Statutory Instrument 20 of 2000

Research (Biosafety) Regulations, 2000

ARRANGEMENT OF SECTIONS

PART I

PRELIMINARY

Section

  1. Title
  2. Application.

PART II BIOSAFETY BOARD

  1. Establishment and composition of Biosafety Board.
  2. Functions of Board and exercise thereof.
  3. Tenure of office and remuneration of members.
  4. Vacancies in Board.
  5. Meetings of Board.

PART III

CONTROL AND MONITORING OFUSE OF GENETICALLYMODIFIEDORGANISMS

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

PART IV

INSTITUTIONAL BIOSAFETY COMMITTEES

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

PART V

BIOSAFETY STAFFOFCOUNCIL

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

PART VI

GENERAL

  1. Conflicts of
  2. Fees for registration or permission in relation to foreign research.

IT is hereby notified that the Vice-President has, in terms of section 32 of the Research Act [Chapter

10:22] and after consultation with the Research Council of Zimbabwe, made the following regulations:

PART I PRELIMINARY

  1. Title

These regulations may be cited as the Research (Biosafety) Regulations, 2000.

2.     Interpretation

In these regulations—

“accident” means any incident involving an unintended general release of genetically modified organisms which may have an immediate or delayed adverse impact on the environment;

“biosafety committee” has the meaning assigned to that term in section 17;

“biosafety officer” has the meaning assigned to that term in section 17;

“biosafety guidelines and standards” means biosafety guidelines or standards issued in terms of subsection

(1) of section 9;

“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 Biosafety Board established in terms of section 4;

“contained use” means any activity in which organisms are genetically modified, or in which such genetically modified organisms 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;

“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;

“general release”, in relation to genetically modified organisms, means the introduction of genetically modified organisms into the environment by whatever means, where the organisms are no longer contained by any system of barriers and are no longer under any person’s control, so that the organism is likely to survive and be disseminated; “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 genetically modified organism which could lead to an adverse impact on the environment;

“inspector” means a person appointed as an inspector in terms of section 21;

“member” means a member of the Board, and includes an alternate member appointed and acting in terms of subsection (4) of section 4;

“monitor” means maintain regular surveillance over, check, warn about or the record a situation or process;

“organism” means any biological entity, whether microscopic or not, capable of replication;

“permit” means a permit issued in terms of section 12;

“project” has the meaning assigned to that term in section 17;

“project supervisor” has the meaning assigned to that term in section 17;

“recombinant DNA” means genetic material produced by the combining of DNA molecules from different organisms; “register” means the register established in terms of section 10;

“registered user”, in relation to genetically modified organisms, means a user of such organisms whose premises are registered or to whom a permit has been issued in terms of section 12;

“release”, in relation to genetically modified organisms, means a general release or a trial release;

“risk” means the combination of the magnitude of the consequences of a hazard, if it occurs, and the likelihood that the consequences will occur; “secretary” means the secretary of the Board designated as such in terms subsection (2) of section 4;

“trial release” means the deliberate release of genetically modified organisms into the environment in the open under conditions where the degree of dissemination of the genetically modified organisms is limited by chemical or physical barriers or by built-in barriers which prevent the survival of such organisms in the environment;

“user”, in relation to genetically modified organisms, means a person who

  • owns or controls any facility utilised or to be utilised for any potentially harmful research referred to in section 3, or generally for the development, production, use or application of genetically modified organisms, including any facility utilised or to be utilised in connection with the contained use or trial release of such organisms; or
  • carries on any potentially harmful research referred to in section 3, or undertakes the contained use or trial release of genetically modified organisms; or
  • sells or markets genetically modified organisms or utilises such organisms, and is required by the terms of any biosafety guidelines or standards to be authorised to do so by the Board;

“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 genetically modified organisms.

3.     Application

These regulations shall apply to

  • the following techniques, which, for the purposes of Part VA of the Act, shall be deemed to constitute potentially harmful research or undertakings—
    • techniques in which recombinant DNA molecules or genetically modified organisms are employed in—
      1. in vitro fertilisation in human beings and animals; or
      2. conjunction, transduction, transformation or any other natural process; or
      3. polyploid induction;
    • techniques in which genetically modified organisms as recipient or parental organisms are employed in— A. mutagenesis; or
      1. the construction and use of somatic hybridoma cells; or
      2. cell fusion (including protoplast fusion) of plant cells; and
    • any activities involving genetically modified organisms that are declared by the Council in terms of paragraph (b) of subsection (5) of section 9 to constitute potentially harmful research or undertakings. PART II

BIOSAFETY BOARD

4.     Establishment and composition of Biosafety Board

4.(1) The Council shall establish a safety board known as the Biosafety Board which shall consist of at least three and not more than fifteen members appointed by the Council.

