Directive No. 04/2009 issued to determine the Requirements for the Transport 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 x‰TmmRà x‰TmmRà x‰TmmRà x‰T DIRECTIVE FOUR LW ?ÃêNN l¥ÙÙZ mà§T ÃlÆcW GÁ¬ãCLW ?ÃêNN l¥ÙÙZ mà§T ÃlÆcW GÁ¬ãCLW ?ÃêNN l¥ÙÙZ mà§T ÃlÆcW GÁ¬ãCLW ?ÃêNN l¥ÙÙZ mà§T ÃlÆcW GÁ¬ãC REQUIREMENTS FOR THE TRANSPORT 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 4mm¶Ã q$ R 4mm¶Ã q$ R 4mm¶Ã q$ R 4 LW ?ÃêNN l¥ÙÙZ ���� ��� W GÁ¬ãC lmwsN ywÈ mm¶ÃÝÝ LW ?ÃêN b¸ÙÙz#bT wQT l!kst$ y¸Cl# -NöCN lmk§kL -ÃqEW ¥à§T y¸gÆWN GÁ¬ãC mwsN xSf§g! çñ Sltgß½ Slz!H bdHNnt ?YwT xêJ q$ R xNq{ 22 m\rT YH mm¶Ã w aLÝÝ KFL xNDKFL xNDKFL xNDKFL xND 1. |û 1. |û 1. |û 1. |û YH mm¶Ã «LW ?ÃêNN l¥ÙÙZ ���� ��� W GÁ¬ãC lmwsN ywÈ mm¶Ã q$ R 04¼2001´ tBlÖ l!-qS YC§LÝÝ 3 DIRECTIVE No. FOUR A DIRECTIVE ISSUED TO DETERMINE THE REQUIREMENTS FOR THE TRANSPORT OF MODIFIED ORGANISMS WHEREAS it is important to determine the obligations of any applicant in transporting modified organisms so as to prevent any risks that could arise. 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. 04/ 2009’ issued to determine the Requirements for the Transport 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 2 �2(3 � ��$� ���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 >?@( 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. «A� >?@(´ ¥lT �9W wYM �� 9B� C* wYM � D�E �� y¸ktL ÃL¬qd t}:ñN lmk§kL +4' F�! � ����G > H ��II(� $4� ����2 ���9 ���' ���� 1 2 03/2001 � � NOP' �Q @R 4.8 ��( 4.9 � ��G,G,' �1BW* � , ���W +�� P ,W LW ?ÃêN � �s„½ XNÄ!ÃDg#½ XNÄ!k¥c$½ XNÄ!wgÇ wYM �(H2�N* MRMR =(X �Y� l@§ � �� � QM §Y XNÄ!Wl# ��,� nWÝÝ 10. «��C� LqT´ ¥lT kGN²b@ bmn= SMMnT msrT LW ?ÃWN � ��# �(�)# ��2ZP 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@¬ ��( � ��[ \]^6# §Y l!ktL y¸CL xdU nWÝÝ 12. «ßéè÷L´ ¥lT � !" 1 2 362/1995 �b�@W �)A/ F��� ] c dn# yµR¬e ��F �� F��� fXg]4 �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 3333. . . . ��������������������W tfÉW tfÉW tfÉW tfÉ6666nT wsNnT wsNnT wsNnT wsN YH mm¶Ã bxyR½ ��)$ wYM bçn l@§ mNgD LW F�W kxND wd l@§ hP �¥zêwR §Y tfɸ YçÂLÝÝ 4444. ln©! f”D xsÈ . ln©! f”D xsÈ . ln©! f”D xsÈ . ln©! f”D xsÈ 4.1 LW ?Ã!NN b¥ÙÙZ |‰ §Y lms¥‰T �6i4� n©! �4� +�9>W f”D sÀ m|Rà <� ymNÄT f”DN kÆl|LÈn# �69>W �,-�j ��A xlbTÝÝ 4.2 yn©!ãC i”D xsÈ Â MZgÆ s!µÿD �4� ��9>W f”D sÀ m�Rà b@T 4W ?ÃêNN l¥ÙÙZ y¸mzgb# n©!ãCN 1 2 lmwsN YC§Lk b¸g M DNgt¾ LqT bsW wYM bXNSúT @NnT wYM bxµÆb! �� l�2m y¸Cl# g#ÄèCN lmµS � �n4( �6ooGW H4 bqE yêST >ÍN � ���,��� �,-� ���ÝÝ 4.3 �4� ��9>W f”D sÀ m|Rà b@T ln©!W f”D y¸s-W by2 ›mt$ Æl|LÈn# y¸ÃzUjWN yLW ?ÃêN xÃÃZ ¥ÙÙZ SL-ÂN bx Ub! s!ÃLF )n �Y ���ÝÝ 5555. ¥mLkÒW y¸Y²cW mr©ãC . ¥mLkÒW y¸Y²cW mr©ãC . ¥mLkÒW y¸Y²cW mr©ãC . ¥mLkÒW y¸Y²cW mr©ãC 5.1 LW ?