II. Biosafety and GMOs – Technical and Technological issues

The technical and technological issues involved in biosafety are numerous and often very complex. For the purpose of this briefing paper, only the most central will be summarised, as a means of focusing on how the debate is progressing, and on the most relevant issues and informational needs, rather than on cataloguing the list of problems or recent cases.

A. Scientific Aspects of the Controversy

The scientific bases of the GMO controversies must be the beginning point of this analysis. However, even the publicly available scientific literature tends to address the GMO issue with an inappropriate lack of scientific rigour. The following discussion outlines the nature of both the scientific issue, and the problem of awareness among economists, sociologists and other activists and commentators involved in the issue.

1. Popular Viewpoints

The biosafety controversies are so complex that the full extent of the scientific debate is not generally understood. Instead, the positions of many people – even scientists and people at the highest governmental levels – are formed on the basis of a very simplified statements of the issue. At their simplest, the controversies over GMOs and biosafety are typically expressed as follows:

1)      On one side are those who feel that products and processes of genetic modification are generally safe and beneficial, and that their use should be fostered and encouraged. The underlying assumption of this view is that the scientific bases for genetic manipulation and other processes are sound, well understood and can be well managed and controlled by the modern biotechnology industry.

2)      Opposite in many ways to this first view, however, are those who focus on the risks and unknowns regarding GMOs’ possible impact on ecosystems and species (and on human health and other factors.)

3)      Yet a third view focuses on the intent behind research and development in molecular biology – i.e., that it provides a potentially dangerous example of the manner in which social structures (including granting agencies, governments, NGOs, industry, and even institutions of higher learning themselves) have come to place an undue level of emphasis on “discovery that can be put to work” rather than on developing the requisite scientific understanding of the underlying processes that will be necessary to understand and predict the impact of those discoveries on humans and the planet.6

The foregoing simplistic descriptions constitute the general understanding in most of the world. Although expressed non-scientifically, they appear to be equally represented in the scientific community as they are in the general population. Hence, one’s position on GMOs is often simply an extension of one’s pre-existing general orientation:

-        Those tend to distrust government or corporations, or to believe that scientific “certainties” cannot be relied on (because they seem to change so frequently), probably ascribe to the position #2, above.

-        Others, who generally believe in scientific development as a source of answers, also feel that, where a new technological solution creates problematic side-effects, science will usually be able to solve these problems. These people tend to accept position #1.

-        A third group seems to feel that scientific advances can find answers and operate in a safe manner, but are less likely to do so when the focus of that development is on the creation of commercial applications and products and the maximisation of corporate profit. Holders of this view espouse position #3.

These generic responses, however, do not suggest a way forward regarding GMO and biosafety issues.

2. A More Detailed Summary of the Main Points of Scientific Controversy

It is fair to assume that the scientific controversies regarding genetic science cannot be resolved or decided on the basis of a simple restatement of the scientific issues, and no paper can at present provide a definitive statement regarding the controversial scientific issues. In order to determine a focus for decision-making in this area, however, we must develop a more detailed collective understanding of the scientific controversy that underlies the biosafety debate.

While a usable-length background paper cannot thoroughly discuss these issues, this paper does intend to move beyond the most basic formulation of the problem, and give some idea of how it must be understood for purposes of examining its impacts on conservation and sustainable use of biological resources and ecosystems. Hence, before examining the various ecological and socio-cultural impacts and benefits of GMOs, we must briefly outline the underlying science involved, as a basis for understanding.7

a. Background: From selective breeding to genetic modification

For centuries farmers have used selective breeding to improve both crops and stock. The most traditional method was,

Over time, breeding controls in both plants and animals, and even in useful microbes (such as yeasts used in bread and winemaking) grew more sophisticated, including processes for developing hybrids.

As variety development began to have a greater commercial element, additional concerns arose. It was essential to ensure that a plant variety was “stable”– that is, through generations of selective breeding to completely eliminate undesirable recessive traits so that the variety would “breed true” in future. This was a pre-condition, if the developer of that variety wished to protect his “intellectual property rights” in that variety. In 1961, the International Union for the Protection of New Varieties of Plants (UPOV) amalgamated existing rules and principles for determining whether a variety is “stable,” creating a standard that is now, generally accepted. It has been suggested that this development (a precursor to modern work on intellectual property rights (IPRs) for traditional genetic modification of plant and animal varieties, as discussed below) may not have been a positive step, given that less stable varieties may be less vulnerable to diseases.8

The push for “stability” in the crop variety and other factors have caused the traditional agricultural development processes to be extremely lengthy. Both traditional breeding and hybridisation methods, however, are dependent on the availability of species that are already adapted for use in the region. If a desired trait (resistance to a particular disease or fungus, for example) is not available, it may not be possible to develop it through these methods.

The beginnings of a major change in this process came into being in the 1950s, when James Watson, and Francis Crick discovered the structure of DNA – the double helix of nucleotides that, they postulated, forms the blueprint of life. This discovery provided a new theory of genetics – that by altering this genetic coding one can give organisms new characteristics not possible under natural evolutionary processes, selective breeding, or even hybridisation. The theory that they used to explain their discovery was that these characteristics will continue to replicate themselves in stable and predictable dependable ways, because they have been integrated into the DNA coding, which was believed to directly control the way in which cells replicate and specialise within the organism. (Although the basic theory of DNA as the primary code of all life has undergone significant theoretical adjustment since the days of Watson and Crick, this general view, and its current progeny will be described in this paper as the “Watson-Crick theory,” to distinguish it from the developing theories discussed below that recognise a variety of other essential building blocks of life, including especially proteins such as RNA.)

By the 1970s, it became possible to isolate individual genes, refashion them and copy them in cells. The significant commercial possibilities of this capability were recognised instantly, and development began primarily through research and development programs in corporate and academic institutions. The first genetically altered whole foods (the so-called FLAVRSAVR tomatoes) appeared on the US markets in 1994. Since then, many other such commodities have been developed.

