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15 May 2019
The recent European Court of Justice's (ECJ's) ruling in Confédération paysanne v Premier ministre(1) regarding the status of organisms obtained by new breeding techniques as genetically modified organisms (GMOs) has again brought the scope of the South African GMOs Act (15/1997) into question.
New breeding techniques include many new and sophisticated tools for genome editing, for example:
The difficulty with regulating organisms created through such techniques is that these organisms may be indistinguishable from organisms which have naturally evolved.
This question fundamentally relates to:
The ECJ ruled that:
This ruling shows that clear consideration has been given to the risks or hazards to health and the environment.
The ECJ's decision is relevant to the South African position, since the definition of 'GMOs' in the EU directive (ie, "an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination") is almost identical to the South African GMOs Act's definition of a 'GMO' (ie,"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").
South Africa has a holistic strategy to interpreting statutes based on a constitutional, contextual or purposive approach. The ordinary grammatical meaning of words and phrases must be interpreted in the context of:
Notably, the South African Constitution compels the interpreter to consider the spirit, purport and objects of the South African Bill of Rights, including the democratic values of human dignity, equality and freedom when interpreting legislation. Further, the Constitution provides that when interpreting any legislation, every court must prefer any reasonable interpretation of the legislation that is consistent with international law over any alternative interpretation that is inconsistent with international law.
In the context of an initial grammatical interpretation of 'GMO' as defined in the GMOs Act, it is unclear whether a 'trigger' must be:
Further, the phrase "modified in a way that does not occur naturally through mating or natural recombination or both" is also ambiguous. Does it mean that:
The difference between the two interpretations is that in the first case, an organism with genes or genetic material that has been modified (including by human intervention) but has a natural character that may occur in genes or genetic material by mating or natural recombination would not be a GMO and would therefore not be regulated.
However, if the second case were to be followed, regardless of whether the organism has a genetic modification that occurs naturally, if the modification were artificial (ie, through human intervention), the organism would be a GMO and therefore would be regulated.
The grammatical interpretation of the definition of 'GMO' set out in the GMOs Act and its use throughout the act and its regulations and guidelines appears to provide ample evidence that the GMOs Act aims to regulate not only GMO products themselves, but also activities, including the development and production of GMOs (ie, both a process and product-triggered interpretation).
Further, techniques where recombinant DNA molecules or GMOs are employed in "conjugation, transduction, transformation or any other natural process" are specifically excluded from the application of the GMOs Act. This provides support for the interpretation that only genetic modification that is outside of what might be achieved naturally by mating or natural recombination (ie, 'natural process') is regulated as a GMO.
The GMOs Act's objectives also include the following phrases, which are important for a holistic interpretation:
These phrases indicate that the definition of 'GMO' should be considered in the context of the objectives relating to responsible use and limitation of harm or any hazard to the environment or human and animal health.
This interpretation also aligns with the constitutional imperative to consider the context of the Bill of Rights, under which everyone has the right to:
Therefore, arguably rather than a blanket regulation of non-natural processes (including the use of new breeding techniques) for genetic modification of organisms (or the organisms created by such processes) there is provision within a system that is both process and product-triggered to focus on genetic modification that is likely to be more harmful, hazardous or risky to the environment, human and animal health than that which might be achieved by natural mating or natural recombination. Such an assessment should be performed by the regulator on a case-by-case basis, preferably considering information provided by an application through a preliminary notification procedure.
It will be interesting to follow the development of legislation in this field.
For further information on this topic please contact Joanne van Harmelen at Edward Nathan Sonnenbergs Inc by telephone (+27 21 410 2500) or email (email@example.com). The Edward Nathan Sonnenbergs Inc website can be accessed at www.ensafrica.com.
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