National Biotechnology Authority Act
- Commenced on 1 September 2006
- [This is the version of this document at 31 December 2016 and includes any amendments published up to 31 December 2017.]
- [Note: This version of the Act was revised and consolidated by the Law Development Commission of Zimbabwe]
Part I – Preliminary
1. Short title and date of commencement
2. InterpretationIn this Act—“accident” means any incident involving an unintended release of biotechnology products into the environment which may have an immediate or delayed adverse impact on the environment;“Authority” means the National Biotechnology Authority established in terms of section 4;“biosafety committee”, “biosafety officer”, biotechnology research institute”, “project” and “project supervisor” have the meanings assigned to those terms by section 29;“biotechnology” means any technique that uses living organisms or parts of organisms to make or modify products, to improve plants or animals, or to develop micro-organisms for specific purposes;“Board” means the National Biotechnology Board established in terms of section 6;“contained use” means any activity in which products of biotechnology processes are cultured, stored, used, transported, destroyed or disposed of, and for which physical barriers or a combination of physical barriers together with chemical or biological barriers or both are used to limit contact thereof with the environment;“Chief Executive Officer” means the Chief Executive Officer of the Authority appointed in terms of section 18;“control” means to examine, regulate, manage or direct any activity within a person’s jurisdiction;“DNA” means deoxyribonucleic acid;“environment” means the aggregate of surrounding objects, conditions and influences that affect the life and habits of human beings or any other organism or collection of organisms;“Environmental Management Agency”, “Health Professions Council” and “Medicines and Allied Substances Control Authority of Zimbabwe” means the agency, council and authority established respectively by the Environmental Management Act [Chapter 20:27] (No. 13 of 2002), the Health Professions Act [Chapter 27:19] (No. 6 of 2000) and the Medicines and Allied Substances Control Act [Chapter 15:03];“Fund” means the Biotechnology Fund established by section 43;“general release”, in relation to a product of biotechnology, means the introduction of a product of biotechnology into the environment by whatever means, where the product is no longer contained by any system of barriers and is no longer under any person’s control;“gene therapy” means any technique for delivering functional genes to replace aberrant ones into living cells by means of a genetically modified vector or by physical means in order to genetically alter the living cell;“genetically modified organism” means an organism the genes or genetic material of which have been modified in a way that does not occur naturally through mating or natural recombination or both, and “genetic modification” shall have a corresponding meaning;“hazard” means an intrinsic biological, chemical or physical characteristic of a product of biotechnology which could lead to an adverse impact on human beings, plants, animals, micro-organisms and the environment;“inspector” means a person appointed as an inspector in terms of section 32;“member” means a member of the Board;“Minister” means the Minister responsible for Science and Technology Development or any other Minister to whom the President may, from time to time, assign the administration of this Act;“monitor” means maintain regular surveillance over, check, warn about or record a situation or process;“organism” means any biological entity, whether microscopic or not, capable of replication;“permit” means a permit granted in terms of section 25;“potentially harmful research or undertaking” means any activity involving the processes or techniques referred to in section 3(2)(a) or (c) which the Authority has, in terms of section 22(5)(b), declared to be potentially harmful research or a potentially harmful undertaking;“product of biotechnology” means any organism or part of any organism resulting from the application of any biotechnology technique, and includes a genetically modified organism;“recombinant DNA” means genetic material produced by the combining of DNA molecules from different organisms;“register” means the register established in terms of section 23;“registered user”, in relation to products of biotechnology, means a user of such product whose premises are registered or who is granted a permit in terms of section 25;“release”, in relation to a product of biotechnology, means a general release or a trial release;“Research Council” means the Research Council of Zimbabwe established in terms of the Research Act [Chapter 10:22].“risk” means the combination of the magnitude of the consequences of a hazard, if it occurs, and the likelihood that the consequences will occur;“trial release” means the deliberate release of a product of biotechnology into the environment in the open under conditions where the degree of dissemination of the product of biotechnology is limited by chemical or physical barriers or by built-in barriers which prevent the survival of such products in the environment;“user”, in relation to a product of biotechnology, means a person who—(a)owns or controls any facility utilised or to be utilised for any potentially harmful research or undertaking, or generally for the development, production, use or application of products of biotechnology, including any facility utilised or to be utilised in connection with the contained use or trial release of such product; or(b)carries on any potentially harmful research or undertaking or undertakes the contained use or trial release of products of biotechnology; or(c)sells or markets products of modern biotechnology or utilises such product, and is required by the terms of any biotechnology guidelines or standards to be authorised to do so by the Authority;“waste” means any matter, whether gaseous, liquid or solid or any combination thereof, which, in the opinion of the person controlling or possessing it, is an undesirable or superfluous by-product, emission, resolve or remainder of any process or activity in connection with products of biotechnology.
