Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024

Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 1 GOVERNMENT NOTICE NO. 368 published on 17/5/2024 THE ENVIRONMENTAL MANAGEMENT ACT, (CAP. 191) REGULATIONS (Made under section 230(2)(d) and (e)) THE ENVIRONMENT MANAGEMENT (ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES) REGULATIONS, 2024 ARRANGEMENT OF REGULATIONS Regulation tittle PART I PRELIMINARY PROVISIONS 1. Citation. 2. Application. 3. Interpretation. PART II OBJECTIVES 4. Objective. PART III MANAGEMENT OF GENETIC RESOURCES 5. Ownership over genetic resources. 6. Duty to safeguard national interest. PART III ADMINISTRATION AND INSTITUTIONAL FRAMEWORK 7. National Focal Point. 8. Function of National Focal Point. 9. Competent Authority. 10. Functions of Competent Authority. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 2 11. Responsibilities of local government authority. 12. Duties of local community. PART V CONTROL AND MANAGEMENT OF ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES 13. Access to genetic resources. 14. Application of Access Permit. 15. Procedures for application for Access Permit. 16. Responsibilities of Access Permit holder. 17. Restriction for export. 18. Application for Export Clearance Certificate. 19. Accompanying documents. 20. Import or transit Clearance. 21. Restriction on transfer of permit. 22. Intellectual property rights for local community. 23. Validity of Export Clearance Certificate. 24. Suspension, cancelation or revocation of Export Clearance Certificate. 25. Monitoring of compliance of Access Permit or Export Clearance Certificate. PART VI BENEFIT SHARING MECHANISMS 26. Benefit sharing. 27. Categories for benefit sharing. 28. Written Prior Informed Consent. 29. Benefit Sharing Agreement. 30. Copies of agreement. 31. Review of Benefit Sharing Agreement. PART VII RIGHT OVER ACCEESS AND BENEFIT SHARING OF GENETIC RESOURCES 32. Rights of local community. 33. Rights of Access Permit or Export Clearance Certificate holder. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 3 PART VIII GENERAL PROVISIONS 34. Offences and Penalties. 35. Transitional period. 36. Duty to feedback. 37. Record keeping. 38. Appeal. 39. Powers to issue policy guidelines or directives. SCHEDULES Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 4 THE ENVIRONMENTAL MANAGEMENT ACT, (CAP. 191) REGULATIONS (Made under section 230(2)(d) and (e)) THE ENVIRONMENT MANAGEMENT (ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES) REGULATIONS, 2024 PART I PRELIMINARY PROVISIONS Citation 1. These Regulations may be cited as the Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024. Application 2.-(1) These Regulations shall apply to access and benefit sharing arise from the use of genetic resources or associated traditional knowledge, naturally occurring or naturalised breeds in in-situ or ex-situ conditions intended for research, commercial or non-commercial purposes within or out of Tanzania. (2) Without prejudice to sub-regulation (1), these Regulations shall not apply to access to genetic resources or associated traditional knowledge which (a) done by local community among themselves and for their own consumption; (b) certified for food or other consumptive purposes as prescribed by sector specific laws or which do not result from commercial purposes or not for import or export to other countries of not origin; (c) derived from fauna and flora as defined by the existing laws relating to breeding and variety; (d) intended for approved educational research purposes in Tanzania Academic and research Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 5 Institutions recognised and managed by the Competent Authority; or (e) derived from human. Interpretati on 3. In these Regulations, unless the context otherwise requires “Council” shall have the meaning ascribed to it under the Act; “benefit” means any monetary or non-monetary gain or profit or interest or advantage arising from or accruing to or out of commercialisation, non-commercialisation, industrial application or economic use of the biological or genetic resources or associated traditional knowledge used to derive, develop or modify a product or process; “monetary benefit” means payment made or benefit accrued from utilisation of genetic resources or associated traditional knowledge; “intellectual property right” means ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property; “clearing house” means a web-based information sharing platform for facilitating the implementation of Nagoya Protocol; “access permit” means a written document issued by Competent Authority to authorise a person to access genetic resources or associated traditional knowledge; “export clearance certificate” means a written document issued by the National Focal Point to a person intending to export genetic resources be it for commercial or non-commercial; “research permit” means a written document issued by Competent Authority for research to a person who intends to carry out research on genetic resources or associated traditional knowledge; “commercialisation” means utilisation of genetic resources or associated traditional knowledge for financial gains or Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 6 other profit-oriented purposes; “associated traditional knowledge” means the accumulated knowledge that is vital for conservation and sustainable use of genetic resources which is of socio economic value, and which has been developed over the years in local communities; “Benefit Sharing Agreement” means an agreement entered between applicant and Competent Authority for the purpose of stipulating the benefit framework that accrue from utilisation of genetic resources or associated