Genetically Modified Organisms Act [No. 15 of 1997]

Government Gazette, Vol. 383, No. 18029, 23 May 1997

Act

To provide for measures to promote the responsible development, production, use and application of genetically modified organisms; to ensure that all activities involving the use of genetically modified organisms (including importation, production, release and distribution) shall be carried out in such a way as to limit possible harmful consequences to the environment; to give attention to the prevention of accidents and the effective management of waste; to establish common measures for the evaluation and reduction of the potential risks arising out of activities involving the use of genetically modified organisms; to lay down the necessary requirements and criteria for risk assessments; to establish a council for genetically modified organisms; to ensure that genetically modified organisms are appropriate and do not present a hazard to the environment; and to establish appropriate procedures for the notification of specific activities involving the use of genetically modified organisms; and to provide for matters connected therewith.

(English text signed by the Acting President.)
(Assented to 20 May 1997.)

BE IT ENACTED by the Parliament of the Republic of South Africa, as follows:

Definitions

  1. In this Act, unless the context otherwise indicates-

                                i.            "accident" means any incident involving an unintended general release of genetically modified organisms which could have an immediate or delayed adverse impact on the environment; (xxi)

                               ii.            "appeal board" means an appeal board appointed in terms of section 19; (iv)

                             iii.            "applicant" means any person in control of facilities and activities involving genetic modification of organisms and includes "user"; (i)

                            iv.            "Committee" means the Advisory Committee established by section 10; (xvii)

                              v.            "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; (vii)

                            vi.            "control" means to examine, regulate, manage or direct any activity within a person's jurisdiction; (vi)

                           vii.            "Council" means the Executive Council for Genetically Modified Organisms established by section 3; (xxv)

                         viii.            "department" means the Department of Agriculture; (ix)

                             ix.            "Director-General" means the Director-General: Department of Agriculture; (x)

                              x.            "environment" means the aggregate of surrounding objects, conditions and influences that influence the life and habits of man or any other organism or collection of organisms; (xx)

                             xi.            "general release" 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; (iii)

                           xii.            "gene therapy" means a 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; (xii)

                          xiii.            "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; (xiii)

                         xiv.            "hazard" means an intrinsic biological, chemical or physical characteristic of a genetically modified organism which could lead to an adverse impact on the environment; (xiv)

                          xv.            "inspector" means any person appointed as an inspector in terms of section 15; (xvi)

                         xvi.            "Minister" means the Minister for Agriculture; (xviii)

                       xvii.            "monitoring" means the maintaining of regular surveillance over, the checking of, the warning about or the recording of a situation or process; (xix)

                      xviii.            "notification" means the presentation to the Council of documents containing the information required by the Council; (viii)

                         xix.            "officer" means an officer as defined in section 1(1) of the Public Service Act, 1994 (Proclamation No 103 of 1994), read with section 1 of the Public Service Amendment Act, 1996 (Act No. 13 of 1996); (v)

                           xx.            "organism" means a biological entity, cellular or noncellular, capable of metabolism, replication, reproduction or of transferring genetic material and includes a micro-organism; (xxii)

                         xxi.            "permit" means a permit referred to in section 5(a) and includes a written authority; (xxiii)

                        xxii.            "prescribed" means prescribed by regulation; (xxix)

                      xxiii.            "registrar" means the person appointed under section 8; (xxvi)

                     xxiv.            "regulation" means a regulation made under this Act; (xxvii)

                       xxv.            "risk" means the probability of causing or incurring a loss or damage or an adverse impact or a misfortune; (xxviii)

                     xxvi.            "this Act" includes the regulations; (xv)

                    xxvii.            "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; (xxiv)

                  xxviii.            "user" means any natural or legal person or institution responsible for the use of genetically modified organisms and includes an end-user or consumer; (xi)

                      xxix.            "waste" means any matter, whether gaseous, liquid or solid or any combination thereof, which is, in the opinion of the person in whose possession or under whose control it is, an undesirable or superfluous by-product, emission, residue or remainder of any process or activity in connection with genetically modified organisms. (ii)

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Application of Act

  1. (1) This Act shall apply to-

a.      the genetic modification of organisms;

b.      the development, production, release, use and application of genetically modified organisms (including viruses and bacteriophages); and

c.      the use of gene therapy.

