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Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997)

1. Definitions

 

In this Act, unless the context otherwise indicates—

 

"accident"

means any—

(i) incident involving an unintentional environmental release of genetically modified organisms that is likely to have an immediate or delayed adverse impact on the environment or on human or animal health within the Republic, or
(ii) unintentional transboundary movement of genetically modified organisms that is likely to have an immediate or a delayed adverse impact on the environment or on human or animal health;

[Definition substituted by section 1 of Act No. 23 of 2006]

 

"activity"

means my activity with genetically modified organisms but is not limited to the importation, exportation, transit, development, production, release, distribution, use, storage and application of genetically modified organisms only;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"appeal board"

means an appeal board appointed in terms of section 19;

 

"applicant"

means any person in control of facilities and activities involving genetic modification of organisms and includes 'user';

 

"biosafety"

means the level of safety when risk management measures must be taken to avoid potential risk to human and animal health and safety and to the conservation of the environment, as a result of exposure to activities with genetically modified organisms, and "biological safety" shall have a corresponding meaning;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"Biosafety Clearing-House"

means an information-sharing exchange mechanism established under Article 20 of the Protocol;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"Committee"

means the Advisory Committee established by section 10;

 

"commodity clearance"

means the authorisation to use a genetically modified organism as a food or feed, or for processing, but excludes the planting of a genetically modified organism as a release into the environment;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

conditional general release

means a release of a genetically modified organism under specific imposed conditions to regulate or monitor the use of that genetically modified organism for a specified period of time;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

contained use

means the development, production, cultivation, use, application, storage, movement, destruction or disposal of genetically modified organisms within a facility, installation or other physical structure, including a greenhouse that are controlled by specific measures, including physical barriers or in a combination of physical barriers together with chemical or biological barriers or both, that effectively limit contact of the genetically modified organisms with humans, animals and the external environment and their impact on humans, animals and the external environment;

[Definition substituted by section 1 of Act No. 23 of 2006]

 

"Convention"

means the Convention on Biological Diversity;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"control"

means to examine, regulate, manage or direct any activity within a person's jurisdiction;

 

"Council"

means the Executive Council for Genetically Modified Organisms established by section 3;

 

"department"

means the Department of Agriculture;

 

"Director-General"

means the Director-General: Department of Agriculture;

 

"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;

 

"environmental impact assessment"

means the process used to assess the potential impact of an activity on the environment by collecting, organising, analysing, interpreting and communicating information on such activity;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"extension permit"

means a permit issued for activities relating to genetically modified organism; for which a permit had been issued previously;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"general release"

means the release of a genetically modified organism into the environment by whatever means, where the organism is no longer contained by any system of barriers;

[Definition substituted by section 1 of Act No. 23 of 2006]

 

"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;

 

"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 any person appointed as an inspector in terms of section 15;

 

"Minister"

means the Minister for Agriculture;

 

"monitoring"

means the maintaining of regular surveillance over, the checking of, the warning about or the recording of a situation or process;

 

"notification"

means the presentation to the Council of documents containing the information required by the Council;

 

"officer"

means an officer as defined in section 1(1) of the Public Service Act, 1994 (Proclamation 103 of 1994), read with section 1 of the Public Service Amendment Act, 1996 (Act 13 of 1996);

 

"organism"

means a biological entity, cellular or non-cellular, capable of metabolism, replication, reproduction or of transferring genetic material and includes a micro-organism;

 

"permit"

means a permit referred to in section 5(a) and includes a written authority;

 

"prescribed"

means prescribed by regulation;

 

"Protocol"

means the Cartagena Protocol on Biosafety to the Convention, that has been negotiated and adopted by the Parties to the Convention, acceded to by the Republic on 14 August 2003; A copy of the Protocol is attached for information purposes in the Annexure;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"registrar"

means the person appointed under section 8;

 

"regulation"

means a regulation made under this Act;

 

"release"

means release into the environment and includes a trial release, conditional general release and general release;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"risk"

means the probability of causing or incurring a loss or damage or an adverse impact or a misfortune;

 

"this Act"

includes the regulations;

 

"transboundary movement’

means the movement of a genetically modified organism from the Republic to another country or from another country to the Republic;

[Definition inserted by section 1 of Act No. 23 of 2006]

 

"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"

means a person who conducts an activity with a genetically modified organism;

[Definition substituted by section 1 of Act No. 23 of 2006]

 

"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.