traditional knowledge; “Data Sharing Agreement” means a formal contract that detail what data may be shared and their appropriate use; “Material Transfer Agreement” means an agreement between the competent authority or its representative and collector, setting out the terms under which genetic resources can be transferred from one party to another; “competent authority” means the government office, ministry, department, regulatory authority, research institution, local government authority or agency responsible for management of any aspect of genetic resources or associated resources; “Mutual Agreed Terms” mean conditions set out in an agreement between providers and collectors for the access to and utilisation of genetic resources or associated traditional knowledge as well as sharing of benefits resulting from their utilisation; “utilisation of genetic resource or associated traditional knowledge” means use of genetic resources or associated traditional knowledge for commercial or non-commercial purposes; “non-commercial utilisation” means utilisation of genetic resources or associated traditional knowledge for academic, research or other non-profit oriented purposes; “benefit sharing” means sharing in fair and equitable manner of monetary and non-monetary benefits accrued to or from the utilisation of genetic resources or associated Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 7 traditional knowledge between collectors and rightful holders; "collector" means a person or agent of that person who obtained a permit to access genetic resources or their derivative products or components or associated traditional knowledge occurring or originating from Tanzania; “National Focal Point” means the Ministry responsible for environment; “applicant” means a person who makes a formal application for the access to genetic resources or associated traditional knowledge; “written prior informed consent” means a consent in a written form given by a respective Competent Authority or local community to a collector to access genetic resource or associated traditional knowledge; “genetic resource” shall have the meaning ascribed to it under the Act; Cap. 191 “Act” means the Environmental Management Act; “access” means obtaining, possessing and using genetic resources or associated traditional resources conserved, whether derived products and, where applicable, intangible components, for purposes of research, bio-prospecting, conservation, industrial application or commercial use; “fair and equitable manner” means the measures taken to ensure that the benefits arising from the utilisation of genetic resources or associated traditional knowledge, as well as the subsequent applications and commercialisation, are shared in a fair and equitable way among all those organisations or communities identified as having contribution to resource management, research and development or commercialisation; “genetic materials” shall have the meaning ascribed to it under the Act; “Minister” means the Minister responsible for environment. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 8 PART II OBJECTIVES Objectives 4. The objectives of these Regulations are to (a) prescribe procedures and manner for access to genetic resources; (b) promote sustainable management and utilisation of biological diversity; (c) create a framework for sharing of benefits arising from the use of such genetic resources or associated traditional knowledge; (d) enhance education and public awareness on access to genetic resources; and (e) recognise, protect and support the inalienable rights of local communities over genetic resources or associated traditional knowledge found within their area. PART III MANAGEMENT OF GENETIC RESOURCES Ownership over genetic resources 5. The right to determine, control and regulate access to genetic resources and its associated traditional knowledge in Tanzania is vested to the government for the benefit of people and shall be exercised in accordance with these Regulations or any other relevant written law. Duty to safeguard national interest 6. A person exercising jurisdiction in accordance with these Regulations shall, in making any decision, order, exercise of any power or performance of any function or duty, shall uphold Tanzania national interest. PART IV ADMINISTRATION AND INSTITUTIONAL FRAMEWORK National Focal Point 7. The Ministry responsible for environment shall be Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 9 the National Focal Point for the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation. Functions of National Focal Point 8. The National Focal Point shall (a) ensure that the United Republic of Tanzania benefits from the genetic resources or associated traditional knowledge accessed; (b) issue an export clearance certificate for transboundary movement of genetic resources; (c) establish contacts and linkages with national, regional and international agencies and institutions; (d) provide and coordinate policy guidance of matters related to access and benefit sharing arising from the utilisation of genetic resources or associated traditional knowledge of the United Republic of Tanzania; (e) collaborate with the office or ministry responsible for environment in the Revolutionary Government of Zanzibar on matters related to access and benefit sharing under Nagoya Protocol; (f) ensure operationalisation of National Clearing House Mechanism of all genetic resources accessed, exported or imported or transit through United Republic of Tanzania (g) facilitate capacity building in collaboration with the stakeholders on matters related to implementation of these Regulations; (h) co-ordinate, monitor and assess the implementation and enforcement of the provisions of these Regulations; (i) monitor and assess the effectiveness of activities being carried out by relevant Competent Authority in order to ensure compliance with these Regulations; (j) promote public participation and awareness on access and benefit sharing of genetic resources and Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 10 associated traditional knowledge; (k) Receive from the Competent Authority inspection reports on authorisation of the country of origin of the genetic resources imported into or exported from or through Tanzania; and (l) perform any other functions necessary for effective implementation of these Regulations. Competent Authority 9.