Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 (S.I. No. 42 of 2010)

SJJPRlement to fbe RqJ.J!.bliLoiZqjJIQLa GOJ!(}rn[ljenl Gp zet/!Lda.1j!dfridc.!J!., 11th June, 2U10 STATUTORY INSTRUMENT No. 42 OF 2010 The lliosafety Act, 2007 (Act No. 10 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 PART I PRELIMINARY 1. Title 2. Interpretation PART" IMI'ORTAIATION OF GENETICALLY MODIFIED ORGANISMS 225 3. 4. 5. 6. 7. 8. 9. 10.• It.12. 13. 14. Prohibition of importation ofgenetically modified organism for food, feed or processing Application for pemlit to import genetically modified organism for food, feed or processing . Consideration of appl ication Referral to other agencies Public consultation Grant of permit Rejection ofapplication Permit conditions Labelling ofconsignment for importation Approval ofgenetically modified organisms for direct use to be entered in Register Notice ofarrival of shipment Suspension, revocation, or cancellation ofpermit PART III LABELLING AND TRACEABILITY 15. Scope of Part 16. Traceability 17. Labelling Copies of this Statutory Instrument can be obtainedfrom the Government Printer, Po. Box 30136, 10101 Lusaka. Price K14,500 each. 226 Statutory Instruments 11 th June, 2010 I 8. Exemption 19. Traceability requirements for food and feed produced from genetically modified organisms 20. Application to place on market food, feed or product derived from g netically modified organisms 21. Unique identifiers 22. Withdrawal ofcertain genetically modified organisms 23. Risk management measures 24. Inspection and control measures 25. Register • 26. Appeal to Tribunal 27. Fees • lith June, 2010 Statutory Instruments 227 1. These Regulations may be cited as the Biosafety (Genetically Title Modified Organisms for Food, Feed and Processing) Regulations, 2010. • • , IN EXERCISE of the powers contained in sectionforry-six of the Biosafety Act, 2007, the following Regulations are hereby made: PART I PRELIMINARY 2. In these Regulations, unless the context otherwise requires "Authority has the meaning assigned to it in the Act; "feed" means any substance, whether processed, semi processed, or raw, which is intended for animal consumption; "final consumer" means the ultimate consumer who will not use the product as part ofany business operation or activity; "food" means any substance, whether processed, semi processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance that is used in the manufacture of food, but does not include cosmetics, tobacco or substances used only as drugs; "genetically modified organism" has the meaning assigned to it in the Act; "import" has the meaning assigned to it in the Act; "ingredient" means any substance, including a food or feed additive or a component ofa compound ingredient, used in the manufacture or preparation of a foodstuff or feed and present in the final product, whether or not in a modified form; "label" means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of food or feed; "operator" means a natural or legal person who places a product on the market or who receives a product that has been placed on the market in Zambia, or from another country, at any stage of the production and distribution chain, but does not include the final consumer; "placing on the market" has the meaning assigned to it in the Act; Interpre tation 228 Statutory Instruments lith June, 2010 Prohibition of importation of genetically modified organism for food, feed or processing Application for permit to import genetically modified organism for tood, Jero or processing " pre packaged "means packaged or made up in advance in a container, ready for offer to the consumer, or for catering; " produced from genetically modified organisms "means derived, in whole or in part from genetically modified organisms, but not containing or consisting ofgenetically modified organisms; "Register" means the Register established under regulation 24; "the first stage of the placing on the market of a product" means the il~itial transaction in the production and distribution chains, where a product is made available to a third party; "traceability" means the ability to trace genetically modified organisms and products produced from genetically modified organisms at all stages oftheir placing on the market through the production and distribution chains; "Tribunal" has the meaning assigned to it in the Act; and " unique identifier" means a simple numeric or alphanumeric code which serves to identify a genetically modified organism on the basis ofthe authorised transformation event from which it was developed and providing the means to retrieve specific information pertinent to that genetically modified organism, PART II IMPORTATION OF GENETICALLY MODIFIED ORGANISMS 3. A person shall not import a genetically modified organism for direct use as food or feed or for processing unless (a) the importation is duly authorised by the Authority; (b) the genetically modified organism is authorised for commercial distribution as food or feed in the country oforigin; and (c) regardless of the intended use, the genetically modified organism poses no significant risks to human or animal health, biological diversity, non genetically modified crop or the environment. 