Biosafety Proclamation (No.655/2009)

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Short Title This Proclamation may be cited as the “Biosafety Proclamation No.655./2009”. 2. Definitions In this Proclamation, unless the context otherwise requires: 1/ "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; qÜ R %3 ُאb ዓـ�ו ףם ዲ� ו.ዓ 1ְךqN 2 4 הጳጉ ֹו� 15 th Year No. 63 ADDIS ABABA 9 th September, 2009 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4963 2/ “እ�I�:ֳُד ”ױ ָውጥ ׁያው� ُףםא ወይُץֱוֳُ ו፣ ֳץוץו፣ ֳُץו፣ ወደ ገץ ው�ጥ ֳד�ገֹُו፣ ወደ ውጪ ֳֶאክ፣ ፣ �ዝግׂُשָ �ጤـֳ ፍ፣ֳֶـ�דֳ �ዚُףُ� ውרֳ ፣(נIדֳ ጓጓዝ፣ ֳገ�ያדֳ ፣ُנודֳ ወይו ֳእ��6 א�ድ٪kُ�ُ ֳאጠוׂש፣ פካ ጥע(ፋֳ וወይ ُ�@אֳ ግ)�ُ፣וֳ ዕ:�ُ דዋָ �ው፤ 0ዊ ጥ�� ׁይወُא�ዘ ֳُד ”ُףםא“ /3 ָውጥ ׁያው እ�ዲገn דድנግ �ው፤ 4/ “ዝግ ጠ:ר� ֳُד ”וׂשው ወይו �እ6ُר� ጤ0 ወይו � ካּתֹו ֶይ የגከָـ ያָׂٍשደ ـፅዕ@� ֳאከֶከָ ው0נዊ ከֳֶ ٍጥף�ገ נ6ዊ0 ��ጥּׁש� ያעאא ውּתገـ� ጣp �ወጣውָםֳֹו� ከـፈׂשደው �ፋُ ֳ�ָֹוጠ qٍ ـወ��ው ָውጥ ׁያዋ� እ�ዲסר፣ እ�ዲያድጉ፣ እ�ዲከ٠ד፣ እ�ዲወገዱ ወይُץֱוُ ו �ገድא ֶַ �ֲ� צוጨ �ץוץו �0 �ጥIו ֶይ እ�ዲውִ דድנግ �ው፤ 5/ “የـጤ� ֳָُד ”ׂُש ከግ�ዛx א��ጨ �ֳ �ውጥ ׁያውָ ُנטא ُ�וו� ግድ፣ ֳוግ)፣ ֳእץዳٍ וግ)፣ ካּתֹו� ፣ץוץוֳ ያ�ُ፣עדـ�דֳ ፅዳُ፣דֳ ፣ֹٍוץ ዋُ xُ፣ ֳውz ው�ጥـ�אֳ ֳእ��6ُ א@፣ ֳרው ወይו ֳእ��6ُ ֱክ0ו ወይו ֳֶַ ጥIא� וዋָ ወደ ካּתֹו �ዲዳד �נድנግ �ው፤ 6/ “ከግ�ዛx የא�ጨ ֳُד ”ُ�וו� �ዚֱ ዋጅ ُנטא እ�ድ እ�I�:ױ እ�ዲ ጥ የרגጣp የָםֳֹוከ ץ�ገـዎ�ٍ ጽֽፍ �ው፤ 7/ “ֳገ�ያ דIֳُד ”(נ ָውጥ ׁያው� �ጨאዋָ ከግ�ዛx የדֳ ׂُשָ �ጤـֳ ዳٍץ�እ ֶ|� ִ�ׂשـከ �ُ�וו� �b ወገـ�׳ֳ צו�ጠُ� ጨא ُ�(ግו �ገድא ֶַ� וያጭ፣ ��ጦٍ ወይֹּל� ፍ �ው፤ֳֶـ�ד ֳُד ”@ፅዕـ ያዊג@ዊ0 �ኮף�ֱד“ /8 ከד�bውו እ�I�:ׂש� ױጥٍ ወይו �ገድ የא עዘዋዋـ�ገץ �ኮ@ג� ጨרנ�ׁד� צוqף�ֱד ٤ዊ ወይו ץֹו� ፣ُנטא צዊ BCٍዎ٤፣ የpֶֹׁו ዕውׂُש ወይו ጥ�) ֶይ የגደץ� ִٍዊ ውጤُ �ው፤ 2/ "transaction'' means any making or use of any modified organism in teaching, production, import, export, transit, release, contained production, transport, placing on the market, or use as pharmaceutical, as food, as feed or for processing; 3/ “making” means the development of a modified organism through modern biotechnology; 4/ “contained use” means any operation in which modified organisms are produced, grown, stored, destroyed or used in some other way including for teaching and research isolated by physical and chemical barriers in space not exceeding the requirement stated in the appropriate directive issued by the Authority with a view to effectively preventing their contact with, and their unintended impact on, human, animals and the external environment; 5/ “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; 6/ “advance informed agreement” means a written consent granted by the Authority for the undertaking of a transaction in accordance with this Proclamation; 7/ “placing on the market” means obtaining an advance informed agreement for deliberate release and 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; 8/ “socio-economic impact” means any direct or indirect adverse effect that results from a transaction on the social or cultural conditions, the livelihood or indigenous knowledge systems or technologies of a local community, including on the economy of the country; 4¹þ9)%3 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4964 9/ “ጠ�I” ֳُד ከየُbውו እ�I�:ׂש� ױ ጥٍ ወይـ� וዘዋዋא ע�ገድ፣ � ጭץ፣ ውר� ጊዜ וጅנ� וካከֳb ወይא� ወይו �እ��6 ጤ0፣ �)ዝּ ׁይወُ፣ � ካּתֹו፣ רנ�ֱד�qף�ֱד ٤ዊ፣ �ኮ@ וዊ BCٍ፣ ወይֱֶֹו וያዊ ወይג � ገّע �ኮ@ג፣ ֶይ ֵከָـ የ٤ָג ደጋ �ው፤ 0/ “ፕِצኮָ” ֳُד � ዋጅ ּׁשጥץ 3)%2/09)(5 የፀደׂשው የ)ዝּ ׁይወُ ኮ�،ֹּל�� የካٍץኼ0 የደׁـ�� ׁይወُ ፕِצኮָ �ው፤ ”ያ xُעםא ዊף׀( ጣ� ያֳውָם“ /01 ጽ 7 እ�ከ 02ׂש� ኮִ ከِצ�ፕ ֳُד የـዘנዘـ �ُסግُףֹו እ�ዲያ�ፈፅו ָውጥ ׁያው ወደ �ُዮጵያ ከֶגክ�ُ ገא ץ�ግָם ُםጣ� የרـጠው וּהـ �ው፤ � ֳُד ”�ጣָםֳֹו“ /02ዋጅ ּׁשጥץ 2)(5/09)(5 የאּהּהـው የ�ُዮጵያ ፌዴֶףዊ ዲזክתףያዊ עፐ)ֵክ የ ካּתֹו ጥ�: ָםֳֹוጣ� �ው፤ ያעםא ጪר ጠው ፈ:ድרـጣ� የָם“ /03 xُ” ֳُד የ�ግድ ወይו የףם ፈ:ድ እ�ዲרጥ �ֱግ ָםጣ� የרـጠው ד�b ውו የא�ግُם ካָ �ው፤ ይֱ ֳُד ”עጣጣּבـ“ /04ዋጅ0 � ዋጁ ያዎ٤עאא የወጡ ደ�q٤0 ُנטא ֶַ 0ָךـጋገጥ የፍנדֳ �ውْף�ከא የּׁשጥጥץ እוץጃ እ�ዲወ�ድ ָםֳֹוጣp א�ـየ ُנטא ያעאא ያወጣውג� ው �ው፤ר ጃנאይወُ የׁ ـ��ዊ የደֱף׀(“ /05 ! ፅׂש� ኮִِצ�ፕ ֳُד ”ዓُץם ּשዘግגውጥ ֱያዋ� የֳָ� ُנטא 6ይ�6ዊ፣ ጥֹו�ዊ፣ ካּתֹוያዊ0 ׁግ �ክ �ጃዎ٤�0 የָውጥ ֱያዋנאያያዝ� �ገ�ُדֳ ድ ָውውጥוከُ የֳָאג� ዓُ �ው፤ץם ጋנዘـጣp የָםֳֹו� 06/ “ክָָ” ֳُד ��ُዮጵያ ፌዴֶףዊ ዲזክתףያዊ עፐ)ֵክ ׁገ א�ግُם ክָָ ו�bውד ውـከֳאـጽ #7 የׂש� የ �ֲתዲ� דـዳዋ የከפእ0 የድ ֹו� ፤ָףוይጨ �٤צዳደـ� 9/ “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; 10/ “Protocol” means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity ratified by Proclamation No. 362/2003; 11/ “competent national authority” means the