-(1) For the purpose of compliance and enforcement of these Regulations, relevant government offices, ministries, departments, agencies, local government authorities and institutions responsible for management over specific genetic resources or associated traditional knowledge shall be known as Competent Authority. Cap. 226 (2) Without prejudice to sub-regulation (1), the Tanzania Commission for Science and Technology established by the Tanzania Commission for Science and Technology Act shall be Competent Authority in relation to management, monitoring, promoting and coordinating research on genetic resources or associated traditional knowledge. Functions of Competent Authority 10. the Competent Authority shall have the following functions (a) receive and process application for a permit to access genetic resources or associated traditional knowledge; (b) review the application and recommend to the National Focal Point in writing on the issuance of Export Clearance Certificate of genetic resources or associated traditional knowledge; (c) collaborate with the ministry responsible for local government authority in the process of application to access genetic resources or associated traditional knowledge managed by local government or local community; (d) collaborate with the National Focal Point or other relevant authorities, in monitoring the utilisation Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 11 of genetic resources or associated traditional knowledge; (e) ensure protection of rights of the local community in which genetic resources or associated traditional knowledge are found; (f) establish a depository for representative samples, information, technology or associated traditional knowledge of genetic materials accessed, imported or exported; (g) submit to the National Focal Point annual reports relating to the implementation of these Regulations; (h) to ensure that technology transfer or information exchange in relation to genetic resources or associated traditional knowledge is affected by persons accessing them; (i) facilitate negotiation and conclusion of all Material Transfer Agreement, Data Sharing Agreement and Mutual Agreed Terms include terms and conditions upon which access is to be granted; (j) ensure that all Materials Transfer Agreements, Data Sharing Agreements and Mutual Agreed Terms contain sufficient provisions for the sharing of benefits arising out of use or application of genetic resources or associated traditional knowledge of Tanzania; (k) ensure inclusion, involvement and engagement of relevant local community in the process of accession of genetic resources or associated traditional knowledge found within their area, including their prior informed consent; and (l) perform any other functions necessary for effective implementation of these Regulations. Responsibil ities of local governmen 11. For avoidance of doubt, the local government authorities managing genetic resources or associated traditional knowledge found in their area of jurisdictions shall Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 12 t authorities have responsibilities to (a) facilitate applicant to access genetic resources or associated traditional knowledge; (b) ensure the right of local communities over genetic resources or associated traditional knowledge is protected; (c) participate in the process of access to genetic resources or associated traditional knowledge; (d) provide advice on issues related to access or use of genetic resources or associated traditional knowledge; (e) protect cultural norms, rights, value or heritage on genetic resources or associated traditional knowledge; and (f) keep records of agreements and written prior informed consent. Duties of local communiti es 12. Local communities shall have responsibilities to (a) issue a written prior informed consent on access to genetic resources or associated traditional knowledge found within their area as prescribed in the First Schedule; (b) conserve and manage genetic resources; (c) preserve and protect traditional practices, norms and ethic derived from availability of genetic resources or associated traditional knowledge; (d) use genetic resources or associated traditional knowledge found within their area of jurisdiction in a sustainable manner; and (e) preserve or protect any other traditional knowledge; PART V CONTROL AND MANAGEMENT OF ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES Access to genetic 13. A person shall not access, develop or utilise Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 13 resources genetic resources or associated traditional knowledge of Tanzania without obtaining a permit from appropriate Competent Authority. Application of Access Permit 14. A person who intends to access genetic resources or associated traditional knowledge for commercial or non commercial purposes, shall apply for Access Permit from the appropriate Competent Authority. Procedures for application of Access Permit 15.