As an example, a simplified description of one of the many processes9 by which GMOs are developed (recombinant DNA) is attached as an Annex to this paper. In essence, “genetic modification ” or “genetic engineering” techniques enable scientists to find individual genes that control particular characteristics, separate them from the original source, and transfer them directly into the cells of an animal, plant, bacterium or virus.10 This process is based on the above-described premise that the DNA code is known, that it controls all of the specimen’s characteristics, that it is inheritable, and that it is common to all life.

From this perspective, there are three major differences between selective breeding and genetic modification:

  1. In genetic modification, scientists can take individual genes from one plant, animal or microbe and insert them directly into the DNA of the cells of another, or may modify an existing gene within that organism. This work does not rely on the Mendelian approach of traditional breeding, which seeks to standardise a characteristic by weeding out other characteristics (recessive genes) over many generations.

  2. Genetic modification has been expected to provide a way of giving a plant or animal new, inheritable qualities much more quickly than through the use of traditional methods, and to allow the addition of qualities that are entirely new to the species.

  3. Modification allows genes to be transferred in ways that are not found in nature, between different species and even between animals and plants.

b. The Scientific Debate

This modern life science created astounding possibilities whose very novelty and power suggested to some the need to challenge the technology before any other factors were considered. Some commenters’ description of genetic manipulation as an exercise of “nearly godlike power” is evidence of the level of discomfort felt in response to highly publicised achievements (such as the production of the cloned sheep, Dolly, by Ian Wilmut of the Roslin Institute and Keith Campbell of the biotech firm PPL Therapeutics in Scotland in March, 1997.11)

On the more scientific level, however, the debate goes beyond personalities. Concerns expressed by some geneticists focus on the belief that it is premature to introduce GMOs into the environment now, based on scientific, conservation and other concerns, and do not rest upon an objection to humans “acting like gods.”

Although these concerns are not new, they are increasingly based on two recent scientific discoveries, and their apparent import. The first of these discoveries is founded on the results of the Human Genome project, which were significantly different from those predicted by the prevailing view of DNA. Those results suggest that DNA is not sufficiently varied and does not allow a sufficient number of combinations to account for all biologically replicated traits, even of simpler life forms. This suggests that there are other factors which are also “building blocks” of life.

In combination with a longer-held position regarding viral transfers, this position is bolstered by several empirical results observed in recent scientific studies, including

In all of these cases, the proponents of this position argue that there are other not-yet-understood processes or substances that are essential to the development or replication of life forms. The most common assertion is that the cellular reproductive proteins play this role. This would possibly account for the fact that results of DNA modifications are not limited to the particular characteristics of the replaced gene. Some theorists postulate a process called “alternative splicing” by which changes in a particular gene can be “shared” with other genes, through the medium of RNA (which has a very minor role in the Watson and Crick view of molecular genetic processes).

3. Access to Information and Other Implications for Decision makers

As further discussed below, one of the greatest problems within the scientific debate relates to informational limitations. Most of the available scientific information regarding GMOs is held by corporate and research institutions whose motives are sometimes questioned, as they are viewed as having a strong financial interest in ensuring that GMOs are perceived as positive contributions to human life. These concerns include the fact that many GMO projects suffer a high percentage of failures that are not clearly disclosed or explained. Although there are numerous reasons why these entities should retain close control on this material, it is also true that scientific analysis of the “debate” described above, is severely limited by the lack of access to this closely-held information.

On the other hand, some of the most well publicised opposition to GMOs has sometimes taken the form of high-profile press announcements that do not stand up under initial scrutiny. There was initial dramatic publication of the Bt maize story, in which “environmentalists” claimed that pollen from Bt maize spread to local milkweed, where it was eaten by monarch butterflies, more than half of which quickly died. This story, although excellent at gaining attention, was discredited by the statement that the Bt gene was inserted in maize for the express purpose of making that maize toxic to Lepidoptera (the taxonomic order of butterflies and moths), as a means of avoiding the need to poison the corn borer (a caterpillar that is extremely damaging to corn and maize) – another Lepidopteran species. Following the “discrediting” of the Bt maize story, publicity died away, and in the limited follow up stories, it was not possible to determine, for example,

As to the latter, there are two very serious issues that cannot be currently addressed without that data. On one hand, Bt that is incorporated into the maize’s DNA must unavoidably be eaten by the ultimate consumer of the maize (although it has generally not been considered toxic to humans, the scientific basis of this statement has not been publicised in connection with Bt maize). On the other, pesticides and the manner in which they are applied are a serious environmental and health problem. If it is proven that Bt maize is “no worse than the use of Bt pesticide,” that fact is not necessarily praise for the product.

In this light (and coupled with questions of precaution and responsibility discussed below), it seems apparent that, while basic underlying science involved in GMOs remains in dispute, there will be a continuing need for organisations such as IUCN — unbiased scientific analysts and “knowledge networks”– to develop and provide sound and balanced information regarding all aspects of the GMO question, including key questions regarding their impact on species and ecosystems.

B. Economic and Political/Institutional Aspects

A second realm of concern in this area encompasses economics and political concerns. This area has seen a large volume of material regarding GMOs, much of which utilises inconsistent approaches, or fails to clarify the type of physical/scientific questions that are being discussed.

The economic/political debate is often very individual, and debated at the local level, or with regard to specific introductions or proposals. One of the best ways to understand how these issues arise and how they fit into the overall GMO controversy is by utilising two primary organising mechanisms: (i) risk/benefit analysis, and (2) risk management techniques (licensing and labelling).12

(As mentioned above, the basic “scientific controversy” cuts across all of these issues. Except where necessary to clarify the problems involved in trying to apply a risk-benefit analysis to the overall GMO issue at present, this section will assume that the reader has already read the previous sections, and is aware of the difficult and currently unresolved basic debate concerning the scientific understanding of the GMO process, and its relevance to any determination regarding the safety of GMOs.)

1. Risk/benefit Analysis

It has been typical, in examining national and commercial development, to utilise the economic approach known as the “cost/benefit analysis.” In essence, the aim of this approach is to examine the value of the activity or product (its benefit) in comparison to the costs incurred in undertaking, producing, and/or using it.

To be effective, a cost/benefit analysis must consider all of the costs and benefits, and not be limited to financial expenditures and profits. In seeking a proper balance, economists have developed a long series of mechanisms for valuing and comparing various types of costs. In addition to direct and indirect payments, these mechanisms allow the recognition of such items as “opportunity costs” (losses of valuable opportunities, where one is committed to a particular action), the often unvalued costs of use of or damage to “free” resources (e.g. air, water, soil), social costs, environmental benefits and delayed benefits.

