Introduction

The Genetically Modified Organisms (GMO) Act (15/1997), as amended, provides the requirements to ensure the responsible development, production, use and application of GMOs.

South Africa has been a member of the Cartagena Protocol on Biosafety since 14 August 2003. Under the protocol, the Department of Agriculture Forestry and Fisheries (Directorate Genetic Resources) is the recognised competent national authority responsible for ensuring that all provisions and obligations relating to the protocol are met.

The registrar is responsible for the GMO Act's administration. The act further provides for the appointment of:

  • an advisory committee, which is responsible for evaluating the risk assessment (scientific data relating to food, feed and environmental impact) submitted for every application; and
  • an executive council, which will make the final decision on the authorisation of a specific activity.

Inspectors are also appointed to monitor authorised activities concerning GMOs.

Scope of act

The GMO Act applies to:

  • the genetic modification of organisms;
  • the development, production, release, use and application of GMOs (including viruses and bacteriophages); and
  • the use of gene therapy.

The act does not apply to:

  • techniques involving human gene therapy;
  • activities in which recombinant DNA molecules or GMOs are not employed; or
  • activities in which GMOs are not employed as recipient or parental organisms.

Important definitions

Under the GMO Act:

  • a 'GMO' is an organism whose genes or genetic material has been modified in a way that does not occur naturally through mating, natural recombination or both; and
  • an 'organism' is a biological entity (cellular or non-cellular) capable of metabolism, replication, reproduction or the transfer of genetic material. This includes micro-organisms.

Application process and responsibilities

Any entity or person planning to perform a regulated activity under the GMO Act must prepare an application to the registrar and pay the application fee. Regulated activities include:

  • activities involving genetic modification;
  • the experimental or trial release of a GMO;
  • the contained use of a GMO; and
  • the general release of or commodity clearance regarding a GMO.

The registrar's office provides application templates, which list the information to be provided regarding the GMO.

An application is first assessed by the registrar's office to ensure that all formal requirements have been met. Thereafter, the application is assessed by the advisory council with the sub-committee's assistance. The advisory council and sub-committee comprise highly qualified scientific researchers from various universities, institutes and science councils who perform a technical assessment of the application. The advisory council then makes a recommendation to the registrar's office on whether to approve the application.

The advisory council's findings are considered by the executive council, which makes the final decision on the approval of the applied-for activity. The executive council comprises the advisory committee chair and officials from six government departments responsible for matters relating to:

  • agriculture;
  • health;
  • the environment;
  • labour;
  • trade and industry; and
  • science and technology.

Under the act, the general public must be informed of notifications through ads published in major newspapers. Public comments are considered during the evaluation of an application.

Approval may be granted with or without conditions that the applicant must meet. An appeal process exists for applicants that fail to obtain an approval. Further, applicants must notify the registrar of any problem relating to the release and use of a GMO and assist with solving the problem to the registrar's satisfaction.

The GMO Act also allows any party that feels aggrieved by an advisory council decision to appeal to the minister for agriculture, forestry and fisheries, who has the final decision on the matter.

For further information on this topic please contact Joanne van Harmelen at ENSafrica by telephone (+27 21 410 2500) or email (jvanharmelen@ensafrica.com). The ENSafrica website can be accessed at www.ensafrica.com.

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