-(1) Procedures for application of the Access Permit shall be in accordance with the laws governing specific genetic resources or associated traditional knowledge. (2) Without prejudice to sub-regulation (1) and any other written law related to genetic resources or associated traditional knowledge, every Competent Authority shall, when dealing with application for Access Permit to such resources adhere to the following: (a) a written prior informed consent which has been obtained from local community or respective local government authority; (b) a Benefit Sharing Agreement framework which is established in accordance with these Regulations; (c) whether conservation status of a genetic resource is known; (d) whether the impact to the local community is assessed; (e) whether the access will cause genetic erosion or affect any function of the ecosystem; (f) the access may not adversely affect food security; (g) the use of the genetic resource or associated traditional knowledge is not for the purposes contrary to the national interest; (h) the use of the genetic resource or associated traditional knowledge is not for the development of biological or chemical weapons for military or terrorism purposes; (i) the applicant has not committed an offence under Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 14 any other laws applicable in or outside Tanzania; (j) the applicant has not been declared bankrupt or insolvency; (k) the application complies with the requirements of these Regulations or any other written law; and (l) the use of genetic resources or associated traditional knowledge is not contrary to the related international agreements or instruments to which the United Republic of Tanzania is a party. Responsibil ities of Access Permit holder 16. The Access Permit holder shall have responsibilities to (a) adhere to Materials Transfer or Data Sharing Agreements in accordance with these Regulations; (b) inform the Competent Authority of all discoveries made during the validity of the granted Access Permit; (c) provide a semi-annual and annual report on the status of ongoing collection for genetic resources and associated traditional knowledge; (d) In the event that the collection is of a duration of three months or less, provide a final report of collection of genetic resources or associated traditional knowledge; and (e) ensure the benefit arises from genetic resources or associated traditional knowledge are shared in accordance with these Regulations. Restriction for export 17. A person shall not export genetic resources without export clearance certificate prescribed in the Second Schedule. Application for export clearance certificate 18.-(1) A person who intends to export genetic resources for commercial or non-commercial purposes, shall apply for export clearance certificate to the National Focal Point. (2) An application for export clearance certificate shall be made in a prescribed Form in the Third Schedule. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 15 Accompan ying documents 19. An application for export clearance certificate shall be accompanied by (a) a written prior informed consent from a local community managing genetic resources or associated traditional knowledge; (b) access permit or research permit issued by a Competent Authority; (c) Benefit Sharing Agreement; (d) Mutual Agreed Terms; (e) Material Transfer Agreement; (f) proof of payment of an application fee prescribed in the Fourth Schedule; and (g) any other relevant information or document as may be required by the National Focal Point upon submission of the application. Import or transit clearance 20. For the purpose of compliance to the Nagoya Protocol, a person imports in or transit genetic resources through Tanzania shall, declare the genetic resources in his possession or under his control to customs at the point of entry or exit, and shall provide evidence of lawful acquisition of such genetic resources from the country of origin. Restriction on transfer of permit 21. Export clearance certificate or access permit issued under these Regulations shall not be transferable without authorisation of issuing authority. intellectual property rights for local community 22.-(1) The National Focal Point shall facilitate protection of the community intellectual property rights as they have enshrined and protected under the norms, practices and customary law found in or within local communities whether such law is written or not. (2) The publication of any written or oral information of a genetic resource, associated traditional knowledge, the presence of genetic resources in a gene bank, any other collection or its local use may not preclude the local community from exercising its community intellectual Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 16 property rights in relation to the genetic resources or associated traditional knowledge. Validity of export clearance certificate 23. Export clearance certificate issued under these Regulations shall be (a) valid for the period specified in it; and (b) applicable to the genetic resources or associated traditional knowledge specified therein. Suspension , cancelation or revocation of export clearance certificate 24.-(1) Where the holder of export clearance certificate contravenes any of the terms or conditions imposed, the National Focal Point shall through a written notice, notify the holder on the intention to suspend, cancel or revoke the permit. (2) The holder of export clearance certificate shall be required, within thirty days of receipt of the notice to show course as to why the certificate should not be suspended, cancelled or revoked. (3) Upon receipt of representation, the National Focal Point shall within fourteen working days communicate the decision to the export clearance certificate holder. (4) Where the National Focal Point suspends, cancels or revokes an export clearance certificate, shall publish such decision at least in three newspapers with nationwide circulation. Monitoring of compliance of access permit or export clearance certificate 25.