institution of a country of export of any modified organism designated by the government of that exporting country to carry out the functions stipulated under Articles 7 to 12 of the Protocol; 12/ “Authority” means the Environmental Protection Authority of the Federal Democratic Republic of Ethiopia established pursuant to Proclamation No. 295/2002; 13/ “competent licensing agency” means any organ of government empowered by law to issue a business license or a work permit; 14/ “inspector” means a person appointed pursuant the directives issued by the Authority to undertake examination and any other control measures to ensure compliance with this Proclamation and with regulations and directives issued hereunder; 15/ “national biosafety clearing-house” means a system of acquisition and management of, and access to, information established by the Authority based on Article 20 of the Protocol in order to facilitate the exchange of scientific, technical, environmental and legal information and experience with modified organisms; 16/ “region” means any regional state referred to in Article 47 of the Constitution of the Federal Democratic Republic of Ethiopia and includes the Addis Ababa and Dire Dawa city administrations; 4¹þ9)%4 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4965 07/ “ �ውׂשጠይגየ ֳُד ”ካ٤ָא እ�I�:דֳ ױካְድ ከግ�ዛx የא�ጨ ጣpָםֳֹוֳ ጠውרእ�ዲ ُ�וו� ያֳאከר ـው �ው፤ 08/ “ፈ:ድ የרـጠው רው” ֳُד ከግ�ዛx የא�ጨ ُ�וו� ከָםֳֹוጣp የרـጠው ው �ው፤ר ግׁ� וው ወይר צፈጥـየ ֳُד ”ውר“ /09 የרው�ُ א)ُ የרـጠው ካָ �ው፤ ገֳጸውـ�ወ�ድ ጾٍ የ ו�bውד /!�ጋገץ ፡፡ָףוይጨ ו�ُױ 3333.... የـፈጻُ�ג ወר�የـፈጻُ�ג ወר�የـፈጻُ�ג ወר�የـፈጻُ�ג ወר� 1/ የዚֱ /ጽ /2/ እ0 /3ׂש� �ጽ �ዑׂש� ድ�ጋጌዎ٤ እ�ደـጠּׁש� ֲ@ ይֱ ዋጅ גፈፃـ ይֶ ױ:�እ�I ו�bውד� ይֲ0ָ፡፡ 2/ �ُዮጵያ ያፀደ٤ׂשው እ�ከֲ� ድרֳ �נው ׁክ0ו የֲג��፣ ��ُዮጵያ ግዛُ @ፅዕـ ጎጂ וያָፍ� ወይג�ዚُ የףُ� የודጣُ እድָ የֳውו የֳֹוـ� ָውጥ ׁያው የֳאגከُ ዓֳו ዓׂשፍ ُ�וו� ��ُዮጵያ ـፈጻג ይֲ0ָ፡፡ /ጽ /2ׂש� �ጽ �ዑׂש� ጣp �ዚֱָםֳֹו /3 የـጠُשׂש እ�I�:ױዎ٤� የֳאגከُ נאጃ �ዚֱ ዋጅ ውאּהּהـ� ُנטא ጽ 03ׂש� ዓُץם ጃנאይወُ የׁ ـ��ዊ የደׁף׀( ֹُו�ገדֳ�ُ፡፡ 4444.... የ ዋጁ ዓֶדየ ዋጁ ዓֶדየ ዋጁ ዓֶדየ ዋጁ ዓֶד የ ዋጁ ዓֶר� דው0 �እ��6ُ ጤ0፣ �)ዝּ ׁይወُ፣ � ካּתֹו፣ רנ�٭ד�q٤0 � ጠ: ֶዩו ��ገץ ֶይ ከָውጥ ׁያዋ� ֵደנ� የ٤ֳגው� ִٍዊ ـፅዕ@ ُנׂש�ד ወይו ��6ד �נጃ ድנዊ�ُ ደٍ�ו� ያ�� እ�ከּת �ው፡፡ 5555.... ከግ�ዛx የא�ጨ ُ�וו�ከግ�ዛx የא�ጨ ُ�וו�ከግ�ዛx የא�ጨ ُ�וו�ከግ�ዛx የא�ጨ ُ�וו� 1/ የዚֱ ዋጅ ጽ 3 ድ�ጋጌዎ٤ׂש� እ�ደـጠּׁש� ֲ�ው ከግ�ዛx የא�ጨ ו�bውד� ውר �ያֶገ �ُ�וו� እ�I�:ُףדראֳ ױ ይፈׂשድֳُו፡፡ 17/ “applicant” means any person who submits an application to the Authority seeking an advance informed agreement to engage in a transaction; 18/ “authorized person” means any person who has been given an advance informed agreement by the Authority; 19/ “person” means a natural or juridical person; 20/ any expression in the masculine gender includes the feminine. 3. Scope of Application 1/ Without prejudice to the provisions of sub article (2) and (3) of this Article, this Proclamation shall apply to any transaction. 2/ Any treaty, provided that it has been ratified by Ethiopia, on the regulation of modified organism that is to be used as a pharmaceutical for humans, that is to transit through Ethiopian territory or that has been declared to have no adverse effect shall be applied throughout the territory of Ethiopia. 3/ The Authority shall place information regarding the transactions referred to under sub-article (2) of this Article on the National Biosafety Clearing House established under Article 13 of this Proclamation. 4. Objective of the Proclamation The objective of this Proclamation is to protect human and animal health, biological diversity and in general, the environment , local communities and the country at large by preventing or at least managing down to levels of insignificance the adverse effects of modified organisms. 5. Advance Informed Agreement 1/ Without prejudice to the provisions of Article 3 of this Proclamation, no person shall engage in any transaction without obtaining an advance informed agreement. 