National Biotechnology Authority (Agricultural Biotechnology Products) Regulations, 2018 (S.I. 160 of 2018)

Statutory Instnnrent 160 of 2018. ICAP.14:31 National Biotechnology Authority (Agricultural Biotechnology hoducts) Regulations, 2018 IT is hercby noffied that the Minister of Higher and Tertiary Blucatiou, Science and Technology Development has, itr tetms of section 59 of the National Biotechnology Authority Act lChapter 14:3ll and after consultation with theAurhority, made the followlng O regulations: ARRANGEMENT OF SECTIONS PARTI hu,nr,m.nnv Section 1. Title. 2. InGrpretation. 3. Purposes. 4. Applications. PART U Tnnr. euo Cor.a,m.<ral Rgtasp or Brormru-rm., BrorrsflcroEs AI.ro Brosrs{ulA}vrs, Tncriluclt- Colrmarrrp 5. Technical committee. 6. Functioncornmittee. PART III Arpucerrou m. Rnssn&cf,roN To It'oonr, F,xponr, Com,renctnlup on Cnnrv our a Tnral Rsrnse or BromruzER, Btorestlcoss AND Brostnaur.arvrs 7 Apdication for registration, 8. Gxant orrefireal forissuance. 9. Validity and renewal. National Biotechnology Authority (Agricultural Biotechnology Products) Regulations, 2018 PART IV Am,rcarrow non Brosarsry hupoxr PERlrm Section 10. Application. 11, Grant or refusal for issuance. 12. Validity and renewal. PARTV GMO Drcr-anenotAND oRGMO CkFrcArEsK)R Beoxrs 13. Application. 14. Grant or refusal for issuance. 15. Validity and ngnewal. PART VI Bros,cFE'rY TMNSTT PERr\,trr 16. Application. 17. Authorization of GM products. 18. Transiting GM products. PARTVII TnLqL REt-EAsu .\ 19. Application. v 20. Review of application. 21. Appoval. 22. Monitoring. PART VItr Cotuvm.cmr Rrrgsr 23. Application. tw {\\ f S.I. 160 of 2018 ^-\ Section 24. Review of application. a5. Approval. 26. Monitoring. PAR| D( Ntscenaxpous 27. Monitoring for compliance and keeping of register. 28. Appeals. 29. Review of decision. 30. Registration of decisions with the National BCH. 31. Confldential Information. 32. Offences and penalties. Fm.sr Scrn'nulp; Fees. Spcoxo ScnmuLe: Forms. PAR| I PnsulrNanv Title 1. These regulations may be cited as the National Biotechnology A Authority(AgriculturalBiotechnologyProducts)Regulations, 2018. Interpretation 2. In these regulations "Agricultural Biotechuology Products (ABPs)" tueaus arry product which contains living organisms and/or components thereof which, when applied to seeds, plant srufaces, or soil; promotes growth by increasing the supply or availability of nutrients to the host plant, or controls plalt diseases, insect pests and weeds; "Authorig," means the National Biotechnology Authority; 1845 a l National Biotechnoiogy Autlrority (Agricultural Biotechnology Products) Re gulations, 2018 "biofertilizers" means a substance which contains living microorganisms which, when applied to seed, plant surfaces, or soil, colonizes the rhizosphere orthe interior of the plant and promotes grorvth by increasing the supply or availabilitl,ofnutrients to the host plant: "biofungicide" means a substauce rvhich contains naturally occurring organisms and/or their by-products that can be employed for the conlrol of pathogenic ftingi; "bioherbicides"m eans preparations made up ofmicroorganisms such as bacteria, viruses, fungi and certain insects such as parasitic wasps, painted lady butterfly that can target specific weeds, "bioinsecticides" means nahually crccurring organisms, or their by-products'that can be employed for the control of insect pests; "biopesticides" means biological preparations of predatory, parasitic organisms, or their pesticidal substances for pest(weeds, insects, diseases) control. Viruses, bacteria, protozoa, f'ungi, and mites and certain plants may be used as bio-pesticides; "biosafety" means measures that need to be taken up for the preveltionof large-scale loss of biological integritl,, rvith a primary lbcus on both ecology and humal health or the contai nrn ent pririciples, teclrnologies and practice s that are implemented to prevent ttrrintentional exposure to pathogens atd toxins, or their accidental release in the environment, "Biosafety Clearing House (BCII)" means a mechanism set up by the Cartagena Protocol ou Biosafet5, to the Convention on Biological Diversitl, to facilitate the exchange of information onLiving Modffied Organisms (LMOs) and assistthe parties to better comply withtheir obligations under the Protocol; "biostirnulant' means any biologicalibiologically derived substance(s) whose function when applied to plants or the rhizosphere is to stimulate natural processes to 1846 ,.