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New breeding techniques and regulation of genetically modified organisms
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:
transcription activator-like effector nucleases; and
clustered regularly-interspersed short palindromic repeats.
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 definition of 'GMOs' in the GMOs Act and which organisms will fall within this definition and be regulated as GMOs under the GMOs Act; and
which organisms will be excluded from the application of the GMOs Act.
Interpretation of statutes
The ECJ ruled that:
all organisms obtained by mutagenesis are GMOs insofar as the techniques and methods of mutagenesis alter an organism's genetic material in an artificial way; and
only organisms obtained through techniques or methods of mutagenesis, which have conventionally been used in a number of applications and have a long safety record, are excluded from the scope of the EU GMO Directive.
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:
the act's regulations and any supporting guidelines;
historical factors relevant to the legislature's meaning when drafting the legislation; and
present government policy.
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.
Meaning of 'GMO'
In the context of an initial grammatical interpretation of 'GMO' as defined in the GMOs Act, it is unclear whether a 'trigger' must be:
product-based (ie, the organism must still contain the modification of the gene or genetic material modification for the act to apply); or
process-based (ie, the genes or genetic material of the organism must at some stage have been modified, but need not still be modified, for the act to apply).
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:
if the modification of the genes or genetic material is outside of what may occur through natural mating or recombination, then the organism is genetically modified and therefore regulated; or
if the modification of the genes or genetic material is performed by artificial or human intervention (ie, not naturally), or is outside of what may occur through mating or natural recombination, then the organism is genetically modified and therefore regulated?
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:
"limit possible harmful consequences";
"effective waste management";
"risk assessment"; and
"are appropriate and does not present a hazard".
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:
an environment that is not harmful to their health or well-being; and
have the environment protected.
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.
(1) Case C-528/16.
This article was first published by the International Law Office