4¹þ9)%5 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4966 ُףדראֳ ױ:�እ�I ו�bውד� /2 የגፈָግ רው �ዚֱ ዋጅ0 � ዋጁ ያዎ٤עאא ወጡُ ደ�q٤0ג� ُנטא ጣpָםֳֹוֳ ከ٢ָאד ዘጋጀـየ ُנטא (נIדֳ�ُ፡፡ ُ�וו� �ጨאጣp ከግ�ዛx የָםֳֹו /3 �ዚֱ ካ٠ָא �ጠُ እ�ዲ٢ֳውאֳ ዋጅ የֳאـከً ግዴٍዎֶُחדֳ �٤ ጠየIא (ץׂשዋ�ُ0 እ�ዲያ ּׂש� ይ٤ֶָ፡፡ 6666.... የ ግዴٍ ካ٤ָא ግዴٍየ ካ٤ָא ግዴٍየ ካ٤ָא ግዴٍየ ካ٤ָא 1/ ው� �ዚֱדገוየጠ�I ግ ካ٠ָאዋጅ ያዎ٤עאא ወጡ ደ�q٤0ג� ُנטא ֹוካְድ0 ዘገד ያבֳֹו ውֳֹו ُ:( ُנטא ጣp ያ�ፈָጋִָםֳֹו ו�ውֹוዘጋጀُ፣ ዘገד ካֶْው ከַֹר ٤�ዶ٤ ጋָםֳֹוֳ ץጣp (נIדֳ�ُ፡፡ 2/ የጠ�I ግוገד ዘገֹוው ከዝץዝב ץያዊ ُ�ٍCው ـ�ጨנֵ ו�ד עדዳው סጭֹו የُ�ٍCው� ይዘُ ּה�ּה ٤ָג� ከያዘ אግֳጫ ጋא ץIנ) ֳ�ُ፡፡ 3/ የጠ�I ግוገד የדካְጃ0 ዘገֹו የדዘጋጃ ወጪ � �ፈ₪א ካ٠ָאֳ�ُ፡፡ ጠፍֳא የُ0 ጽፎֳא �ُ��וጠፍֳא የُ0 ጽፎֳא �ُ��וጠፍֳא የُ0 ጽፎֳא �ُ��וጠፍֳא የُ0 ጽፎֳא �ُ��ו ....7777 1/ �ዚֱ ዋጅ ג� ُנטאወጡ ግֹו)�ُ የָውጥ ُנטא ያዎ٤עאא ው ደ�q٤0ֶֹْו ׁያዉ� ُ��ו � b0 �እ�ግֵዘbץד ገָፅ ፅBፍ �ָውጥ ׁያው ጥIָגየ ዎ٤ּה�ּה ֶይ ֳـָֹוጠፈ�ُ ָውጥ ֱያው ከxב ـከף ዝግ BCٍ ውጪ ד�bውו እ�I�:א ױካְድ የֳ�ُו፡፡ 2/ “�ዘֶאנዊ ׁו�ድ�0 የֳـወጠ ׁያው ይገn�ُ ይֲ0ָ” የָג ወይ66אـ וይ ግָጽ ያֲָ� ጽBፍ �ጥIִ ֶይ ֳאጠፍ የـከֳከֳ �ው፡፡ 3/ �ָውጥ ׁያዋ� ጥIָ ው�ጥ የגገ�ው� ُ��ו ውጥ ׁያዉָ ו��bውד ውـא ጠፈ�ُ ጽBፍ ֶይ 6ይገָጹֳـ� የـከֳከֳ �ው፡፡ ו�ו ው �ጥIִ ው�ጥר ו�bውד /4 ዓይ�ُ ָውጥ ׁያው የדይገn�ُ ֲאp� ካנጋገጠ “ָውጥ ׁያው የֳ�ُו” የָג ጽBፍ ֳֵጥፍ�ُ ይ٤ֶָ፡፡ 2/ Any person who intends to engage in any transaction shall submit to the Authority an application prepared in accordance with this Proclamation and regulations and directives to be issued pursuant to this Proclamation. 3/ The Authority may, as a condition for giving any advance informed agreement, require the applicant to furnish a guarantee which shall be sufficient to meet his obligations under this Proclamation. 6. Responsibility of Applicant 1/ The applicant shall use a qualified expert to undertake a risk assessment and prepare the report in accordance with regulations and directives issued pursuant to this Proclamation and submit the same to the Authority together with any other documents determined as necessary by the Authority. 2/ Besides a detailed technical analysis, a risk assessment report shall include a brief statement summarizing the report in non technical terms. 3/ The cost of carrying out a risk assessment and writing a risk assessment report shall be borne by the applicant. 7. Identification and Labeling 1/ No transaction shall be carried out outside of the contained conditions of a laboratory unless the package of the modified organism has been labeled in both Amharic and English in accordance with the relevant regulations and directives issued pursuant to this Proclamation. 2/ It is prohibited to write “may contain modified organisms” or any equivalent unspecific statement on a label. 3/ It is prohibited to leave out any modified organism that is in the package of a modified organism unwritten on the label. 4/ Any person is entitled to write the words “contains no modified organism” when the product in a package is known to be free from modified organisms. 4¹þ9)%6 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4967 8888.... ָውጥ ׁያው ወደ ገץ ው�ጥ ד�ገָֹُוውጥ ׁያው ወደ ገץ ው�ጥ ד�ገָֹُוውጥ ׁያው ወደ ገץ ው�ጥ ד�ገָֹُוውጥ ׁያው ወደ ገץ ው�ጥ ד�ገֹُו 1/ ከግ�ዛx የא�ጨ 6 ُ�וו�ይዙ ָውጥ ׁያው� ወደ ገץ ው�ጥ ד�ገֹُו የـከֳከֳ �ው፡፡ 2/ ָውጥ ׁያው� ወደ ገץ ው�ጥ ֳד�ገֹُו ከግ�ዛx የא�ጨ ُ�וו� እ�ዲרጥ ከץׂשג�ው ָאדከ٢ ጋף የגያያዘው p የֶኪውֲאֳ� ֶחـጃ ُክክֳb0 የנא ገָם ץጣ� ያֳው )ף׀ዊ עםאያ xُ ִב ٪ֶፊ�ُ אውרዱ� የעםאያ xً ٪ֶፊ �ፊדץው ያנጋገጠ�ُ ֲא� ֳ�ُ፡፡ ዝግ ٤ַֹ 0ُףםא ....9999ጠ:٤ַֹ 0ُףםא٤זׂש ዝግ ጠ:٤ַֹ 0ُףםא٤זׂש ዝግ ጠ:٤ַֹ 0ُףםא٤זׂש ዝግ ጠ:٤זׂש 1/ ָውጥ ׁያው� የר ףרגው የגጠוׂש סוץו ያُ፣ץֹׁו ��ው ወֶጅ ׁያዋֹْו የגካְድ�ُ� qٍ0 የ ካּתֹוው� BCٍ אـ ׁץא ¬:�ጥ א�Iድ וገוገא� ይ�ُ ያֳው�0ֹוׂשـ �6ይ�6ዊ�ً ِץ� � ካּתֹו ֶይ ጠ�I የדያ�ከָُ� ץףט ጠ�I� ወደ ٤ָגየ ُרከֵ ָـከא� ��ׂשא ጃנዊ�ُ ደٍ�ו�ֳ�ُ፡፡ 2/ �ዝግ የ ጠ:וׂש BCٍ �ָውጥ ׁያው ׂُשָ �ጤـָֹו ውר �የֲ ג:ጠـ �bውד צוው� ጨֳـከגክ�ያُ የו ו�וደጋ ֳُנׂש�ד �ፈֶጊ የֲp የደֱ��ُ ጥ�:¬ዎא ٤ወרዳْው� ው� ָውጥ ׁያውףרـጋገጥ እ0 የנד ወይו የዋֳ�ُ� ገָግֹُ እ�ዲBו (ዝገא� ُـ�ክ �רያָٍ ו��bውד ያዝאֳ�ُ፡፡ 3/ ዝግ ጠ:וׂש �ዚֱ ዋጅ ُנטא ُנטא ያዎ٤עאא ወጡ ደ�q٤0ג� ֳዚB ـግד ץֹוካְጃ ָםֳֹו�ጣp ٢( ጠው qٍרـ� ዝግq ፈ:ድאـ ካְድאֳ�ُ፡፡ 6ֳፍד �ዚُף6ֳፍ�ُד �ዚُף6ֳፍ�ُד �ዚُף6ֳፍ�ُד �ዚُףُ� ....0000 1/ ָውጥ ׁያው� ��ُዮጵያ ግዛُ �ኩָ ውר ፈָግג6ֳፍ የדֳ �ዚُףُ� ይֱ�p ֳָםֳֹוጣp �Iድגያ 6דወI ֳ�ُ፡፡ ጣp ��ُዮጵያ ግዛُ �ኩָָםֳֹו /2 ያָፍּת �ዚُףُ�ደገb ֲ@ የגያገ�ው� ָውጥ ׁያው �ፕِצኮִ የנאጃ ץםዓُ እ�ዲገֳፅ דድנግ ֳ�ُ፡፡ 8. Importation of Modified Organisms 1/ Importation of any modified organism without obtaining an advance informed agreement is prohibited. 2/ An application for an advance informed agreement for the importation of a modified organism shall be accompanied by a statement signed by the head of the competent national authority of the country of export to the effect that the competent national authority takes full responsibility for the completeness and accuracy of the information provided. 