS 2U2bho -OLW?7Y 2WWe-b Sida B7a0 OV bOWY -OV-OloVY bh? PL YUCK c6dO Lk a6YU “V 2hlO Pho L£bVWap YISTFLY -OV abtho -LVSb'7-+-NS FU -LUY-O%030 bbb LeeG Pb YPUEDV Hh6SO kek oUV WSL Low 16 a) Ensure that all the modified organism in storage or processing areas is secured against unauthorised access; b) Maintain data on any modified organism stored or processed in the premise and ensure that the data are readily accessible to inspectors; c) Ensure that emergency procedures that are to be employed in the event of any unintended release or other accident are always ready; d) Ensure that a daily inspection of the modified organism stored in the premise is undertaken by a responsible person to check that no unintended release or leakage is occurring. 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