\ ,-\ S.I. 160 of 2018 enhance nutrient uptake, nutrient efficiency, tolerance to abiotic stress and crop quality; "biotechnology" means any technique that uses living organisms or parts of organisms 1o make or modify products, to improve plants or anirnals, or to develop micro-organisms for specifi c purposes ; "export" means to send agricultural biotechnology products out of Zirnbabrve; "genetically urodifled organism" (GMO) means an olganism the genes or genetic material of whichhave been modified in a way that does not occul naturally through rnating or natrual recombinatiouorboth, and' genetic modifi cation' shall have a corresponding meaning; "GMO declaration or certifi cate" means an official docunrent stating the GMO status of a product; "Institutional Biosafety Committee (IBC)" rneans a biosafety comurittee established in tenns of section 30 of the National B iotechnology Authority Act [C hapt e r I 4 : 3 1l; "im1xlrt" means to bring agricultural biotechnology products into Zimbabwe; "medical biologics" means a medical product which is produced from an organisrn e.g. animals, humans, microorganisms and marnql2linl cells and are used in the treatment, prevention or diagnosis of diseases and other rnedical conditions; "microorgauism" means bacteria, viluses,fungi, mycoplasma, cell lines, algae, protozoans and nematodes; "nanobiotechnology" means any of several forms of biotechnology employing devices at nano scale; "pest'' meals any organism or like agerrt wbatsoever, including a virus, which is iniu'rical to the growth or existence of living plants or injurious to plant products or capable of producing a disease of plants in whatever stage of development it may be; "product" means agricultural biotechnology product; LUl National Biotechnology Authority (Aglicultural Biotechnology hoducts) Regulations, 2018 "synthetic biology" (synbio) the design and construction of new biological parts, devices, and systems, or the re designof existing, natural biological systems for rseful purposes. "transit" ureatrs to uansport agricultural biotechnologl, prodtrcts via Zimbabwe; "veterinary biologics" means viruses, serums, torins, or analogous prcducts ofnatural or synthetic origin rvhrch are intended for use in the management, diagnosis, preveilion and treatment of animals. Purpose 3. The pruposes of these regulations pffsuantto section 59 of the Act are to (a) regulate the import, export, transit, handling, use aud application of biofertilizers biopesticides (bioinsecticides, biofungicides and bioherbicides) and biostimulants; (b) monitor and manage the risks associated with the use of biofertilizers, biopesticides and biostimulants; (c) provide mechanisms for edorcement of obligations arisilg out of the use of biofertilizers, biopesticides and biostimulants in a bid to prctect the environment, animal ald humans whilst enhancing food production with reduced chemical input usage. Applicatiotz 4. (1) These regulations shall apply to all biofertilizers, biopesticides and biostimulants for import, export, transit, trial and commercial release and any other purposes in Zimbabwe. (2) These regulations shall not apply to food or feed or food and feed additives, veterinary biologics, synthetic biology products. nauobiotechnology products, medical biologics and biotechnology products used in the fcrcd industries. .+\ 1848 I S.L 160 of 2018 PAKT II Tnrer- aNo Colaumqer RrLeAse oE Brosnru:zBns, BropESTrcrDES AND BIOSD\,{LI-ANTS Technical comnittee 5. ( 1 ) The Authority shall establish an al ftoc techrri cal comrnittee which shall consist of at leasttlree members appointed bytheAuthority. (2) Selectionof committee members shall be basedon expertise required for a given application (3) Appointed members can be part of more than one ad hoc technical committee. (4) This comrnittee shall be appointed for every specific application and it shall handle all matters relating to such application. Functiott of comnittee 6. The general function of the committee shall be to advise the Artrhority on all aspects concerning the use of biof'ertilizers, biopesticides and biostimulants in agriculture and reconmend commercialization or trial studies. PART III Appuc.rnoN ron R.gclsrp,uroN ro Lvponr, Bcoxr, Com,rmcmu;n oR C.q.nny orr Tnrar Rrt.rase op Bromrtrr-rzm.s, BIoeEsncrDES AND Brosrrvur-tr.rrs Applic atio n Jbr re gi s tr ati o n 7. ( 1 ) No person shall im port, e xport, commercialize or cany out a trial release of biofertilizers, biopesticides and biostimulants without a registration certificate Form I'BP 2 issued by the Authority. (2) An application for registration shall be made to the Authority in Form ABP1 and shall be accompanied by all the nec€ssary attachrnents as specif,ed in the cunent guidelines and the appropriate fee prescribed in the First Schedule. t&l,9 National Biotechnology Authority (Agricultural Biotechnology Products) Re gulations, 20 I 8 Grant or refinal for issuance 8. The Authority shall consider an application for registration within 72 houn and rnay -(a) approve the application; (b) contact the applicant requesting for further documents or information before granting the certificate; (c) reject the application giving reasons for refusal in writi,g: rvsDv^ avr rerusq r! Provided that where an application is rejected or granted with conditions theAuthority shall infonn the applicant of his or her right of appeal under section 28. Validity and renewal 9. (1) A registration certificate issued in terms of section 8 shall be valid for a period of one calendar year and may be renerved annually thereafter. (2) A person shall apply for the renewal ofthe registration certificate issued in terms of section 8 at least one month before the expiry ofthe issued certificate. (3) An application for the renewal of a certiflcate issued in te rm s of s e ction 8 shall contain in addition to all the accompanying documeuts required for the initial registration (a) a copy ofthe expired certificate; (b) a proposal for amending or complementing the conditions of the original approval (in case of new ,^ products); (c) fee prescribed in the First Schedule; (4) The Authority shall consider an application for renewal within two rveeks of receiving the application and may (a) approve the application; or (b) approve the application with conditions; or (c) reject the application stating the reasons for rejection in writing;or (d) notify the clientif furtherdocuments are required. 