(1) The Competent Authority shall be required to monitor compliance of terms and conditions set out in the access permit in accordance with these Regulations or relevant legislation of such specific genetic resources or associated traditional knowledge. (2) The National Focal Point shall monitor compliance of the terms and conditions set out in the export clearance certificate. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 17 PART VI BENEFIT SHARING MECHANISMS Benefit Sharing 26.-(1) The benefit accrued from collection, modification and utilization of the genetic resources or associated traditional knowledge shall be shared in accordance with the principles of fairness and equitable and Mutually Agreed Terms. (2) The export clearance certificate holder shall facilitate both monetary and non-monetary sharing of benefit arising from the use of genetic resources or associated traditional knowledge. (3) For the purpose of this regulation (a) monetary benefit may include (i) access fee and fee per sample collected or acquired; (ii) fee for analysis of collected or acquired sample; (iii) upfront payments; (iv) milestone payments; (v) payment of loyalties; (vi) research funding; (vii) joint ownership of relevant intellectual property rights; (viii) joint ventures; (ix) license fee in case of the genetic resource or its associated knowledge is to be utilised for commercial purposes; (x) fees to be paid to trust fund supporting conservation and sustainable use of biodiversity; (xi) export fee per sample collected or acquired; and (xii) salaries and professional fee where mutually agreed; (b) non-monetary benefit may include (i) collaboration, cooperation and contribution in scientific research and development Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 18 programmes; (ii) sharing of research and development results; (iii) participation in product development; (iv) permission to use genetic resource facilities including laboratory and database of the collaborating parties; (v) transfer of knowledge and technology related to genetic resources; (vi) capacity building; (vii) permission to use scientific information relevant to conservation and sustainable use of biological resources; (viii) permission to collect sample; (ix) equipment and infrastructure support; or (x) community development support. (4) Where genetic resources or associated traditional knowledge is collected in a protected area, the collector shall pay entry fee and other applicable fee to the respective Competent Authority. (6) Dividend of profit derived from the use of genetic resources or associated traditional knowledge shall be shared in accordance with these Regulations and the Mutual Agreed Terms. Categories for benefit sharing 27. Benefit Sharing Agreements shall depend on the specific purpose of access to genetic resources or associated traditional knowledge which may include commercial or non commercial purposes. Written prior informed consent 28. (1) A collector shall not access genetic resources or associated traditional knowledge of Tanzania without a written prior informed consent from relevant Competent Authority. (2) Without prejudice to sub-regulation (1), a written prior informed consent shall be granted in accordance with manner prescribed in the relevant written law governing specific genetic resources or associated traditional Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 19 knowledge. Access and Benefit Sharing Agreement 29.-(1) Before access or utilisation genetic resources or associated traditional knowledge the applicant and relevant Competent Authority shall negotiated and entered into a Benefit Sharing Agreement. (2) The Benefit Sharing Agreement shall to contain the following: (a) full details of the parties to the agreement which include (i) names; (ii) identification; (iii) address; (iv) registration number and business address for a business person; and (v) any other related information which may be required by a Competent Authority; (b) information and description of the intended genetic resources to be accessed, which may include (i) name of the genetic resource or associated traditional knowledge to be accessed; (ii) type of genetic resources; (iii) quantity of genetic resources to be collected; (iv) geographical or ecological area where the genetic resource is to be collected; and (v) any other related information which may be required by a Competent Authority; (c) description of time intended to be spent in access and other stages of utilization of genetic resources or associated traditional knowledge; (d) description on purpose of access of genetic resources or associated traditional knowledge; (e) intended use of the genetic resources or associated traditional knowledge; (f) modality and type of benefit sharing; (g) rights and responsibilities of parties providing or Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 20 accessing the genetic resources or associated traditional knowledge and Benefit Sharing Agreement; (h) ownership and management of data and research findings; (i) reason for suspension or termination of agreement; (j) procedure for termination of access permit; (k) consequences of the breach of terms and conditions of Mutual Agreed Terms; (l) conditions in relation to intellectual property rights associated with genetic resources or associated traditional knowledge; (m) limitations if any on the possible use of the genetic resources or associated traditional knowledge; (n) strategy relating to biodiversity conservation; (o) right and obligation of parties; (p) settlement of disputes; (q) amendments; (r) description on force majure; and (s) such other relevant information as may be required for necessary facilitation Benefit Sharing Agreement. Copies of agreement 30.