These intangibles, while sometimes acceptable with regard to costs, must be differently evaluated with regard to risks. Human activity has advanced to a point where it sometimes tolerates and assumes potential risks whose magnitude cannot be fully predicted, valued, or even completely understood in advance of the activity. As a result, mechanisms have been developed and are still evolving regarding the valuation of this, most critical, component of the cost side of the equation –“physical and environmental risks.” Although it appears that the use of this so-called “risk/benefit analysis” is not clearly warranted with regard to all GMO decisions, it is a familiar structure around which the relevant political, social and economic issues of GMOs are often examined. The following discussion points out both the manner in which such an analysis has been presented in the context of GMOs, and the various ways in which this structure can and cannot be used as a mechanism for evaluation of GMO issues. The conversion of this concept into that of a risk/benefit analysis is not universally recognised, it too, is becoming an important tool of decision makers. While the mechanism for “risk/benefit” analysis is not firmly established, there is a general consensus that two factors must be considered in applying such an analysis –

The magnitude question includes not only the extent of potential damage, but also the costs of remediation if possible, and many other factors. Magnitude of the risk is often difficult to assess with regard to a particular activity or condition that has little or no “historical antecedent” (i.e., that have not been created or undertaken regularly over a long enough time for its impacts and long-term effects to be well documented.) For example, the magnitude of potential damage from the Y-2K computer system problem was vastly overestimated in prevent assessments of that risk. It remains true, however, as demonstrated by events of 11 September, 2001, that risks of very great magnitude should not be ignored, even when their likelihood is perceived to be very small, so long as they are not absolutely impossible.

The likelihood evaluation is typically based on experience with similar situations in the past. Thus, one’s ability to evaluate the likelihood of long-term or delayed damage will improve over time. Likelihood evaluations are least valuable where they involve an activity or science that is new or previously unmeasured. In these cases, likelihood may be calculated based on “similarity” to other situations, and the strength of this data will depend on the extent of similarity. As noted in Part II.C.1, below, however, similarity has not proven to be a very effective measure of risk.

In the context of GMOs, the concept of risk/benefit analysis involves controversy as to both the benefits and the risks. The following discussion briefly examines the two components separately.

a. Evaluating Benefits

Possibly the most difficult aspect of undertaking a balanced analysis of the GMO issue, particularly when charged with the mandate of applying “scientific rigour,” is the evaluation of benefits of GMOs. While claims of such benefits abound, statistical and other supported documentation of them is extremely limited.14 For example, numerous statistical databases provide clearly documented information on the use of GM seed in various parts of the world, market coverage, and similar statistics. The following table is typical of the most available data:

Source: ISAAA Global Review of Commercialised Transgenic Crops 200115

From these sources we can find that the estimated global area of cropland on which transgenic or GM crops were cultivated in 2001 was 52.6 million hectares (130 million acres). This was a 19 per cent increase over the same figure for 2000, and, of course, a 100 per cent increase over 1995.16 As of 2001, transgenic crops were grown by 5.5 million farmers.

Similar data from these sources shows that Western Europe and the US have committed an unprecedented percentage of their arable land area to GM crop cultivation, while other regions have utilised GMOs much less. This type of information is easily obtainable from a great many different sources.

Direct information about consequent increases in land productivity, farmer’s livelihoods, and regional food production figures are less readily available. Even when relevant data can be found, it is not expressed in correlation to GMO usage data17 General data on, for example, gross and per capita food production is available from FAO’s World Agricultural Information Centre (WAICENT) (www.fao.org/waicent) and reports such as “The State of Food and Agriculture” and “The State of Food Insecurity,” which FAO produces annually. No conclusions can realistically be drawn from these statistics until they are linked more directly to particular crops and regions, however, it may be notable that, despite the annual increases in the volume of land devoted to GM crops (as noted above), there was also a significant drop in world production of cereal grains in 2001.

Without statistical data to support the benefits from GM crops, one is left with only the financial benefits to analyse. Here, the benefits may be greater in developed countries than for the developing world, given that agriculture in developed countries has long utilised hybrid varieties (requiring annual seed purchase, rather than “seed saving”), and is more dependent on the purchase and use of pesticides and commercially marketed soil emoluments.

b. Evaluating Risk

The risk side of the risk/benefit analysis must necessarily involve an understanding of the scientific controversy.

c. Examples

The applications and potential applications of GMOs vary across a wide spectrum. In examining their “risks and benefits” one must recognise many distinctions, based on the nature of the activity involved. GMOs are used in a variety of very different ways. Concerns about these uses cannot be completely understood, without first recognising this variety of uses and objectives. In particular, where a GMO is to be introduced into the uncontrolled environment, the risks to that environment are significantly greater than when it is to be utilised solely within laboratory or other controlled environments.

(i) Uses in Controlled Environments

The use of GMOs in activities within controlled environments is generally recognised as acceptable practice. GMO development (even where the product is designed for introduction outside) occurs in controlled conditions, and is subject to rules that have been in existence (and constantly under scrutiny) for more than three decades (since the commercial application of genetic modification technology first appeared to be possible.)

The most prevalent examples of contained use are research-related. In many instances, the objective of the research will be the development of an organism for introduction into the uncontrolled environments. (These uses will be discussed below.) In medical research, however, the product of the research is derived directly from the laboratory. For example, the use of genetically modified animals in medical research has increasingly become a tool for creating “models” of human disease and help in the assessment of new therapies, avoiding problems that have made modelling difficult with naturally occurring animal models. Recently, researchers have successfully created four GM mice strains each with a different mutation of the cystic fibrosis gene (the most common genetic defect in northern Europeans). (Colledge, 1995).

Risk analysis in these instances focuses around the ultimate use of the product – e.g., whether it will have any unintended health effects, create conditions or susceptibilities that can be transmitted to others, etc. Where the issues involve animal health, there may be additional questions about how that animal fits in the food chain (i.e., whether it poses any health risks to humans who eat its meat or drink its milk). These risk issues fall squarely within the “debate” described in part I.A.3, above.

