biotechnology

The South African Genetically Modified Organisms Act, No. 15 of 1997, and its regulations came into force on 1 December 1999 amidst concerns from the scientific community who felt that it placed unnecessary restrictions upon their research activities and from various concerned bodies which felt that the release of genetically modified organisms could have adverse consequences on the environment.

The Act has, as its primary aims, the provision of measures to promote the responsible development, production, use and applications of genetically modified organisms and thereby limit possible harmful consequences to the environment. To do this the Act establishes certain structures ranging from an Executive Council to inspectors. The former is responsible for advising the Minister for Agriculture on all aspects concerning the development, production, use, application and release of genetically modified organisms while the latter are empowered to enter places where organisms are being genetically modified under conditions of contained use to determine whether the provisions of the Act are being or have been complied with.

Perhaps the most important advisory body created by the Act is the Advisory Committee which comprises ten ministerial appointees, eight from the fields of science applicable to the development and release of genetically modified organisms and two public sector appointees who have knowledge of ecological matters and genetically modified organisms.

This committee acts as the national advisory board on all matters concerning or related to the genetic modification of organisms and it may appoint subcommittees to deal with specific matters.

Another appointee under the Act is the registrar who is responsible for issuing permits which are necessary for the import, export, development, production, use, release and distribution of genetically modified organisms in South Africa. Exceptions to this requirement are organisms used under conditions of contained use in academic and research facilities and scheduled organisms already cleared for commercial release.

the regulations

authority to import, export, develop, produce, use, release or distribute genetically modified
organisms

With the exception of organisms that are used under conditions of contained use in academic and research facilities, and for those organisms specified in Table 3 of the Annexure, no applicant may import to or export from the Republic of South Africa, or develop, produce, use, release or distribute any genetically modified organism in the Republic of South Africa except in terms of a permit to undertake such an activity. In addition, an applicant shall also comply with the provisions of all other laws regulating the importation and exportation of genetically modified organisms.

risk assessment of activities

No person shall undertake any activity involving genetic modification unless a suitable and sufficient assessment of the risks created thereby to the environment and human health has been made. Furthermore, a lack of scientific knowledge or consensus on the safe use of genetically modified organisms shall not be interpreted as indicating a particular level of risk, an acceptable risk or an absence of risk.

registration of facilities and maintenance of records

With the exception of facilities which were active prior to 1 December 1999 and which shall submit applications for registration to the registrar on or before 30 November 2000, all facilities shall be registered with the registrar. An application for registration shall be submitted to the registrar on a form that is obtainable from the office of the registrar. A separate application shall be lodged with the registrar in respect of each facility and each such application shall be accompanied by a locality map that clearly indicates where the facility is situated.

In the case of facilities which were active prior to 1 December 1999, if the Minister, upon the advice of the Committee, deems it necessary that the facility should be registered prior to the expiration of the one-year period, he or she may, by way of a written notice to the user, require that a particular facility by registered within a period specified in that notice.

Upon registration of a facility, the registrar shall furnish, within three (3) months of receipt of an application, the applicant with a certificate of registration and a copy of the guidelines. The user of a registered facility shall, inter alia in hard copy format, keep and maintain the certificate of registration and all records pertaining to risk assessments. The certificate of registration and records pertaining to risk assessments shall, upon request, be made available to the registrar or an inspector.

The user shall notify the registrar of any change to the information provided in terms of this regulation and shall not dispose of any list, register and record maintained in terms of this regulation.

applications for and issue of permits

Unless the contrary is stated elsewhere in the Regulations, a person intending to conduct any activity specified in column 1 of Table 1 of the Annexure, shall conduct such activity under the authority of a permit issued by the registrar on application submitted to the registrar on a form that is obtainable from the office of the registrar. The application for a permit shall be made not less than the number of days specified in column 2 of Table 1 of the Annexure, prior to the proposed commencement of the activity for which the permit is required.

The Council and Committee shall attend to applications within reasonable time frames as may be determined by the registrar from time to time in order to enable the registrar to issue permits within the number of days specified in column 2 of Table 1 of the Annexure opposite the corresponding activity. Written reasons for an inability to provide any information that is requested in an application form shall be furnished to the registrar when submitting the application form.

The applicable application fees specified in Table 2 of the Annexure shall accompany each application. On receipt of an application for a permit the registrar shall -

• acknowledge, in writing, receipt of such application within two (2) working days of such receipt; and
  
  
• examine the conformity of the application to the requirements of the Act; and -
  
  
  • if the application does not conform to the requirements of the Act in any respect, immediately refer the application back to the applicant and request the applicant to rectify the application; or
    
    
  • if the application conforms to the requirements of the Act, submit the application to the Council for consideration.
    
    On receipt of an application from the registrar the Council may approve the application and authorise the registrar to furnish the applicant with the applicable permit to undertake the activity concerned; or refuse the application and furnish written reasons therefor. In considering the application the Council may consider the socio-economic impact that the introduction of a genetically modified organism may have on a community living in the vicinity of such introduction.

The registrar may also, at his or her discretion, fast track any application for an activity involving genetically modified organisms for which a permit had previously been issued.

public notification of proposed trail release and general release of genetically
modified organisms

The applicant shall notify the public of any proposed release of genetically modified organisms prior to the application for a permit for such release. Public notification shall be in the form of a standard notice, obtainable from the office of the registrar, published in the printed media informing the public of the intended release. The notice shall, inter alia, require the applicant to fill in the following details:

• full name and address of the applicant;
• a full description of the genetically modified organisms that the applicant proposes to release;
• a description of the proposed trial release, including the area and environment in which the release is to take place;
• a request that interested parties submit comments or objections in connection with the intended release to the registrar within a period specified in the notice: Provided that such period shall not be less than thirty (30) days after the date on which the notice appears in the media; and
• the address, of the registrar, to which comments or objections may be submitted.

• the circumstances of the accident;
• the identity and quantity of the genetically modified organisms released;
• any information that is necessary to assess the impact of the accident on the environment and human health; and (iv) the emergency measures taken to avoid or mitigate any adverse impact of such accident on the environment and human health; and
• all appropriate short-term, medium-term and long-term measures are taken to avoid or mitigate any adverse impact of such accident on the environment and human health.

• be lodged with the Minister in writing within thirty (30) days from the date on which the appellant was notified in writing of the decision or action concerned;
• state the reference number and the date of the document by means of which such appellant was notified of that decision or action;
• state the grounds on which the appeal is based; and
• be accompanied by the fee specified in item 5 of Table 2 of the Annexure.