4. An application to import a genetically modified organism for direct use as food or feed or for processing shall be in Form I set out in the First Schedule. • • 11 th June, 2010 Statutory Instruments 229 • • 5. (1) The Authority shall, within fourteen days from the receipt of an application under regulation 4, examine the application to determine if it meets the requirements of the Act and these Regulations. (2) The Authority shall, where the application meets therequ irements of the Act and these Regu lations (a) accept the application and inform the applicant in Form 1I set out in the First Schedule; and (b) forward a copy ofthe application to the Scientific Advisory Committee. (3) The Scientific Advisory Committee shall evaluate an application referred to it under sub regulation (2), particularly the risk assessment studies conducted and actions taken by the relevant regulatOly authorities in the countly oforigin, and submit its report to the Authority within thiliy days from its receipt of the application. (4) The Authority shall, where an application is incomplete or defective, inform the applicant in Form III set out in the First Schedule and give the applicant a period within which to correct the defects in the application. (5) Where an applicant to whom a notice is sent under sub regulation (4) fails to correctthe defect within the period specified by the Authority, the Authority shall reject the application. (6) An applicant whose application is rejected under sub regulation (5) may re submit the application after the defect is corrected. (7) The Authority may request an applicant to submit additional information in relation to the application in Form IV set out in the First Schedule. Consideration ofapplication 6. (I) The Authority shall furnish the following agencies with a Referral to copy of an application for their comments: other (a) the Plant Quarantine and Phytosanitary Service, if the agencies genetically modified organism is a raw agricultural commodity intended for direct use as food or processing into food; and (b) the authorised veterinary services, if the genetically modified organism is intended for direct use as feed or for processing into feed. (2) The agencies refered to under sub regulation (1) shall submit their comments to the Authority within thirty days of receipt of the application. 230 Statutory Instruments 11th June, 2010 •9 (I) The Authority shall reject an application (aJ if the genetically modified organism in respect of which the application is made poses risks to human or animal health, biological diversity, non genetically modified crop or the environment; or (bJ if the application does not meet the requirements of the Act or these Regulations. (2) A notification of a rejection of an application shall be in Form VI set out in the First Schedule. 10. A permit holder shall comply with the following conditions: (aJ the genetically modified organism shall be impOlied solely and exclusively for direct use as food or feed, or for processing into food or feed, and not for field testing or propagation; Public 7. (1) An applicant shall, within fifteen days from the receipt of consultation the acceptance ofthe application by the Authority, publish a notice, in at least two daily newspapers of general circulation in Zambia, inviting interested parties to send their comments or objections on the proposed importation for direct use as food or feed, or for processing, to the Authority within a period of thirty days from the date ofpublication of the notice. (3) An applicant shall submit to the Authority proof of the publication within fifteen days from the date ofpubl ication. 