1850 I I S.I. 160 of 2018 Part IV ApprrcaloN ron Brosar,gry Illpoxr Pmr'rr Application 10. (1) No person shall import biofertilizers, biopesticides or, biostimulants without an import permit Form ABP4 issued by the Authority. (2) An application for an import permit shall be made to the Authority as in FonnAts P3 and shall be accompanied by an application fee as prescribed in the First Schedule. (3) In c onsidering an application for a biosafety import permit. the Authority shall require the applicant's letter to (a) have company logo, physical and postal addresses aud telephone numbers; (b) have original author's signature, be dated aud bear company's offi cial stamp; (c) specify type and quautity ofproductto be irnported; (d) specify couutry of origin and port through which the consignment is to enter Zimbabrve; (e) include a GMO declaration/G}'zlO Certificate which shall meet the following (i) be on origiual letterhead, be.ar physical and postal addresses and telephone numbers of the testing laboratory; (ii) be issued by a testing laboratory accredited to a competent authority in the country in u,hich the testing facilities are located; (iii) hai,e original signatule ofthe person in charge of the testing facilities, dated and officially stamped; (iv) bear a certificate number; (v) state name and address of the importing orgauisation; r851 National B iotechnology Authority (A gricultural Biotechnology Products) Regulations, 201 8 (v i) state the type, v ariety/brand and quantity sampl ed; (vii) state place of samplirg, .sampling method and quantity of source material; (viii) date of testing of not more than three months and the random sampling procedure; (ix) provide clear specifications ofthe PCR analysis including : sample number, PCR Cycles, Limit of Detection (rvhich shouldbe not rnore than 0.O2Vo). (a) The Authority may prescribe a pre-shipment inspection prior to importation in order to gather more information on the exact nature of the ploduct including production, GM status, quality a-nd storage ofthe product andraw materials; this rvill be done as prescribed inFolnABP5. Grant or refusal for issuance 11. The Authority shall consider an application for a permit within 72 hours and may (a) approve the application with no special conditions, or (b) approve the application with conditions for example, a post-shipment inspection as in FormABP6; or (c) contact the applicant requesting further documents or information before granting the permit: Provided that rvhere an application is rejected or granted with conditions theAuthority shall infonn the applicant of his or her right of appeal under section 28. Validity and renetval i2. (1) A permit granted in terurs of section 11 shall be valid for a period of three months from the date of its issue and may be renerved if it expires before all the stated quantities have been imported. (2) If a product fails to reach the country within the designated date on the permit, an application for renewal of the permit shall be subrnitted two weeks before the expiry date. t852 S.I. 160 of 2018 (3)An applicationforrenewal of apernritinterms of subsection (2) shall be done ouly once aud shall (a) contain all the docuruents required for the iuitial application; (b) copy of the expired permit; (c) provide official evidence from the customs authority r,vith received and outstanding quantities of the product for nhich a renewal of the permit is being souglrt. (4) The Authority shali consider au application for renewal within 72 hours of receiving the application and may (a) approve the applicatior1 or (b) approve the application with conditions; or (c) reject the application stating the reasons for rejection inwnting. PART V GMO Dscr-aretroNs AND GVIO CsRTInCATES FoR Erponrs Applicatiott 13. (1) No person shall export biofertilizers, biopesticides, biostimulants without complying with exportation rules as provided for in this section. (2) An application to ex1rcrt shall be submitted to theAuthorif as in Form ABPT and shall be accompanied by, an applicatiol fee prescribed in the First Schedule and shall meet the following (a) have a company logo, physical and postal acldresses and telephone nurnbers; (b) have original author's signature, be dated and bear conpany's official stamp; (c) specify type and quantity ofproduct to be exported; (d) state the method by rvhich the product was produced; (e) state mode