9. Making and other forms of Contained Use 1/ Any person who makes a modified organism shall take into account the characteristics of the parental organisms used, the research site and the surrounding environment, and apply scientifically acceptable and environmentally sound practices based on the precautionary principle in order to minimize possible risks to insignificant level. 2/ Any person that uses a modified organism under contained conditions shall ensure that the necessary safety precautions, including measures to limit the detrimental effects of any unintentional release, are taken and shall keep records of all the making or use of the modified organism and of any unforeseen event encountered. 3/ Any contained use shall take place only in a facility registered by the Authority for such use in accordance with regulations and directives issued pursuant to this Proclamation. 10. Transit 1/ A person who wishes to carry out any transit of a modified organism through the territory of Ethiopia shall notify the authority before that transit takes place. 2/ The Authority shall place any modified organism that it deems dangerous to transit through the territory of Ethiopia in the Biosafety Clearing-House of the Protocol. 4¹þ9)%7 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4968 00001111.... የׁዝ) 6ُـፎየׁዝ) 6ُـፎየׁዝ) 6ُـፎየׁዝ) 6ُـፎ ֹוዘገ דገוጣp የጠ�I ግָםֳֹו /1 እ�ደደרנው ዘገֹוው� �ׁዝ) ٍ�דወּׂשያ ውٍ٤צ �ኩָ ֳֳֹוድָךץዎנרד� ٤ ጨُ ከ �ድ ወץ ֶָ�ֳጠ ጊዜ ያـ� የِר(רא �٤) ֳ�ُ፡፡ 2/ ከግ�ዛx የא�ጨ אֳ� ُ�וו��ጠُ ወይאֳֶ� ו�ጠُ የּשץׂשג ያየـ� (�ው የጊዜ ገደרጣp �ወָםֳֹו ٤ِ ው�ጥ �ጽֽፍ אIנ) ውֹْוֳ ዓُץ� ጃנא ይወׁُ ـ��ዊ የደֱף׀(ዓُץ� ጃנא ይወׁُ ـ��ዊ የደֱף׀(ዓُץ� ጃנא ይወׁُ ـ��ዊ የደֱף׀(ዓُץ� ጃנא ይወׁُ ـ��ዊ የደֱף׀( ....00002222 ይወׁُ ـ��ዊ የደֱף׀( ጣpָםֳֹו /1 וּהּהד ዓُץם ጃנאֳ�ُ፡፡ 2/ �ዚֱ ُנטא /ጽ /1ׂש� �ጽ �ዑׂש� የאּהּהגው የደֱـ�� ׁይወُ נאጃ ያዝא ጃዎ٤נא �ִُـከגዓُ የץם ֳ�ُ፡ �/ �ָውጥ ֱያዋ� እውׂُש ያֶْው �� ُዮጵያ ው�ጥ የגገ® בֳֹוያዎ٤ ፣ו�ድـ ٤ַֹ 0ָךףዛדጅ ጃዎ٤፤נא ֳ/ ወደ ገץ ው�ጥ እ�ዲገ0ּש ወደ ውጭ እ�ዲֶኩ ፈ:ድ የרـጣْው0 የـከֳ ከִ የָውጥ ֱያዋ�� ዝץዝץ፤ ּ/ ይֱ ዋጅ ג�ፈIደው ُנטא የָאד ּשנׂשከ٢ዎ٤�፤ /אግֹו)�ُ ያֶْው� ዋጆ٤፣ ደ�q٤፣ ደ�q٤�፤ ץףט ያዎ٤0 የעאא ጋנዘـየ וּהּהאֳ �ׂُשָ �ጤـያָ /ט ዊ የף׀( ו��bውדደጋ ጊዜ ዝግጅُ�፤ �ጠُאֳ ُ�וו� �ጨאከግ�ዛx የ /נ ጃዎנא ፈָጋْውגጣp የָםֳֹו ٤�፤ ו�bውד /רግֹו)�ُ ያֳው የBֳُ ዮֹּל፣ ֱጉףዊ0 የ)ዙ ገוו� ٤צ �ِ٤0 የ ደِ٤�፤° ץףט ₪/ ָውጥ ֱያዋ� ወደ ገץ ው�ጥ �ዲገּש እ0 የـጤ� ָׂُש እ�ዲካְድֹْוው ው6C፤ ָךנጨאደ�ُ� የׂשጣp የፈָםֳֹו 11. Public Participation 1/ The Authority shall, upon receipt of the risk assessment report, disseminate it to the relevant stakeholders through a public notice and accept comments for a period of not more than one month. 2/ Comments on the granting or refusal of an advance informed agreement for the transaction may be made in writing by any person within the time limit specified by the Authority. 12. National Biosafety Clearing-House 1/ The Authority shall establish a National Biosafety Clearing-House. 2/ The National Biosafety Clearing-House to be established pursuant to sub-article (1) of this Article shall contain information on: a) a roster of experts that shall include the names, contact addresses and relevant information on experts in Ethiopia in modified organisms; b) a list of modified organisms that have been approved and rejected for import and export; c) applications lodged pursuant to the provisions of this Proclamation; d) relevant proclamations, directives, guidelines and codes of practice; e) any national emergency response plan to manage any accidental release; f) information required by the Authority for giving an advance informed agreement; g) any relevant bilateral, regional and multilateral agreements and arrangements; h) the Authority’s final decisions on the importation and on the deliberate release of modified organisms; 4¹þ9)%8 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4969 �ይֱ /ׂשዋጅ ֳד�ፈፀו የגያ�ፈָጉ ጃዎ٤�፡፡נא עדጨـ ٤ַֹ 3/ ወደ )ף׀ዊ ደֱـ�� ׁይወُ የנאጃ ו0ْውד ּُשዓُ ው�ጥ የገץ� ዘገֹוዎ٤0 ר�ዶ٤ ֳׁዝ) ክፍُ ֲא� ው፡፡ֹْוֳ 4/ �ዚֱ ዋጅ � ُנטא ጽ 03ׂש� ጃ ወደנא ُ��רወـእ�ዲያዝ የ ץ�ጢו� ዓًץם ጃנא ይወׁُ ـ��ዊ የደֱף׀( እ�ዳይገֹו የـከֳከֳ �ው፡፡ ጃנא ያዝגየ ץ�ጢו� ጃנא ያዝגየ ץ�ጢו� ጃנא ያዝגየ ץ�ጢו� ጃנא ያዝגየ ץ�ጢו� ....00003333 1/ እያ�ዳ�ዱ እ�ዲያዙ ץ�ጢו� ካ٤ָא ֳُ የגፈָጋْው� נאጃዎָםֳֹוֳ ٤ ጣp የ6דወI א)ُ ֳው፡፡ 2/ ֳደֱـ�� ׁይወُ0 ֳֶַ וክ�ያُ �ፈֶጊ ֲא�p ו��ጢא ץጠ�I የֳ�ָُםֳֹו ֹ( וጣp ያُ��א� ይገָጽֳָٍ፡፡ ካ٠ָא ֳ ጃ ֳይِנא וወይ ָדד��ዚB ይ וካ٠ָא ዛָ፡፡ץרከ٢ው� ይָאד 3/ የዚֱ /ጽ /1/ እ0 /2ׂש� �ጽ �ዑׂש� ድ�ጋጌዎוס@ּת ٤ � ץׂשגየ ካ٠ָא ו�ጊዜו ጃዎ٤נא ִُـከגየ ּُש ץ�ጢו��ዲያዙ ይፈׂשድו፡ �/ የָውጥ ֱያው א ُ��וግֳጫ፣ የ 0ו� ካ٠ָאድָךף፣ የእ�I� qٍ፤ 0דው ዓֶױ: ֳ/ ָውጥ ׁያው� ֳאከָٍـ የגያ� ٤ָ ዘዴ0 እIድ እ�ዲBו የ ደጋ ያ ዝግጅُ፤גּהּהא ּ/ ֵደץ� የ٤ָג ደጋ ግוገד፣ ֳـ� ይֹּٍל� ו የד�ያዝ ወይו ካּתֹו� የדወክ ـጽዕ@፡፡ 4/ ካ٠ָאIץqُ የנ��ው� ָאדከ٢ ከנרዘ �ዚֱ /ጽ /3ׂש� �ጽ ��ዑׂש� ከـዘנዘץׂשـ�� ُס የנאጃው� ו�ጢ ጠ�Iא ጣpָםֳֹו ዊ�ُףֳ�ُ፡፡ i) other information that is required to implement this Proclamation. 