The most important conclusion of this paper is also the simplest: GMOs exist, and cannot be unmade. Regardless of one’s personal, institutional or national position on the GMO issue, the most important objective of any responsible decision-maker will be to find a way of responding to the existence of, and requests regarding, the promotion of products, commodities, and technologies that are, at minimum, both important and controversial.
In this connection, decision-makers are already the recipients of untold reams of written advice, and hours of testimony, advising them on their responsibilities, and the particular choices they should make. It is not the objective of this paper to add to that volume of literature. Instead, the following is a discussion of the nature of the decision-maker’s obligation and objective, and the manner in which decisions on this issue can be responsibly undertaken.
Given the breadth of opinion on GMOs – ranging from a belief that they are inherently dangerous to a belief that they are the best hope for continued human survival – it seems clear that the only acceptable governmental responses will be those that are
based on freely available scientific and statistical information.
Accordingly, it is strongly suggested that decision-makers give immediate attention to the implementation of the Cartagena Protocol on Biosafety. As noted above, even before turning to the primary focus requirements of the Protocol (public processes for “risk assessment” and “advance informed agreement,”) it will be essential to undertake the critical step of developing an overall national policy on biosafety and the manner in which the risks and potential of GMOs will be analysed, addressed and communicated.
1. Procedures and the “Scientific Controversy” — Accessing Closely-held Scientific Information
Explained in terms of the approach of this paper, it will be essential, initially, to address the most significant uncertainty – the uncertainty regarding the science underlying GMOs and the proposals for their introduction outside the laboratory (the “scientific controversy”.)
This issue is dubbed “most significant” regardless of the view one takes on the inherent safety or danger of GMOs, for the simple reason that it requires the decision-maker to directly address an extraordinarily technical issue. The difficulty of this task is enhanced by the fact that very little direct scientific information is made available, apart from characterisations of the scientific situation, whether by industry or by avowed opponents to GMOs.
The availability of dependable, unbiased information is the key to the decision-maker’s ability to make a responsible science-based decision. Yet the serious deficiency in available information may be quite difficult to remedy.
It may be necessary to call for action in support of decision-makers at the international level, before any serious difference in the way information is guarded and used will be felt, Even when such information is freely available, it will be critically important to develop institutional capacity to understand and assess it, and thus to apply it to policy development and decision on GMO-related proposals.
In the meantime, the decision-maker is faced with a difficult problem – how to determine whether sufficient information is available to support a final decision – and possibly the even more difficult choice: Whether to make policy choices and other decisions before sufficient information is available, or to refuse to take a decision on an action that might have significant current benefits for the decision-maker’s country and constituency.
These factors affect some of the most basic procedural decisions as well. For example, as noted in II.B.2.a, above, the adoption of specific standards and procedures for risk assessment is a matter of significant expert disagreement at present. This means that even the decision to apply a risk-assessment standard must be addressed through substantive technological analysis.
2. Procedures for Addressing Economic and Socio-cultural Controversies Regarding GMOs
As noted above, the decision-makers’ task only increases in complexity, when they turn to the socio-cultural and economic issues. Procedurally, these issues require attention first to the need for good and sufficient data (economic and social analyses, as well as geographic-region- and crop-specific data concerning the direct impacts of GMO introduction) on particular factors and claims such as volume or dependability of production. In addition, however, the process must also address more difficult issues, including determining whether there are social, cultural or economic risks, and how to balance those risks against the potential gains that are offered by the proponents of introduction.
Most important, the process must not only be transparent but reciprocal. Informed public participation (input) processes are essential to effective decision-making, particularly with regard to difficult and controversial issues such as GMOs. Particularly, where such a decision involves some kind of weighing of risks and benefits, it is essential that parties on all sides of the issue clearly understand how these choices will be made, and that the process is rigorously and publicly followed. Moreover, it is absolutely essential that all legitimate input bearing on the issues relevant to the decision-making process, including especially that of local people and all sectors of the civil society, be accepted and seriously considered. More than anything else, this will help those who oppose the final decision to recognise its validity within the institutional system.
Because of the nature of the controversy surrounding GMOs, and the call for special mechanisms to address it under the Cartagena Protocol and other international instruments, 62 (as well as in some parts of the domestic and international press), it is important to ensure the maximum transparency, receptiveness, and procedural rigour in all decisions involving GMO policy and applications for GMO use.