of transport and containrneut measures to be taken during transpofiation; 1853 National Biotechnology Authority (Agricultural Biotechnology Products) Regulations, 2018 (0 state the country the consignment is to be received and portthrough which corsignment is to leave Zimbabwe. Grant or refiisal for issltance 14. The Authority shail consider au application for a GMO declaration and/ or GIviO certificate within 72 hours and uray (a) issueaGMO declarationFormABll8orGMO certiflcate Fonn ABPS or both as the case maybe; or \ (b) refuse to grant a GIvIO certificate or declaration; or (c) contact the applicant requesting further documents or information before making a decision on granting the GMO certiflcate or declaration. (d) notify the applicant if the test to be employed requires more time: Provided that rvhere an application is rejected or granted with couditions theAuthority shall inform the applicant of his or her right of appeal under section 28. Validitl andrenewal 15. (1) A GMO declaration or certi-0cate granted under these regulations, shall be valid for a period of three months from the date of its issue and may be renes,ed if it expires before the stated quantities have been exported. (2)At least two weeks before the expiry ofthe permit, a person can apply for the reneulal of the GMO declaration or certiflcate. .G\ (3) An application for renerval of a GIvIO declaration or certiflcate issued under these regulations shall (a) contain all the documents required for the initial application; (b) contail a copy of the expired GMO declaration or certiflcate, (c) provide official evidence from the customs authority with received and outstanding quantities ofthe product for lvhich a renerval of the permit is being sought. 1854 A\ , S.I. 160 of 2018 (4)'Ihe Autlnrity shall consider au application tbr reneu,al within 72 hours of receiving the application arrd may (a) issue a GIvIO declaration or certificate, (b) refuse to grant a GMO declaration or cefiiflcate; or (c) contactthe applicantrequesting further documents or infonnation before makitg a decisiou on granting the permlt. PART VI Brosare-ry Tn cNsrr hntal' Application 1 6. ( 1 ) No person shall transit agricultural biotechnology products across Zimbabwe rvithout a biosafety transit pernit, Fonn ABPl2 issued by the Authority. (2) An application for a biosafety transit perrnit shall be made in Form ABPl1 as highlighted in Form ABP1O and should be accompauied by appropriate transit application fee prescribed in the First Schedule, a copy of the import permit issued by the receiviug country indicating quantity and GIvIO status of the product. (3) Consiglnents passing tluough Zimbabwe will be inspected at ports of entry and exit. (4) Transportation of agricultural biotechnology products within Zimbabwean borders requires thatthe products be appropriately packaged and transported in accordance rvith applicable International standards e.g. IAIA PI 602, IAIA iP 650 depending on tlre nature of the consigmrent Autlrcrisation of GM products 17. In the event of trausit of GMOs or GIvIO products the Authority (a) shall restrict accesses to the consignmeut until set protocols are observed; and (b) shall set conditions for such transit: and 1855 National Biotechnrlogy Authority (Agricultural Biotechnology Products) Regulations, 20 1 g (c) requir signment to meet any costincurr and supervised transit as set on ermit. Transiting GM prcducts . . 1 8. (1) A person trausiting G\4Os or GMO products shall at the exiting port, provide a copy of the approval granted by the A;flrority. (2) An approval to transit shall inclucle (a) conditions issued byAuthority as per the ccnsignment; (b) a statement that trre shipment meets transit conditions under these regulations. (3) Ievant regulatorl, agencies to port of "it.y *i exit is consi PART VII Txrar RneA.ss AytplicationJor a trial release perndt L9. (l) No person shall carry out potentially harmful research or undertake the contained use or trial release of biofertilizers, biopesticides, and biostimulants without a valid permit issued by the Authority. (3) The Authority may issue an alternative version of Form AB15 depending on the nature of the agricultural biotechnology product. Revie+y of application 20. (L) Upon receiving an application, the Authority shall ^\ 1856 S.I. 160 of 2018 (a) screen the application for completeness; (b) assess all attachments; (c) carry out safety assessments; (d) carry outcouf,rmatory tests or validate rnethods proposed by the appliczurt; (e) request for furtherdocuments or infonnation ifnecessary l (2)An applicant may (a) refer to data or results from previonsll, published articles; (b) submit additional information that the applicant considers relevant. Approval 21. O) The Authority shall communicate its firral decision withinX) days of receipt of the applicationrvhichcouldleadto (a) granting of a permit, Form ABP16; or (b) refusal; or (c) granting of a permit with special conditions. (2)Where theAuthority, after ariskassessrnent, considers that it is necessary for tlrc proposedprodtrct to be subjected to contained, isolated or quarantined use, the Authority shall comnaunicate its decision to the applicant in rvritiug and relevant provisions shall apply. (3)The Authority uray opt not to supervise trial release where it feels sufficient experience or information exists to conclude that the environrnental release of a proposedplrduct does not pose significant harm to the environment. (4)Where information i s available that an approved activity poses risk to human health, auimals or the environment, the Authority may amend or revoke the approval. 