3/ The public shall have access to any record or document filed in the National Biosafety Clearing-House. 4/ Any information determined as confidential pursuant to Article 13 of this Proclamation shall not be placed on the National Biosafety Clearing-House. 13. Confidential Information 1/ Every applicant shall have a right to notify the Authority specifying the information to be treated as confidential. 2/ Following a written request by the applicant for keeping information confidential, the Authority shall determine the information which is essential for biosafety and for other reasons not to be confidential and inform the same to the applicant. The applicant may then agree with the Authority or withdraw his application. 3/ Notwithstanding the provisions of sub article (1) and (2) of this Article, in no case may the following information supplied by an applicant be kept confidential: a) description of the modified organism, name and address of the applicant, purpose and location of the transaction; b) methods and plans for monitoring the modified organism and for emergency response; c) the evaluation of possible effects, in particular any pathogenic or ecologically disruptive risks. 4/ If the applicant withdraws the application, the Authority shall respect the confidentiality of the information except for that part referred to in sub-article (3) of this Article. 4¹þ9)%9 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4970 00004444.... ው6C ጣጥר ጣጥው6Cר ጣጥው6Cר ጣጥው6Cר �ው� እ�ዲנׂשየ ካ٠ָא � ጣpָםֳֹו /1 Bו �ፕِצኮִ0 �)ף׀ዊ የደֱـ�� ׁይወُ የנאጃ ץםዓُ ው�ጥ የגገ� ው� נאጃ፣ የבֳֹוያዎ٤ �0(ר6ـ� የየֳֹוድָךץዎ٤ ጤ�0ד� �ያየُـ� ከֳאגከٍْው የא�ግُם ካֶُ ጋץ ይ ው6Cֶ ከ٢ָאד �ውנׂש� ץካከאא� �ጠُאֳ�ُ፡፡ 2/ ው6C ከראጠً �ፊُ ָםֳֹוጣp �ፈֶጊ ֹ�א የٍየው� ـጨנא עדጃ ካ٠ָא�ዲያץׂש) ֵጠይI ይ٤ֶָ፡፡ የـጠየׂשው� נאጃ ያֶד �נׂש�bውו ዘנרከ٢ው� እ�ደָאד ካ٤ֳא ይּבጠָף፡፡ 0(ר6ـ� ያዎ٤בֳֹוጣp የָםֳֹו /3 የֳֹוድָךץዎ٤ �05 ُשנ�ደ ያየِ٤ـ� �ውֹוዘገ דገוው�ጥ የጠ�I ግ 0ׂُש ፡וገוገא� �/ እ�I�:ױው� ከُ�ו� ያֳፈ ጠ�I የדያ�ከָُ ֲאp� ካא� ዘገֹוው� ያֳ Iድא BCٍ ד�ጽደI ከግ�ዛx የא�ጨ ً�וו�� ይרጣָ፤ ֳ/ ֵከִـ የ٤ִג ጠ٤ּב� � דـ� �ו� ወደ וn�ُ ֵወገዱ ወይד ُ�ُ ደנጃ ֵש�ׂש እ�ደ٤ִג ካא� ዘገֹוው� ያጸድI0 ጠאֳ �٠ּב�ግ ٍُ የגያ�ፈָጉ ግዴٍዎ٤ እ�ዲ �ً�וו� �ጨאከግ�ዛx የ ִח ይרጣָ፤ �אֳ ደገፈ ው6Cـጃ የנא ֳָךـ� /ּ ጠُ እ�ዲ٢ֳው עדጨـ �ካ٠ָא ይጠይ:ָ፤ (ץׂשጃ እ�ዲያנא ወይו ግ ከግ�ዛxנድד� ው� ውድIֹוዘገ /א የא�ጨ ً�וו�� ይከֳክֶָ፡፡ 4/ �ዚֱ ُנטא /ጽ /1ׂש� �ጽ �ዑׂש� ው6Cው ከרـጠ �|ֶ � �ድ 6ُ�ו ጊዜ ው�ጥ ָםֳֹוጣp የው6Cው� Iጂ ወደ ጃנאይወُ የׁ ـ��ዊ የደֱף׀( ֹُו�ገד ዓُץםֳ�ُ፡፡ 14. Decision making 1/ The Authority shall make its decision on the application by taking into account the information presented by the applicant, the information found in the Protocol and the National Biosafety Clearing-Houses, expert opinion and stakeholders’ comments, and in consultation with the concerned public agencies. 2/ The Authority may, prior to taking a decision, request for further information as it may deem necessary. Any applicant who fails to supply the required further information shall be deemed to have withdrawn the application. 3/ The Authority shall, within 15 days after it has received the opinion of experts as well as stakeholders’ comments, evaluate the risk assessment report and: a) approve the report without conditions and give its advance informed agreement if it is convinced that the transaction will not pose any significant risk; b) approve the report and issue an advance informed agreement with conditions that must be fulfilled in order to eliminate or reduce to insignificant level risks if it is convinced that such risks can be effectively contained; c) require the applicant to provide more information to enable better informed decision making; or d) reject the report and deny an advance informed agreement. 