ÃWN l¥ÙÙZ y¸flG ¥NM xmLµC ¥mLkÒWN b{/#F lÆlSLÈn# ¥Q,B xlbTÝÝ 8 2. Scope of the Directive This Directive shall apply to the air or land transport or howsoever otherwise moving from one place to another of any modified organism. 3. Licensing a Driver 4.1 In order to be engaged in the transport of modified organisms, a driver shall be licensed by the competent licensing agency and certified by the Authority. 4.2 When licensing and registering drivers, the competent licensing agency may limit the number of drivers that will be registered to transport modified organisms and shall require the consignment to be adequately insured to cover any harm to human or animal health or the environment that may result from any accidental release. 4.3 The competent licensing agency shall only issue a license once the driver has satisfactorily passed an established training programme given every 2 years by the Authority on the handling and transportation of modified organisms. 4. Application information 5.1 Any person who wishes to transport any modified organism shall apply in writing to the Authority. 9 5.2 b @p 4.1 m\rT y¸q2B ¥mLkÒ kz!H b¬C ytzRz„TN mr©ãC mÃZ xlbTÝÝ h. l!ÙÙZ y¬sbW LW FÃW ��( q?' ��7��� 4' F�' Ñl# TKKl¾ mGlÅ XNÄ!h#M úYNúêE* ytlMì SrC ytlw-bT K !n@½ l. y¸ÙÙzW m-N mGlŽ /. LW ?Ãs wYM +4' F�s ��7�' q?+4' F�s ��7�' q?+4' F�s ��7�' q?+4' F�s ��7�' q? y¸núbT ï¬ SM xD‰š½ m. LW F�s ��( +4' F���( +4' F���( +4' F���( +4' F�ssss ��7�' q?��7�' q?��7�' q?��7�' q? y¸wsDbT ï¬ SM xD‰š½ 5.3 LW ?ÃWN ��( +4' F�' ��7� q? ��( +4' F�' ��7� q? ��( +4' F�' ��7� q? ��( +4' F�' ��7� q? l¥ÙÙZ ¥mLkÒ XNdqrblT ÆlSLÈn# y¸ÙÙzW QL y¸dRSbT ï¬ lZG x ”qM yt\‰ mçn#N ÃrUG  +� ;< ���= $((�t l!klkL wYM bQDm h#n@¬ wYM µlQDm h#n@¬ l!s YC§LÝÝ �4� ��9>W f”D sÀ ���� <� ( �Hu ÃBW?4:: 5.4 y¸ÒL vY �6ooGW H4 bsW* bXNSúT -@NnT* bxµÆb! §Y l!dRS y¸ClWN -NQ lmqnS byT bk#L XNd¸�4. b N”q& �P@� xlbTÝÝ 5.5 +� ;< k��= $((�� UR yts- mà§T ÃlbT GÁ¬ µLtkbr wYM yts-W �wP µLtৠ�4� ��9>W f”D sÀ m|¶Ã b@T LW ?Ãs ��( +4' F�s ��7�' q? XNÄYÙÙZ l!klKL YC§LÝÝ 10 5.2 Any application for a permit that is submitted under Article 4.1 shall contain: (a) A full and accurate description of the modified organism or the object made from the modified organism is to be transported, including the scientific and common names and the transformation event; (b) A statement of the quantities to be transported; (c) The name and address of the place from where the modified organism or the object made from the modified organism is to be transported; (d) The name and address of the place to which the modified organism or the object made from the modified organism is to be transported; 5.3 Upon receipt of any application to transport any modified organism