Benefits in these cases include not only the health benefit, but also the possibility that benefits can be obtained more quickly than would be possible if relying on older, more conventional research procedures.

With very limited exceptions,18 these uses of GMOs do not appear to relate to the issues of concern to IUCN.

(ii) Introduction and Use in the Uncontrolled Environment

The risk/benefit analytical issues increase in complexity where the GMOs are to be introduced into the uncontrolled environment. Here, although the “scientific debate” is a great concern, there are many other concerns that arise regardless of which scientific picture ultimately receives general acceptance.

One of the most prominent developments of GM technology has been the creation of transgenic agricultural crop varieties, and commercially useful marine species. As noted above, GM agriculture is increasing almost exponentially in developed countries. Mariculture, too, is developing, with notable recent activities regarding the introduction of GM fish species, particularly in developing countries. The following examples of benefits and risks of GMOs are based on these uses.

Benefits:

The benefits that have been identified as possible outcomes of GM agriculture/mariculture are many and varied, for example19:

Similarly, genetically-engineered bacteria have been approved for agricultural use in the United States, with the object of increasing nitrogen-fixing properties of certain agricultural crops. The object of these introductions too will be to replace naturally occurring species.24 Such projects have also developed microbes for use in bioremediation of certain kinds of soil contamination.

Controversies, however, have turned on the manner of valuing these benefits. One key issue is the extent to which they can be or have been proven. Evidence linking particular benefits to GM use has been limited, and often provided only in episodic form. For instance, as noted above, agricultural statistics are difficult to find that provide appropriate linkages between GM crops and productivity – which would appear to be the basic raison dêtre for the introduction of such crops as elements under developing-country “food security” programmes. Claims that varieties can be developed more quickly with GM techniques than through more traditional methods are also not entirely supported by available facts. Even the materials on pesticide minimisation have been questioned, because they tend to focus on the pesticide demands of the particular farmer using GM crops, rather than more generally on the sub-region.

The benefits of food security and of the concept of “issue-specific solutions” to particular agricultural problems are sometimes questioned as well. It is argued that these programmes may engender over-dependence of a particular community or district on a smaller number of “miracle” varieties that are resistant to common pests, hazards, or conditions – leading to more serious food shortages when that variety is found to be susceptible to other (less common) events or threats.

In general, the controversies over benefits are functions of lack of specific, statistically valid information.27 As with all environmental decision-making, the existence of reliable data is a prerequisite to making decisions that benefit all.

Risks:

The risk analysis in regard to the use of GM varieties should address both the risks that the “scientific debate” will disclose instability in GMOs, and the risks that exist regardless of the outcome of that debate.

General risk analysis based on the “scientific debate”: Many variations of these concerns exist, depending on many factors. In general, these concerns revolve around the possibility that the genetic change to and subsequent introduction of one species will impact other species, or cause other changes in the introduced species.

One particular concern relates to the possibility of horizontal gene transfer,28 in marine and freshwater ecosystems. This concern is particularly relevant because of evidence with regard to various types of species introductions (introduction of naturally or conventionally bred alien species as well as GMOs), regarding escape of mariculture species from their “farms.” Evidence that, in marine ecosystems, there exist viral or bacterial agents that can reassemble free-floating DNA, supports these concerns. . This, in turn, has raised questions about the potential of horizontal gene transfer from GM fish in “fish farms” to wild stock.

In terrestrial ecosystems, confidence in the impossibility of this type of horizontal transfer is higher; however, numerous scientists have indicated that viral transfer may still be possible. In addition, the gene replacement may not be stable, so that it can have other impacts on the organism, and its surroundings.29

Risks Applicable under Either Scientific Paradigm: Numerous environmental risks related to GMO use may apply even if one assumes that DNA is the sole determinant of cellular reproductive patterns. Among these concerns are the following –

Ecological stability of the GMO: Even under the Watson-Crick view of DNA, each gene may control several different traits in a single organism. Insertion of a novel gene can have an unintended auxiliary impact on the rest of the host’s genome that results in unforeseen side effects. For example, mustard seeds engineered for herbicide resistance were also found to be twenty times more fertile than their non-GM equivalent.30 Not all such collateral effects are immediately recognisable. Arguably, the relatively limited life cycle of most annual agricultural crops might act as an informal safeguard against this problem. However migratory and/or long-lived species such as fish or trees differ from most agricultural crops in that they endure in or between landscapes or seascapes for long periods of time. For risk assessment purposes, it is difficult to assess this type of risk. Although many collateral impacts could, like conventional mutations, be harmful or fatal to the carrier, others may not, or may in longer-lived species be transmitted to offspring well before the defect becomes known.

Many of these risks are essentially identical to risks incurred with regard to introductions of non-GMO species. Concerns about genetic contamination, competition, ecosystem damage, and inability to “undo” ill-advised introductions, for example, are equally significant with regard to the introduction of naturally or conventionally bred alien species.34 Similarly, selection pressures are at least as relevant to the use of pesticides as to GMOs.

These facts do not suggest that that GMOs are safe or beneficial, however, nor that they should be less scrutinised simply because they share potential risks with other serious conservation problems. Alien invasive species are among one of the most serious environmental threats currently recognised, and have been singled out for urgent international attention;35 while pesticides have long been targeted as environmentally dangerous.

d. Research and Sources of Information

The key factor in all of these activities is the availability of dependable, scientifically accurate information, which the decision-maker can feel confident relying on. In general, regardless of its ultimate probity, scientific information provided by the applicant – who is seeking approval of a GMO introduction, often for commercial reasons – will be viewed with suspicion if it cannot be verified by external sources, independent reproduction of test results, and other confirmations, from independent, non-biased sources.

This need is particularly evident in an evolving and expanding area such as molecular genetics. Few government agencies can afford to employ specialised experts whose level of understanding is sufficient to validate the applicant’s claims internally prior to issuance of the decision. Often their only alternative is to select among a small group of experts available to them – often provided either by the proponent of GMO introduction, or by avowedly anti-GMO organisations. It may not be appropriate for the decision-maker to simply take a “middle position” between these extremes. Increasingly, it will be essential to understand the scientific, economic and social issues, and to be able to separately evaluate the evidence and scientific justifications for the competing positions, in order to make a decision that satisfies the decision-maker’s ultimate duty to his/her country and constituency.