  1. This Act shall not apply to techniques-

a.      involving human gene therapy;

b.      in which recombinant DNA molecules or genetically modified organisms are not employed-

                                                        i.            in in vitro fertilisation in humans and animals;

                                                       ii.            in conjugation, transduction, transformation or any other natural process: and

                                                     iii.            in polyploidy induction;

c.      in which genetically modified organisms as recipient or parental organisms are not employed-

                                                        i.            in mutagenesis;

                                                       ii.            in the construction and use of somatic hybridoma cells; and

                                                     iii.            in cell fusion (including protoplast fusion) of plant cells.

Executive Council of Genetically Modified Organisms

  1. (1) There is hereby established a council to be known as the Executive Council for Genetically Modified Organisms, which shall consist of not more than eight members appointed by the Minister.
  1. The members referred to in subsection (1)-

(a) shall be one officer of each of the following national departments of State:

                                                        i.            The Department of agriculture;

                                                       ii.            the Department of Arts, Culture, Science and Technology;

                                                     iii.            the Department of Environmental Affairs and Tourism;

                                                    iv.            the Department of Health;

                                                      v.            the Department of Labour; and

                                                    vi.            the Department of Trade and Industry, who shall have knowledge of the implications of genetically modified organisms with regard to the sector represented by his or her department;

b.      shall include the chairperson of the Committee; and

c.      may include any other person

  1. The Minister shall designate a chairperson and a deputy chairperson from among the members of the Council.
  2. The deputy chairperson shall exercise all the powers and perform all the duties of the chairperson whenever the chairperson is unable to do so.

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Objectives of Council

  1. The Council shall advise the Minister on all aspects concerning the development, production use, application and release of genetically modified organisms, and to ensure that all activities with regard to the development, production, use, application and release of genetically modified organisms are performed in accordance with the provisions of this Act.

Powers and duties of Council

  1. In order to achieve its objectives, the Council may-

a.      require any applicant for a permit to use facilities for the development, production, use or application of genetically modified organisms or to release such organisms into the environment, to submit to the Council through the registrar, an assessment of the risk and, where required, an assessment of the impact on the environment of such development, production, use, application or release, as the case may be;

b.      require the registrar to examine the conformity of an application to the requirements of this Act;

c.      require the registrar to maintain a register of all facilities involved in the contained use or the trial release of genetically modified organisms as well as the names and addresses of persons concerned with such contained use or trial release of genetically modified organisms;

d.      require notification by the applicant of any intended change in the type of activities or release involving genetic modification of organisms being undertaken at facilities for which approval was granted in terms of paragraph (g), in which case the Council may require the applicant to apply for a new permit;

e.      require the registrar to arrange for the inspection by an inspector of facilities where activities with or the release of genetically modified organisms are being undertaken;

f.       require the registrar to arrange for the inspection of all activities as he or she may deem necessary, including contained use, trial release and general release to ensure that all terms and conditions attached to a permit issued under this Act are complied with;

g.      after consideration of the risk assessment and, where required, the environmental impact assessment referred to in paragraph (a), and in consultation with the Committee, approve, subject to the provisions of this Act and any other law and in accordance with such terms and conditions as the Council may deem necessary, the use of the facilities concerned for the purpose for which the application was made, or the release of genetically modified organisms into the environment, and authorise the registrar to issue a permit accordingly;

h.      (i) require that the user immediately notify the registrar both orally and in writing of any accident involving genetically modified organisms and require that the registrar be supplied with information on the circumstances of the accident, the identity and quantity of genetically modified organisms released, any information necessary to assess the impact of the accident on the environment and the emergency measures taken to avoid or mitigate any adverse impact of such accident on the environment;
(ii) require the registrar to appoint a panel to enquire into and report on the causes of an accident, and to make recommendations to the Minister with a view to avoiding similar accidents in the future and with a view to limiting the adverse impact of such accidents;

i.        inform any other country of any accident that may have an impact on that country's environment;

j.        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;

k.      promote co-operation between the Republic and any other country with regard to research, development and technology transfer in the field of the genetic modification of organisms;

l.        with the consent of the Minister approve and publish guidelines for all uses of genetically modified organisms;

m.    advise the Minister on-

                                                        i.            prohibitions;

