Biosafety (Amendment) Proclamation No.896 /2015

PRACRE bRl-AR ATNEASE (TAMN bRl 106 LM FEDERAL NEGARIT GAZETTE OF THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA 1# WIRT 900t avC 2R A& KNG oA T 47 BT 9.9° AR LLLAR SPNEGNLT LTANN P Aot PhC LT ALt Pom 21* Year No.66 ADDIS ABABA 14" ‘August , 2015 L [N APE ®PC EFIR/E0E 9.9° PRNTIT MLOT (TTNA L) APE...... R BiFEE CONTENTS Proclamation No.896/2015 Biosafety (Amendment) Proclamation...Page 8308 APE &TC ZT5/20.% AN Mot APED ATTTIA Pom APE NALMTI T heoT PoMat APE ¢TC | FEE/EAE 1NN 017904071 OATPRE &fREAT STheOLT ¢TAAR w1 @328 KPR Wi (B) oowddr PUh A o2 An & ABC CON LU APE “PRATIT meoT (TTANL) APE «PC ZPIE/ENL" 00 AmPd LTFAAR g.7799¢ PRAHT MLOT APE 4TC AIRTLhFAG- HATAA & CAPE NIPR € 00 NIPRT (B)T ()7 (B)T (D)7 (18)7T (1Z) AT (1) +ACHw 09htaF hED 300 KIPRT (8)T (B)T (I8)T (%) AS (IZ) +ThtPa: 4E35/00.8 "8/ ‘AP Ve CINT Ao AT PUY L9 haa vea- Pronf LU hdet Pronf L AL A4N Ptpavav ae+eC nooin £ PO Unit Price 17'95 PROCLAMATION No. 896/2015 APROCIAMATION TO AMEND THF. BIOSAFETY. BPROCLAMATION WHEREAS, it has become necessary to amend the Biosafety Proclamation No. 655/2009; NOW, THEREFORE, Article 55(1) of the Constitution of the Federal in accordance with Democratic Republic of Ethiopia, it is hereby proclaimed as follows: 1. Short Title This Proclamation may be cited as the "Biosafety” (Amendment) Proclamation No.896 /2015". 2. Amendment The Biosafety Proclamation No. 655/2009 is hereby amended as follows: 1/ Sub-articles (1), (4), (6), (9), (12), (17) and (18) of Article 2 are deleted and replaced by the following new sub-articles (1), (4), (6), (9), (12), (17) and (18): "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 the traits has been changed by 126 oM 7y iE Negarit G. P.O.Box 80001 NS Euid] bofith 126 onm ke BR 1WA E +3 BNE 9. Federal Negarit Gazette No. 66, 14" August, 2015 ......pag 8309 8/ ‘N7 AP 0T NGo- 0L %/ P l ~ LS HLEY anth 0 fiiZovae T Lt 0L Pavéo- hatt etaom0T vfar o1 x0T S off OxhAL AL PoLh A PATPR TROTT AovhAhA 1ERART N34 14T haa IS 0°LL0ES QoMo A-H1La avgvl e (1ML 04T AANAM 0 tofior Ao-T VPo7 RTL04ET AT.015 oLy TIVCTIT g°CI°CT MI°C Ahh aeah 9°CI°C a-hig. L40 PAT PP AANT ‘W Pavien, APPYT T AU AP P ALYT (AIC 00T of AN, AeAPP OATL AoTP Meo- AL ATPAPON ATLRLD hLr0bs P9LAT PALTS A 101 ‘M TINT QA CT Novhhas RS 0L L 18T O3 Nho oL mS7T 00Hh hLoTT axhan, oL 00425 ADTILeR Uit AL hAoT HheP +605 Novavyen-k: (-0Nh hLoOT POPT NAE mFLUT QAL 0NHh hLoT AATT QAIC OPA Pom-t »CYTS Axhanee TPNLAOT AL ALCH PTLTA TR 01 CLLAECT 0fL9° ULLATCT TIat NIRPLI® Thta PARANLS PRF “LLNEC @ L9° “LL0C 1o introduction of any foreign gene whether taken from another organism, from a fossil organism or artificially synthesized; 4/ contained use’ means any operation up to field trial in which modified organisms are produced ,destroyed or used in some other way including for teaching and research isolated by physical chemical barriers in space not exceeding the requirement stated in the appropriate directive issued by the Ministry with a view to effectively preventing contact with, and their unintended impact on ,human, environment; 6/ -advance informed agreement’ means a written consent granted by the Ministry for the undertaking of any transaction of modified organism destined to release into the environment in the country other than for contained use; 9/ ‘risk* means short, medium or long-term danger that may befall on human or animal health, biological diversity, the environment or conditions arising from the impact of modified organism on the conservation and sustainable use of diversity, especially with regard to the value of biological diversity, indigenous knowledge systems and