As a result, the biosafety issue offers a paradigm and justification for the continuing need to support independent research (i.e., research that is not connected to commercial or industrial development). Perhaps the largest single factor contributing to the overall controversy is the fact, referred to elsewhere, that an overwhelming majority of the research and data regarding GMO development is held very closely by corporate developers.

It is likely that, as frequently noted, a company’s desire to protect its research and development processes and activities against commercial “espionage,” is probably the reason behind this attitude regarding data security. However, the fact that test results and materials exist, which are not available to independent researchers, creates a perception that these files contain data indicating higher levels of risk than is generally alleged – data that would, if known, negate the applicant’s chance of obtaining approval for a GMO introduction. Clearly, the need for a broader understanding and verification of the current scientific status of GMO work in a particular area would ultimately benefit both applicants who are acting in good faith and civil society groups who are suspicious of GMO introductions.

The problem, however, is not simply one of access to data from commercially motivated research and development (R&D) programmes. It is also apparent that research that is not product-oriented may take an entirely different approach, and may thus encounter an entirely different order of results. Hence, it is important for research programmes to be funded “for purposes of enhancing general scientific understanding”– something that one cannot expect of commercial R&D.

To date, there is no market-based solution to the need for this kind of research, even where it is essential to the ultimate commercial objective (such as obtaining official permission for GMO introduction or improving public perceptions of GMOs and GMO-safety.) Diversified funding for independent, non-commercial, public-sector research into molecular genetics and other issues of GMO safety seems to be the only possible solution. Promotion of this objective may be one of the most important mechanisms by which the controversies described in this paper are resolved, and effective, safe integration of GMOs into regulated national and regional frameworks for sustainable use of biological resources can ever become a reality.

FAO and its Codex Alimentarius (a series of voluntary standards for food and agriculture) are attempting to fill some of the knowledge/information gaps by providing database information about the experiences of member countries.36 Databases under development include a comprehensive list of “biotechnology” policy documents of FAO members; attempts to compile available information which governments are able to supply concerning particular GMOs, and ongoing work for the development of standards such food labelling and related testing issues (described below). Decision-makers and the civil society may find it essential to co-ordinate with and support these initiatives.

2. Risk Management

The risk management process forms a second focus of the economic/political component of the GMO/biosafety issue. Where a risk/benefit analysis concludes that risks exist with regard to a GMO introduction or other activity, but are sufficiently outweighed by the benefits of that action, it will probably still be required both practically and legally, to take steps to “manage” the risk, and to ensure that damage will be minimised, should the risk become a reality.

Elements of currently used and proposed risk management process include a variety of different kinds of activities. To a large extent, the specific protective measures imposed on the GMO user will be determined based on scientific factors linked to specific details of the GMO and the proposed use.37 These issues, too, turn on the ability of the decision-maker to rely on unbiased scientific experts who are able to analyse each proposal or application, and determine what controls are needed, and what the best available technologies and practices are.

Technical issues at this level cannot be examined in this paper. However three important components of risk management are impact assessment, public awareness/participation, and the design of regulatory systems. These concepts, all very important in this field, are critically important to GMO-related governance. It is not possible to overstate the importance of the public’s contribution to effective decision-making, as well as the importance of public awareness, within the context of government decisions on matters and activities affecting the environment.

a. Impact Assessment Processes

Within the concept of risk management, the mechanism of impact assessment plays a crucial role. Although extending well beyond the scope and detail of many Environmental Impact Assessment (EIA) procedures, the assessments mandated under national biosafety-related legislation, and especially under the Cartagena Protocol (described below) provide a clear foundation on which at least some of a country’s various decision-making, permitting, labelling and other processes relating to GMOs could be based.

Unfortunately, although the need for risk assessment is undisputed, the particular parameters of that investigation are difficult to quantify in the biosafety area, given the fact that GMO introductions are a relatively new innovation. In many cases, the primary scrutiny focuses on a concept called “substantial equivalence,” under which GMO products are compared to the product they are designed to replace.

In some cases, substantial equivalence may be used as the basis only for determining whether a GM introduction must be licensed. That is, if the GM product is similar enough to the product it is replacing, then it may be introduced with minimal administrative involvement.38

In many more difficult instances, however, substantial equivalence is used as a basis for decisions regarding the safety of proposed GMO introductions. According to the World Health Organisation, the substantial equivalence mechanism is designed to take into account both intended and unintended changes in a plant or the foods derived from it,39 by identifying similarities and differences between the new food and the conventional counterpart. Thereafter, safety assessments and risk/benefit analyses assess the safety of identified differences (sec. 3, para. 16) regarding the substitution of the product, as food. Risk managers subsequently judge this and design risk management measures as appropriate.

Unfortunately, this approach has very little direct relevance to any of the risks identified with regard to GMOs. Although effective in other areas (such as seed management programmes based on more traditional methods of new variety development), the reliance on the substantial equivalence test in the case of GMOs, may serve as a distraction from the more serious need to consider other measures of the safety of GMOs, and thus to develop other mechanisms for managing those risks.

In this connection, it is important to note that the development of agreed risk management measures would provide a real benefit for both the GMOs proponents and the communities and ecosystems that would be most affected by the identified risks. In general, where a government permit is given on the basis of full disclosure of risks, and where the permit-holder meets his risk management obligations, the permit-holder is not liable (or is held to a lesser standard of liability), for damage caused by the disclosed risk. Thus, if good and sufficient analytical models can be developed for determining the risk from an introduction, the proponent has a safety net of protection against liability for “the unimaginable,” while at the same time, local communities are better protected against those risks.

