Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010

1. These Regulations may be cited as the Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010. Title

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; Interpre­ tation "final consumer" means the ultimate consumer who will not use the product as part of any 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 foo�, 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 of a 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, inark, 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; ·( . . • 228 Statutory Instruments 11th June, 2010 ,· " 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 of genetically modified organisms; "Register" means the Register established under regulation 24; "the first stage of the placing on the market of a product" means the i�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 of their 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 of the authorised transformation event from which it, was developed and providing the means to retrieve specific information pertinent to that genetically modified organism. PART II lMPORTAT!ON OF GENETICALLY MODIFIED ORGANISMS

3. A person shall hot 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 of origin; and (c) regardless of the intended use, the genetically modified organism poses rio 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. Prohibition of importation of genetically modified organism for food, feed or processing Application for permit to import genetically modified organism for food. feed or processing I Ith June, 2010 Statutory Instruments 229

5. (1) The Authority shall, within fourteen days from the receipt Consideration of application 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 therequirements of the Act and these Regulations- (a) accept the application and inform the applicant in Form II set out in the First Schedule; and ·, (b) forward a copy of the 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 regulatory authorities in the country of origin, and submit its report to the Authority within thirty 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 correct the defect within the period specified by the Authority, the Authority shall reject the applicat ion. (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.

6. (I) The Authority shall furnish the following agencies with a Referral to other agencies copy of an application for their comments: (a) the Plant Quarantine and Phytosanitary Service, if the 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 (I) shall submit their comments to the Authority within thirty days ofreceipt of the application. ,· 230 Public consultation Grant of permit Rejection of application Permit conditions Statutory Instruments 1 Ith June, 2010

7. (1) An applicant shall, within fifteen days from the receipt of the acceptance of the 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 of publication of the notice. (3) An applicant shall submit to the Authority proof of the publication within fifteen days from the date of publication.

8. (1 )The Authority shall, within thirty days from the acceptance of an_application, approve the application if the use of the 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 of time during which 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 of which 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 further 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. 9 (I) The Authority shall reject an application- {a) 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 (b) if the application does not meet the requir�ments 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 foilowing conditions: (a) the genetically modified organism shall be imp01ied solely and exclusively for direct use as food or feed, or for processing into food or feed, and not for field testing or propagation; -. 11th June, 20 I 0 Statuto,y Instruments 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 health,biological diversity, non genetically modified crop or the environment; (c) all packing materials, shipping containers and all other materials accompanying the genetically modified organism 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 importation 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; (I) the genetically modified organism shall be subject to the application of measures 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 organ ism, 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) if new 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 __ 23_ 2 _____ S_1a_1_u1_o_ry_b_1s_11_·,_,m_e_n_1_s _________ 1_1_th_J_ u_n_e_,_2 _0 _10 _/ 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 pennit holder shall import the genetically modified organism only at the port of entry designated in the permit; (j) 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 importation 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 of genetically modified organisms that have been approved for importation for direct use as food or feed, or for processing.

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 of arrival of every shipment of the genetically modified organism, notify the Authority of such arrival in Form VII set out in the First Schedule.

14. (l)A perrnit shall be revokedif- (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 of the genetically modified organism; (c) the pem1it holder violates the relevant phytosanitary and biosafety regulations and measures or any condition imposed in the permit; .. Labelling of consignment for importation Approval of genetically modified organisms for direct use to be entered in Register Notice of arrival of shipment Suspension, revocation or cancellation of permit 11th June, 2010 Slatu/ory lnslruments 233 . , (d) the authority to commercially distribute the genetically modified organism in the country of origin is SUSJJended 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 tl1e 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 of a permit shall be in Fann VIII set out in the First Schedule. ( 4) A suspension, revocatio'n or cancellation of a permit shall be endorsed on the permit. PART Ill LABELLING ANO TRACEABILITY 1 5 . This Part applies, at all stages of the placing on Scope of Part the market, to (a) products consisting of, or containing, genetically modified 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. ( I ) 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 of genetically 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 (I) is transmitted in writing to the operators receiving the products . 236 Statutory Jnsirziinents I Ith June, 2010 Unique identifiers (3)The Authority shall, where the application meets the requirements of these Regulations, accept the application and inform the applicant of such acceptance in Form II set out in the first · Schedule. ( 4)A permit 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. 2 I. (I )A producer of a genetically modified organism for food or feed shall develop a unique identifier for each genetically modified organism. (2) Where consent or authorisation is granted under sub­ regulation (3) of regulation 20, for the placing on the market ofa genetically modified organism, the Authority shall communicate the unique identifier for the genetically modified organism in writing, to the Biosafety Clearing House. (3) The unique identifier for each genetically modified organism shall be recorded in the Register. Withdrawal of certain genetically modified organisms