8. (1 )The Authority shall, within thirty days from the acceptance ofan application, approve the application if the use ofthe genetically modified organism for food or feed, or for processing, does not pose any significant risks to human or animal health, biological diversity, non genetically modified crops or the environment. (2) In calculating the thirty day period refered to under sub regulation (I), the period oftime during wh ich the Authority awaits further information from an applicant or from any relevant regulatory authority in the country of origin of the genetically modified organism in respect ofwhich an application is made shall not be included. (3) A permit to import a genetically modified organism for food, feed or processing shall be in Form V set out in the First Schedule. (4) A permit may be renewed for a fUliher period of five years where the holder shows that the continued importation of the genetically modified organism as food or feed, or for processing, does not pose any risks to human or animal health, biological diversity, non genetically modified crop or the environment. Rejcction of application Permit conditions Grant of permit II th June, 20 10 Statutory IllStruments 231 • • (b) the genetically modified organism shall be maintained and disposed of in such a manner as to prevent any risks to human or animal heaIth,biological diversity, non genetically modified crop or the environment; (c) all packing materials, shipping containers and all other materials accompanying the genetically modified organ ism shall be treated or disposed of in such a manner as to prevent any risks to human or animal health, biological diversity, non genetically modified crop or the environment; (d) the permit holder shall give an inspector access, during regular business hours, to the facility where the genetically modified organism is located and to any records relating to the imp0l1ation of the genetically modified organism; (e) the genetically modified organism shall be identified with a label showing the permit number, name of the genetically modified organism and the date of importation; (f) the genetically modified organism shall be subject to the application ofmeasures including final disposal, which the Authority considers necessary to prevent its accidental or unauthorised release; (g)the permit holder shall (i) in the event of any accidental or unauthorised release of the genetically modified organism, report to the Authority verbally, immediately upon discovery, or in writing, within twenty four hours; and (ii) notify the Authority in writing, as soon as possible, but not exceeding three working days, if the genetically modified organism or associated host organism is found to have characteristics substantially different from those listed in the application for a permit, or suffers from any excessive mortality or morbidity, unanticipated effect on non target organisms or other unusual occurrence; (h) ifnew information becomes available indicating that the genetically modified organism could pose significant risks to human or animal health, biological diversity, non-genetically modified crop or the environment, the applicant shall 2 3 2 S. ta l u lo ry I. ns l rU rn e n l. S ll t h J u ne , 2 0 1 0 / Labelling of consignment for importation Approval of genetically modified organisms for direct use to be entered in Register report to the Authority who shall immediately take measures to protect human or animal health, biological diversity, non genetically modified crop or the environment; (i) the permit holder shall import the genetically modified organism only at the port of entry designated in the permit; OJ the permit holder shall comply with such other conditions as the Authority may consider necessary or desirable to prevent any risks to human or animal health, biological diversity, non genetically modified crop or the environment; and • (k) the permit holder shall comply with such other conditions specified under the Act. 11. A consignment for imp0l1ation shall be labelled in accordance with the requirements specified under Part Ill. 12. The Authority shall record in the Register the genetically modified organisms or products ofgenetically modified organisms that have been approved for importation for direct use as food or feed, or for processing. Notice of arrival of shipment Suspension, revocation or cancellation of permit 13. A holder of a permit for the importation of genetically modified organisms for direct use as food or feed or for processing shall, within fifteen days from the date ofarrival ofevery shipment of the genetically modified organism, notify the Authority ofsuch arrival in Form VII set out in the First Schedule. 