Still, the proper application of substantial equivalence, and in particular the assumptions upon which both principles are founded and applied, are outstanding issues that may determine the extent to which the risks of GMOs can be accurately identified and subsequently minimised or eliminated. Strong arguments exist regarding scientific uncertainty, borne of relatively few but very clear technological problems that cast doubt on “substantial equivalence” as an indicator of safety or appropriateness. In the face of these concerns it has been noted that:

“The degree to which [GMO-caused] disruptions occur is not known at present, because the modern biotechnology industry is not required to provide even the most basic information about the actual composition of the transgenic plants, to any regulatory agencies. No tests, for example, are required to show that the plant actually produces a protein with the same amino acid sequences as the original bacterial protein. Yet this... is the only way to confirm that the transferred gene does in fact yield the theory-predicted product. Similarly, no detailed analysis of the molecular structure and biochemical activity of the alien gene and its protein product, in the transgenic crop are required before it can be introduced. This is not even required as to the initial generations, where some commenters suggest that multigenerational testing and follow-up is also possibly required.”40

b. Public Awareness/Access to Information

Public access to information is an important cornerstone of public participation and is one tool that could help to realise the benefits and avoid the risks of modern biotechnology. This concept is well recognised in Principle 10 of the Rio Declaration, and in the recently adopted Åarhus Convention on Access to Information, Public Participation in Decision-Making, and Access to Justice in Environmental Matters.

Transparency and Capacity: Simple “transparency” and “access” to relevant documents, however, may not be sufficient in the case of biosafety issues. Arguably, the concept of access to information must include, in some way, access to the tools and expertise with which to understand that information. While merely providing “access” to the data will be sufficient in many developed countries that are home to highly specialised and active NGOs, even here the balance of expertise weighs heavily on the side of the GMO proponents – often the companies or institutions that developed the GMOs.

Labelling, Standards and Certification: Beyond the public’s access to governmental documents and processes, however, there are other mechanisms by which public awareness and access to information can be encouraged, including product labelling, food safety standards and general consumer protection laws, all of which are designed to foster awareness and communicate public preferences to the commercial proponents of GMOs in a way that will get their attention. These mechanisms can be effective if they are accurate, specific, clearly expressed in understandable language, unbiased, and based on full disclosure of the relevant facts by the GMO proponents.

By contrast, labelling mechanisms can become meaningless where they are allowed to become generic, are written in an overly technical style, or are known to be propounded in a self-interested manner. In California, a major referendum requiring disclosures of toxic and carcinogenic substances in public places and consumer goods was basically invalidated by regulations that allowed those disclosures to be made in generic terms.41

Confidential Information and “Trade Secrets”: One of the key concerns in this regard relates to the proponent’s need to maintain some information as “confidential.” While the basic realities of modern business clearly underscore the need for confidentiality, it is also true that confidentiality provisions are often used as a means of avoiding disclosures.

In the face of increasing recognition that activities, including especially species introduction, in one country may have serious impacts on neighbouring countries, labelling and other access to information is increasingly addressed at international and regional levels. A critical institution in this field is the UN Food and Agriculture Organisation, whose Codex Alimentarius is one of the primary vehicles through which these issues are being addressed.

Direct Public Participation and Awareness Mechanisms: With regard to direct public participation in biosafety related decision-making, a small number of countries, including particularly Denmark, the Netherlands, and New Zealand, are also taking a leading role in developing mechanisms for public awareness.42 These countries’ legislative provisions require relatively broad-based stakeholder processes addressing certain aspects of modern biotechnology, including the release of GMOs. Such processes help the governments and regulatory agencies to gauge public opinion, generate dialogue, gather useful information and develop awareness within their populations on modern biotechnology.

c. Design of Regulatory Systems for GMO Development and Use

In many different fields of endeavour, technological capacity to act has moved significantly faster than has the governmental (and in some cases the technical) ability to oversee and regulate it. As a consequence, many concerns relating to the risk of GMOs are directed more closely to the apparent lack of societal and governmental restraints on GMO developers and users, rather than to addressing particular scientific issues. This suggests that a third key element of the risk-management process involves a reconsideration of regulatory mechanisms and systems for governmental oversight of GMO development and use.

One fact, which has been identified as underlying many recent GMO-related problems, relates to the cost of the pre-production (R&D) phases in GMO development. It is generally true that the costs of the entire process from prospecting for or otherwise locating genetic material through to having a GMO in readiness for commercial production can be extremely long, and that during this period there is frequently very little return on the company’s investment of personnel, technology, and money. Governmental regulatory involvement in this process usually happens at the “product” end – that is when a product is complete and its developers are seeking relevant government approvals for marketing, introduction in agriculture, etc. The combination of factors suggests that, at the time of governmental approvals, there is a great incentive on the part of the company to obtain the approval – an incentive shared by governments, given that one important part of their mandate is support to industrial and commercial growth and development.

Current initiatives have been proposed that approach this in a variety of ways, including longer-term use of containment strategies, stringent product safety criteria, etc. Ultimately, however, the most effective option may be a relatively deep restructuring of the way that governments oversee the GMO development and approval processes, such as the approach proposed by the “Safety First Initiative.” In essence, this approach would attempt to “anticipate and resolve safety issues as far upstream of commercialisation as possible.”43 From the earliest stages of the development process, GMO researchers would be called upon to address and incorporate safety issues, including both safety during the development process, and planning and testing for safety and traceability of the ultimate GMO product.

The safety-first approach is currently proposed as a voluntary, industry-driven system; however, it may be that companies would find a greater incentive to use such a system if it streamlined final governmental approval processes. In order to do this, the system would have to be tied to a programme of formal governmental “milestones” which are confirmed during the various phases of the development process.

C. Socio-cultural Impacts

It is in the area of socio-cultural impacts that the controversy over GMOs and biosafety takes on its most complex aspect. On one hand food production, food security and livelihood improvement are all critical elements of sustainable development, to which GMOs and other products of modern biotechnology are often cited as important contributions. On the other hand, the introduction of GMOs can affect humans, (as well as animals and ecosystems), particularly at the community level, in many ways beyond direct physical sustenance, not all of which are beneficial.