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 information 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 of withdrawal of genetically 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. .. Risk management measures

23. Risk management measures shall be implemented in accordance with the provisions of the Act. 11th June, 2010 Statutory Instruments 237

24. An inspector may, subject to the provisions of the Act, conduct inspections, as maybe appropriate, to ensure compliance with these Regulations. Inspection and control measures

25. (1) The Authority shall establish and maintain a Register Register for purposes of these 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 of the Authority under Appeal these Regulations may appeal to the Tribunal in Form XI set out in Tribunal the First Schedule. to

27. The fees set out in the Second Schedule are payable for the Fees matters set out therein . . . 240 Statuto,y Instruments I Ith June,.2010 7 8 9 Location of Projects Use of genetically ( ) Food ( ) Feed ( ) Processing ( ) Placing on U,e modified organism/ product of GMO Previously held licences in Zambia, if any, by Permit/licence !Type and Licence No.) market Name and Type of Genetically Modified Organism/Location applicant issued under the Biosafety Act, 2007 0, Currently held licences in Zambia, if any, by applicant issued under the Biosafety Act, 2007 11 Currently held Zambia, if any, by subsidim comEanies issued under the Biosafety Act, 2007 (a) rci (d) (e) (I) Permit/Licence {Type and Licence No.) (a) rci t e) I) Name and Type of Genetically ModifiedOrganism/I'..ocatidn (a) (a) (b) (b) (c) (c) (d) (d) (e) (e) (I) (I) Permit/Licence (Type and Name and Type of Genetically Modified Organism/Location Licence No.) (a) (b) (c) (d) (e) (l) (a) (b) (c) (d) (e) (l) ' '

12 . Have you been convicted of an offence involving fraud or dishonesty or of any , offence underthe Biosafety Act, No. 7 of 2007, or any other law within or outside Zambia? Ifyes,specify details: ............................. Nature of offence: ........ .................................................................................................... . .............................. Date of Conviction: ................. ............................................ Sentence· ......... ......... ........ ..................................................................................................... .. .......................................

13 . Have you ever applied for a Permit to import GMOs or Products into Zambia or outside Zambia?Ifyes, please give details below- . .. ' . TypeofPennitapplied Name and Type of Use of Genetically Date ofapplicatior Status of for and country in Genetically whichpennitwas applied for Modified Modifiec!Organism Organism applicatior (Granted, rejectedor pendine)• 1 1 th June, 201 0 St atuto ry In struments 241 If application was rejected, give reasons for rejecHon:

