The Cartagena Protocol on Biosafety: Implications for Research & Development -A Third World Perspective
by Gurdial Singh Nijar, Third World Network, Penang, Malaysia
The Cartegna Biosafety Protocol (CBP) was finally concluded and adopted in the wee hours of 29th January 2000 at Montreal. The 4-year negotiations were kicked off by Decision II/5 made by the 2nd meeting of the Conference of the Parties to the Biodioversity Convention at Jakarta in November 1995. The rancourous nature of the negotiations was inevitable. Right from the outset, the US had led a sustained and aggressive campaign to keep Genetically Modified Organisms (GMOs) from being regulated by an international UN regime. At the final stages of the negotiations, the US garnered the support of other countries from the South – Argentina, Chile and Uruguay. Together with Canada and Australia they formed the formidable ‘Miami Group’ that is largely blamed for scuttling the scheduled conclusion and adoption of the Protocol in Cartagena (Columbia) in February 1999. It took all the diplomatic acumen of the Chair of the meeting, against the backdrop of the aborted Seattle meeting of the WTO, to resuscitate the negotiations which finally led to its adoption.
The consensus protocol document is predictably weak and its ambit considerably weakened – despite the efforts of the developing world – organised as ‘The Like Minded Group’, and, the European Union. Nonetheless it is possible to salvage some key beneficial provisions.
This paper examines one particular facet: the possible impact of the Protocol on Research and Development (R&D) activities in relation to GMOs from a Third World perspective.
B. The Relevant Provisions of the Cartagena Biosafety protocol (CBP)
Article 2(2) requires that any development of GMOs be done in a manner that prevents or reduces risks to biodiversity and human health. Article 16(4) states that as part of risk management, any development of GMOs must undergo ‘…an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use.’ This provision states that it is without prejudice to Article 16(2).
Article 16(2) states that measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of GMOs on the conservation and the sustainable use of biodiversity (and human health). And risk assessment has to be carried out in accordance with Annex III. This Annex sets out the general principles, the methodology and the points to consider in carrying out the risk assessment.
This means that these requirements must be observed in the domestic development of GMOs covered by the BP. In so far as research is a component of development, these requirements must be adhered to in the R&D of GMOs covered by the protocol.
C. What are these requirements? And how different are they from existing practices? Will adherence to Annex III impede R&D in GMOs?
One element that is new and that may have potential impact is the need to adhere to the precautionary principle. This principle is clearly embedded in the protocol. The objective of risk assessment as set out in Annex III is ‘to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment.’ And throughout the CBP, lack of scientific certainty is not to hamper a Party from making a decision with regard to a GMO. Indeed the objective of the CBP explicitly makes the precautionary approach as set out in Principle 15 of the Rio Declaration the overriding basis for the attainment of the objective of the Protocol.
Consonant with this, paragraph 4 of Annex III states that:‘Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable level of risk.’
This clearly suggests that where there is a lack of clear scientific knowledge or there is no clear scientific consensus, it is yet permissible to conclude that risk may exist. This could shape the nature of research and development methodologies. Indeed one of the methodological approach suggested by Annex III where there is uncertainty regarding the level of risk is the implementation of appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment. What is appropriate, and what ‘monitoring’ model must be designed? Nowhere is this specified. But the provision certainly imposes added obligations on researchers to design their R&D in a manner that takes into account the prevailing divided opinion on the risks associated with the development of GMOs.
For a start, the case by case approach coupled with the need to take into account the receiving environment, and the need to adhere to the precautionary principle – all made necessary in the risk assessment/management scheme of the CBP suggests that it would not be possible to envisage ‘eventually ... a global system whereby a product is tested once and approved everywhere’ . This dream of industry runs counter to the core element of the Protocol.
How then will R&D conditioned by the precautionary approach/principle be shaped?
D. The Precautionary Principle/Approach and its impact on research and development
Generally a GMO is developed to express the trait of the inserted gene. Then approval is sought for the introduction of the GMO on an experimental basis in contained conditions (say a greenhouse); and then it moves to unlimited use in the fields or the wider community. These steps represent ongoing research and development of the GMO for its eventual commercialisation. The precautionary approach could alter the content and duration of these steps in rather important and crucial ways.