3. Application of Act
Part II – National Biotechnology Authority
4. Establishment of AuthorityThere is hereby established an authority, to be known as the National Biotechnology Authority, which shall be a body corporate capable of suing and being sued in its own name and, subject to this Act, of performing all acts that bodies corporate may by law perform.
5. Functions and powers of Authority
6. Board of Authority
7. Disqualifications for appointment as member
8. Terms and conditions of office of members
9. Vacation of office by appointed members
10. Suspension of appointed members of BoardThe Minister may suspend from office an appointed member of the Board against whom criminal proceedings are instituted for an offence involving dishonesty and, whilst that member is so suspended, he or she shall not carry out any duties or be entitled to any remuneration or allowances as a member.
11. Filling of vacancies on BoardOn the death of, or the vacation of office by, an appointed member, his or her office shall be filled within three months in accordance with section 6.
12. Meetings and procedure of Board
13. Committees of Board
14. Remuneration and allowances of members of Board and committeesEvery member of the Board or of a committee or co-opted persons shall be paid—
15. Disclosure of interests by members of Board and committees
16. Minutes of proceedings of Board and committees
17. Validity of decisions and acts of Board and committeesNo decision or act of the Board or a committee or act that is authorized by the Board or a committee shall be invalid solely because there was a vacancy in the membership of the Board or the committee or because a disqualified person purported to act as a member of the Board or the committee, as the case may be, at the time the decision was taken or the act was done or authorized.
18. Appointment and functions of Chief Executive Officer of Authority
19. Execution of contracts and instruments by Authority.An agreement, contract or instrument approved by the Board may be entered into or executed on the Authority’s behalf by any person generally or specially authorized by the Board for that purpose.
20. Reports of Authority
21. Minister may give Board directions on matters of policy
Part III – Control and monitoring of biotechnology
22. Power of Board to regulate biotechnology practices
23. Register of facilities and permits
24. Certain facilities and research to be registered or permitted
25. Application for and grant or refusal of registration or permission
26. General duty of care to be observed by users of products of biotechnology
27. Notification of releases and accidents
28. Returns to be furnished by registered users
Part IV – Biosafety Committees
29. Interpretation in Part IVIn this Part—“biosafety committee” means a biosafety committee established in terms of section 30;“biosafety officer” means a person referred to in section 30(1)(a);“biotechnology research institute” means a facility or associated group of facilities engaged in biotechnology research;“project” means any project involving biotechnology research;“project supervisor” means a person so designated in section 31(1);“specified level of risk” means a level of risk specified by the Board for a purpose referred to in section 22(2)(c).
30. Biosafety Committees
31. Project supervisors
Part V – Inspectors of Authority
32. Appointment and functions of inspectors
Part VI – Financial provisions relating to Authority
34. Funds of AuthorityThe funds of the Authority shall consist of—
35. Investment of moneys not immediately required by AuthorityMoneys not immediately required by the Authority may be invested in such manner as the Board, in consultation with the Minister, may approve.
36. Financial year of AuthorityThe financial year of the Authority shall be a period of twelve months ending on the 31st December in each year.
37. Accounts of Authority
38. Audit of Authority’s accounts
39. Powers of auditors
40. Authority to make certain charges to revenue account
41. Establishment and operation of general reserve
42. Meeting of deficiencies
Part VII – Biotechnology Fund
43. Establishment and object of Fund
44. Composition of FundThe Fund shall consist of—
45. Administration of Fund
46. Application of FundMoneys in the Fund shall be applied to the following purposes—
47. Financial year of FundThe financial year of the Fund shall be a period of twelve months ending on the 31st December each year.
48. Books of account and audit of Fund
Part VIII – Levies
49. Imposition of levies
50. Withdrawal, suspension or increase of leviesWithout derogation from section 21 of the Interpretation Act [Chapter 1:01], the Minister, in consultation with the Authority, may, by statutory instrument—
51. Consultation required for imposition, withdrawal, suspension or increase of leviesBefore publishing a statutory instrument in terms of section 49 or 50, the Minister shall cause the Authority to consult any organisations of producers, processors and buyers of product of biotechnology who will be affected by it.
52. Failure to pay, collect or remit levies
53. Recovery of unpaid leviesA levy and any interest or surcharge connected therewith shall be a debt due to the Fund, and any amount of levy or of such interest or surcharge that is not paid, collected or remitted may be recovered by the Minister, in his or her capacity as trustee of the Fund, by proceedings in a court of competent jurisdiction.
54. Minister’s powers in respect of levies in case of emergency
Part IX – General
55. Conflicts of interest
57. Fees for registration or permission
60. Repeal of Regulations made under Part VA of Cap. 10:22
History of this document
31 December 2016 this version
01 September 2006