-(1) Any agreement concluded under these Regulations shall be in six original copies to be distributed to (a) applicant or collector; (b) Competent Authority; (c) National Focal Point; (d) manager or authorised representative of genetic resources or associated traditional knowledge; (e) local government authority where the genetic resources or associated traditional knowledge is found; and (f) local community in case the genetic resources or associated traditional knowledge managed by a person. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 21 Review of Benefit Sharing Agreement 31.-(1) Terms and conditions in the Benefit Sharing Agreement shall be reviewed within the time agreed and provided in the agreement between the parties. (2) Any provision of the signed Benefit Sharing Agreement may be amended after consultation and approval of the parties to the agreement. PART VII RIGHTS OVER ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES Rights of local community 32. Local communities shall, where the genetic resources or associated traditional knowledge are found within their areas of jurisdiction, have right to (a) access of genetic resources or associated traditional knowledge for consumption; (b) be consulted for issuance of a written prior informed consent on access to genetic resources or associated traditional knowledge; (c) participate in scientific research and other activities involving genetic resources or associated traditional knowledge collected from their area of jurisdiction; and (d) share monetary or non-monetary benefits arising from utilisation of genetic resources or associated traditional knowledge found within their area of jurisdiction. Rights of access permit or export clearance certificate holder 33. Access permit or export clearance certificate holder shall have right to (a) access to genetic resources or associated traditional knowledge as per the granted access permit; (b) sustainable use as per the terms and condition set out in the access permit or export clearance certificate; (c) fair and equitable sharing of benefit arising from the utilisation of such genetic resources or Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 22 associated traditional knowledge in accordance with these Regulations; and (d) renew or extend access permit in accordance with the specific legislations governing specific Competent Authority issued the permit. PART VIII GENERAL PROVISIONS Offences and penalties 34. -(1) A person who (a) access genetic resources or associated traditional knowledge without a written approval issued by Competent Authority; (b) breach any terms and conditions attached to the permit granted under these Regulations or any other relevant laws; (c) fails to furnish information related or connected to access to genetic resources or associated traditional knowledge required under these Regulations or relevant laws; (d) provide false, misleading or deceptive information in order to secure an approval; and commits an offence and shall, on conviction be liable to a fine of not less than fifty thousand shillings but not exceeding one billion shillings or to imprisonment for a term of not less than three months but not exceeding seven years or to both. (2) A person shall, on conviction of an offence under subregulation (1), be prohibited from accessing genetic resources or associated traditional knowledge of Tanzania. Transitiona l period 35.-(1) Access permit holder engaged in access to genetic resources or associated traditional knowledge before coming into force of these Regulations, shall be required to comply with the requirements of these Regulations within twelve months from the date commencement. (2) Without prejudice to the provision of subregulation (1), any payment payable for access to genetic resources or associated traditional knowledge in accordance Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 23 with these Regulations or any other written law shall be paid during the transitional period. Duty to give feedback 36. The access permit or export clearance certificate holder granted under these Regulations or any other relevant laws, shall be required to give feedback of any result, development or naturalized breeds connected to the genetic resources or associated traditional knowledge accessed. Record keeping 37. The access permit holder or export clearance certificate holder, shall be required to keep information, documents and records of transactions connected to the genetic resources or associated traditional knowledge accessed. Appeals 38.-(1) A person aggrieved by the decision made under these Regulations, in accordance with the provision of the Act. (2) Where an appeal under subregulation (1) lies to the Minister, it shall be made, within thirty days from the date of decision and shall be by way of a letter stating the grounds of appeal attached with the decision made under these Regulations and any necessary documents as the Minister may require. (3) The Minister shall make decision on the appeal within fourteen days from the date of receipt of an appeal. (4) The Minister shall within seven days from the date of his decision, communicate his decision and the reasons for the decision to the appellant Powers to issue policy guidelines or directives 39. The Minister may issue policy guidelines or directives to facilitate effective implementation of these Regulations. Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 24 FIRST SCHEDULE (Made under regulation 12(a)) PRIOR INFORMED CONSENT FORM FOR ACCESS TO GENETIC RESOURCES OR ASSOCIATED TRADITIONAL KNOWLEDGE I/We ................................................................................................................................................... ..... being the manager/custodian of the following genetic resources or associated traditional knowledge: ................................................................................................................................................... ..... ................................................................................................................................................... ..... (State the type of genetic resources or associated traditional knowledge) Provide location Information Village/street: ………………………………………………………………. Ward:………………………………………………………………………… District/Town/Municipal/City:…………………………………………….. Region:……………………………………………………………………… hereby consent that ............................................................................................................... (Name and address of applicant for prior informed consent) may apply to the Competent Authority for consideration to access the above stated genetic resources or associated traditional knowledge found in my/our management/custody. This consent is granted subject to the following conditions (1) ..................................................................................... (2) ..................................................................................... (3) ..................................................................................... (4) ..................................................................................... This consent is granted this………………………… day of…………………….20………….. …………………………………………… Signature/Seal of the Managing Authority Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 25 SECOND SCHEDULE (Made under regulation 17) THE UNITED REPUBLIC OF TANZANIA THE ENVIRONMENTAL MANAGEMENT (ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES) REGULATIONS, EXPORT CLEARENCE CERTIFICATE Certificate No...................……. This is to certify that ………………..................................……of P. O. Box………....……………… clearance has been granted to export genetic resources from ...................................................................…….(name country of origin of the genetic resources) to..............................................................................................(name transit (if any) and destination country) ……………………………………………………………………………………… List by name, type and size of genetic resources knowledge collected and intended to be exported …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …… This certificate is to acknowledge that the above-mentioned collector, obtained an Access Permit as a requirement for an approval to export the above-mentioned genetic resources of Tanzania origin. The certificate is to approve that, the permit holder be allowed on transit and accepted in the country of destination with such genetic resources. This certificate shall not be valid for any subsequent export. Terms and conditions for this certificate are set out overleaf. Name…………………………….…………………...…. Signature ……………….……………………………... Date……………………….……………………………… Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 26 Minister responsible for Environment THIRD SCHEDULE (Made under regulation 18(2)) APPLICATION FOR EXPORT CLEARANCE CERTIFICATE To*: ...........................................................(address of the National Focal Point) ................................................................... ............................................................ ….. ……………………………………………. I/We*..............................................................of .................................................... here by apply for.............................................................................................................................................. ................... The Export Clearance Certificate is being applied in respect of the following genetic resources (attach the Access Permit) issued by the relevant Competent Authority. ................................................................................................................................................... ..... ................................................................................................................................................... ..... I/We* hereby further declare that to the best of my/our knowledge that, the information given in this application is correct and true. Date Signature of Applicant FOR OFFICIAL USE ONLY Application received and worked by ................................................................................ (name of the officer) This………………………..day of ………………………………………..20………………… *Delete whichever is not applicable Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) 27 FOURTH SCHEDULE (Made under regulations 19(f)) FEES FOR EXPORT CLEARANCE CERTIFICATE PURPOSE NON-CITIZEN PRESCRIBED FEES NON COMMERCIAL Application for Export Clearance Certificate of genetic resources Individual: USD 150 Corporate: USD 300 FOR COMMERCIAL Application for Export Clearance Certificate of genetic resources Pharmaceutical’s: USD 1,000 Other product: USD 1,500 CITIZEN NON COMMERCIAL Application for Export Clearance Certificate of genetic resources Individual: Tzs 50,000/= Corporate: Tzs 150,000/= FOR COMMERCIAL Application for Export Clearance Certificate of gnetic esources Pharmaceutical: Tzs 200,000/= Other products: Tzs 1,000,000/= Dodoma, SELEMAN SAID JAFO ……………….., 2024 Minister of State- Vice President’s Office Union and Environment