This, for example, was the course taken by Monsanto in its application for transgenic corn expressed to target the corn rootworm complex of insects. Monsanto moved from greenhouse scale research to unlimited use in the field in one year. The accelerated process appears exceptional as the whole point about the initial experimental field-trial approvals is to collect detailed data on expression levels, environmental impacts and performance under field conditions. From experimental to full registration of a transgenic crop usually takes 2-4 years. The approach represents a departure from the precautionary approach as envisaged by the CBP.
How could the precautionary approach have altered the research design and development of say the Bt- corn – either to provide against the European Corn Borer or for rootworm control (Cry3Bp)? It has been convincingly argued by Chuck Benbrook and Steve Suppan that the following important changes would ensue if the precautionary principle was adhered to.
(1) The research would focus on an assessment of the need for the technology: is it necessary?
The example of the Bt-corn is instructive. Less than 10% of acreage planted with corn, after another crop, requires insecticide treatment. Crop rotation does the management. So the treatment of all fields with Bt-corn is unnecessary. Resistance could easily develop. ‘Prescriptive use’ would serve the purpose better and more efficiently.
a. Extended Research
The precautionary approach therefore would have focussed on defining when and where the technology would be used. Growing of the Bt-corn would have been restricted to areas where there was a real threat. This would reduce insecticide use and associated risks; and costs as well.
With the restricted use, conditions could have been imposed for wider planting in the subsequent years- such as requiring the applicant to explore new scouting techniques so as to identify with more precision acres at risk in the following season. More in-depth monitoring of the pest’s movement would have also provided useful information.
This, say Benbrook and Suppan, is an example of how applying the precautionary approach can stimulate needed research and advance scientific understanding.
b. Greater ‘research’ participants
The research should be
· by the applicants (to justify approvals for planting elsewhere);
· by farmers (requiring them to experiment with resistance management strategies); and
· by public sector researchers (on Bt-toxin level expressions levels in various tissues and over time, ecological impacts, moth mating behaviour and movement, and the impacts on soil microbial communities).
This would provide better information and some field experience for the decision-making process; it could also serve as an early warning system, catching possible impacts. The impact on the Monarch butterfly became known only some three years after the first commercial planting.
If and when confidence developed, then incremental use may be considered provided there was an ability to target acres where threat justified use, there was adherence to a proven and effective management plan; and a firm basis to project minimal adverse ecological impacts.
(2) The precautionary principle and the accurate assessment of expression levels
Application of the precautionary principle in the assessment of genetic technology rests upon reasonably accurate exposure estimates. So levels of Bt proteins in various plant tissues must be known over time for a variety of purposes.
a. Adequate data base of expression levels
The research design would measure levels in roots, leaves, stalks, silks, pollen, grain and residues. Variation in levels must be known over time.
These data are necessary in order to:
· project efficacy and reliability across a range of soil types and cropping systems;
· assess whether the high-dose criteria has been met;
· determine the potential for soil microbial community impacts or impacts on soil insects, worms, etc;
· analyse impacts on non-target beneficials including insects in the same family and important general predators;
· estimate dose levels in animal feeds and human foods through grain, silage, roughage and stalks and impacts on animal digestive systems.
In the Bt-corn targeting the European corn borer (ecb), the Bt-corn was on the market for three years before a judgment was made that it did not meet the high-dose criterion. There was also not enough attention to expression levels in pollen – which was the key factor in assessing risk to the Monarch butterfly. Also there was no attention to Bt protein fate in the soil through root exudates and break down of tissues in the soil.
The research model must be designed to include adequate sampling.
b. Developing an adequate data base of environmental fate of the transgene
There will have to be better information on the environment fate of the transgenic trait as they move through the environment. This has been underscored by the recent findings in Germany showing gene flow in the wild from rapeseed pollen via the digestive system of bees.
There is also evidence that gene flow can and does occur in soil bacterium, the guts of earthworms, and nematodes.
c. A longer time period
Developing an adequate data base on expression levels and environment fate prior to any approvals beyond the experimental will require a longer time period. Benbrook and Suppan envisage a minimum of 3-5 years.
So many expressions and environmental consequence scenarios will have to be analysed. For some methods do not even exist.
d. Dealing with uncertainty.