14. !Appendices (fhis is in addition to the information required in lhe Second Schedule, the Third Schedule and other information required under the Act) ' ,· .. Appendix No. 1 Project details and outline Should include steps to be taken in implementation; monitoring and evaluation; and disposal of waste) Appendix No. 2 Names and qualifications of person(s) responsible for the planning and carrying out of the use of the genetically modified organism, including lhose responsible for supeivision, monitoring and safety, in particular qualifications o( U1c responsible scientist Appendix No. 3 Pholocopics of curricula vilae, work permits and 0U1cr relevant permits issued by the Immigration Department, in U1e case of foreign individual Appendix No. 5 Published scientific literature relating to Urn genetically modified organism or product of a genetically modified organism (Should include information on risks posed by the Genetically Modified Organism to human or animal heath, biological diversity, non-genetically modified crop or the environment Appendix No. 6 Risk Assessment(Should include measures required under the Biosafety Act, 2007) Appendix No. 7 Notification from the exporter or country of origin in accordance with existing international agreements oll'the trans boundary movement of the genetically modified organism Appendix No. 8 Documentalion to show that the genetically modified organism or product of a genetically modified organism is al1owed for commercial distribution as food or feed by the relevant regulatory authority in the country of origin and does not pose any significant risk to human or animal health, biological diversity, non- genetically modified crop or U1e environment I 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 country of origin have determined that the genetically modified organism does not pose any significant risk to human or animal health, biological diversity, non-genetically modified crop or the environment Appendix No. 1( Public liability insurance Appendix No. 11 Any other information which the Authority may consider necessary or require to prevent any significant risk to human or animal hea1U1, biolobrical diversity, non-genetically modified crop or Urn environment I hereby declare that the genetically modified organism is lo 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 Stat11/01y Instruments I I th June, 20 I 0 Applicm,t (Name) Dntc Sig11t1ture of Applicrml FOR OFFICIAL USE ONLY Received by:-r:--:::--::--:-- --:-,-----c-- Offlccr (Nn111c nml sigm1f11re) ­ RECEIPT NO. Amount Received Serial No. of application: _ _____ _ ____ _ STAMP .. ' . I I th June, 2010 S1atuto1y 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 ( 1 ...... . . . ........... . . ..................................................... . ··················································································································· IN THE MATTER OF (2) . . ..................................... you are hereby notified that your application for (3) ... .................. . has been accepted and you arc directed to - (a) publish your application for public notification in two newspapers of general circulation in Zambia within fifteen days hereto; (b) include in your public notice, provision to solicit comments from the general members of the public rel ating to yourapplication; (c) ensure that the comments from the public are submitted to the Authority within thirty days from the date of publication 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 Alltliority (I) Here insert the full names and address of the applicant (2) Here insert U1e reference No. and \)'Pe of application (3) Here insert the type of application J .. 244 St atutory Instr um ents I Ith June, 2010 Form Ill (Regulation 5(4)) (I) Here insert the full names and address of the applicant (2) Herc insert the reference No. and type of application 3) Here insert the type of application 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 TO RECTIFY DEFECTS RELATING TO APPLICATION To ( !) . . . . .. . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... . . ·································································································· 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 within 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 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 0 0 0 0 , , . , , , , , , , , , , , , , , National Bios afety Auth ority •• .. I Ith June, 20 I 0 Statutory Instruments 245 Form IV (Regulation 5(7)) REPUBLIC OF ZAMBIA The Biosafcty Act, 2007 (Act No. 7 of 2007) The Biosafcty (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 REQUEST FOR ADDITIONAL INFORMATION To ( I) . . . . . . . . . . . . . . . . ......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IN THE MATTER OF (2) . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . ..... . . . . . . you are hereby requested to furnish the following information or documents in respect of your application for .. ... within . . . . . . . . . days: (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .... . (b) . . .. . . . . .. . .. · · · · · · · · · · · · · ·· · ·: · ·· · ·· · ·· · · · · ·· . . . . . . . · · · ·· · ·· · ·· · ·· · ·• · ·· · ·· · · · · ·· · ··· (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . .. .. . (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . . . . . . . . . . (I) Herc insert the full names and address of applicant (2) Here insert the Reference No. and type of applicati on •· ·• If you 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) ........................................... . (3)Signnturc of Registrar o f Authority Registrar 246 Statut o,y Instr ument s 11th June, 20 I 0 Form V (Regulation 8(3)) REPUBLIC OF ZAMBIA The Biosafcty Act, 2007 (Act No. 7 of2007) The Bios,1fcty (Genetically Modified Organisms for Food, Feed and Processing) Regnlations, 2010 PERMIT No. · . . . . . . . . . . . . . . . ... . . . .... .. PERMIT (Section . . . . . . . . . . . . . . .. . . . . . . of the Biosafety Act, No. 7 of2007) Holder's name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . . . . . . . . . . . . . . . . . . . .. . . ..... . . . . . . This Permit shall apply to the following genetically modified organism product of a genetically modified organism . ............. . . . . . . . . . . . .. . . . . ... .. ....... .. ........ ........ . . . . .' . . . . . . . . . . . . . . . . . . . .. ... ... . . . . .. . .. . .. . .. . . . . . . ................. ............................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......... . . . . . . . . . . . which shall b e 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 of the Permit are as shown in theAnnexures 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 A uthority I Ith June, 20 I 0 St atuto 1y lnstn1 1 11ents 247 Fann VI (Regulation 9(2)) REPUBLIC OF ZAMBIA The Biosafcty Act, 2007 (Act No. 7 of 2007) The Biosafcty (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 NOTICE OF REJECTION OF APPLICATION To (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . .. . ·······································································•······· ................................... . IN THE MATTER OF ( 2) . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. . . . . . . . . . you are hereby notified that your application for (3) .... . . . . . . . . . . . . . . . . .... has been rejected on the following grounds: (Ii) . . .. . . . . . . . . . . . . . . . . . . . . . . .. . .. . . . . .. . . . . .. . . . . .. . . . . . . . . . . .. . . . . .. . .. . . . . . . . . . . .. .. (b) . . . . . .. . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .. . . . . . . . . . . . . . . . . .. . . . . . . . ... . (c) . . .. . . . . . . . . . . . . . .. . . . . ... . . . . . . . . . . . . . . . . . . · · · · ·· · · · · · · · . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . .. . . . . . . . . . . . . . . . .. (ii) . . . . . . . . .. . . . . . . . .. . . . . .. . . . . .. . . . . . . . . . . . . . .. . . . . . . . .. . Dated this . . . . . . . . . . . . .. . . . . . , . . . . day of . . . . . . . . . . . . . . . . . . . 20 .......... . (I) Herc ins en the full names and address of applicant (2) Here insert the reference No. and type of application (3) Here insert the type of application National Biosafety A uthority .. 248 Statuto1y Instruments ! Ith June, 20 I 0 Form VII (Reg11/atian 13) REPUBLIC OF ZAMBIA The Biosafcty Act, 2007 (Act No. 7 of2007) The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010 NOTICE OF ARRIVAL OF SHIPMENT OF GENETICALLY MODIFIED ORGANISM To: THE NATIONAL B1osArETY AurnoRITY IN THE MATTER OF ( I ) . . . . . . . . . ...... ... . . . . . . . . . ........ . ... .. ... . 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 of the consignment: . . . . . . . . .. . . . . . . . . . . . . .. ......... . (c) address at which consignment is being kept at time of this notice: · · · · · · · · · · ······· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·· · · · · · · · · · · ····· · ······ (d) country of origin: .. . . . . . . . ............... . . . . . . . . . . . . . . . . . . ........... . . . (e) name of the shipper : . . . . . .. . . . . . . . . . . . .... . . . . . . . . . . . . . . . . . . . . ........ . (f) name and address of the imp01ter: . . . . . . . . . . . . . . . . . . . . . . . . . . ....... . (g) quantity of the genetically modified organism imported: · · · · · · · · · · · · · · · · " ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '"''"' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '"'''''""'"''''' Dated this . . . . . . . . . . . . . . . . . . . . . . . . day of . . . . . . . . . . . . . . . . . . . 20 ......... . (3) . .. ... · · · · · · · · · · · · · · · " · · · · · · · · · · · · · · · · · · · . ..... . . . . . . . . . . . . . . . . .. . . Signature of Permit holder (4) . . . . . . .... ........... . . . .. . . . . . . . . . . ...... · · · · · · · · · · · · · · · · · · · · · · · ··· Full names of Permit holder (I) Here msert the Pennil No. (2) Hen; l!lSert the name and type of Genetically Modified Organism (3) Herc insert the signature of thepcm1it holder (4) Herc insert the full names of pennit holder .. I Ith June, 20 I 0 Statutory Instruments 249 Form VUI (Regulation 14(3)) REPUBLIC OF ZAMBIA The Biosafcty Act, 2007 (Act No. 7 of2007) The Biosafcty (Genetically Modified Organisms for Food, Feed andProcessing) Regulations, 2010 NOTICE OF SUSPENSION, REVOCATION OR CANCELLATION OF PERMIT TO (I ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . · · · ·········.-············· ·· ··················································································································· ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••oo••••••••••••••••••••••••••••••••• IN THE MATTER OF (2) ..... . . . . . . . .. . . . . . . . ... ......... . . . . . ....... . you are hereby notified that your Pennit for the following genetically modified (I) Here insert the full names and address of the pennit holder. (2) Here mscrt Permit No. organism/product ofa genetically modified organism: . . . ............ . ......................... issued at ...... ................ the . .................. day ... .............. , 20 ...... Has been *revoked, cancelled or suspended on the following grounds: (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . (b) ..... ..... . . . · · · · · · · · · · · · · ·· · ·· · ·· · ·· · • · · ·· · . . . . . . . . . . . . .. . .. . .. . .. . . : . . . . . . . . . . . (c) . . ... . . . . . . . . . . . . .. . .. . .. . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . .. . . . . . . . . (<lj . . . . . . . . . . . . . . . . . . . . . . . : . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dated this ... ........ . . ........... . . . ... day of ............. 20 .......... . National Biosafety Authority *Delete as appropriate J . ' ,. · I . ' 250 Statutory Instruments 11th June, 2010 Fonn IX (Regulation 20(4)) REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (ActNo. 7 of2007) The Biosafcty (Genetically Modified Organisms for Food, ,Feed 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 of 2007) Holder's name . . . . . . . . . . . . . . . . . . . . . ....... . . . . . . . . .. ................. . . . . . . . . Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .................. . . . . . . . . . . ............... . This Permit shall apply to the following genetically modified organism/product of a genetically modified organism The genetically modified organism/product of a genetically modified organism shall be placed on the market at the following places: (a) .................. . . .. . .. . . . . . . . .. . . . . . . . ..... . . . . .............. . .. . . . . . . . .. . � ................................................................................... _ (c) . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. and (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . . . . . . . ) processing ( ) feed, or for ( as ( ) food, The Permit is granted for a period of . . . . . . . .. . . . . .. . . . . . . . . . . . . . . commencing on the . . . . . . . . . . day of . . . . . . . . . . . . . , 20 . . . . . . . . . . . . . . . The conditions of grant of the Permit are as shown in the Annexures attached hereto. Issued at . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . this . . . . . . . . . . . . . . . . . . . . . . . . day of . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . , 20 . . . . . . . . . . ., l - . - ENDORSEMENT OF REGISTRATION This Permit has this . . . . . . . . . .. . . . . . . ... day of.. . . . . .. . .. . . . . . . . . , 20 . . . . . been registered in the Register. National Biosafety Authority 1 1th June, 2010 Statutory Instruments 25 1 ,. ., -r . . , Fonn X (Regulation 22(3)) REPUBLIC OF ZAMBIA The Biosafety Act, 2007 (Act No. 7 of2007) 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 (! ) . . . . . . . . . . . . . . . .............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . "-. . . . . IN THE MATTER OF (2) ...... . . . . ..................... ........... .. you are hereby notified of the *withdrawaVsuspension of sale of the following genetically modified food, feed or products placed on the market byyourself under the authority of permit No. (3) ......... issued at . . . . . . . . . ... ...... .. the ... . . . . . . . . . . . . . . . . day of . . . ..... . . . . . . . . . . . . . . . 20 . . . . . . . . . . . . ...... . (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . . . . . . . . . . . . . . . (b) . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (c) ................... . . . . . . . . . . . . . .. . .. . . . . .. . . . . .. . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . (cp . ...................................................................... ......... . The *withdrawal/suspension of sale of the genetically modified is based on the following grounds: (qi . . . . . . . . . . . .. . . . . .. . .. . .. . . . . . . . .. . . . . .. . .. . .. . .. . . . . . . . . . . . . . .. . . . . . . . .. . .. . .. . . . . . (b) . . .. . . . . . . . .. . .. . .. . .. . .. . .. . . . . . . . .. . . . . . . . .. . .. . .. . .. . .. . . . . .. . . . . . . . .. . .. . .. . . . . . (c) . . .. . . . . .. . .. . . . . . . . . . . . . . .. . .. . . . . . . . .. . . . . ..... . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . (cp . . .. . . . . . . . . . . .. . . . . . . . .. . . . . . . . . . . . . . .. . . . . . . . . . . . . . .. . .. . .. . .. . .. . . . . .. . .. . .. . . Dated this . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . day of . . .. . . . . . . 20 ............. .. . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . *Delete as appropriate National BiosafetyAuthority (I) Here mscrt tl1e full names and address of Ilic pcnnit holder. (2) Here insert Pennit No. (3) Here insert Permit No. 25 2 Statuto,y Instruments 11th June, 2010 Form XI (Regulation 26) REPUBLIC OF ZAMBIA The Biosafcty Act, 2007 (Act No. 7 of2007) '. The Biosafcty (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 of appeal) appeal against the decision of the Authority on the following grounds:* (q) . . . . . . . . . . . .. . .. . .. . .. . .. . .. . . . . .. . .. . .. . .. . . . . .. . .. . .. . .. . .. . . . . .. . .. . . . . . . . .. . (b) . . .. . . . . ..... . .. ... . . . . . . . . . . . . . .. . . . . . . . . . . .. . .. . . . . . . . .. . .. . . . . . . . ....... . ..... . (c) . . . . . .. . .. . . . . .. . . . . . . . .. . .. . .. . .. . . . . . . . .. . .. . . . . . . . . . . . . . . . . .. . . . . .. . . . . ...... . (d) . . . . . . . . . . . . . . . : . . . . . .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ . Dated this . . . . . . . . . . ........... day of . . . . . . . . . . . . . 20 . . . . . . ..... . . . . . . Signature of Appellant •· * Attach brief if necessary. I Ith June, 2010 St atuto ry Inst r u ments 253 SECOND SCHEDULE FEES I. Application for pennitfor importation of GMO 28 5,040

2. Application to place on market food, feed or product derived from GMO 50,000 9,000,000 B. CHITUWO, Min is/e r of Science, Te chnology and Vo c ational Training LUSAKA 2nd June , 2010 [ MSTVT.1 9/8/2 ] J ., • . , 254 St atu tory Instru m ents 1 Ith June, 2010 . •·