                                                       ii.            the authorisation and exercise of the necessary control of imports;

                                                     iii.            the development, production, use, application, release and distribution of genetically modified organisms;

                                                    iv.            the authorisation or notification of contained uses;

                                                      v.            the authorisation of trial or general releases;

                                                    vi.            the control measures to be taken in the event of an accident;

                                                   vii.            any other matter with regard to genetically modified organisms;

n.      make recommendations to the Minister on the appointment of members to the Committee.

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Vacancies in Council

  1. (1) A vacancy in the Council shall occur when a member

a.      ceases to be an officer;

b.      is absent without leave from more than three consecutive meetings of the Council;

c.      resigns;

d.      is removed from the office in terms of subsection (2);

e.      dies.

 

  1. The Minister may at any time remove a member of the Council from office if the Minister is of the opinion that such member is no longer competent to fill his or her office or that he or she has misconducted himself or herself.
  2. A vacancy in the Council shall be filled as soon as practicable in accordance with section 3.
  3. Whenever the Minister is satisfied that any member of the Council is prevented by illness or any other reason from performing the duties of his or her office, the Minister may appoint any other person whom he or she considers suitable to act as the deputy of that member while such member is so prevented, and such deputy shall during the period he or she so acts, perform the functions of the member in whose stead he or she has been appointed so to act: Provided that a person appointed as the deputy of the chairperson or the deputy chairperson shall only perform the duties of an ordinary member, unless the Minister otherwise directs.

Meetings of Council

  1. (1) Meetings of the Council shall be held at such times and places as the chairperson may determine from time to time: Provided that the first meeting shall be held at a time and place determined by the Minister

2.      The quorum for any meeting of the Council shall be a majority of the members

3.      A decision of the Council shall be reached on the basis of consensus.

4.      The Council may determine its own procedures to be followed at its meetings and cause minutes to be kept of its proceedings.

5.      The Council may co-opt other knowledgeable persons to serve on the Council in order to advise the Council whenever the Council deems it necessary.

6.      The Council may invite written comment from knowledgeable persons on any aspect of genetic modification which lies within the Council's brief.

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Appointment of registrar

  1. (1) (a) As soon as possible after the composition of the Council and whenever necessary thereafter the Minister shall, after consultation with the Council, appoint a suitably qualified and experienced person as registrar.

b.      An appointment under paragraph (a)-

                                                        i.            shall terminate if the person resigns as registrar;

                                                       ii.            may be terminated by the Minister if the registrar does not perform his or her duties satisfactorily.

  1.  The registrar-

a.      is charged with the administration of this Act;

b.      may exercise such powers and perform such duties as may be conferred upon or delegated or assigned to him or her by or under this Act or by the Council.

  1. Whenever the registrar is for any reason absent or unable to perform his or her functions, or whenever a vacancy in the office of the registrar occurs. the Council may designate a member of its staff to act in that capacity until the registrar resumes his or her functions, or a registrar is appointed in terms of subsection (1), and that member has, while so acting, such powers and shall perform such duties of the registrar as may be delegated or assigned to him or her by the Council.
  2. Any action of the registrar may at any time be withdrawn or amended by the Minister.
  3. The Director-General shall designate' subject to the provisions of the Public Service Act, 1994 (Proclamation No. 103 of 1994), as many officers of the department as may be necessary to assist the registrar in the exercise of his or her powers and the performance of his or her duties.

Functions of registrar

  1. The registrar shall subject to the instructions of and the conditions laid down by the Council-

a.      issue a permit as required or prescribed under this Act;

b.    &n