14. (l)A permit shall be revoked if (a) the permit holder provides false information in the application or declaration relating to any shipment of genetically modified organisms; (b) the permit holder refuses to allow the inspection of the physical containment facility or intermediate destination ofthe genetically modified organism; (c) the permit holder violates the relevant phytosanitary and biosafety regulations and measures or any condition imposed in the permit; • 11th June, 2010 Statutory Instruments 233 • (d) the authority to commercially distribute the genetically modified organism in the country oforigin is suspended or revoked; or (e) new information becomes available to the Authority indicating that the genetically modified organism, if allowed for its intended use will result in significant risks to human or animal health, biological diversity, non genetically modified crop or the environment. (2) The Authority may suspend, for any period, revoke or cancel any permit issued under this Act, if in the opinion of the Authority, any genetically modified organism or product of a genetically modified organism to which the permit relates poses any risk to human or animal health, non-genetically modified crop, biological diversity or the environment. (3) A suspension, revocation or cancellation ofa permit shall be in Form VIIT set out in the First Schedule. (4) A suspension, revocation or cancellation ofa permit shall be endorsed on the permit. PART III LABELLING AND TRACEABILITY 15. This Part applies, at all stages of the placing on Scope of Pan the market, to (a) products consisting of, or containing, genetically mod ified organisms, placed on the market in accordance with the Act; and (b) food and feed produced from genetically modified organisms, placed on the market in accordance with the Act. 16. (1) At the first stage of the placing on the market of a Traceability product, including bulk quantities, consisting of, or containing, genetically modified organisms an operator shall transmit the following information in writing to the operator receiving the product: (a) that the product contains or consists ofgenetically modified organisms; and (b) the unique identifier assigned to the genetically modified organisms in accordance with these Regulations. (2) An operator shall, at all subsequent stages of the placing on the market of products, ensure that the information received in accordance with sub regulation (1) is transmitted in writing to the operators receiving the products. 234 Statutory Instruments 11th June, 2010 •Labelling Exemptions (3) In the case of products consisting of or containing mixtures of genetically modified organisms to be used only and directly as food or feed or for processing, the information referred to in sub regulation (1) may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all the genetically modified organisms that have been used to constitute the mixture. (4) An operator shall put in place systems and standardised procedures to allow the holding of information specified in sub regulations (1), (2) and (3) and the identification, for a period of five years from each transaction, ofthe operator by whom, and the operator to whom, the products have been made available. 17. (1) For products consisting of or containing genetically modified organisms, an operator shall ensure that (a) for pre packaged products consisting of, or containing genetically modified organisms, the words 'This product contains genetically modified organisms' or 'This product contains genetically modified [name of organism(s)]' appear on a label; and (b) for non pre packaged products offered to the final consumer, the words 'This product contains genetically modified organisms' or 'This product contains genetically modified [name of organism(s)]' shall appear on, or in connection with, the display of the product. (2) An operator shall label genetically modified food and feed in a manner that ensures that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner and to enable the control and verification of labelling claims. • 18. (1) Regulation 5 does not apply (a)to traces ofgenetically modified organisms in products in a propOition of less than the 0.9 percent threshold: Provided that the traces of genetically modified organisms are adventitious or technically unavoidable and the genetically modified organisms have been subject to a scientific risk assessment; and (b) to traces of genetically modified organisms in products intended for direct use as food, feed or for processing in a propOltion ofless than the 0.9 percent threshold: II th June, 2010 Statutory Instruments 235 • Provided that the traces of genetically modified organisms are adventitious or technically unavoidable. (2) These Regulations do not apply to food which contains or has genetically modified organisms in a proportion ofless than 0.5 percent: Provided that the presence of such genetically modified organisms is considered technically unavoidable and the organisms have been subjected to a scientific risk assessment and considered to be safe. 19. (1) An operator shall, when placing a product produced from genetically modified organisms on the market, transmit the following information in writing to the operator receiving the product: (a) an indication of each of the food ingredients which is produced from genetically modified organisms; (b) an indication of each of the feed materials or additives which is produced from genetically modified