communities; and their animal and the external socio-economic biological local 12/ ‘Ministry’ or ‘Minister’ means the Ministry or Minister of Environment and ,srespectively; Forest Ll L2oA 16T onm wvC 2R 100 &+ BiE 95 Federal Negarit Gazette No.66, 14" August, 2015 .....p 8310 TZ/ hovah 0T P.me oy ATPOFA ATHLL W0 Povian, NPT 0L AR LPL AT4.0mo ATLLOES Pavdnt Oar tarD i%/ 42L& etamaer e TINT WML Povyn, AFPIT 0L AR LIL hoLLaEs ehamo- do- 017 g/ OAPE hATPR € 70:0 W3R (IE) ¢Poe PILNEAT A& HOD RIPRT (TB)T (R)T (B8) a5 (AE) +teang°lar 10C 300 KHPRT (18) A5 (B) 10:0 W3R (BF) hG (B0) vro- HAITIPA: I8/ ‘NoeS e PO mLot TINT V) Novcé, lava- 27 rhaLh A7 ®f APO OPTI @Rt I°C A+ oong- A%04%L P4 AL 0rhagh AQL7 eTIPSET 1267} n7hLeT A) hat 0e%% Ahe W2 hire 4924, men, P MWPATT 0f ATL mPOYE 0T1PAPAT T4PEP LHFAENDS oS PN avhah POFG ROHAN hAVAD PTI8PA 1&4T aen, PTLRLD RSO UCEY PUIRPAS pavgelp +90C Yar-1 B/ AR 42 TN MLV APE oowld ADP Mhfo? of KhaN oAPPF ALMIPC U7 AP PI° AFCIC 0 LT NTPUCT AZIPA AP hfaor? @& RIC ATININT hLLAES ORUE PTLAT 4P o1 17/ ‘applicant’ means any person who submits an application to the Ministry seeking an advance informed agreement or a special permit to engage in a transaction; 18/ ‘authorized’ person’ means a person who has been given an advance informed agreement or a special permit by the Ministry to engage in a transaction;” 2/ sub-articles (19), (20), (21) and (22) are added after sub-article (18) of Article 2 of the Proclamation and the existing sub-articles (19) and (20) are re-numbered as sub-articles (23) and (24): “19/ 'modern biotechnology’ means the application of: a) In vitro nucleic acid techniques, including recombinant deoxyri bonuclic acid and direct injection of nucleic acid into cells or organelles; b) fusion of cells beyond the taxonomic family; that overcome natural physiological, reproductive or recombination barriers and that are not techniques used in traditional breeding and selection; 20/ ‘special permit’ means a written permit granted by the Ministry for importation of a modified organism for contained use in research or teaching but not for release into the environment in accordance with this Proclamation; ¢ EalYia LRlh 126 onm kT ZF 100 £ ¢ 0L 9.9 Federal Negarit Gazette No. 66, 14" August, 2015 .....pa >0\! A5/ ‘Po-er AN TIAT AT hmfo} hao-ei> R1C VT o0& AI1C o0T A%7010F 29240 Gor 10-17 F/ QAPE NTISTFog9® w8 “QA~ANY" oA N P7L wCH UL EC” 17200 kAl 8/ PAPE AR 8 twCr NLhtae- AA0 AR 8 k “8.LAPE 9477 PAPE. AT~ /00§ OATNAT mST (NNh ALOTT ORNALT Q7VNLANTS NAmFAe AAIC AL hAOT HheP? ALCH P9LTA@T AAFT TRAT PLT 0L (LI Ahh WIPII DT RLE L4N TININT RS g/ NeeS e PI0 hmLoOTT mIC ANNAh Lot PTAPT NAE AmPPP PPN ERTNE +&&M1T3S ERTHE HooC LT s R LY | hmeu" %/ PAPE. WiPR & twCh N°LhtAo- A4N AR G kA “& QM0 Povya, AP A/ PHY APE AMPR F L0 ARAme T MIFeo Go homn Pavyn, [(Eadaa o WLt ALTY AoT hfa? ok nET RhaN, PoAdP ATP0PAT NLL A LTAn 21/ ‘foreign exporter’ means any person under the jurisdiction of another country who exports a modified organism;” 3/ the designation “Authority” appearing anywhere in the Proclamation is deleted and replaced by “Ministry”; 4/ Article 4 of the Proclamation is deleted and replaced by the following new Article 4: “4. Objective of the Proclamation The objective of the Proclamation shall be to: and animal human health, biological diversity and in general, the 1/protect environment, local communities and the country at large by preventing or at least managing down the adverse effects of modified organisms to levels of insignificance; and 2/enhance access to and transfer of technologies, including modern biotechnology, that serve for conservation and sustainable use of biological diversity.” 