4/ The Authority shall lodge a copy of the decision given in accordance with sub article (1) of this Article in the National Biosafety Clearing-House within one week of issuing it. 4¹þ9)& gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4971 00005555.... ው6C �ֳאከֳ�ው6C �ֳאከֳ�ው6C �ֳאከֳ�ው6C �ֳאከֳ� ጣp �ֳָውጥ ׁያው ያገ�ውָםֳֹו /1 ዲ� נאጃ ወይו የנ��ው נאጃ ٤ָגእ�ደ ָـድ ጠ�I ֵከֹוከ וገאገת ካֳאከרـ ـጥِ የנ�� ከግ�ዛx የא�ጨ עדጨـ וዝ፣ ወይנרֵ ُ�וו� ግዴٍዎ٤ ֵካُ�ًـ ይ٤ֶָ፡፡ 2/ �ً�וו� �ጨאከግ�ዛx የ ካ٠ָא ካገ� �|ֶ ֵደ٤ָגֳ� �ץ ከֹוድ ጠ�I ጣp ወዲያውpָםֳֹוֳ �ጃ ካገנא 6ወIדֳ�ُ፡፡ ُ�וו� �ጨאጠው ከግ�ዛx የרـ� /3 የـካד ــ�bውו ግዴٍ 6ይֶח ከנׂש 0וּברው� ֵያױ:�ጣp እ�Iָםֳֹו ָውጥ ׁያው እ�ዲወገድ �ከ דድנግ ድـ �נገּת ֲ@ ያገ�ው� እוץጃ ֵወ�ድ ይ٤ֶָ፡፡ �ጨאከግ�ዛx የ ױ:�እ�I ו�bውדֳ /4 ክ�ያُ እ�ደገ0ו ከָከִא� ُ�וו� እ�ዲٍይ የָאד (ץׂשגከ٢ � ዲ� 6ይ�6ዊ נאጃ ከـደገፈ እ�ደ ዲ� ይ ይ٤ֶָ፡፡ ይֱֵٍ ג�ድጋ ከ٢ָאד ካֲֳ� ግ� ክָከֶው የፀ0 ይֲ0ָ፡፡ 00006666.... ከግ�ዛx የא�ጨ ُ�וו� ፀ�ِ ֵּבይ ከግ�ዛx የא�ጨ ُ�וו� ፀ�ِ ֵּבይ ከግ�ዛx የא�ጨ ُ�וו� ፀ�ِ ֵּבይ ከግ�ዛx የא�ጨ ُ�וו� ፀ�ِ ֵּבይ የ٤ָ�ُג ጊዜ የ٤ָ�ُג ጊዜ የ٤ָ�ُג ጊዜ የ٤ָ�ُג ጊዜ �ጠው የጊዜ ገደ) ው�ጥ እ�Iאׂשـ� /1 ከግ�ዛx נ��ጥِ የרـ �ከ0ወـው ካָױ: የא�ጨ ـ ُ�וו�ፈፃُ�ג ይנּהጣָ፡፡ 2/ �ዚֱ ُנטא /ጽ /1ׂש� �ጽ �ዑׂש� ُ�וו� �ጨאከግ�ዛx የ נ��ጥِ የרـ וወ:גየ ُ�ּתገـ �ጥנּהא ُ�גፈፃـ ُ�ו ףם � �ውזው:ـ ካ٤ָא ጣpָםֳֹוֳ ው�ጥ �ጽֽፍ 0ׂُש ይ٤ֶָ፡፡ (נIד 3/ �ዚֱ ُנטא /ጽ /2ׂש� �ጽ �ዑׂש� ጣpָםֳֹו ֳُ(ץׂשת ከ٢ָאד ከግ�ዛx የא�ጨው ـ ُ�וו�ፈፃُ�ג እ�ዲףዘו ወይו የጠ�I ግוገדው እ�ዲከֳ� ወይו �ድጋג እ�ዲףר �" የ0ׂُש ףם ው�ጥ אወר� ֳ�ُ፡፡ 15. Review of Decision 1/ Any advance informed agreement given may be revoked or subjected to additional conditions if the authority obtains new information that shows, or a review of existing information indicates, any significant risk from the modified organism. 2/ Where information becomes available to the applicant after receiving the advance informed agreement on possible significant risk, the applicant shall immediately notify the Authority. 3/ If any condition contained in an advance informed agreement is not strictly complied with, the Authority may take any action that it may consider appropriate for the immediate cessation of the transaction, including the destruction of the modified organism. 4/ Any application to reconsider a refusal of an advance informed agreement for any transaction shall be treated as a new application if it is accompanied by new scientific information. Otherwise a refusal shall be final. 16. Duration of Validity of an Advance Informed Agreement 1/ An advance informed agreement shall expire if the transaction has not been performed within the time frame set out for it during its approval. 2/ Any applicant who wishes to challenge the appropriateness of expiry of an advance informed agreement pursuant to sub-article (1) of this Article may submit a written application to that effect to the authority within fifteen days from the date of expiry. 3/ Within 30 working days from the receipt of an application pursuant to sub-article (2) of this Article, the Authority shall decide whether to extend the validity of the advance informed agreement or to order the revision or the redoing of the risk assessment. 4¹þ9)&1 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4972 00007777.... ፈ:ድ የרـጣْው רዎ٤ ግዴٍዎ٤ፈ:ድ የרـጣْው רዎ٤ ግዴٍዎ٤ፈ:ድ የרـጣْው רዎ٤ ግዴٍዎ٤ፈ:ድ የרـጣْው רዎ٤ ግዴٍዎ٤ 1/ ፈ:ድ የרـጠው ד�bውר וው �ጸደׂשው የጠ�I ግוገד ዘገֳאـ� ֹוከـው የጊዜ ገደ) ው�ጥ �ֳגያካ°ደው እ�I�:ױ የፅBፍ ዘገֹו (נIד ጣpָםֳֹוֳֳ�ُ፡፡ 2/ ፈ:ድ የרـጠው ד�bውר וው �ይዞٍው ያֳው� ד�bውו� ֳገ�ያ ያָנׂש� ָውጥ ׁያው ከָםֳֹוጣp ዲ� ከግ�ዛx የא�ጨ 6 ُ�וו�ያገn ֳֶַ רው 6ָፎ እ�ዲרጥ ይፈׂשድֳُו፡፡ ው�0רው የר ጠውרـፈ:ድ የ ו�bውד /3 የ ��6ُ� ጤ��ُ እ�ዲBו ካּתֹו� ከד�bውו ጠ�I የגጠ)I�ُ� የ ደጋ ያ �ָُ �ዚֱגּהּהאዋጅ ג� ُנטאወጡ ደ�q٤0 עאאያዎُנטא ٤ ዘጋጅِ ץ�ግـאֳ�ُ፡፡ ው �ይዞٍውר ጠውרـፈ:ድ የ ו�bውד /4 የד נ���bውו ָውጥ ׁያው ּתጠፋ�ُ ወይנרּת וI�ُ ወዲያውp ֳָםֳֹוጣp 6ወIדֳ�ُ፡፡ ያעםא ጪר ጣْው የፈ:ድרـጣ� የָם ያעםא ጪר ጣْው የፈ:ድרـጣ� የָם ያעםא ጪר ጣْው የፈ:ድרـጣ� የָם ያעםא ጪר ጣْው የፈ:ድרـጣ� የָם ....00008888 xِـ ٤ግُףֹוxِـ ٤ግُףֹוxِـ ٤ግُףֹוxِـ ٤ግُףֹו ያעטא ጪר ጠው ፈ:ድרـጣ� የָם /1 xُ ከግ�ዛx የא�ጨ נׂשֶֶ ُ�וו�� ው� እ�ዲያካְድױ:�እ�I ካ٤ָא ከאፍׂשድ የـከֳከֳ �ው፡፡ �ጨאጠው� ከግ�ዘx የרጣp የָםֳֹו /2 �ጣָם ዝץרת וያግድ ወይת ُ�וו� የרـጠው ፈ:ድ רጪ עםאያ xُ ֵዚያው እ�I�:ר ױጥُِ የנ��ው� ፈ:ድ דገድ ወይנרא וዝ ֳ�ُ፡፡ 00009999.... የּבـጣጣעየּבـጣጣעየּבـጣጣעየּבـጣጣעዎ٤ዎ٤ዎ٤ዎָם ٤ጣ�0 ـግָם ץֹוጣ�0 ـግָם ץֹוጣ�0 ـግָם ץֹוጣ�0 ـግץֹו የዚֱ עጣጣּבـ ו�bውד /1ዋጅ0 � ዋጁ ያዎ٤עאא ወጡ ደ�q٤0גየ ُנטא ጋገጥ፡נדֳ �ውْף�ከא ካגወደ ױ:�እ�I ו�bውד /� ְድ�ُ qٍ ወይוּהـ ו ው�ጥ ፣ֹُוግד ֳ/ የגካְደው� እ�I�:א ױፈ0ֹּלـ ዱרእ�ዲወ ጃዎ٤וץካከያ እـ�ד ُዕዛዝ א�ጠُ፣ 17. Duties of Authorized Persons 1/ Every authorized person shall, within the time specified in the approved risk assessment report, submit to the Authority a written report on the transaction that he has been carrying out. 2/ No authorized person shall transfer any modified organism that has not been put on the market to any other person without obtaining a new advance informed agreement from the Authority. 