Even after fully addressing the above issues, however, the task of GMO decision-making remains a process of extraordinary complexity. It is not enough simply to consider the basic scientific, economic, and socio-cultural issues, or to design models for addressing them. There remain larger, overarching concerns, including precaution, development, and national sovereignty whose application must overlay (but still through a clear, transparent process, which is rigorously applied) individual consideration and disposition of specific questions of fact, eligibility, or other matters.
For example, key crosscutting issues, such as the “development principle” and principled action in the area of bilateral and multilateral aid may unite within the biosafety realm. Florence Wambugu argues this point compellingly regarding the need for African countries to avoid exploitation and participate as stakeholders in the transgenic biotechnology business:
"They need the right policies and agencies, such as operational biosafety regulatory agencies, breeders’ rights, and an effective local public and private sector, to interface with multinational companies that already have the technologies. Consumers need to be informed of the pros and cons of various agricultural biotechnology packages, the dangers of using unsuitable foreign germplasm, and how to avoid the loss of local germplasm and to maintain local diversity. Other checks and balances are required to avoid patenting local germplasm and innovations by multinationals; to ensure policies on intellectual property rights and to avoid unfair competition; to prevent the monopoly buying of local seed companies; and to prevent the exploitation of local consumers and companies by foreign multinationals. Field trials need to be done locally, in Africa, to establish environmental safety under tropical conditions."63
Beyond these basic commercial and informational needs, however, are the needs for institutional mechanisms to address less obvious or expected issues. In light of the fact that the GMO issue is relatively new, there is a need for a broader level of institutional controls, to address issues that have not arisen yet, but will in future. Experience in other “new” fields of law (those relating to computer software, electronic business transactions, nuclear power, telephones and space travel, to list a few) suggests that unexpected results can cover a gamut from unintended perverse incentives to overvaluation of national commercial markets due to drastic alterations in public demand.64
In this connection, it is important to remember that the most important arbiter of GM issues will be national law.65 And within the national legislative arena, there are basically five different key policy venues in which choices made can have a significant impact on the various opportunities and incentives for the development, marketing, and use of GM crops and other GMOs. These are:
National biosafety law and policy;
National trade law and policy;
National intellectual property rights law and policy;
Food safety, health, and consumer choice law and policy; and
Public research policy.
Awareness of the manner in which each of these can address GMO issues will be a key type of capacity-building, and help assure responsible decision-making and informed public participation.
Examples of how governments and others can prepare to meet these challenges might include:
Development of mechanisms to address legal and financial responsibility for approved introductions "gone bad." In general, one who introduces a specimen is held liable for damages it causes, unless s/he properly disclosed the risks, and complied with government permits and requirements. One serious concern for many developing (and even developed) countries is how they will deal with liability (or will pay for remedy) where the introducer has met their disclosure and permit obligations, but the introduced species still proves to be harmful under any of the scenarios alluded to above – whether as described under the “scientific controversy”, or caused in other ways (unpredicted invasiveness and secondary impacts on traditional agriculture).
Ensuring prompt response (containment, removal, etc.) in the event of an inappropriate introduction, or a need to 'rescind'an introduction.Here also,legal provisions that limit the liability of an introducer who takes prompt remedial measures may encourage such action.
Imposing restrictions on safe use. As noted in other contexts, some kinds of GMOs are suggested for use only on a specified percentage of total land under cultivation in this particular crop. These restrictions work in areas which utilise large industrial farming techniques, but may not be effective if imposed areas in which farms are typically very small. Legal and institutional arrangements should pre-evaluate sociocultural conditions relevant to farming communities and regions, and identify types of restrictions and approaches that do not appear amenable to local social conditions.
Developing a GMO risk analysis model that addresses the issues of protein transfer and other kinds of risks unique to GMOs. Current risk analysis mechanisms rely on conventional analytical processes used for other introduced plant varieties.
Expediting decision-making. As with invasive species and a number of other environmentally damaging situations, the possibility of a “GMO accident” suggests the need for contingency plans, relating to how these situations will be addressed.
In addition to these, instantly addressable issues, a number of other issues will require broader institutional and legal developments, including the scientific advances necessary to enable them. Such issues include:
The need for post-approval monitoring of species introduction, as a risk management technique. In general, scientific and administrative mechanisms do not currently exist that would satisfy the need for ongoing assurance regarding the performance and safety of GMOs.