5/ Article 5 of the Proclamation is deleted and replaced by the following new Article 5: “5. Advance Informed Agreement 1/ Without prejudice to the provision of Article 3 of the Proclamation no person may engage in any transaction destined for release of modified organism to the environment without obtaining an advance informed agreement from the Ministry. b wtin 126 DM hrC BRIV & 43 Ri% 997 Feder al Negarit Gazette No. 66, 14" August, 2015 ......pa 8.3‘1 g/ A0-T nmPa} oL Khal PooALP 2/ Any person who intends to engage in any ArPOPOT ATy L PI%4.N7 trans action destined for release of modified P¥E0® Ao MY APEST NhPE organism to the environment shall submit aow/l Nom- FRNLE AG to the Ministry an applicati on prepared in i i lamati d the avav P P aow PHNIE accordance with this Proclamation an MavARF ATLLNES TIPLA RO regulations and directives issued hereunder. £/ hpmin eovian, a1t ATy 3/ Any applicant intending to obtain an MEmge ROANT QY APE advance informed agreement shall comply a0t Qom-t 230 ne with the requirements set in the regulations aoavy ¢ PFPFaANETT PNLCAT and directives issued hereunder.” AT RANTn” %/ CAPR W& % AQh ATPR B AT PR 6/Articles 6 to 20 of the Proclamation are FhtATo- hA3P&R 4 AOh AIPR RS renumbered as Articles 7 to 21, respectively, and Vhar POLhdbAm RGO RIPR the following new Article 6 is added: I &N "%AR LI “6. Special Permit &/ TIFo9 Qo AR 4P ALOMor 1/ No person may engage in any contained PHY? AP P AIPaPa A LHLE use transaction without obtaining a special ALTAP: permit. g/ PN AP WIPAFA A LhLL 2/ Any person who intends to obtain a special PUUAT TP G- AR 4P permit for contained use transaction shall ATROma LUT APE ATINLAT submit an application to the Ministry in N%0om: L30T WG aoavlePF accordance with the regulations and aow/lt A0S LY N directives issued hereunder. PLA AANT P/ At 4.2 etama- TiFo 9 do- 3/ A person granted a special permit may not AP mPfad wf hAhan, AP release a modified organism into the PANTI°: environment. i/ 0N AmPPI° g°CIC P7LeNYLL 4/ Any person who is conducting research in WY Qo Lo PTIPE a contained use shall take all necessary ACPE Nva-de hAFPaFao- measures to completely avoid the risks that APMme POLTNTT mIET (o may arise from the transaction.” Mo AalT:" % SLLTIE LoD 126 oum krC EX WA E ¢4 BT 9o 813 Federal Negarit Gazette No. 66, 14" August, 2015 ......pe, 7/ ChPE Widb&x B (0TS MLV RIPR 300 AR (B) oowlt WiRHIIM0) twCh n°Lhtao: K40 A& B Arhkas “BAOT hfa? @f KAIC a-OT TN &/ D0 PR, AFPT @ LI° AR 4P ALTY ADT hfot 0L AIC @07 71010+ ¢-Fhaha o g/ eoomdde LFPLT ATIVTL PILPCA TJANT AL 4L WIE h2M Povien, AT ALAT RETAPon £/ hrmn eovian, a1 ATL0mo A“2L0E4 Moo\ hF eoLeeCN Y o9° Ao NAhao RIC V2 avOdT Ao-PS LA P T AANT: 9/ AR 4PL RILAT ALL0ES PoLPC “levADF o, Aho phéloe PAT wfat VT haae are oC Heen adid AANT" %/ PAPE WIPR 1% 100 KWiPR () (hPs MY AIPx 300 Ridk (B) oowlt WIRTAOWe) 100 AIPR (&) UT PoLhtam: A%O 700 RIPR (D) teng° i As Yo/ “LL0ES POLh AT PLav PSP 70 ARGANT AR 2P L LATA: V) ¢tmePaoy PCIC LUT RPE ATINEAT° 307§ el e P avwl AT POLLNLATY +RPTS ~CHET o LA me (1,41 Nom 7/ Article 9 of the Proclamation (as renumbered pursuant to sub-article (6) of this Article) is deleted and replaced by the following new Article 9: “9. Importation of Modified Organisms 1/ Importation of any modified organism without obtaining an advance informed agreement or a special permit is prohibited. 2/ An application for contained use is not subject to an advance informed agreement but to a special permit. 3/ A person who applies to the Ministry for an advance informed agreement shall have a recognition as the law of the exporting country authorizes the exporter to take such responsibility. 