The role of GMOs in food security and sustainable development was recognised at WCC-2:

[T]he environmental questions surrounding biotechnology need to be addressed, yet the technology as a whole offers great promise – of environmental, social, and economic benefits – that should not be inhibited unnecessarily.44

Such recognition is not new, nor is the relationship between this factor and developments in agricultural technology. The 1987 Brundtland Report noted food security as a critical issue for “our common future,” but noted also that merely increasing gross production is not enough:

There are places where too little is grown; there are places where large numbers cannot afford to buy food. And there are broad areas of the earth, in both industrial and developing nations, where increases in food production are undermining the base for future production.... Agriculture does not lack resources; it lacks policy to ensure that the food is produced where it is needed and in a manner that sustains the livelihoods of the rural poor. We can meet this challenge by building on our achievements and devising new strategies for sustaining food and livelihood security.45

That report noted an unprecedented growth in food production in North America and Europe between 1950 and 1985, despite flattening of the rate of population growth in those regions. It attributed this production increase to two factors. On one hand, it noted an extension of the food production base (“larger cropped areas, more livestock, more fishing vessels, and so on.”) But it recognised that “most of [the rate of growth] is due to a phenomenal rise in productivity....[including] by

On the other side of this coin, however, food production and relationships with their lands and ecosystems are based on the balance that all cultures, from most to least developed, achieve between their physical and economic environments. Biosafety is, in all senses, an ethical issue.

Socio-cultural concerns have been the least understood side of this debate. Even where actual social and cultural impacts of GMOs have been well explained and documented, response to them has rarely involved anything more than a dismissal of “traditional mythology” and a failure to recognise the role of food and other species in the spiritual life and world view of the community. This is clearest with regard to traditional communities, where cultural practices are often integrally connected with the traditional and natural aspects of food species. This disconnection begins at a level of intervention that is much less intrusive than the introduction of GMOs –

The cost of making available year-round seasonal resources is that the natural cycle and food chain is adversely affected and the traditions and knowledge that form the whakapapa (genealogy) of that resource is lost. The value of end-products developed from resources and knowledge of indigenous peoples is usually far greater than the benefits returning to those peoples....The respect for the reproduction of life as a continuation of genealogy is a paramount concern.... Social, cultural and ethical concerns are just as important as new technologies.47

While the advocates of a particular scientific paradigm are not expected to espouse (or even necessarily understand) the unique world views of each cultural group impacted by the introduction of GMOs, they should, arguably, be called upon to ensure that communities, including particularly traditional communities are not negatively impacted at the cultural or social level by these introductions. Hence, GMO introductions and the social and practical mechanisms involved must, at a minimum, recognise these sensitivities.

Beyond this, they must recognise and address critical environmental and biodiversity factors that are integrally tied to humanity’s residence on planet earth. A number of concerns should be addressed through socio-cultural assessment of the impact (socio-cultural risks and benefits) of GMOs. These include:

The fact that these concerns must be addressed is not, specifically a criticism of GMOs. Many similar concerns are relevant in all conventional aid and commercial transactions involving developing countries. GMOs and related research have, in a number of cases, enabled solutions to specific agricultural problems. This is a particularly hopeful phenomenon, in light of the general criticism of GM crops – that the benefits are geared toward seed companies and northern hemisphere farmers. Recent work in Kenya and South Africa has recognised a broader mandate of agriculture development programmes to help level the playing field for marginalised farmers by overcoming these constraints.

In South Africa, for example, the private and public sector have joined forces to produce drought tolerant crops and at the University of Cape Town scientists have engineered the first maize plants to resist maize streak virus. The International Rice Research Institute is pioneering efforts to develop a strain of highly productive and pest-resistant rice which, they claim, could increase poor farmers’ yields from two to six tonnes an acre.

Small-scale farmers in eastern Africa have also benefited by using hybrid seeds from local and multinational companies. To these farmers, "transgenic seeds...are simply an addedvalue improvement to these hybrids. Local farmers are benefiting from tissue-culture technologies for banana, sugar cane, pyrethrum, cassava, and other crops. There is every reason to believe they will also benefit from the crop-protection transgenic technologies in the pipeline."50

Targeted research and product development which recognises and accepts traditional methods such as seed saving, and their vital importance within the marginalised farming systems of many developing countries can be a major contributor to food security and sustainable livelihoods.


6An example of this tendency is offered (by Dr. Jack A. Heinemann, Founding Director of the New Zealand Institute of Gene Ecology) “the Hort+Research adoption of gene-silencing technology for introducing virus resistance in tamarillos in the late 1990s ... known as post-transcriptional gene silencing (PTGS) depends on a molecular mechanisms that is still unknown. ... It is ... known now (but not when Hort+Research modified the tamarillos) that the effect can be heritable and can transfer between species.” (Letter to Wren Green, May 17, 2002).

7Please note that, although scientific input was sought and obtained, this summary of that input was written by a non-scientist, for use by persons who may not be experts in genetic sciences..

8Commentary submitted by the International Federation of Organic Agriculture Movements (IFOAM).

9In preparing this paper, the lead author has learned more than she ever expected to about 15 separate types of gene manipulation technology, and about the application of the science of proteins and other non-dna substances in the five currently recognised taxonomic kingdoms. She cannot provide more than a summary of the basic scientific controversy which underlies all of them – i.e., whether or not it is scientifically appropriate to rely on the current dna-centric view of biosafety (heir to the original explanation of the Watson-Crick discoveries). The bibliography lists a few of the most accessible of a large range of books and papers reviewed, and does not include lectures received in person or by telephone, from a variety of individuals.]

10It is also possible to produce synthetic genes.

11Although the process that created Dolly does not involve genetic modification, the manipulation involved in the cloning (non-sexual reproduction) a mammal relies on the current version of the Watson- Crick model

12This paper does not advocate addressing all GMO issues as “risk assessment” problems. Currently, such an approach may be inappropriate, for example, due to the controversy over the scientific safety of GMOs, and the lack of generally accepted basis for evaluating the risks. GMOs are a quite new phenomenon, and the only long-term “risk data” available consists of hypotheses by persons on both sides of the debate. Even accepting these, risk-benefit analysis cannot be used, since one side of the debate says in effect that there is virtually no risk at all, and the other side that the risk is incalculably high. No matter how you organise a risk/benefit formula for such a discussion, the analysis would result in mathematical absurdity.
            However, risk assessment issues and the problems associated with applying this mechanism, are very illustrative of the current state of the political, economic, and institutional debates relevant to GMOs.