1857 National B iotechnolo gy Authority (Agricultural B iotechnolo gy Products) Regulations, 20 18 Monitoring 22. (l) Aperson issued with a pernrit under these regulations together rvith tlre relevant IBC shall carry out periodic monitoring of the trial release and submit reports to the Authority. (2) The Authority shall ensure tlnt all appropriate measures are taken to avoid adverse effects on the health of humans, animal aud the environment, which might arise from the release of any agricultural biotechnology product. (3) In the event of a release of any agricultural biotechnology product forwhich no approval rvas granted, the Authority shall eusure that (a) necessar), measrues are taken to terminate the triai release of such products; (b) remedial action is taken, if necessary; in case of unintentional release; (c) the pubtic is informed and appropriately advised of such release. PART VIII Col,nr,mncnr Rr.Lsasg Application 23. (l) No person shall place on the uralket; biofertilizers, biopesticides or biostimulants without a valid Product registration cerlificate Form ABP17 issued by the Authority. (2) An application for a product registration certificate for biofertilizers, biopesticides or biostimulants shall be made to the Authority inFormABP14 and shal I be accompaliedby all the necesMrli' 411ashnrentS including Form ABP15 as provided for in Form ABP13 and the application fee prescribed in the First Schedule. (3) TheAuthority may issue analternative versionofForm ABP15 depending on the nature of the agricultural biotechnology product. 1858 A\ ^\ S.i. l60 of 2018 Review of application ?A.Upot receiving an application, the Auflrority shall (a) screen the application for completeness; (b) assess all attachments; (c) cauy out safety assessments; (d) carry outconfi rmatorytests or validate methods proposecl by the applicant; (e) request for further documents or information. Approval 25. The Authority shall cornmuricate its f,nal decision witrrin 120 days of receipt of tn" uppfi*ti"" *nitn couta lead to (a) granting of a pernit; or (b) refusal to gralrt a permit; or (c) granting vvith special monitoring conditions required. A4ottitoring PART D( Irftscrr-urvpous Mottitoring for compliance and keeping of register oJ contpliance ise with otherrelevant Govenunent any imported/exported/transited ducts for compliance with the (2) TheA*thority shalr maintain a register, rvhich shall contai:r a1l applications made to, and decisio,s rnade by, theA.thority *nda. these regulations. 1859 National Biotechnology Authority (Agricultural Biotechnology Products) Regulations, 201 8 Appeals 28. ( 1 ) Any person who is ag grieved by a decision of theAuthority may appeal to the Board with the prescribed fee within 14 working days from the date he or she is notif,ed ofthe decision. (2) Subject to subsection (3), the period betrveen the lodging of the appeal in terms of subsection (1) and its determination shall not exceed 30 days, and ifthe appeal has not been determined after that period it shall be deemed (except in the case of an appeal against the rejection of an application for a permit or conditional $anting or suspension or cancellation of a pernit) to have been determined in favour of tire appellant. (3) The Board may before deciding an appeal request the appellant to make such further written submissions or supply such further information as he or she considers will be of assistance in determining ttre appeal, in which event the thirty day period referred to in subsection (2) shall be extended by a further period so that the appeal ruay be determined on a date no later than 60 days from the date rvhen the appeal was lodged. ( ) On an appeal underthis section, the Board may confirm, vary or set aside the decision or action appealed against. (5) Upon making its determination, the Board shall notify the appellant and the,A.uthority stating its reasons for the determination. (6) If the determination is favourable to the appellant the Authority shall within seven working days from the date of such notif.cation, grant to the appellant the permit in question. (? For the avoidance of doubt it is cleclared that where (a) an appeliant whose application for a permit has been rejected or whose permit is granted conditionally or whose permit has been suspended or cancelled; and (b) the appeal has not been determined timeously in accordance with subsectiou (2); such appellant has aright undertheAdministrative JusticeAct IC hapter lO:28) to apply to the High Court to compel the appellate authority 1860 A ,A {. A\ ^^\ S.I. 160 of 2018 to furnish