4/ An application for a special permit for the importation of a modified organism shall be accompanied by a statement signed by the foreign exporter indicating the identity of the modified organism.” 8/ sub-article (4) of Article 15 of the Proclamation (as renumbered pursuant to sub-article (6) of this Article) is renumbered as sub-article (5) and the following new sub-article (4) is added: “4/ The Ministry shall issue special permit to an applicant if: a) there are facilities and institutional systems required to conduct the specified research as per the regulations and directives issued pursuant to this Proclamation; — w EALIIR &L 126 oum drc ZF WA E 43 Rid 990 8314 Federal Negarit Gazette No. 66, 14" August, 2015 ......pag A) No-o-s of ARAN, e9LAPd et ) ReOAWE PCET AL téAle- NPT Paa- NPT AT ) L&Ay AP 0L of AIFETE ATl POLPNTA LLE@Y PP PR LC #CHT 20 ho” i/ PAPE ATPR TZ (RTS ANY AIPR 100 KPR (B) oowld RIRFGI0) Tl A°Lh-tae: A%.0 K32 1% HHhda “1%. h7H0 Pavyan NF°F°1 TS AR .38 0ta- POLER0T L B/ A@P mPa ATUL 6 L KhA, AFLAPP eHAm W0 o, AT ARAC %00 P0F LUTA: &/ AN AP+ PHOm AL 4L ARTPN GO0t 00T LUPTAR MrenF a%0Has eham AN Povien, AFPPYE AP oC P05 LUSA: 8/ AL i 0% KW AIRAPE PtébLa homin AT 0L AN AnPEP PrAMm AR 4L ALHT AL g0 \Plaor AFPrE 0L AL &5 0P 0OLEL0T L AILGUPAT 4L Prame- G0 ALOOANT LTANE FO0Fe T AT TAAG eham hrnn, eovian, A9 A LHTI° AT oC OPlo- Qi 03 POLBLOT L AFLENTNT 8.5 L eHAmar Ao A oAt LTAA: £/ Pavyn, b) the transaction is not destined for release to the environment; c) the has the qualification to conduct the research; and applicant required d) if standard operating procedures that prevent or minimize risks to the insignificant level are in place.” 9/ Article 17 of the Proclamation (as renumbered pursuant to -sub-article (6) of this Article) is deleted and replaced by the following new Article 17: “17.Validity Period of Advance Informed Agreement and Special Permit 1/ An advance informed agreement for commercial release of modified organism shall be valid for ten years. 2/ A special permit for contained use shall be valid for five years. 3/ An advance informed agreement for transit of modified organism shall be valid for three months. 4/ The authorized person may request for extension of the validity period of advance informed agreement for a commercial release or a special permit for contained use of modified organism one year before the expiry date of the validity period. S/ The authorized person may request for extension of the validity period of advance informed agreement for transit of modified organism one month before the expiry date of the validity period. w nreve LLod 12¢T onm hrc 21900 & ¢y BT 99 Federal Negarit Gazette No. 66, 14" August, 2015 .....pag %315 Y RIPE H00 AreR (8) aowlt MaeoAhF APCNAT AL h2pin, Pavyen.ar AP T RILEUT 0L9 PmIP 1Mo WHLhAN o9 (£ WHewe A o0 2TAaan" I/ PAPE AIPR RE (hT4 QMY ATPR P00 RIPR (F) opwlt WrRAIM0-) 700 AIPRT () AT (8) dwclo M°Lhtat Kh%0 700 AHRT (F) AS @) +thtPA: “£/ e1PP4h wobF o (LY AFPR H00 AR (8) oowldt 03 1tat Ao P afo MNUA wLoTT ARMAN, AT Nde- mS AL ehé m3P 077eahtTA ThTF 03 Vb P JAAO Ty 8/ “ULhES QY RIPR 00 ATER (8) owld +amCTE e tat 0P Gov-¢ (102440 VAP°OT Proe 5T oOT Ao-P hfar? “Thik} 0L9° ANTTEAT TP WAOT " 18/ hAPE RH4x & (€74 OV ATPR TN RIPR (B) oowlA WiRTOEar) +Po POLNTA® RS0 RTPR RE WS AT TongClo- 10CE RTPRT RET RE AS AT A% PR FhtATFa- Wito FOT RGT AS RE vro- AAIN1PA: "RE. LR PRVYrT VLT h7The hoet A%2LAT4 tme PP RS RUHE VLot (W7%eaht oot POLeTING NP PRUTIT VRO ATe DO 7L CT hE 0T 07%0M 2730 oWl LRETA:: 6/ The Ministry may, upon the receipt of an application pursuant to sub-article (4) of this Article, decide whether to extend the validity period of an advance informed agreement or to order the revision or the doing of the risk assessment.” 