This presentation evaluates the current South African regulatory framework concerning genetically modified organisms ("GMOs"), notably the Genetically Modified Organisms Act, 15 of 1997 ("the GMO Act"), and the regulations made under it, which came into effect on 1 December 1999. The wider debate regarding whether or not it is appropriate to genetically modify living organisms at all, is referred to but is not discussed in any detail in this presentation.
In essence, this presentation aims:
This presentation is based on the following assumptions.
1. The genetic modification of living organisms and the use of food and other products derived from GMOs will continue to be permitted, on some basis, in South Africa. (In other words, I do not address the foundational issue of whether or not these activities should be prohibited entirely, as a full discussion of the relevant issues is beyond the scope of this presentation).
2. The process of producing and using GMOs created potential risks to the health and well-being of humans and other species and to the environment generally, and the nature and extent of these risks are poorly understood at present. For the first time in the billions of years of the Earths evolution, a single species has gained a significant degree of control over the process of evolution itself. The potential repercussions of exercising this power are incalculable and require careful consideration. According it is wise to proceed with caution.
3. The regulation of GMOs is an issue of vital importance not only to each of us (who may already be consuming GM food) but also to other species, to our country, to Africa and ultimately to the planet. Accordingly it is important to take account of the views of all concerned.
4. It is imperative that the production and use of GMOs in South Africa is effectively regulated, and that the regulatory system gives precedence to the interests of the general public and of the wider community of living things rather than the interests of any particular interest group.The context
Laws are always a product of different forces in society and cannot be properly understood unless the context in which they arise and are implemented, is taken into consideration. In this case, it is important to appreciate the very powerful forces operating at both the international and national level in relation to the regulation of genetically modified organisms. It is no exaggeration to state that a great global battle is currently been fought to determine whether or not private parties (primarily a few large transnational corporations) will be permitted to own a significant proportion of the economically valuable living organisms of the Earth. If private companies are permitted to own the rights to control and genetically manipulate these organisms they also stand to gain control over most food production on the planet.
Five major transnational corporations (the so-called "gene giants") (1) dominate the international biotechnology industry and own the vast majority of the patents taken out on GMOs and other life forms. They also control a very significant proportion of the international seed industry, and consequently one of the primary means of production of world food. These companies argue that the technical innovations that have made GMOs possible, are an essential part of the solution to the worlds problems, including feeding the hungry millions in developing countries (2). They maintain that it is essential that they be granted monopoly rights over genetically engineered organisms (and indeed, over other life forms) to ensure that they have sufficient financial incentive to continue to innovate.
Against them are ranged a variety of individuals (particularly farmers in developing countries), the governments of many developing countries and other concerned individuals and organisations. The reasons for the opposition vary, but include: moral and ethical objections to the concept of genetic engineering, concerns about the risks posed by GMOs and fears that this represents a form of "neo-colonialism" which will ultimately increase the dependency of food producers in the developing countries of the South on huge Northern-based transnational corporations.
The context in which South Africa is situated in this wider debate is also relevant to an assessment of the South African legislation. South Africa has advanced technology and scientists able to genetically modify organisms but is also a developing country with a high reliance on agriculture, situated in a continent that depends primarily on small-scale agriculture to feed its people. The combination of advanced scientific capacity within a developing country is particularly significant because it is clear that in the near future the major markets for GM seeds will be in the developing world.
The biotech industry (as exemplified by the organisation "Africa-Bio") sees South Africa as the gateway to Africa. Therefore, from the perspective of the gene giants, it is very important that they be able to conduct field trials in South Africa and also that GM products (i.e. foodstuffs containing GMOs) are accepted by the public in South Africa. The willingness of the South African Government to promote field trials of GM crops and the GMO Act is already being hailed by these interests as an example that other African countries should follow.