reasons why the determination of his or her appeal has not been made timeously and for such other relief that the High Court may grart urder thatAct. Review of decisions Z9.Where the Authority or a person granted an approval uuder these regulations considers that (a) a change incircumstiances has occuredthatmay infl ueuce the approval or the conditions issued urder the approval; ot (b) additional relevant scientific 61 lgshnical informatiol has become available, the Authority may on its own volition or on the request of the person granted the appro'val, reyiew its decision. Registration of decisions with the Biosafetl Clearing Ilouse (BCH) 30. TheAuthority shall register all decisions pertaining to GIVIOs or GM products made under these regulations on the BCII. C o nfi dential inJonn a.tio n 31. (1) An applicant may indicate the inforrnation in the application which should be treated as confidential aud shall give verifiable justification for such indication. (2) The Authorit"v shall make a decision on the applicatron made in terms of subsection (1) after consultation with the applicant and the Authority shall cornrnunicate its decision in rvriting to the applicant. (3) The Authority shall not disclose to a third palty any informatiou considered to be confidential and shall respect the intellectual properry- rights related to the information received. (4) The Authority shall not treat or consider the following iufonnation as confi dential (a) the name of the applicant's organisation; (b) addrcss of the applicant's organisation; 1851 t National Biotechnology Authority (Agricultural Biotechnology Products) Re gulations, 20 18 (c) name of contact Pemon; (d) e-mail address, telephone and fax number of contact person; (e) name of the agricultural biotecbnology product to be released; (0 location and size of planned introduction; (g) pu4)ose of plamed introduction; -\ (5) Where the applicant withdraws an application made in \2 terms of this section, the Authority shall respct the confidentiality of the information declared. Offences and penalties 32. Arry person who violates the provisions of sections 7(1), 10(1), 13(1), 1q1), 19(1), 23(1) commits an offence and is liable to a fine not exceeding level 12orto imprisonment not exceeding five years or to both such fine and such imprisonment. Rnsr ScHsDur-E (Sectiow 7,9,10,13, 16, l9 CId23) FEES Sectinn Description Form Fees $US 7(2) Application for registration ABPl 500 ro(2) Application for a biosafety import permit ABFT} t 0OO MT/m3 or lrss 30 1001 MT/m3 - 5 000 MT/m3 q 5 001 MT/m3 - 10 000 MT/m3 50 l0 001 MT/m3 - 15 0OO MT/m3 @ Above 15 000 MT/m3 80 Additional cost for emersencv oermits 20 Permit renewal Fee for new oemrit Amendment of permit 10 t862 a .-----&-.--- + a S.I. 160 of 20tr8 Key Assumptions lm3 = 1000 litres 1kg = | 1i1," 1MT = 1000k. lMT = 11143 =1 000kC =10@litres (a) Sample collection fees exclude accommodation and meals. In the case that the inspectors nray need to sleep for any number of days, the cost will be borne by the clienl (b) The number of inspections r.vill be agreed depending on duration of tr,ial release and the nature of the producl 1863 Sectinn Description Form Fees $US Inspection lee per truck 20 r3(1) Application for biosalety export permit GMO declaration certifi cate r\BP7 100 L3(2) GMO Testing fee per sample 2fi t6(2) Application for biosafety transit permit ABP] I 20 Inspection: Human Expertise fee per inspector per day 50 Transporl Clients r.r,ill meet transport costs and these will be charged using the prevailing Automobile Association of Zimbabwe rates t National Biotechnology Authority (Agricultural Biotechnology Prodtrcts) Regulations, 20 1 8 Srcoxo Scseout: FORMS 21, Prircess Drive, Nervlands P. O. Box CY379, Harare. Tel: +263 4.78285619 Ermit nba@nba.ac.zw Website: www-nba.ac.zw TITLE: Application for certificate of registration of institutions involved in biotechnologr research and applications rcgulated under the NBA Act ICHAPTER 14:311of 20f,6. NOTE: This registrationJormis applicable to those institurions andindividuals rtho wish import, export, carry out trial release, conunercialize, and use BioJertilizers, Biopestides ond Biostimulants. TO: The Chief Executive Officer and Registrar National Biotechnology Authority Address I hereby apply to be recogrised as a registered organisation in accordance with the National Biotechnology Authority Act: l (a) Name of organi sation: ...................... (b) Organisation's registration No. (Plmse enclose cenified copics of your cefiifrcate of incorpomtion, CRl4rtar clearance cerlificate and company profile) ZIMBABWE LgA t I S.L 150 of 2018 ABPl 21, Prinms Drive, Newlm& P, O, Box CY3?9, Ilanre. "Iel: +?53 41W85619 Bnail: rba@nba.ac.m W-ebsito: wwsnbaac,zsr (c) Physieal address:. (d) Postal ddress (e) Telephone Number:... Fax Nurnber: E-mail address: (h) If is desired for only a part of the organisation to be registered, clear identification, includingphysicallocation, ofihatpartis:.................... (o G) a (a) If the applying is par t of a group or subsidiary of a holding cornpany, the narne of that group of company. 