organisms; and (c) in the case of products for which no list of ingredients exists, an indication that the product is produced from genetically modified organisms. (2) An operator shall put in place systems and standardised procedures to allow the holding ofthe information specified in sub regulation (I) and the identification, for a period of five years from each transaction, of the operator by whom, and to whom, the products referred to in sub regulation (I) have been made available. (3) Sub regulations (I) and (2) do not apply to traces of genetically modified organisms in products for food and feed produced from genetically modified organisms in a proportion of less than the 0.9 percent threshold establ ished for those genetically modified organisms, if the traces ofgenetically modified organisms are adventitious or technically unavoidable. 20. (I) An application for the placing on the market offood and feed and products derived from genetically modified organisms shall be made to the Authority and shall include a unique identifier for each genetically modified organism. (2)An application under sub-regulation (I) shall be in Form 1set out in the First Schedule. Traceability requirements for food and feed produced from genetically modified organisms Application to place on market food, feed or product derived from genetically modified organisms 236 Statutory Instruments 11th June, 2010 Unique identitiers Withdrawal of certain genetically modified organisms Risk management measures (3)The Authority shall, where the application meets the requirements ofthese Regulations, accept the application and inform the applicant of such acceptance in Form II set out in the first Schedule. (4) A penn it to place on the market food, feed and products derived from genetically modified organisms shall be in Form IX set out in the First Schedule. 21. (l)A producer of a genetically modified organism for food or feed shall develop a unique identifier for each genetically modified organism. (2) Where con ent or authori ation i granted und r sub r gulation 3) of regulation 20. ti r the pIa ing on the market of a geneticall modified organi m the Authority shall communicate the unjque identifier for the genetically modified organi m in writing, to the Biosafety Clearing House. (3) The unique identifier for each genetically modified organism shall be recorded in the Register. 22. (1) The Authority shall withdraw a genetically modified product where it has adverse effects on human and animal health, biological diversity, non genetically modified crops or the environment, including socio economic conditions. (2) If new information or a re assessment of the existing infonnation reveals that the use of food or genetically modified food approved by these Regulations endangers human health, or the feed endangers animal health, the Authority shall immediately suspend the sale of such food. (3) A notice ofwithdrawal ofgenetically modified food, feed or products, or suspension of the sale of such food, feed or products shall be in Form X set out in the First Schedule, and such withdrawal or suspension shall be endorsed on the permit. (4)The Authority shall require the person whosubmitted the application for approval to import, store, transport, distribute or sell food or feed withdrawn or suspended under this regulations, as the case may be, to withdraw the product from the market and such person shall immediately comply with the requirement. 23. Risk management measures shall be implemented In accordance with the provisions of the Act. • lIth June, 2010 Statutory Instruments 237 measures Register Inspection and control • 24. An inspector may, subject to the provisions ofthe Act, conduct inspections, as maybe appropriate, to ensure compliance with these Regulations. 25. (1) The Authority shall establish and maintain a Register for purposes ofthese Regulations. (2) The Authority shall record in the Register all available sequencing information, reference material for, and any other information relating to, genetically modified organisms that are authorised or not authorised to be put into circulation in Zambia. 26. Any person aggrieved with the decision ofthe Authority under Appeal to these Regulations may appeal to the Tribunal in Form Xl set out in Tribunal the First Schedule. 27. The fees set out in the Second Schedule are payable for the Fees matters set out therein. 