On the other hand, the majority of African countries are united in their opposition to the introduction of GM crops into Africa and the patenting of life forms. In fact, the Organisation of African Unity ("OAU") has called upon African countries to adopt legislation based on a draft model law, which promotes the protection and rights of local communities, farmers and breeders. This is based on an approach which emphasises community rights over biological resources as a means of countering what is perceived as a new attempts to "enclose the commons" by privatising rights to indigenous knowledge, seeds and plants. Furthermore, SADC policy is that all development in the region should benefit the poor majority, since if they do not benefit from development, the region will never be socially and politically stable.
These divergent camps are also apparent within South Africa, with organisations such Africa-Bio (representing the interests of companies involved in biotechnology) arguing that the new technology represents important development opportunities for South Africa, while others argue that it is not in the interests of the majority of South Africans to increase the dependence of small-scale food producers on purchasing relatively expensive seeds and the chemical inputs (such as herbicides) that are used in conjunction with them. There is also clearly the potential to alienate other African countries if South Africa chooses to adopt a position very different from the majority of other African countries or to depart from stated OAU positions on this issue. In fact South Africas relations with other African countries continues to be negatively affected by the Governments as yet unofficial policy of facilitating the use of GMOs in South Africa (3).A yardstick for evaluating GMO legislation in South Africa
In order to evaluate legislation it is necessary to determine the purposes for which it was enacted and the degree to which it has been successful in achieving those purposes. This is not a straightforward matter in relation to genetically modified organisms since there are widely different views as to what is in the interests of the South African public in this regard. However, the GMO Act makes it clear in the preamble that it is intended "to provide for measures to promote the responsible development, production, use and application of genetically modified organisms ".
Whatever ones views on the potential benefits offered by GMOs, it seems clear that any regulatory system must be able, at the very least, to stand scrutiny when measured against the following criteria.
Evaluation of the Genetically Modified Organisms act and regulations
Unfortunately, it would appear that the South African legislation is deficient in all of the key respects identified above.
Compliance with the Constitution, international obligations and NEMA
Obviously one of the primary yardsticks for measuring the adequacy of the existing laws is the environmental right contained in the Constitution, Section 24 of the Constitution provides that:
"Everyone has the right-
Accordingly, the question we must ask is whether the existing law and the measures taken to implement it are reasonable to achieve the objectives set out in this right.
We must also look at the National Environmental Management Act, and in particular, to the principles set out in section 2 of the Act which "apply throughout the Republic to the actions of all organs of State that may significantly affect the environment".
It is also important to take account of relevant international law and legal instruments, including the Convention on Biological Diversity, and in particular the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (even though this has not yet been signed by South Africa). The GMO Act does not meet the requirements of the Cartagena Protocol and will require amendment if South Africa ratifies the Protocol.
Scope of the legislation
The scope of the GMO Act has been criticised on a number of grounds, including the following.
Informed decision making
The procedures by which decisions are made regarding whether or not to grant permits in relation to the use, import or export of GMOs are deeply flawed. Some of the main shortfalls are discussed below.
a) The precautionary principle
It is well accepted at an international level that authorisations in relation to GMOs must be dealt with on the basis of the "precautionary principle". This principle was expressed as principle 15 of the so-called "Rio principles" of 1992 as follows:
The Cartagena Protocol reaffirms the precautionary principle and a precautionary approach is also enshrined in South African legislation in section 2 of NEMA that provides that:
This approach is particularly important in dealing with the issues presented by GMOs where the novelty of the technology and the incredible complexity of the living systems of our planet, mean that it is currently impossible to determine the consequences of the release of GMOs into the environment with any degree of certainty.
However, the GMO regulations provide that:
"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." (Regulation 3(2))
This effectively means that a lack of scientific knowledge or consensus is to be regarded as neutral and should not be taken into account in risk assessment. This is directly contrary to the spirit of the precautionary principle, which is intended to establish a bias in favour of protecting the environment in situations of scientific uncertainty.
b) Risk assessment
The GMO Regulations provide that:
"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." (Regulation 3(1))
It is unclear whether this covers, for example, the sale of GMO products or even the release of GMOs.
