Genetically Modified Organisms legislation: briefing by GLOBE

Meeting report

ENVIRONMENTAL AFFAIRS AND TOURISM PORTFOLIO COMMITTEE
8 May 2001
GENETICALLY MODIFIED ORGANISMS LEGISLATION: BRIEFING

Chairperson: Mr M Kalako

Documents Handed Out
Assessing the effectiveness of South Africa's legislation regarding genetically modified organisms (See Appendix)

SUMMARY
South Africa's legislation on genetically modified organisms was assessed with a view to how the Committee would deal with any future amending legislation to the Genetically Modified Organisms Act of 1997. Previously, opposite views on this issue had been presented to the Committee by an agricultural college. This presentation provided by Globe Southern Africa gave new insight on the matter. It was asserted that research needs to be conducted on the long term effects of genetically modified organisms such as the new 'wonder seeds' imported by multinational seed companies who presently view South Africa as the gateway to the rest of Southern Africa.

MINUTES
The Chairperson stated that the objective of the meeting was to expand their knowledge on
Genetically Modified Organisms (GMOs). Mr Cormac Cullinan, an environmental lawyer from ENACT, spoke on behalf of Globe Southern Africa. See his presentation document: 'Assessing the effectiveness of South Africa's legislation regarding genetically modified organisms'.

Discussion
Some comments and questions by committee members:

Dr.Rabinovitz ( IFP) felt that the current situation on GMO implementation in South Africa should be investigated. She suggested a workshop with the industry so that a proper report on this matter would be made focussing on the effects on long-term health.

Mr Moss (ANC) congratulated the presenter on broadening their views on the matter and stated that due to this new information presented to them they now needed to amend the existing legislation contained in the GMO Act 15 of 1997.

Ms Xingwana (ANC) said that the presentation was an eye opener on the legislation that had already been passed. When the GMO legislation of 1997 was processed there was no account tabled before Parliament on the dangers that GMOs would have on the human body over a long period of time. Since no research was done on the matter, the views of other countries had not been taken into account when the Act was passed.

Appendix:
GLOBE SOUTHERN AFRICA Parliamentary Lecture Series

by Cormac Cullinan

INTRODUCTION

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:

- to indicate briefly the international and national context within which the regulation of genetically modified organisms is taking place;

- to identify criteria which may be used to assess the adequacy or otherwise of laws regulating the genetic modification of organisms; and

- to evaluate current South African laws in the light of these criteria.

This presentation is based on the following assumptions.

· 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).

· 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 Earth's 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.

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.

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") 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 world's problems, including feeding the hungry millions in developing countries. 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 Africa's relations with other African countries continues to be negatively affected by the Government's as yet unofficial policy of facilitating the use of GMOs in South Africa.

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 one's 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.

· Is the legislation consistent with the Constitution, South Africa's international obligations, and with the National Environmental Management Act, 107 of 1998 ("NEMA") - the Act that provides the legal framework for dealing with matters affecting the environment?

· Is the scope of what is being regulated sufficiently wide to encompass all relevant issues? (This would include both what organisms and products are being regulated and the activities being regulated.)

· Does the legislation establish procedures that are sufficient to ensure that all decisions taken by the regulators are made on the basis of adequate information? (For example, in the case of GMOs this would include requiring that proper risk assessments and environmental impact assessments are conducted and the information made available to the regulators prior to their making decisions as to whether or not to grant permits.)

· Is there is an appropriate system for ensuring the adequate exchange of information between countries in relation to imports and exports of GMOs and products derived from them?

· Are the users and consumers of GMOs or products made from GMOs in a position to make informed decisions about their use? (This may relate, for example, to the labelling of foods containing GMOs).

· Do appropriate mechanisms exists that enable the wider public to be involved in decision-making relating to GMOs and the effective implementation of the laws? (This will includes access to information concerning GMOs as well as rights to participate in decision making processes and to monitor compliance.)

· Does the law provide adequate remedies in the case of non-compliance? (This would include monitoring mechanisms, enforcement mechanisms and liability regimes that impose liability for harm caused on those responsible.)

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-

- to an environment that is not harmful to their health or well-being; and

- to have the environment protected, for the benefit of present and future generations, through reasonable legislative and other measures that -

- prevent pollution and ecological degradation;

- promote conservation; and

- secure ecologically sustainable development and use of natural resources while promoting justifiable economic and social development."

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.

The Act applies only to living organisms that have been genetically modified and does not cover GMO products, such as food from GM crops or eggs from chickens fed with animal feeds containing GMOs.

The definition of "genetically modified organism" has been criticised by scientists as being inadequate on a number of grounds. These includes the fact that "organism" is not defined and accordingly it would appear that it may not include, for example, prions, which are the causative agents of a series of major neuro-degenerative diseases such as the so-called "mad cow disease" (BSE) and the human equivalent, Creutzfeldt-Jacob disease.

The key activities regulated (contained use, imports and exports, field trials and "general releases") are not clearly defined and these definitions are likely to cause problems.

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.

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:

"In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."

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:

"A risk-averse and cautious approach is applied, which takes into account the limits of current knowledge about the consequences of decisions and actions;"

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.

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.

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.

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.

Public participation

It is clear from the Constitution and from legislation such as NEMA that public participation in relation to decisions affecting the environment and the health and well-being of people is now one of the cornerstones of our society. However, most of what is contained in the GMO Act runs counter to this.

For example:

the Act provides for the establishment of an Executive Council for Genetically Modified Organisms and for an Advisory Committee but there is no provision for public participation in either body;

section 18 of the Act restricts access to information concerning GMOs and although subsection 18(2) specified certain information that must not be kept confidential, in practice the National Department of Agriculture has not been prepared to release most of this information; and

prospective field trials need only be advertised in local newspapers, and consequently the general public is unaware of where field trials are being undertaken in South Africa.

Remedies

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.

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 liability for damage caused by the use or release of a genetically modified organism shall be borne by the user concerned…"

Section 1 of the Act states that:

"'user' means any natural or legal person or institution responsible for the use of genetically modified organisms and includes an end-user or consumer;"

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 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 one's 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.