or an object that has been made of a modified organism the Authority shall verify that the place to which the consignment is to be transported is appropriate for contained use, and may refuse or give with or without conditions an advance informed agreement for the intended transportation and shall notify the competent licensing agency through a copy. 5.4 Any route for the consignment should, where practicable, be planned carefully to minimize risks to human and animal health and the environment. 5.5 If any requirement or condition contained in an advance informed agreement is not strictly complied with, the competent licensing agency may order the immediate cessation of the transportation of the modified organism or the object made of a modified organism. 11 5.6 Æl|LÈn# �9>W +� ;< ���= $((�� �9,� y¥ÙÙZ f”D �ts- �sÆT qN W$ �4� ��9>W f”D sÀ m|¶Ã b@T yf”ÇN GLÆ+ lÆl|LÈn# mS-T xlbTk Æl|LÈn#M +� ;< ���= $(��t Q©! wd B/@‰êE ydHNnt ?YwT mr© |R›T ¥SgÆT xlbTÝÝ 5.7 �4� ��9>W f”D sÀ m|¶Ã b@T n©!ãC ¥ÙÙÏãC ktsÈcW f”D xNÚR y¸-b@WN yxs‰R ‰T ¥à§¬cWN möÈ-R xlbT¿ lz!HM s!ÆL byï¬W Ftš y¥µÿD SLÈN �WÝÝ 5.8 LW ?ÃêNN ��( +4' F�! ��7% q?xy y¸ÃÙg#Z ¥NM x¹kRµ¶ bQ @R 5.3 yt-qs#TN 9�zy +�@�� b“§ y+nt$ ysnìc$ YzèC mÈÈ¥cWN lmlyT mft> xlbTÝÝ 5.9 byBS §Y bmÙÙZ §Y Ãl yLW ?ÃêN ��( +4' F�! ��7% q?xy QL bg#ø wQT xq¥m-# XNÄYlêw l¥DrG � BQ m¬sR xlbTÝÝ 5.10 LW ?Ãs ��( +4' F�' ��7� q? ��)$ b¸ÙÙZbT g!z@ ymFsS wYM l@§ xdU b!ÃU mW n©!W q lÖ ytzrz„TN tGƉT mfiM xlbTÝÝ h. ��d+2D�W * +nt$ yfssbTN xµÆb! mklL½ l. yxdU g!z@ yXRĬ xgLGlÖT � �� ÃSfLG XNdçn mwsN½ /. h#n@¬WN mgMgM tgb!WN XRM© mWsD½ m. Sltf-rW xdU wYM Slxfúss# lxSÅß#½ l H{ tqÆY½ �4� ��9>W f”D sÀ m|Rà b@T �Æl|LÈn# ¥úwQ½ 12 5.6 Within seven days of issuing any permit following the advanced informed agreement given by the Authority, the competent licensing agency shall inform the Authority, which shall lodge a copy of the advance informed agreement in the National Biosafety Clearing House. 5.7 The competent licensing agency shall carry out inspection of drivers and vehicles to ensure compliance with permit conditionalities and for this purpose is empowered to execute spot checks. 5.8 The driver who is to transport modified organisms or objects made of modified organisms, upon receiving the document specified in Article 5.3, shall inspect the load and documentation to ensure that the consignment complies with the description contained in the documentation. 5.9 Any consignment containing modified organisms or objects made of modified organisms being transported over land must be secured with load restraint to prevent movement of the load during travel. 