1865 National Biotechnology Authority (Agricultural Biotechnology Products) Re gulations, 20 18 21, Prircess Drive , Newlands P. O. Box CY379, Ilrre. Tel: +263478)35619 Enail: nba@nbaac.zw Wcbsite: wv.nba.ac.zw ABPl If the applying organisation is controlled by orassociated with aforeign company, the name and address of that group of holding company. 3. (a) Number of enployees: (b) \Vorkinghoursfrom:..... ...to:................ (c) Indicate shifts q,here appticable:...... 4. (a) Name and title of the head of organisation: .-.................... (b) Name and title of the organisation representatrve: ................. (c) What are the intended biotechnology researches and/ applications? (d) Are the1, sm.1l or large - scale operations? (b) 1866 ZIN,IBABWE ilA S.I. 160 of 2018 21, Princess Drive, Newlan& P. O. Box CY379, Harare. "lel: +?i3 478?3fi19 Emeil: nba@nbaac.zw Websitq ww,nbarc.zw ABPl a a 6. Should the National BiotechnologyAuthority have any queries in connection with this application, the person to contact is. Signed: Position wi thin the applyin g organisation:... Verified by the CEO: ... Signature: 1867 ZIMBABWE I National Bioteclrnology Authority (Agricultural Biotechnology Products) Re gulations, 20 1 8 ABP2 sIi\fu .Hltrr-vLvn'F*ctn AND ^t:Gffin, uB. iYh?T.ir" A hli lB Bir.drmlgy &BLly, kadt A 0oElwr.ol Q*trf.cate oJ <fQgistratiorl *o ooo.,xxm il.Md Mxnnotqy Astffiy Act l6q ta:ru CERTIFICATE NUMBf,RI ' \B:\'RI\.(X),OO OO THE NATIONAL BIOTECTINOLOGY AUI HOR! rY HEREBY GRANIS I Or CO}iPANY XYZ C$MPANY ADDRFSS (HLntAt-l[R(-itILl)'ltl[Rl'(-;ttlERt-t)t){$fl]IItO\rIil Ri(;tn''tOCi\Rl(Y (lt11 \toRK lNVOl.\!\\(; BIOTL:(IINOL()(|\ RISL,\I{CII A\l) ,,\l,l'Ll(;\Il(.)S IN AC('(-')ROr\\(1 $/flll 1-lll: PRQllSl()tS tr, 'llll" \r\'l'lf)\dl 0tcr[rot\oto(i- Aut'iERIf] J.-t l(Itit' r+.ltt t)t, 2@1,. pRQI)(lCtS PRO tA), usE) OR Appl-rfiD nY -t1[: R]-Cts-I]RtD tNsl cFs StiAt t l)[ otltxED .{-r oR mou o^!rr' t, Itj ttatiofial Biotedmhgy tudrori$ 2l Pn#E$tiiE !64{d{ li{e TeL +253 4 ?&[67, r2cl ,t ,8n 16, +iI3 i ,82i5a/g E!.1l6.G&ad a ffiJt ail 1868 S.I. 160 of 2018 ABP3 21, Princees Drive, Newlaods P. O. Box CY3/9,Ilararc. Telt +%3 418)35619 Frnail: nba@nha.ac.zw Website: w.nba.ac.zw ATTENTION TO ALL IMPOR.TERS OF AGRICULTURAL BIOTFCHNOLOGY PRODUCTS SF'CTION A The National Biotechnology Authority would like to highlight the following procedures to be adhered to by importers when submitting applications for authority to import agricultural biotechnology products. Any organisation seeking authority from the NBA to import agricultural biotechnologyproducts into Zimbabwe should meetthefollowingrequirements: 1- Firs( the organisation must be registered with NBA and its certificate o[ registration should be valid. To register the organisation must provide the [ollowing documents: Completed CompLny Registration Form CR14 Certificateofincorporation Company profile ZIMRA tax clearance Registrationfee Complete and submit Section B. On submission of the application it must following: be accompanied with the A GM certiflc.ate or declaration from acompetent authority (e.g. NBA in Zmbabwe) in the country of origin 1859 o 3. t* 4* National Biotechnology Authority (Agricultural Biotechnology Products) Re gulations, 20 1 8 ABP3 21, Princess Drive, Nlewlmds P, O.BoxCY379, Hare. Tel: +263 4 78285619 Email: nba@nba.ac.zw Xrebsite: m.nba.ac.zw The GMO certificate must meet the follorving requirements: Be on original letterhead of the laboratory conductingthe test. The letterhead should have the logo, physical and postal addresses and telephone numbers. The testing laboratory should be accredited to a competent authority in the country in which the testing facilities are located. Have the original signature of the person responsible for the testing facilities. Bear the olficial stamp o[ the testing instinrte. The date of te$ing must not be more thau tluree months old. State the date of testing of the prodtrct and date of issue of the certiflcate. Bear the certificate number. State the name and address of the importing organization. Provide clear description of the sample i.e. type, variety, quantity. State the place of sampling, sampling method and quantity of source material. Please note that sampling must be done by the testing laboratory and this should be indicated on the GMO certifcate, hovide clear specif,cations o[ the PCR analysis including: sample number, PCR Cycles, Limit of Detection (which should be not more thaln O.OZVo). Please note that only the PCR method of analysis should be used. hovide the test result and interpretation. Make a declaration/statement about the testing laboratory facilities and procedures. Only GMO declarations issued by the biosafety offi ce of the government in the country of origin of the consignment rvill be accepted. 