The more irreversible the consequences the more conservative should the approving authority be with approvals at every stage. Public researchers should be involved and they should be independently funded. The paramount question will then be: whether the cost-benefit justifies the investment in biotechnology? The public element will spawn a whole new order of issues, such as: who will set the research priorities? Who will own and control the data generated? How will progress of the transgene be monitored and judged relative to the goal: example to decrease the use of the insecticide? What about the role of other resistance management issues? And liability?
This will redirect and broaden the scope and thrust of the agenda for research and development of a GMO - from the commercial impetus and needs of industry to the needs of farmers, society, consumers and the global marketplace.
(3) Impact on Human Health
Gene flow –transgenic DNA picked up by bacteria in the digestive system of rats and translocated through cells in the stomach wall, entering blood and organs – has now been convincingly shown.
Applying the precautionary approach means:
a. that more work will need to be done on the significance of gene flow prior to any approvals for the planting of transgenic crops;
b. this in turn will require the development of new techniques to track gene flow and the fate of the new trait introduced (say Bt-toxins) in animal systems;
c. that the public sector should be responsible for developing, validating and applying these new research tools.
(4) Concerns over resistance and resistance management
There are concerns that transgenic crops will develop resistance. Benbrook and Suppan state that scientists do not yet understand how quickly resistance might spread through a population and across populations, nor how stable and hence irreversible it might be.
How may this affect research and development? Research must take this difficulty into account. The precautionary principle will impose a cautious, incremental approach – especially if the goal of public policy is to prevent the emergence of resistance.
E. Will this affect research and development of ALL GMOs?
The CBP adopts a strange mix of approaches to GMOs depending upon differing situations. This reflects the intense wrangling between the three interest groups especially in the closing moments of the negotiations.
First, it requires all Parties to the Protocol to ensure that the development, handling, transport, use, transfer and release of any GMOs are undertaken in a manner that prevents and reduces risks to biological diversity, including impacts on human health. This must necessarily refer to all domestic activities, which includes research and development [Article 2(2)].
Secondly, the Protocol does not cover:
· GMOs which are pharmaceuticals for humans [Article 5]; and,
· Products of GMOs [by the restricted meaning given to ‘LMO’ and ‘living organism’ in Article 3].
Thirdly, it excludes from the Advance Informed Agreement (AIA) procedure:
· GMOs in transit (those passing through another country en route to the country of import)[Article 6(1)], and,
· the transboundary movement of GMOs destined for contained use undertaken in accordance with the Party of import [Article 6(2)].
Fourthly, only GMOs intended for direct introduction into the environment are subject to the more stringent AIA procedure.
Fifthly, the protocol specifies a different set of procedures for GMOs intended for use as food, feed or for processing. These are GMO commodities.
Sixthly, GMOs that have been declared safe by a meeting of the Parties are exempt from the AIA procedure: Article 7(4).
This means that only a very restricted range of GMOs will be subject to the key core requirement of the CBP – the AIA process. A large number will not be so affected. Does this imply that the preceding discussion about the shaping of the research and development of GMOs is irrelevant?
F. The Role of Domestic Regulations
It is suggested that this is not the case.
a. The Protocol as a Base Line
a. allows for countries to provide a framework to regulate genetically modified organisms; and,
b. does not restrict the right of Parties to take action that is more protective of the conservation and sustainable use of biological diversity and human health. That the parties can go beyond what is covered in the BP is made explicit by Article 5 (on pharmaceuticals) and Article 6 (1) – on GMOs in transit; and, Article 6 (2) on contained use.
The overriding consideration is that domestic regulations or any action taken must be consistent with the provisions and/or objectives of the Protocol. For item (b), the action must also be consistent with the Party’s obligations under international law.
So domestic laws can provide, for example, for GMOs not covered by the Protocol; impose requirements beyond the Protocol and, in particular, provide for a stricter level of risk assessment and risk management. Such laws are being promulgated by several countries of the South, including Malaysia.
In most of these countries the scope and extent of the coverage is being broadened. In such a situation the restriction of the preceding discussion to the ambit of the Protocol will no longer apply.
G. The need to know and take into account the importer’s domestic regulations
So it will be imperative on the exporter or the Party of export to know in advance the domestic regulatory framework, and, importantly, to shape the research and development of the GMO to comply with these requirements. Otherwise there will be problems in marketing the product. Consumer perceptions and fears also play a pivotal role in the acceptance of genetically engineered products. The US administration has taken up cudgels on behalf of its exporters to thwart any attempt to restrict trade in its GMOs, especially commodities. They now have embarked on well-orchestrated digital video conferences in developing countries - to present the unlimited wonders of GMOs. A selective panel and audience – with the token NGOs to boot- are lectured to by some mediocre US Government official who appears larger than life in a video screen.