10/ sub-articles (3) and (4) of Article 21 of the Proclamation (as renumbered pursuant to sub article (6) of this Article) are deleted and replaced by the following new sub-articles (3) and (4): “3/ The custom’s officer shall store the modified organism impounded pursuant to sub-article (2) of this Article in an appropriate storage facility in such a manner that potential risks to biodiversity, the environment and human health are minimized. 4/ The Ministry shall, by examining the samples within five working days, verify whether the material impounded pursuant to sub-article (2) of this Article contains any modified organism or not.” 11/ the following new Article 22 and Article 23 are added after Article 21 of the Proclamation (as renumbered pursuant to sub-article (6) of this Article) and the existing Articles 21, 22 and 23 are re-numbered as Articles 24, 25 and 26 respectively: "22. National BioSafety Advisory Committee A National Biosafety Advisory Committee, accountable to the Minister shall be established by regulation to be issued by the Council of Ministers. AALEIR Lt 126t onm drc B WA T 43 Rif 9. Federal Negarit Gazette No. 66, 14" August, 2015 .....page °'° AT.00%6 hbe-adl &/ MY APE aowlt (710 AL Praow it AP 0L AL LFL ANUFT oL 0%t POLBLNTT UL ATILNG® PPLNT NwANF o LP N1LLT 0L aFzekT oL AL LPR AL L9 Aewli (HOm @43 AL PLT LA “TIT 09 oAz ON+am 035 ¢5T 00T N°22.0k4 AtREod Pod A7 ho%t oot Wi LTAA: g€/ My RiPx 00 AIPR (8) tedro P2 120 o-0T hhdo nae ary onieT eredad MaphF afpdcn LFaFa D9 Ao+ WA 1AL P10 oh3et to1f 01 ¢5T o0 YooahFa-? ALPLCAN LTAAR £/ %62 O%%L h9Uk@- AQAT AT ARLEBET LUT APE ATINLAP N°%om- L7I0F KG avavl e aw/lt LOAT AN 8/ P62 A% h9Uto- (Y ATPR 300 AR (&) aow ot PLLNATT P OCIC o-mold ha-dy 740 2C (G e~¢ 5T NP A0S PLCAAN & MY RIPR 00 AR (B) aoow/ld N°ULATE ehAm oAR? 0°%2avaht 0h? AHeAt9° hwtt PC AT AovANT @Aker (+Am 0% 6 00T AbfeA hGHE KCL MT LI0VF 71PN LTAAN" 23.Grievance Handling 1/ Any person aggrieved by the rejection of an application submitted in accordance with this Proclamation for the issuance or extension of the validity period of an advance informed agreement or special permit, or the suspension or revocation of the agreement or the special permit may, within 45 days from the date of such decision, lodge his complaint with the Grievance Hearing Committee established by the Ministry. 2/ Any person who cannot submit his complaint in accordance with sub-article (1) of this Article due to force majeure may submit his application within 10 days after the end of the force majeure. 3/ The grievance handling committee members and their composition shall be determined by the regulations and directives issued pursuant to this Proclamation. 4/ The grievance handling committee shall up on examining the compliant submitted to it pursuant to sub-article (1) of this Article provide its findings and recommendation to the Minister within five working days. 5/ An applicant aggrieved by the decision of the Minister given under sub-article (4) of this Article may, with respect to error of interpretation of law, appeal to the Federal High Court within 60 days from the date of the decision.” ELRIE 8317 % &flh 126t onm wrc ZF WA X +3 RAA 99 Federal Negarit Gazette No 66, 14" August, 2015 ... page EAPE 720907 L 3. Effective Date LV APE (N&LeEA 1946 200 3P This Proclamation shall enter into force on the hoM0+ ¢7 £9°C P05 LUPTA: date of publication in the Federal Negarit Gazette. A%0 K00 Yh0 E 7 807 9.9° Done at Addis Ababa, this 14" day of August, 2015. MULATU TESHOME (DR.) A&/C ov-ag: tiiav PRESIDENT OF THE FEDERAL DEMOCRATIC PATERE L RGAR LTRENLE TN REPUBLIC OF ETHIOPIA ToHAD