  • Of the members appointed in terms of subsection (1) the Council shall designate a chairman and a deputy chairman of the Board and, subject to section 20, a member to act as secretary of the Board.
  • The deputy chairman of the Board shall exercise the functions of the chairman during any period that the chairman is unable to exercise his functions.
  • The Council may appoint persons as alternate members to the members appointed by it in terms of subsection (1), and any such alternate member may act as a member during any period that a substantive member is unable to exercise his functions.

5.     Functions of Board and exercise thereof

  • The general function of the Board shall be to advise the Council on all aspects concerning the development, production, use, application and release of genetically modified organisms, and ensure that all activities with regard to such development, production, use, application and release are performed in accordance with these regulations.
  • The Board shall have the following specific functions—
  • to evolve a long-term policy for safety in biotechnology in Zimbabwe;
  • to actively promote biotechnology in Zimbabwe;
  • to review project proposals concerning high risk category organisms and controlled experimental trials involving them, and advise the Council on whether to approve, prohibit or restrict such trials;
  • to review reports of all ongoing approved projects and controlled experimental trials involving high risk category organisms;
  • to approve deliberate releases of properly evaluated genetically modified organisms;
  • to approve the large-scale use of genetically modified organisms in industrial production and application;
  • to assist in the clearance of applications for setting up industries based on genetically modified organisms;
  • to monitor and approve the discharge of genetically modified organisms or cells or waste from laboratories and hospitals into the environment;
  • to ensure that biosafety guidelines and standards are adhered to generally and in the execution of projects or controlled experimental trials involving high risk category organisms;
  • to recommend a training programme for biosafety officers;
  • to identify, prioritise and propose areas for standardisation of products of recombinant DNA technology to the Standards Association of Zimbabwe, the Medicines Control Authority of Zimbabwe, the Hazardous Substances Control Board and other relevant bodies;
  • to approve the safety aspects of the import, export, manufacture, processing and selling of any genetically modified organisms or cells, including substances, foodstuffs and additives containing products of genetic engineering;
  • to advise the customs authorities on the import and export of biologically active material and genetically engineered organisms, substances or products;
  • to collect and disseminate information pertaining to safety procedures associated with work on or research into genetically modified organisms;
  • to establish contact and maintain liaison with bodies in other countries and international organisations concerned with monitoring work on or research into genetically modified organisms; (p) to perform such other functions as are provided for in these regulations.

(3) In order to discharge its functions, the Board may—

  • authorise or decline to authorise the any contained use of genetically modified organisms;
  • authorise or decline to authorise any general or trial release of genetically modified organisms;
  • inform any other country of an accident that may have an impact on that country’s environment;
  • co-operate or enter into agreements with any person or institution upon such conditions as the Council and the person or institution concerned may agree upon;
  • promote co-operation between Zimbabwe and any other country with regard to research, development and technology transfer in the field of genetically modified organisms.

6.     Tenure of office and remuneration of members

  • The term of office of members of the Board shall be three years.
  • A member whose term of office has expired shall be eligible for reappointment.
  • There may be paid to a member such fee for attendance at meetings of the Board as the Council, with the agreement of the Minister, may determine.

7.     Vacancies in Board

On the death of, or the vacation of office by, a member, the Council shall appoint a person to fill the vacancy until the expiry of the period during which the member would, but for his death or the vacation of his office, have continued in office:

Provided that, if, but for his death or the vacation of his office, the member would have continued to hold office for less than three months the Council need not appoint a person to fill the vacancy.

8.     Meetings of Board

  • Ordinary meetings of the Board shall be held at such time and place as the chairman of the Board shall decide on not less than fourteen days’ written notice, including an agenda, given to every member:

Provided that an ordinary meeting of the Board shall be held not less frequently than four times per year.

  • Special meetings of the Board may be held at the written request of a simple majority of the members on not less than fourteen days’ written notice, including an agenda, given to every member.
  • If, in the opinion of the chairman, special circumstances so require, the chairman may convene an emergency meeting of the Board on twenty-four hours’ written or verbal notice to every member of the Board.
  • If the chairman of the Board is prevented by any cause from exercising his functions in relation to the Board and the deputy chairman notifies the Council that he is unable to exercise the functions of chairman as provided in subsection (3) of section 4, the Council may appoint a member other than the deputy chairman to act as chairman of the Board and the member so appointed shall exercise the functions of chairman.
  • If at a meeting of the Board the chairman and the deputy chairman are absent and an acting chairman has not been appointed in terms of subsection (4), the members present may elect one of their number to preside as chairman at that meeting.
  • The quorum for any meeting of the Board shall be a majority of the members of the Board:

Provided that if a quorum is not present at any special or emergency meeting of the Board, the meeting shall, subject to at least twenty-four hours’ written or verbal notice to every member, be adjourned to a date not more than seven days later, and the quorum at such adjourned meeting shall be three members.

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