1870 +. ZIVII]ABWE S.L 160 of 2018 21, Princcos Drivo, Nowlao& P. O.BoxCY379,grrrc. T&,+2r'i347828fil9 fuiftila@aac-zw Webrita *vwobaac.z* SF-CTIONR TITLE: Applicado fora Biocafety ImportPemft InAccordance with the Natbual Biotechnologl Authority Act [Cluphr 14 :3 Il Part I; Nature of Appllcant We/I haeby apply for a Biosafety Import Permit in accordance with the Natioal Bidechoolory Authority Act Seled Appropiate Ca@ory: Individual O Organisation O Compony D Fart II: Applienfs Particulars Reqisterpd Narne NBA Certificate of Reeistatim Number PhysicalAddrees EmailAd&ees PtroneNumber ZIMBABWE lgTl National Biotechnology Authority (Agricultural Biotechnology Products) Regulations, 201 8 ABP3 21, Princess Drive, Newlands P. O. Box CY379, IIam. Tel: +263 4 78285d9 Ernail uta@nhaac.zw Website wm,.nba.ac.zw ^ Part III: APPLYING FORr Please tick the appropriate box New C Extension O Replacenrent [l Paft IY: Product Details Renewal O Amendment O Appeat C O tI C] C] NBA Product Regi s tration Number: ...^............. Product Name (lnclttde Trade Name): Product Type (a) Biolertilizer (b) Biopesticide (c) Biostimulants (d) Other A GM Status: Negative tl Positive O Traces D Quantity: Country of origin: Supplier:......... Port of entry: Mode of transpoft: Purpose of import....... t872 ZIMBABWE i S.L 160 of 2018 21, Ptincass Drive, Newlands P. O. Bor CY379, Hrraft. Tel:+%347E?tr56l9 kail:aba@daaqm Wbbsite: gwrb*rczw Part V: Justification for the request If you ticked Renewal/Exteosion/AmendmentiReplacement/Appeal in Part III above, please state the reasons for your request.................. Part YI: Applicanfs Checklist Valid NBA Product Registration Certificate D GMO Certificate (PleaseAttach) Cl GMO Declaration (PleaseAttach) tl Documents to be renewed/extended/ amended C PartYII: Declaration I, ...........,........ (full nanre) declare that the information p,rovided in thie form is accurate and hereby apply for a Biosafety Import Permit under the National Biotechnolory Authority Act lChapter l4:i4 of 2A06 Designation.... Date: .............. Signature: t&r3 7: oq' National Biotechuology Authority (Agricultural Biotechnology Products) Regulations, 20 1 8 ABP4 National Eioteclmology Authority 2l Prin6 DriE, Ne*lands, Hare€ Tel +263 4 7&21 67, +253 ,t ?821.!5, 1263 4 7828561 9 Emill ibr@nb!.*.2* ' !$iosafctl clmport permit Nedo'rot Slot.ahnolo* autMdty A.r ldop: 143 )) Pmir Xo: ff)OO Rif Numbe.: NSA./RA/0GOO.O0OO lseue Dale: Authority ls glven b: o AFiry Oate: 'To lmpn Produd: Quanh'tv: Supplier: hunuy ol Origini GM St&s: Pemit subjed to Condiliods): Psmit ecd bS Post Shipmilt tesLing ol the consiShmenl by the NBA at your co$ TherefoE you arc required to lnldm the NBA on ar.lval ofthe conriSnment priorto dEtrlbution or ue Thk tsrdltk Fnted !o th aFpflatrtrM o, ffaE{rlaE]olft t.UonJ Blddnobw Aurhorlry M rnd dB nd In ay wny ahsolvo ths apElicrnt tbn ohpMnS lith any oh.r ,dutry @f,diHons govemlDglhe lrnpn # @ otrhs.be h ambtu. GO & Rqhra., MrbEr EbEft okiY afr I A hub id Biot6hnolqy. Bicafely. RMdr & IEwloPrndl 1874 S.I. 160 of 2018 AtsP5 21, kiness Drivc, Newlmds P. O. Box CY379, Harare. Tel: +25347{2A56J9 Emil: nba@uba.ac.zw Website: ww.nbeac.zw ATTENTION TO ALL R.EGISTRANTS OF AGRICULTURAI, BI OTECHNOT,CIGY PRODUCTS RF],: SPF.CIF.JCA TIONS F'OR PR E-SHI PMENT INSPECTIONS The National Biotechnology Authority ivould like to highlight the follorving procedures to be adhered to by registra"lts of agricultural biotechnology products where a pre-shipment inspection is required. Pre-shipment inspections (PSI) are required when further information on production, qualiry storage of the product and raw materials is neede.d thereby preventing substandard goods from entering or leaving the country. Clients should take note of the follorving; 1. First, the organisation must be registered with NBA and its certificate of registration should be valid.'Io register, the organisation mnst provide the following documents: Completed Registration Form CR14 Certificateofincorporation Company profile CwrentZIMRA tax clearance Registration fee 2. Upon an order for a pre-shipment inspection, the applicant should ki ndly Liaise with the Authority to arrange dates for the pre-shiprnent inspection. Meet costs ol the inspection exercise; upon obtaining an invoice from the Authority. rs75 t ZIMBABWE Natioual Biotechrology Authority (Agricultural Biotechnology Products) Re gulations, 201 8 ABP5 21, Prircess Drive, Nervlands P. O. BoxCY379,Ilrare. Tel: +?63 47al85619 Emil: nba@nba.ac.zw Websitel wwnba.ac.zw During the inspection, the inspectors shall: Assess handling, testing and packaging of the product. Collect random samples for testing Assess suitability of the production facitity Assess test and trial reports Check quality management system certificates Ctreck factory test records Check product technical data sheets Assess safety and conformity marls from other markets Ask for the distribution license .Ask for the facitity registration certificates Once the inspection is completq theAuthority will either issue; A Pre-shipment Inspection certificate and/or Glr,I certificate Or A rejection note; if inspection lindings demonstrate non compliance. If issued with a rejection note, the applicant nray appeal against the decision 30 days after receiving the note. When the Authority receives the appeal note, a meeting will be convened for discussing the issues. ra76 3 4. ZIN,IBABWE tA