Furthermore, there are no legally binding requirements regarding how risk assessments in relation to the use of GMOs should be conducted. Currently this is done on the basis of voluntary and incomplete guidelines. Furthermore, the regulations impose very short time limits for the regulators to respond which probably means that they have insufficient time to consider any risk assessments that have been done.
c) Environmental impact assessment
The environmental impact assessment regime in relation to GMOs is wholly inadequate. The environmental impact assessment regulations made under the Environment Conservation Act provide that an environmental impact assessment ("EIA") must be undertaken in respect of certain activities which have been identified by notice in the Gazette as "activities which may have a substantial detrimental effect on the environment". These include "the genetic modification of any organism with the purpose of fundamentally changing the inherent characteristics of that organism". This provision is currently not enforced because the requirement to undertake an EIA is triggered by the start of the process of genetic modification (at which stage the nature of the GMO is not even known) rather than, for example, the proposed release or import of a GMO.
There is no provision for the exchange of information with other countries with regard to the import and export of GMOs and GMO products, such as the "advanced informed agreement" (AIA) system set out in the Cartagena Protocol. As a consequence, we are, for example, unaware of the extent to which Indonesia is aware of the risks associated with the recent export by Monsanto of GM rice from South Africa to that country.
d) Consumer choice
The public is not in a position to make informed decisions about whether or not to consume GM products as they do not have to be labelled as such.
a) No information means no checks on Government and the corporations
Generally speaking, the lack of publicly available information on what is happening in relation to GMOs in South Africa makes it extremely difficult to monitor whether or not the existing legislation is being complied with. The public is also not in a position to determine whether or not the legislation is being implemented in a manner that reasonably safeguards the environment and their health and well-being. The situation is exacerbated by the recalcitrant attitude of the National Department of Agriculture in relation to requests for information.
b) A bizarre liability regime
Another of the major flaws in the GMO Act is the thoroughly inappropriate liability regime which it establishes. Section 17(2) of the Act provides that:
The consequences of this liability regime are that consumers may be held liable for harm caused by GMO products which they consume. This liability regime is also wholly inappropriate to engender appropriate caution in those who develop GMOs for profit. CONCLUSIONS"The liability for damage caused by the use or release of a genetically modified organism shall be borne by the user concerned "
The regulation of GMOs is extremely challenging and poses difficult questions for regulators. Proper regulation requires dealing with complex scientific issues, hotly debated ethical issues and taking account of the interests not only of humans, but also of the other co-inhabitants of our unique planet.
However, whatever ones views as to the relative benefits of bio-technology, it is clear that the current South African laws regulating GMOs fall far short of the standards required by our Constitution, NEMA and international trends in this regard. In particular, the GMO Act and regulations are badly drafted, insufficiently wide in scope, woefully deficient in establishing adequate safeguards for the protection of human health and the environment, and biased in favour of the corporations undertaking genetic engineering. In short, they are not in the interest of South Africa and her people.
A complete re-evaluation of the legal framework in this regard is urgently required. In the interim, the National Department of Agriculture should consider imposing a moratorium on the issuing of further permits and should be encouraged to implement the legislation in as transparent and as participatory a manner as possible.
|(1): Monsanto, Novartis, AstraZeneca (formed by the merger between the
Swedish company Astra and the British company Zeneca), Aventis (formed by the merger
between Rhone Poulenc and Hoechst), and Du Pont. These 5 companies account for almost all
(2) These claims are at best questionable and at worst may drecrease food security in developing countries and increase poverty and hunger. Some indication of corporate priorities can be gained by examining patent applications. A study of patent applications made by Zeneca between 1993 and 1998 indicated that most applications were intended to alter product charateristics to make crops more attractive to affluent Nothern consumers or were designed to be used in conjunction with chemicals produced by the same company. In any event, obviously the primary or exclusive purpose of genetic engineering research carried out or sponsored by the gene giants is to increase their profits.
(3) Apparently the Department of Arts, Science and Technology is currently secretly formulating a national biotechnology strategy with input from corporate interests but not from the wider public and NGOs.
(4) Aspects of this section appear to be partially unconstitutional, or at least contrary to the provisions of the Promotion of Access to Information Act which recently came into force.