238 Statutory Instruments FIRST SCHEDULE 11 th June, 2010 (Regulations 4, 5(2), 5(4), 5(7), 8(3), 9(2), 13, 14(3), 20(2), 20(3), 22(3) and 26) Form I (Regulations 4 and 20 (2)) (To be completed in triplicate) REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing), Regulations, 2010 APPLICATION TO IMPORT GENETICALLY MODIFIED ORGANISM OR PRODUCT OF GENETICALLY MODIFIED ORGANISM FOR USE AS ( ) FOOD ( ) FEED ( ) FOR PROCESSING OR TO ( ) PLACE GENETICALLY MODIFIED ORGANISM OR PRODUCT OF GENETlCALLY MODIFIED ORGANSIM ON MARKET (Tick as appropriate) Shaded fields for official use only Licence code Date and Time lllforma/ion Required Inforlna/ioll Provided -J 1. Name(s) of applicant(s) 2. Type of applicant ~3 Company Ic~)perativell Partnership II 3. (a) Nationality (b) Identity card (National Registration Card No. or Passport No.) - Attach copies 4. Notification address Tel: Fax: Email: • • ::::::::::::::::::r::::::::::::::: ::::::::::::::::: :::::::::::::::• 11th June, 2010 5. (n) Company/Institution/ CooperativefPartnership/ NGO name and address (b) Company/Institution/ CooperativefPartnership/ NGO Registration No. (Attach copies of Certificate of registration (c)Shareholders: Statutory Instruments Shareholder Shares held 239 Nationality NRC/ Passport No. • (d) Directors (e) Chief Executive Officer (j) Company Secretary 6. Details of Genetically Modified Organism (GMO) (a) Name (Scientific, common and trade names, constituents, etc) (b)Country of origin Director Name Name Shares held Nationality NRC/ Passport No, Nationality Nationality 240 Statutory Instruments 11th June, 2010 • • Location of Projects Use of genetically ( ) Food ( ) Feed ( ) Processing () Pladngon ti,e modified organism! market product of GMO I Previously held licences Permit/licence Name and Type of Genetically in Zambia, if any, by Type and Licence No.) Modified Organism/ Location applicant i ued under th Biosafety ct,2007 (a (a) r (b)~) (c)(d)e) (e) (f) (f) Currently held licences Permit/Licence (Type I Name and Type of Genetically in Zambia, if any, by and Licence No.) ModifiedOrganism/Location applicant issued under the Biosafety Act, 2007 (a) (a) (b) (b) (c) (c) (d) (d) (e) (e) (f) (f) Currently held Zambia, Permit/Licence (Type and Name and Type of Genetically If any, by Licence No.) Modified Organism/Location subsidiary comoanies i ued under the Bio afety Act, 2007 (a) (a) (b) (b) (c) (c) (d) (d) (e) (e) (f) (f) Have you been convicted of an offence involving fraud or dishonesty or of any offence under the Biosafety Act, No.7 of 2007, or any other law within or outside Zambia? I (yes,specify detail :..................................................................................................................................... INatureo( offence:............................................................................................................ [oat of Conviction: .............................................................................................................. !Sentence: ................................ '" ............................................................................................ . Have you ever applied for a Permit to import GMOs or Products into Zam bia or out ide Zambia?If yes, please give details below rrype of PemJ.itapplied am andTypeof UseofGen tically Dateofapphcatlor Slatusof (orand untIyin Genetically I Modified application which pcmillwas ModifiedOrganism Organism (Granted, applied r rejected or pendin~)· 7 8. 9. 11 13 12 10. 11th June, 2010 Statutory Instruments 241 • • If application was rejected, give reasons for rejection: 1:1- IAppendices (This is in addition to the information required in the Second Schedule, the Third Schedule and olher information required under the Act) Appendix No. ] Project details and outline I Should include steps to be taken in implementation;! monitoring and evaluu tion; and disposal of wast~ ---- . Appendl 0.2 Names and qualifications of person(s) responsible for the planning and carrying out of the use of the gcn ,tically modified organism, including th e respCln. ible for 'upcrvisi n, m nitoring and fety, in particular qualificatiOns of the respon ible scIentist App ldi '0.3 PhotO\opic!> ofcurri ula Vitae, work permits and other rei vant penllit is ued b the Imnugrati n Department, In the case of foreIgn individual Appendl No.5 Publish J 'cnlific literature r lating to thc gen tically modined organIsm or product of a geneti all mouin d organi III (Should indud lOIonl1i1 lion on ri ks posed by th Genetically M dific.! OrgiU1i III to human or animal heath, bl logIcal diveTSlty, non-genetically modified crop or the environment Appendix N .6 Risk Ase smcnt(Should in lude measures reqUIred w,c1er the Biosafety Act, 2007) Appendix No.7 Notificati n from the exporter or country of ongm in accordan \\'ith eXt ting inlemali nal agreements 011 the transboundary movement of the genetica lIy modified organism Appendix No.8 Docum nlalion tosho\ that the geneticall modHieu organism or product of a g n'licall' modJJled organism is allowed (or commerCIal distribution as food or feed by the relevant regulatory uUthOlity in