Legal systems addressing liability for failed or damage-causing GMO introductions may be the most important tool for motivating proponents of GMOs to act responsibly. However, liability depends on the ability to obtain evidence, not only of the damage caused, but of the source of the material or organisms that are causing it. In this connection, traceability is seen as an emerging risk management tool within the biosafety and food safety areas. By and large, specific tracing techniques do not currently exist that would allow identification of the source of a particular GMO problem, but they are reportedly in development. In the meantime, compilation of information regarding GMO behaviour66 may provide a basis for reasonable decisions regarding liability for harm.
In all such situations, it is essential also to ensure greater accountability in the decision-making process. Greater accountability can be supported by
clarifying the specific responsibility of particular officials with regard to permit decisions and oversight,
specifying criteria for decision-making,
requiring public disclosure of the rationales underlying each decision taken, and
providing a right for affected members of the public (in addition to the proponents themselves) to seek judicial or administrative review of decisions.
There remains one additional point to address in these recommendations – the role of national and international assistance, including specifically NGOs and IGOs, in filling the current informational and capacity gaps – that is, in promoting and developing the level of understanding and non-biased scientific capacity needed in order to responsibly address these issues. One might list the following among the areas of need that these organisations can help to fill:
Assisting with the development of national and regional frameworks, both to implement the Protocol, and more generally to address critical biosafety and GMO-related issues, in all countries in which GMOs may be introduced, regardless of whether they have signed or ratified the Protocol.
Promoting projects for in-situ conservation of genetic resources and undertaking projects with NGOs and local communities to facilitate their work in the conservation, development and sustainable use of genetic resources.
Implementing key instruments for addressing the ecological impact of GMOs and other agricultural advances, including the Leipzig Global Plan of Action, the CBD programme of work on Agricultural Biodiversity, the Global Strategy on Farm Animal Genetic Resources, and the Code of Conduct for Responsible Fisheries.
Increasing awareness, particularly of local communities, natural resource-dependent communities and individuals (farmers, fishermen, forest communities, etc.), consumers and policy-makers, regarding issues and controversies relating to GMOs and the manner in which they can knowledgeably and effectively participate in relevant decision-making.
Building the capacity of scientific and administrative departments and experts who may be called upon to deal with these issues, and more generally within the agricultural sector and civil society, with regard to understanding of and participation in relevant decision-making and monitoring processes.
Developing data and case studies relating to the impacts of GMOs on wild and traditionally bred species of plants and animals.
Promoting the diversification of research and research funding relating to biosafety and molecular genetics, to encourage the development of a clearer understanding of the processes underlying these technological innovations (including supporting and encourage programmes for training in evolutionary biology and taxonomy) outside of corporate R&D departments, and inside national governments.
Co-ordinating with and support the work of FAO and its Codex Alimentarius in the development of standards, recommendations and databases for the safe and effective regulation of GMOs and their use; and ensuring that issues of species conservation, ecosystem protection and the rights of indigenous peoples and communities are adequately addressed therein.
Collecting and disseminating reliable, well vetted information on the current state of GMO use, and its known impacts on ecosystems and conservation.
Undertaking research and provide specific guidance for addressing social, cultural and patrimonial impacts of GMO use (intellectual property rights, traditional agriculture (including participative breeding), impacts on indigenous communities.)
Undertaking research and provide specific guidance regarding the social, economic, political and livelihood implication of "free trade" in GMOs on developing countries.
Developing an informed scientific assessment of the state of GMO technology, and about the reliability and completeness of evidence offered on all sides of the “scientific debate” over the accuracy of current understandings regarding GMO processes and safety, and the impact of GMOs on food insecurity, sustainable agriculture, agricultural yield and the environment.
Developing a rigorous assessment of the comparative advantages of genetic sciences and GM technologies, particularly with regard to whether GMOs, the science of genetics, and the new biotechnologies can positively contribute to solving production problems in agriculture.
62Technically, there is no specific requirement in the Cartagena Protocol or elsewhere that would mandate the creation of new Protocol-implementing legislation. In practice, however, in order to ensure that the Protocol’s rather specific risk-assessment provisions are met, at least some “biosafety-specific” provisions are typically adopted by countries implementing the Protocol, whether by amendment of existing legislation or by adopting new.
64Another introduced species, the tulip, caused this kind of impact, nearly destroying the Dutch economy some 250 years ago.
65Matters of agricultural and commodity regulation, as well as those of health and human welfare, are necessarily within the realm of direct national regulatory responsibility. Although the WTO processes operate as a limiting factor for countries engaged in global trade, they specifically do not prevent countries from taking any legislative or policy choices, so long as those choices meet standards relating to non-discrimination and other key issues.
66Such work is in development at FAO, although it is not yet clear what form the ultimate database will take.
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