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national biotechnology Authority BILL, 2005

MEMORANDUM

This Bill establishes the National Biotechnology Authority, a statutory body which will be responsible for managing the import, research, development, production, use and release of all biotechnology techniques, processes and products, ensuring that such activities do not cause adverse effects on health, the environment, the economy, national security and social norms and values. In more detail the Bill provides as follows:

Part I of the Bill deals with preliminary matters, i.e. the title of the Bill, date of commencement and the interpretation of terms.

In Part II of the Bill, clause 4 provides for the establishment of the National Biotechnology Authority which will be a body corporate with the usual features of such corporations. Clause 5 details the functions of the Authority. Central to these functions is to regulate, supervise, co-ordinate, promote and develop biotechnology having regard to the need to maintain safety in the import, export, or manufacture or processing of any biotechnology product. The Authority will be responsible for advising the Minister on matters of national policy in biotechnology..

Clause 6 constitutes a board which will be entrusted with directing and controlling the affairs of the Authority.

Clause 7sets out the general disqualifications for appointment as members of the Board and persons who already serve as members of two or more statutory bodies will not qualify as members of the Board. Clauses 8 to 17 are standard provisions dealing with conditions of service of members of the Board, committees of the Board, the holding of meetings and the appointment of the chief executive, etc. Clause 18 provides for the appointment and functions of a chief executive officer. Clause 20requires the Authority to submit reports to the Minister and the Minister may give directions on matters of policy to the Board (clause 21).

Part III of the Bill makes provision in clause 22 for the control and monitoring of use of products of biotechnology. Of importance is the issuing by the Board of biotechnology guidelines and standard procedures which are binding on all users of product of modern biotechnology. The Board will also establish a register for the purpose of registering facilities utilised for the development, production or use of biotechnology (clauses 2325). Furthermore, the Board shall appoint inspectors whose main purpose is to inspect any activity or process carried out in or upon premises in connection with the use of any product of biotechnology.

Part IV of the Bill makes provision in clause 30 for the establishment of biosafety committees, which shall ensure that any biotechnology guidelines or standards and the terms and conditions of registration are complied with by all persons engaged in biotechnology research, development and application. Every project at each biotechnology research institute shall be monitored by a project supervisor.

Part V of the Bill makes provision in clause33 for the appointment of inspectors of the Authority.

Part VI of the Bill makes provision in clauses 3442 forthe management of the financial affairs of the Authority. Significant is clause 34 under which the main source of the funds of the Authority will include Parliamentary appropriations and grants from the Fund as may be determined by the Minister. The rest of the provisions in this Part are standard.

Part VII of the Bill provides in clauses 43 to 48 for the National Biotechnology Fund. Clause 43 establishes the Fund which will be vested in the Minister as trustee. Central to the objects of the Fund is to promote the marketing and production of, stimulate demand for, research into modern biotechnology. It will also be the purpose of the Fund to ensure that personnel are appropriately trained to fulfil the objects of the Fund and the Authority. Under clause 44, the Fund will consist mainly of levies which will be collected in terms of this Bill and of Parliamentary appropriations. Under clause 45, the Fund will be administered by the Authority on behalf of the Minister and in accordance with instructions given by the Minister. Clause 46 sets out the purposes to which the Fund will be applied. Grants will be made to the Authority from the Fund for the purposes of the functions of the Authority. The Fund will also be applied to meet its objects as set out in clause 44. The cost of administering the Fund will also be met out of the Fund. The financial year of the Fund will be the same as that of the Authority (clause 47) and the Authority will maintain its accounts. The Fund will be audited by the Comptroller and Auditor General in terms of the Auditor and Exchequer Act [Chapter 22:03].

Part VIII of the Bill provides for the imposition of levies under clauses 49 to 51. Under clause 49, the Minister is authorised, for the benefit of the Fund, to impose levies on producers, processors and/or buyers of any product of biotechnology. The details as to how this will be carried out will be prescribed in a statutory instrument to be made by the Minister. Clause 50 provides for the suspension or increase of levies as may be necessary and clause 51 requires that consultations with organisations of producers, processors and buyers of products of biotechnology be held before the imposition, withdrawal, suspension or increase of levies. Failure to pay a levy will be an offence (clause 52) and outstanding levies will be a debt to the Fund, attracting interest or a surcharge and may be sued for in court (clause 53). Clause 54 grants the Minister additional powers regarding the imposition or increase of a levy for a period of six months, and the manner in which this must be done, in the event of an emergency in the biotechnology industry.

Part IX of the Bill deals with general matters pertaining to confidentiality on information acquired in the exercise of functions in terms of this Bill and payment of fees for registration in relation to foreign research. Clause 58 provides for appeals against decisions of the chief executive and the Board to the Minister and the Administrative Court. Clause 59 provides for the Minister’s powers, in consultation with the Board, to make regulations on a wide range of matters relating to the implementation of this Bill. Clause 60 provides for the repeal of The Research (Biosafety ) Regulations, 200, published in Statutory Instrument 20 of 2000.
NATIONAL BIOTECHNOLOGY Authority BILL, 2005

ARRANGEMENT OF SECTIONS

PART I

Preliminary

Section

1.Short title and date of commencement.