3/ Any authorized person shall, in accordance with regulations and directives to be issued pursuant to this Proclamation, develop and implement his own risk management strategy to protect human and animal health and the environment from any risk. 4/ Every authorized person shall immediately inform the Authority whenever any modified organism is lost or stolen from him. 18. Duties of Competent Licensing Agencies 1/ Every competent licensing agency is prohibited from giving a license for any transaction uless the applicant has submitted to it an advance informed agreement. 2/ Every competent licensing agency shall suspend or cancel any license it has given following the decision of the Authority to suspend or cancel the advance informed agreement that it has granted. 19. Powers and Duties of Inspectors 1/ Any inspector may, for the purpose of ensuring compliance with provisions of this Proclamation and regulations and directives to be issued pursuant to this Proclamation: a) enter any place or facility in which a transaction is taking place; b) inspect and order the taking of any corrective measures on the transaction being carried out; 4¹þ9)&2 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4973 ּ/ እ�I�:ױ ከגያካְደው רው ወይו ከ٪ֶፊው נאጃ אጠየI0 דግ�ُ፣ �ግ�®�ُ ያֳው ץጋ ױ:�ከእ�I /א �ድר וዝገ) ወይא ו��bውד ጠውרIጅው እ�ዲ 0ץאץאא ጠየI፣ እ0א ያֳ ክፍያ 0ב0 �ּׁש ו��bውדየ /ט ድ0רውא�ፈֶጊ የֲ� ፍָךـ ግ፣נድד እ�ዲካְድ וካְድ ወይד ይ٤ֶָ፡፡ �ዚֱ עጣጣּבـ ו�bውד /2ዋጅ የרـጠው� ָםጣ�0 ـግץֹו �ُጋُ0 ׂשጠየـ� וከ0ወ� እ�ዲBד ዳֶُדֳֹו ጊዜ ٍאወּׂשያው� 6דየُ ֳ�ُ፡፡ ץጥጥּׁש ግנደגየ ውጫ qٍዎ٤א� ያ0ּתግא�ץጥጥּׁש ግנደגየ ውጫ qٍዎ٤א� ያ0ּתግא�ץጥጥּׁש ግנደגየ ውጫ qٍዎ٤א� ያ0ּתግא�ץጥጥּׁש ግנደגየ ውጫ qٍዎ٤א� ያ0ּתግא� ....!!!! ውጥ ֱያው ይዞ ወደָ ו��bውד /1ገץ ው�ጥ የגገֹו ወይו ከ ገץ የגወጣ ግֳא� (רግּתያ ወይא� וውጫ ס� 6ወIד bـףט ክסוይ ֳֶ የጉֶ ף�� ֳ�ُ፡፡ b ከግ�ዛxـףט ክסוየጉ ו�bውד /2 የא�ጨ 6 ُ�וו�ይ@ד ץ�bውו ግֳר) ָውጥ ֱያው אያዙ� ከጠנጠנ ወይו ָውጥ ֱያው ይዟָ )ֹ የጠנጠנው� ጭ�ُ ካገ� ያግـው0 ጣp ያ6ው:ָ፡፡ָםֳֹוֳ 3/ �ዚֱ ُנטא /ጽ /2ׂש� �ጽ �ዑׂש� የٍገـው� �ገץ የጉסוክ ـףטbው �)ዝ� ׁይወُ፣ � ካּתֹו ወይר� וው ወይו �እ��6ُ ጤ��ُ ֵደשץ የ٤ִג ጠג� �٤ּב�ያ6�� ዘዴ ያוׂש�ጠዋָ፡፡ ጽׂש� �ጽ �ዑׂש� ጣp �ዚֱָםֳֹו /4 0בይ 0ֶ ץው �ገـከٍገ ُנטא /2/ ወ�ዶ ץאץאא� ָውጥ ׁያው ያֳ�ُ ጋገጥנד �pֲאֳ �ֲאֳ�ُ፡፡ 5/ የጉסוክ ـףטb የנـከ�ው ׁያው ָውጥ �ጽ �ዑׂש� p �ዚֱֲאֳ ָךـካְደ ፍـ� ُנטא /ጽ /4ׂש� ከנـጋገጠ ֳףאץו �ጥIו ֶይ የዋֳው ውר ያዘ�ُـֳ ُ�׳�ׂשـ ٢( �ጠא �ֳאאֳ�ُ፡፡ c) request and obtain information from any person carrying out or in charge of the transaction; d) examine and obtain a copy of any record or document related to a transaction; and e) take free of charge samples of any material or substance as required and carry out or cause to be carried out tests he considers appropriate. 2/ Every inspector shall exercise in due diligence and impartiality in the discharge of his powers and duties pursuant to this Proclamation and shall show his identity card whenever requested. 20. Inspections at Points of Entry and Exit 1/ Any person in possession of any modified organism shall, on arrival or departure, declare such possession to the customs officer on duty at the point of entry or exit. 2/ Where a customs officer suspects that any person is in possession of a modified organism or any load contains any modified organism, without a written advance informed agreement, he shall impound it and notify the Authority. 3/ The customs officer shall store the suspected modified organism referred to under sub-article (2) of this Article in such a manner that risks to biodiversity, the environment or human health are minimized. 4/ The Authority shall, by examining samples, verify whether the impounded material referred to under sub-article (2) of this Article contains any modified organism or not. 5/ If any organism surrendered to a customs officer is determined by the Authority not to be modified, the impounded amount after reducing the amount used up during analysis shall be returned to the person who had surrendered it. 4¹þ9)&3 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4974 6/ �ዚֱ ُנטא /ጽ /2ׂש� �ጽ �ዑׂש� ٍግِ የאׂשـጠው �ገץ ָውጥ ׁያው ው�ጥ 0ׂُש "� ጋገጠ0נـp ከֲא ከ�ُዮጵያ እ�ዲወጣ ካָـደנገ �ֲ� ּתገـ וጠָ ወይ:ד� ጣpָםֳֹו ጋָ፡፡ץ�ገድ እ�ዲወገድ ያደא ֶַ 7/ ወደ ገץ ው�ጥ የገֹו ָውጥ ׁያው ይֹוׂשـጥِ �ደُ�רנ qٍ ከBֳُ ጣpָםֳֹו የּבይ ከֶ� ٍُ�ו6 ከጉסוክ ـףטb ወይו ከֶַ ـገּת የא�ግָםֳֹו ُםጣ� ጋֲא� ץ� ָውጥ ֱያው ወደ אጣ�ُ ገץ እ�ዲֳא� ወይו ካּתֹוያዊ ֹוׂשـይ�ُ ድרጃ ֵወוץው ዘዴ እ�ዲወገድ እֳֹו ይ٤ֶָ፡፡ ዱ ግֳጽ ጥፋُרወאֳֶ ጃוץው እּתገـ /8 ጽׂש� �ዚֱ ץׂשـ�� ጋገጠנـካָ ס@א �ዑ� אׂשـግِ የٍ ُנטא /ጽ /3ׂש� ጠው �ገץ ይዘً ָםֳֹו ֹּלֶ�ּתጣpו ֲ� የጉסוክ ـףטbው ـጠያּׂש