National Biotechnology Authority Act [Chapter 14:31]

Chapter 14:31

National Biotechnology Authority Act

Act 3/2006

(TheActwillcomeintooperationonadatetobefixedbythePresident.)

ARRANGEMENT OF SECTIONS

PART I

PRELIMINARY Section

1. Short title and date of commencement.
3. Application of Act.

PART II

NATIONAL BIOTECHNOLOGY AUTHORITY

4. Establishment of Authority.
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 Board.
11. Filling of vacancies on Board.
12. Meetings and procedure of Board.
13. Committees of Board.
14. Remuneration and allowances of members of Board and committees.
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 committees.
18. Appointment and functions of Chief Executive Officer of Authority.
19. Execution of contracts and instruments by Authority.
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

BIOTECHNOLOGYCOMMITTEES

29. Interpretation in Part IV.
30. Biosafety Committees.
31. Project supervisors.

PART V

INSPECTORS OF AUTHORITY

32. Appointment and functions of inspectors.

PART VI

FINANCIALPROVISIONS RELATING TOAUTHORITY

34. Funds of Authority.
35. Investment of moneys not immediately required by Authority.
36. Financial year of Authority.
37. Accounts of Authority.
38. Audit ofAuthority’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 Fund.
45. Administration of Fund.
46. Application of Fund.
47. Financial year of Fund.
48. Books of account and audit of Fund.

PART VIII

LEVIES

49. Imposition of levies.
50. Withdrawal, suspension or increase of levies.
51. Consultation required for imposition, withdrawal, suspension or increase of levies.
52. Failure to pay, collect or remit levies.
53. Recovery of unpaid levies.
54. Minister’s powers in respect of levies in case of emergency.

PART IX

GENERAL

55. Conflicts of interests.
57. Fees for registration or permission.
60. Repeal of regulations made under Part VA of Cap. 10:22.

SCHEDULE

SCHEDULE: Powers of Authority.

AN ACT to establish the National Biotechnology Authority whose function shall be to support and manage biotechnology research, development and application; to provide for the constitution of a board of the Authority; to provide for the establishment of the National Biotechnology Fund for the development of the products of biotechnology; to provide for the fixing of standards of quality and other matters relating to products of biotechnology produced in Zimbabwe; and to provide for matters connected with or incidental to the foregoing.

[Date of commencement : Not yet in force.]

PART I

PRELIMINARY

                       1    Short title and date of commencement

• This Act may be cited as the National Biotechnology Authority Act [Chapter 14:31].
• This Act shall come into operation on a date to be fixed by the President by statutory instrument.

                       2    Interpretation

2. In 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

• 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
• carries on any potentially harmful research or undertaking or undertakes the contained use or trial release of products of biotechnology; or
• 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.