The results are unknown. Third World Governments may have neither the resources nor perhaps the inclination to embark on these promotional exercises. Their GMO product must pass the test on its merits. In other words the research and development must take into account the possible risk assessment and management requirements of the importer; and overcome the public perception of the safety, worth and need for the GMO to be exported.
H. Are we going to be great exporters or great recipients of GMOs and its products?
The first thing to recall is that the biotechnology industry is largely concentrated in the countries of the North. Multinationals control the development of GMO products. Crops have been made resistant to herbicides. Transgenic varieties of cotton, maize and potatoes containing genes from Bacillus thuringiensis(Bt) have been developed to make them resistant to insects. The development (and ownership through patents) of these transgenics is in the hands of MNCs such as Monsanto, Pioneer Hi-Bred, Novartis, Dupont, Agracetus and others. Mergers and take-overs have vested the development and control of these products in even a smaller band of these MNCs.
Take the example of genetically-engineered herbicide-tolerant soybean.
The soya bean market thrives particulary well in the US. It is there dominated by the top four multinationals – Pioneer Hi-Bred, Monsanto, Dekalb and Novartis. They control 41% of the market. More than 50% of the patents on g.e oils are owned by three corporations – Pioneer, Monsanto and Du Pont. The top 10 patentees account for two-thirds of all the patents. The patents mainly relate to making the plant resistant to herbicide. Monsanto owns three-quarters of these patents. The other focus is the alteration of the oil content of soyabean. This field is also dominated by the MNCs - Monsanto, Zeneca and Du Pont.
The field testing, which forecasts the products to emerge in the future, is dominated (80%) by the top 5 companies. Almost all the tests have been to make it resistant to the two top herbicides. Patents and licensing agreements ensure that the market is divided up neatly amongst the most powerful MNCs in the world.
We will therefore largely be the recipient of these products. And the North the main exporters.
Hence our concern lies primarily in ensuring that these genetically engineered products and processes are safe for the environment and human health; and also will not disrupt the social and economic fabric of the society; and as well accord with the ethical and moral values of the society.
Initiation of risk-associated research
This makes it imperative that there be an initiation of risk-associated research as well as for the elaboration of more satisfactory risk assessment methods and procedures. This is suggested by two Norwegian researchers and regulators – Anne Ingeborg Myhr and Terje Traavik. The basis of the research should be the precautionary principle. The authors argue that this is made necessary because the present state of scientific knowledge is inadequate for reliable ecological risk assessment.
‘The basic information with regard to mechanisms governing the environmental interactions of GMOs is insufficient. The ecosystems are too complex and our understanding of them too fragmentary. Furthermore, currently available methods to monitor short and long-term ecological consequences of GMO release are non-existent or unreliable. Finally, the soico-economic and biodiversity aspects of GMO usage are ambiguous, and often unpredictable, based on the present state of knowledge.’
I. Other issues impacting on research and development
The CBP did not set out any provisions on liability. Article 27 merely states that a process will be initiated for the ‘appropriate elaboration of international rules and procedures in the field of liability and redress from the transboundary movements of LMOs. Analysing and taking due account of the ongoing processes in international law on these matters.’
The wording is sufficiently vacuous to allow countries opposed to a liability regime to delay the inclusion of provisions on liability. The process will be dogged by such matters as the nature of the liability, who is to bear liability, limit of the liability, and so on. The Article states that the Parties shall endeavour to complete the process within 4 years. Parties remember vividly that the liability regime under the Basle Convention took some 10 years to be negotiated.
Whatever the outcome, the fact remains that all research and development of GMOs must be mindful of the potential liability that may result. For example, if the efficacy of foliar Bt sprays are undermined by resistance, the biotechnology industry and anyone involved in its transboundary introduction t may well be looking at huge class actions from organic and conventional farmers who rely on conventional foliar insecticides containing Bt. Such a possibility makes it imperative that the R&D is defensive where the incidence of risks and its consequences are unknown.
20th September 2000.