ይֲpו፡፡ 9/ �ዚֱ ُנטא /ጽ /2ׂש� �ጽ �ዑׂש� ٍግِ የּבየው� ָውጥ ֱያው ֳד�ወገድ ወደ ውጪ ׳ֳא וጥ ወይאׂש�דֳ ወጪ ו�bውד ክ የወጣውֶאֳ �ٍገר ُ�ـው א₪ፈ� ֳ�ُ፡፡ !1!1!1!1.... Iጣُ Iጣُ Iጣُ Iጣُ 1/ �ወ�ጀָ ׁግ ድ�ጋጌዎ٤ የ�ֳጠ የגያ� ፡ץׂשـ�� �ጣ ካֲֳׂש ው ጤ��ُ፣ר� ֹ( �ֲ ውר ו�bውד /� �)ዝּ ׁይወُ፣ � ካּתֹו ወይו ֶַ� וወይ �נድדֳ ይ ጉዳֶُ ُנ(�� ካካְደ ከ0 ױ:�ወክ እ�Iדֳ �ገድא �ከ 05 ዓג� ُאደץ� ጽp እُףם ይׂשጣָ፤ ֳ/ የዚֱ� ዋጅ ድ�ጋጌ ወይו �ዚֱ ዋጅ ያעאא ו�ወጣ ደ�) ወይ ُנטא የـደ�ገገው� የֳֶـፈ ד�bውר וው ከ4ְך እ�ከ 7ג� ץ( ְךደץ� የገ�ዘ) ׂשאጮ ወይו ከ �ድ እ�ከ ُ�מ ዓג� ُאደץ� እُףם ወይו �Bֳًו ይׂשጣָ፡፡ 2/ የወ�ጀִ ድץጊُ የـፈጸאው �ׁግ የרው�ُ ጠውרـ� ُ(אካָ ֲת� የIጣً ወ6ר� ��ُዮጵያ ፌዴֶףዊ ዲזክתףያዊ עፐ)ֵክ ወ�ጀָ ׁግ ُנטא ጽ ( ድ�ጋጌዎ٤ׂש� ይፈጸָד፡፡ 6/ If the material impounded and stored pursuant to sub-article (2) of this Article is proved to contain any modified organism and if it is not taken out of Ethiopia within 30 days, the Authority shall destroy it by incineration or by any other method it deems appropriate. 7/ Where any imported modified organism remains unclaimed at the port of entry for more than two weeks, the Authority, together with a customs officer or other appropriate government officer, may take any action necessary to send back the modified organism to the country if came from or to dispose of it in an environmentally sound manner. 8/ Neither the Authority nor the customs official shall be held liable for any deterioration in storage in the condition of the contents of the material impounded and stored under sub article (3) of this Article unless manifest failure to take reasonable measure is proved. 9/ All costs of any disposal, safe-keeping or re-export of any load of modified organism that has been impounded under sub-article (2) of this Article shall be borne by the person who had surrendered it. 21. Penalties 1/ Unless the act entails higher penalty under the provisions of the Criminal Code: a) any person who engages in any transaction with the intention of causing harm to human health, biological diversity, the environment or property shall be punishable with rigorous imprisonment from 10 to 15 years. b) any person who violates any provision of this Proclamation or regulations or directives issued pursuant to this Proclamation shall be punishable with a fine from Birr 4,000 to Birr 7,000 or with imprisonment from one to three years or both. 2/ Where the offense is committed by a juridical person the penalty shall be determined in accordance with the provisions of Article 90 of the Criminal Code of the Federal Democratic Republic of Ethiopia. 4¹þ9)&4 gA ØÁ‰L �U¶T Uz¤È qÜ R ^3 ��� 4 qqqN 2�1 ›.M Federal Negarit Gazeta No. 63 9th September, 2009 …. page 4975 3/ �ֱግ የרው�ُ א)ُ የרـጠው ካָ ጥፋُ תፈፅו ከגወׂשא ُ��רጮ ጋገጥנדֳ ץ�ከא �የׁጉ עדጨـ� ጋُُ� ץֹוግـ �ውֹוገגየ וፈፀא ያָـወጣው የעא ףם �ዚֱ �ፅ �ዑׂש� ጣָ፡፡ׂשይ ُנטא /ֳ/ /ፅ /1ׂש� !2!2!2!2.... ደ�)0 עאאያ የדውደ�)0 עאאያ የדውደ�)0 עאאያ የדውደ�)0 עאאያ የדውጣُ ָםጣ�ጣُ ָםጣ�ጣُ ָםጣ�ጣُ ָםጣ� 1/ የגk�ُו ٤צክץ xُ ይֱ� ዋጅ ያወጣֵ �ያ�ፈָጉ ደ�q٤גየ ו�ፈጸדֳ ይ٤ֶָ፡፡ �ጣp ይֱָםֳֹו /2ዋጅ0 �ዚֱ ጽׂש� �ዑ� �የወጡ ደ�q٤ ُנטא /ጽ /1ׂש� �ያዎ٤עאא ያ�ፈָጉגየ ו�ፈጸדֳ ֵያወጣ ይ٤ֶָ፡፡ !3!3!3!3.... ›ªÌ ¾T>ì“uƒ Ñ>²?›ªÌ ¾T>ì“uƒ Ñ>²?›ªÌ ¾T>ì“uƒ Ñ>²?›ªÌ ¾T>ì“uƒ Ñ>²? ይֱ ዋጅ �ፌዴָף �ጋُע ጋዜጣ ٍُז ከወጣ�ُ ׂש� ጀצו የፀ0 ይֲ0ָ፡፡ ዲዲዲዲዲዲዲዲ�������� וווווווו........ዓዓዓዓዓዓዓዓ 11111111ְךְךְךְךְךְךְךְך22222222 ��������ׂשׂשׂשׂשׂשׂשׂשׂש 44444444 ההההההההጳጳጳጳጳጳጳጳጉጉጉጉጉጉጉጉ ֹוֹוֹוֹוֹוֹוֹוֹו�������� GR¥ wLdgþ×RgþSGR¥ wLdgþ×RgþSGR¥ wLdgþ×RgþSGR¥ wLdgþ×RgþS yxþT×eà ØÁ‰§êE ÄþäK‰sþÃêEyxþT×eà ØÁ‰§êE ÄþäK‰sþÃêEyxþT×eà ØÁ‰§êE ÄþäK‰sþÃêEyxþT×eà ØÁ‰§êE ÄþäK‰sþÃêE ¶pBlþK PÊzþÄNT¶pBlþK PÊzþÄNT¶pBlþK PÊzþÄNT¶pBlþK PÊzþÄNT 3/ In the case of an offense committed by a juridical person, in addition to the penalty imposed to the entity, the officer of the entity who has failed to exercise all due diligence shall be punishable in accordance with sub-article (1) (b) of this Article. 22. Power to Issue Regulation and Directive 1/ The Council of Ministers may issue regulations necessary for the implementation of this Proclamation. 2/ The Authority may issue directives neces sary for the implementation of this Proclamation and regulations issued pursuant to sub-article (1) of this Article. 23. Effective Date This Proclamation shall enter into force up on the date of publication in the Federal Negarit Gazeta. Done at Addis Ababa, this 9th day of September, 2009 GIRMA WOLDEGIORGIS PRESIDENT OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA 4¹þ9)&5