  1. Interpretation.

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

  1. Power of Board to regulate biotechnology practices.
  2. Register of facilities and permits.
  3. Certain facilities and research to be registered or permitted.
  4. Application for and grant or refusal of registration or permission.
  5. General duty of care to be observed by users of products of biotechnology.
  6. Notification of releases and accidents.
  7. Returns to be furnished by registered users.

PART iV

Biotechnology Committees

  1. Interpretation in Part IV.
  2. Biosafety Committees.
  3. Project supervisors.

part v

inspectors of authority

  1. Appointment and functions of inspectors.
  2. Inspections.

part vi

Financial Provisions Relating to Authority

34.Funds of Authority.

35.Investment of moneys not immediately required by Authority.

36.Financial year of Authority.

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

43Establishment 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 and approval 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

  1. Conflicts of interests.
  2. Confidentiality.
  3. Fees for registration or permission in relation to foreign research.
  4. Appeals.
  5. Regulations.
  6. Repeal of regulations made under Part VA of Cap. 10:22

Schedule: Powers of Authority.

Presented by the Minister of Science and Technology Development

BILL

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.

ENACTED by the President and the Parliament of Zimbabwe.

PART I

PRELIMINARY

1Short title and date of commencement

(1)This Act may be cited as the National Biotechnology Authority Act [Chapter14:31].

(2)This Act shall come into operation on a date to be fixed by the President by statutory instrument.

2Interpretation

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 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 term 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;

“Fund” means the Biotechnology Fund established by section 43;

“general release”, in relation to 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 are 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 has 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 to whom a permit has been issued in terms of section 25;

“release”, in relation to products of biotechnology, means a general release or a trial release;

“Research Council” means the Research Council of Zimbabweestablished in terms of the Research Act [Chapter10:22].

“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 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.

3Application of Act

(1)Except where it is expressly provided to the contrary, this Act shall be construed as being in addition to and not in substitution for any other law which is not in conflict or inconsistent with this Act.

(2)This Act shall apply to

(a)all activities aimed at research into and the development, importation, exportation and use of biotechnological processes;

(b)the import export, contained use, release or placing on the market of any product of biotechnology that is likely to have adverse effect on human health, the environment, the economy, national security or social norms and values;

(c)any activity involving biological and molecular engineering technologies such as metabolic engineering, proteomics, metabolomics, nanotechnology, genetic modifications, cloning, DNA-chip technology, bioinformatics and such other technologies as may be declared by the Authority to constitute potentially harmful research or undertakings;

(d)all measures aimed at minimising the impact of biotechnological processes on national security, human health, animals, plants and the environment.

PART II

National Biotechnology Authority

4Establishment of Authority

There 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.

5Functions and powers of Authority

(1)The general function of the Authority shall be to advise the Minister on all aspects concerning the development, production, use, application and release of products of biotechnology, and ensure that all activities with regard to such development, production, use, application and release are performed in accordance with this Act.

(2)The Authority shall have the following specific functions—

(a)to evolve a long-term policy for safety in biotechnology in Zimbabwe;

(b)to actively promote biotechnology research, development and application in Zimbabwe;

(c)to review project proposals concerning high risk category organisms and controlled experimental trials involving them, and make decisions on whether to approve, prohibit or restrict such trials;

(d)to review reports of all ongoing approved projects and controlled experimental trials involving high risk category organisms;

(e)to approve deliberate releases of properly evaluated products of biotechnology;

(f)to approve the large-scale use of products of biotechnology in industrial production and application;

(g)to assist in the clearance of applications for setting up industries based on the use of products of biotechnology;

(h)to monitor and approve the discharge of biological waste from laboratories and hospitals into the environment;

(i)to ensure that biotechnology guidelines and standards are adhered to generally and in the execution of projects or controlled experimental trials involving high risk category organisms;

(j)to recommend training programmes for biosafety officers;

(k)to identify, prioritise and propose areas for standardisation of products of biotechnology to the Standards Association of Zimbabwe, the Medicines Control Authority of Zimbabwe, the Environmental Management Authority and other relevant bodies;

(l)to approve the safety aspects of the import, export, manufacture, processing and selling of any products of biotechnology, including substances, foodstuffs and additives containing products of biotechnology;

(m)to advise the customs authorities on the import and export of biologically active material and products of biotechnology;

(n)to collect and disseminate information pertaining to safety procedures associated with work on or research into modern biotechnology;

(o)to establish contact and maintain liaison with bodies in other countries and international organisations concerned with monitoring work on or research into biotechnology;