the country of origin and does not pose any significant risk to human or animal health, biological diversity, non genelically modified crop or the environment Appendix No.9 If the genetically modified organism is intended for use as feed or for processing into feed, attach documentation to show that the relevant regulatory authority in the COWl try of origin have determined that the genetically modified organism I does not pose any significant risk to human or animal health, biological diversity, non-genetically modified crop or the environment AppendiX No. 10 Public liabili ty insu rance AppendiX No. 11 Any other information which the Authority may consider necessary or require to prevent any significant risk to human or animal health, biological diversity, non-genetically modified crop or the enVlrOI1111ent I hereby declare that the genetically modified organism is to be imported solely and exclusively for direct use as food or feed, or for processing into food or feed, not for field testing or propagation 242 Applicant (Name) Siglllltlire ofApplica/lt FOR OFfICIAL USE ONLY Statutory Instrwnents lith June, 2010 Date • Received by: Officer (Nllme Illld sigllntllre) Amount Received Serial No. of application: RECEJPTNO STAMP lIth June, 2010 Statutory Instruments 243 Form II (Regulations 5(2) and 20(3)) • REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 NOTICE OF ACCEPTANCE OF ApPLICATION To (I .. fN THE MATTER OF (2) you are hereby notified that your application for (3) .. has been accepted and you are directed to (a) publish your application for public notification in two newspapers ofgeneral circulation in Zambia within fifteen days hereto; (b) include in your public notice, provision to solicit comments from the general members of the public relating to yourapplication; (c) ensure that the comments from the public are submitted to the Authority within thirty days from the date ofpublication of the notice; and (d) submit proof of the publication to the Authority within fifteen days from the date of the publication. Dated this day of 20 National Biosafety Authority (1) Here insert the full names and address of the applicant (2) Here insert the reference No. and type of application (3) Here insert the type of application 244 Statutory Instruments REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) 11th June, 2010 Form III (Regulation 5(4)) (1) Here insert the full names and address of the applicant (2) Here insert the reference No. and type of application 3) Here insert the lype of application The Biosafety (Genetically Modified Organisms for Food, • Feed and Processing) Regulations, 2010 NOTICE TO RECTIFY DEFECTS RELATING TO ApPLICATION To (1) . IN THE MATTER OF (2) .. you are hereby notified that your application for (3) . has not been accepted on the following grounds: (a) . (b). . (c) . (d) , . You are hereby given aays ~hin which to correct the defects in your application failure to which your application shall be rejected in accordance with regulation 9 of the Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010. Dated this day of 20 National Biosafety Authority I lthJune, 2010 Statutory Instruments 245 Form IV (Regulation 5(7» / • REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 REQUEST FOR ADDITIONAL INFORMATION To (1) .. IN THE MATTER OF (2) .. you are hereby requested to furnish the following information or documents in respect ofyour application for within days: (a) .. (b) .. (c) .. (d) .. Ifyou fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. Dated this day of 20 (3) . Registrar (1) Here insert the full names and address of applicant (2) Here insert the Reference No and type of application (3)Signuture of Registrar of Authority 246 StatutOly Instruments REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of2007) 11 th June, 20 I0 Form V (Regula/ion 8(3) The Biosdfety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 PERMIT No . PERMIT (Section of the Biosafety Act, No.7 of2007) Holder's name . Address . This Pe1l11it shall apply to the following genetically modified organism product ofa genetically modified organism . .................. which shall be used for • The Genetically Modified Organism/product of a Genetically Modified Organism shall be imported through...... • The Permit is granted for a period of 5 years commencing on the ...................... day of , 20 . The conditions of grant ofthe Permit are as shown in the Annexures attached hereto. Issued at this day of ..............................., 20 . ENDORSEMENT OF REGISTRATION This Permit has this day of ,20 . been registered in the Register. National Biosafety Authority 11 th June, 2010 Statutory Instruments 247 Form VI (Regulation 9(2)) • REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 NOTICE OF REJECTION OF ApPLICATION To(l) . IN THE MATTER OF (2) . you are hereby notified that your application for (3) ........................ has been rejected on the following grounds: (a) . (b) .. (c) .. (d) .. Dated this day of 20 .. National Biosafety Authority (I) Here insert the full names and address of applicant (2) Here insert the reference No and type of application (3) Here insert the type ofapplication 248 Statutory Instruments 11th June, 2010 Form VII (Regulation 13) (I) Here insert the Permit No. (2) Here insert the name and type of Genetically Modified Organism REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 NOTICE OF ARRIVAL Or: SHIPMENT OF GENETICALLY MODIFIED ORGANISM To: TilE NATIONAL BIOSAFETY AUTHORJTY IN THE MATTER OF (l) . you are hereby notified of the arrival of the shipment of (2) ....................................................whose details are as follows: (a) name of the carrier: . (b) date of arrival ofthe consignment: .. (c) address at which consignment is being kept at time of this notice: • (3) Here insert the signature or thepemlit holder (4) Here insert the full names of permit holder (d) country of origin: • (e) name of the shipper: .. (f) name and address of the importer: .. (g) quantity ofthe genetically modified organism imported: Dated this day of 20 . (3) . Signature ofPermit holder (4) , .. Full names of Permit holder 11th June, 2010 Statutory Instruments Form VIII (Regulation 14(3)) 249 REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed andProcessing) Regulations, 2010 NOTICE OF SUSPENSION, REVOCATION OR CANCELLATION OF PERMIT TO (I) . IN THE MATTER OF (2) . you arc hereby notified that your Permit for the fol\owing genetical\y modified organism/product of a genetically modified organism: .. ......................... issued at the day e .., ,20 Has been *revoked, cancelled or sllspended on the following grounds: (a) . (b) . (c) . (d) . Dated this day of 20 .. National Biosafety Authority *Delete as appropriate (1) Here inselt the full names and address of the permit holder. (2) Here insert Permit No. 250 Statutory Instruments REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of2007) lIth June, 2010 Form IX (Regulation 20(4») The Biosafety (Genetically Modified Organisms for Food, yeed and Processing) Regulations, 2010 PERMIT No . PERMIT TO PLACE ON MARKET FOOD, FEED AND PRODUCTS DERIVED FROM GENETICALLY MODIFIED ORGANISM (Section , of the Biosafety Act, No.7 of2007) Holder's nalne . Address . This Permit shall apply to the following genetically modified organism/product ofa genetically modified organism The genetically modified organism/product ofa genetically modified organism shall be placed on the market at the following places: (a) .. (b) '" . (e) '" '" and (d) . as ( food () feed or for ( ) processing Th Permit is granted for a period of .. commencing on the day of 20 . The conditions ofgrant ofthe Pemlit are as shown in th Annexures attached hereto. Issued at this day of , 20 . ENDORSEMENT OF REGISTRATION This Permit has th is day of.. 00' 20 . been registered in the Register. National Biosafety Authority 11th June, 2010 Statutory Instruments 251 Form X (Regulation 22(3)) REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed andProcessing) Regulations, 2010 NOTICE OF WITHDRAWAL OF GENETICALLY MODIFIED FOOD, FEED OR PRODUCTS FROM THE MARKET/THE SUSPENSION OF THE SALE OF GENETICALLY MODIFIED FOOD, FEED OR PRODUCTS TO (I) . fN THE MATTER OF (2) . you are hereby notified ofthe *withdrawaVsuspension ofsaleofthefollowing genetically modified food, feed orproducts placed on the market byyourself under the authority ofpermit No. (3) issued at . the day of 20 . (a) . (b) . (c) . (d) .. The *withdrawallsuspension ofsale ofthe genetically modified is based on the following grounds: (cY . (b) . (c) . (d) . Dated this day of 20 . National Biosafety Authority *Delete as appropriate (I) Here msert the full names and address of the pennit holder. (2) Here insert Permit No. (3) Here insert Permit No. 252 Statutory Instruments REPUBLIC OF ZAMBIA 11th June, 2010 Form XI (Regulation 26) The Biosafety Act, 2007 (Act No.7 of 2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 NOTICE OF ApPEAL TO THE TRIBUNAL IN THE MATTER OF I hereby (Applicant reference and matter ofappeal) appeal against the decision oftheAuthority on the following grounds:* (q} . (b) .. (C) .. (d) : .. Dated this day of 20 . Signature ofAppellant *Attach brief ifnecessary. • 11 th June, 2010 Statutory Instruments SECOND SCHEDULE FEES 253 l. Application for pennitfor importation ofGMO 28 5,040 2. Application to place on market food, feed or product derived from GMO 50,000 9,000,000 B. CHITUWO, Minister ofScience, Technology and Vocational Training LUSAKA 2nd June, 2010 [ MSTvT.19/8/2 ]