5.10 In the event of any spill or other accident during the transportation of the modified organism or object made of the modified organism over land, it shall be the responsibility of the driver to: (a) Secure the area around the vehicle and the spill; (b) Determine whether emergency services are to be called; (c) Assess the situation and react in an appropriate manner; (d) Immediately notify the consigner, the consignee and the competent licensing agency and the Authority of the nature of the spill or accident. 13 6666. . . . ++++LW LW LW LW FFFFÃêNÃêNÃêNÃêN +nèC UR y¸ÃÃz# snìC+nèC UR y¸ÃÃz# snìC+nèC UR y¸ÃÃz# snìC+nèC UR y¸ÃÃz# snìC 6.1 kxND ï¬ wd l@§ ï¬ y¸wsǽ wd xgR WS y¸gb# wYM wd WÀ y¸§k# LW HÃêN ��( +4' F�! ��7% q?xy s!ÙÙz# +ÆlSLÈn# kts- +� ;< ���= $((�� UR mÃZ xlÆcWÝÝ Xnz!HM snìC SLÈN bts-W f¬> wYM töÈȶ b¥N¾W g!z@ l!nbb# ZG° mçN xlÆcWÝÝ 6.2 +� ;< ���=W $((�� b!ÃNS q lÖ �tzrz„TN mr©ãC mÃZ xl��ÝÝ h. y¸ÙÙzW H4 y¸dRSbT hP SM xD‰š½ l. yLW ?Ãs úYNúêE ytlMì SäC ytlw-bT KNên@½ /. y QlÖc$ q$ R xYnT XNÄ!h#M -Q§§ m-N½ m. t=¥¶ yxÃÃZ mr©½ yq$ R yxdU g!z@ XRM©ãC :”W kl@lÖC :”ãC bTKKL mlyt$N mwsD ÃlÆcWN l@lÖC N”q&ãCN y¸ÃmlKt$ mr©ãC½ \. y¹q-# §k! tqÆY xD‰šãC# ySLK q$ éC* \-}~y½ r. ��Wéߧ5 wYM bmk!ÂW WS LW FÃs ytÅnbTN ï¬ y¸ÃmlKT :”WN bÅnW GlsB ytfrm y+�T NDF½ 9. §L�C� LqT wYM �DNgt¾ xdU y¸ÃglGL yDRg!T ZRZRN yÃz yxdU �� �2(3xy mm¶Ã½ 7777. y¸iÂbT g!z@ . y¸iÂbT g!z@ . y¸iÂbT g!z@ . y¸iÂbT g!z@ YH mm¶Ã k qN jMé yi YçÂLÝÝ xÄ!S xbÆ qN ›.M. yxµÆb! MKR b@T sBúb! 14 5. Documents accompanying the transport of modified organisms All modified organisms or objects made of modified organisms that are moved from one place to another, imported, or exported shall be accompanied by an advance informed agreement issued by the Authority, which shall, at all times, be available for inspection by any authorized person or by an inspector. 6.2 The advance informed agreement shall, as a minimum, contain the following particulars: (a) Name and address of the destination of the consignment; (b) Scientific and common names of the modified organism and its transformation event; (c) The number and type of packages and the total quantity; (d) Additional handling information, including emergency measures and any other information necessary to ensure that the consignment will be segregated correctly and to indicate additional precautions that must be taken; (e) The addresses of the consignor and consignee, contact telephone numbers, and e-mails; (f) A load plan, showing where the modified organism is located in the aircraft or vehicle, which must be singed by the person loading the goods; (g) An emergency procedure guide providing emergency procedures that are to be employed in the event of any unintentional release or any other accident. 6. 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