13Mathematically, the calculation of the “value” of any risk or benefit would be expressed as follows:

Risk (or benefit) = Magnitude × likelihood

This makes it clear (to the mathematically inclined) that no matter how enticing the claimed benefit may be or how horrendous the claimed risk may be, the ultimate weight given to it will be determined by the likelihood. In terms of GMOs, evidence proving that benefits will actually be obtained has been relatively rare, as has evidence proving that the claims of benefit are false. The same may be said, however, for regarding risks – apart from many emphatic assertions, very little evidence has been put forward to demonstrate either that significant identified risks are very likely to occur or that they are very unlikely.

14See generally Wolfenbarger and Phifer 2000.

15These figures may be understated, however. Reportedly, in countries such as Brazil (Bonalume, 1999), Mexico and China, farmers cultivate large areas of illegal GM crops. (See also Holland (2000), which notes that 6.7 million hectares are devoted to transgenics in Argentina and at least 300,000 hectares in China.)

16The first GMOs were used in 1996. In that year, approximately 1.7 million hectares were planted in transgenics. All statistics (in this footnote and in the associated paragraph of text) are quoted from Clive James at pp. 1 & 3.

17The Global Review of Commercialised Transgenic Crops 2001 presents comprehensive statistics about how much acreage is planted in GMOs, broken down by type of crop, trait of the GMO (herbicide resistance, etc.), etc. but does not compare yields or other data. See also, Morris, M.L. and M. A. López-Pereira, Impacts of Maize research in Latin America 1996-1997 (CIMMYT Economics Program, Mexico, 1999.)

18Other potential risks may arise out of principles relating to the ethical treatment of animals, including bio-engineered animals, as well as the efficacy of laboratory containment protocols (ensuring that there are no unexpected releases into the uncontrolled environment).

19All of the “benefits” listed in this section are based on direct claims and statements from noncommercial sources – proponents of GMO use. As such it describes only the “purported” benefits. As noted above, the authors have not been able to find any statistical or evidentiary data proving or disproving any of these claims. Also noted above is the fact that the validity or probable validity of these claims is a matter of analysis, which should be based on broader access to scientific data (direct evidence), if possible.

20As noted above, the extent of data validating this assumption is rather limited, however, there are exceptions in which yield data has been well publicised. The Atlantic salmon has received most media attention, particularly those that contain an additional gene for growth hormone production and an antifreeze gene. These fish have shown three-fold growth rate increases and potential to exploit colder waters. Reports indicate that transgenic salmon have also displayed severe deformities, however. (Royal Society of Canada, 2001).

21Formal Statement of the US, (IUCN, publ. 2001) at 34.

22Recent research by WWF shows that since 1988 there have been 184 GM tree field trials globally. More trials have been conducted with poplar than any other species due to its popularity as a pulp and paper species. The U.S. has released the largest number of GM trees via field trials, with 74% of the worldwide total (Asante-Owusu, 1999).

23Zitner, 2001.

24The bacterium, a strain of Rhizobium meliloti, contained genes from five different species and was genetically altered to enhance its ability to provide nitrogen to alfalfa plants on farmland. (Van Aken, 2000).

25U.S. Environmental Protection Agency, 1999. Note other issues with regard to Bt crops, discussed above.

26Arntzen, 1995.

27Wolfenbarger and Phifer 2000.

28Horizontal gene transfer is a relatively new concept, that has been described as the capacity of genetic information to be passed between species in ways that is unrelated to the usual parent-offspring inheritance of genes. (for more technical discussion, see Heinemann 2003) Horizontal gene transfer occurs frequently between viruses.

29Researchers note that GM varieties exhibit traits not expected by virtue of the specific gene replaced. Few documented instances have been released, however, it is not clear whether this is a function of their non-existence or the fact that this information is closely held. In the most publicised example, in 2000, Monsanto admitted that its soybeans contained some unexpected fragments of genetic material. The company concluded that, since “no new proteins were expected to be observed or produced” this was a harmless discovery. A year later, Belgian researchers reportedly discovered that a segment of the plant’s own DNA had been scrambled, in a way that was significant enough that it could be expected to produce a new and unexpected (and experimentally unproven) protein. (Commoner at 46.)

30One theory is that the introduced gene not only enhanced the mustard plants' ability to withstand herbicide application but also unintentionally disrupted the recipient organism's gene sequence that controlled pollination and fertility (Bergelson,1998).

31Some experiments have shown that the rate of cross-pollination between conventional and GM varieties of potatoes are generally low and become negligible when the separation distance exceeds 10 metres (Rogers, 1995). By contrast, Danish field trials have shown that oilseed rape modified for herbicide tolerance can easily cross with wild Brassica species such as wild mustard (Chevre, 1997). Consequently, cross-pollination between GM and non-GM oil seed rape has been detected at distances of up to 2 km.

32Forty years of empirical evidence from the U.S., Japan, Central America and China demonstrates that the use of the pesticides consisting of Bt toxin (a naturally occurring pesticide, now incorporated in numerous crops for resistance to certain insects, as noted above) has allowed some agricultural pests (such as the diamond back moth Plitella xylyostella) to evolve distinct toxin resistant populations. (Tabashnik, 1994).

33One example involves the introduction of barn owls in the Seychelles, to control the population of inadvertently introduced European rats. The owls (natural predators of the rat species in their native surroundings) found other, in some cases endangered, species much easier to catch. They were able to out-compete native species that preyed on these animals, and eventually represented a much more serious threat to the island ecosystem than the rats they were imported to control. Young, T., Legislation and Institutions for Biodiversity Conservation and National Parks in the Seychelles (FAO, 1993).

34A number of other concerns that are generally shared with all development, agricultural or otherwise have similarly been omitted here. One of these, which arose feelingly from IUCN feedback in the preparation of this paper, is the issue of ethical treatment of animals.

35See Decisions V-8 and VI-23 of the Conference of the Parties to the Convention on Biological Diversity.

36The International Plant Protection Convention (co-located with FAO and operating in close coordination with that organisation) may eventually offer another, more focused source of information and support. At present, the standards development process under the IPPC has not resulted in the level of information and capacity-supporting procedures and data that is currently available through the Codex. The development of IPPC standards is discussed in section IV.A.2 below.

37Except where the GMO use will be entirely in contained (laboratory) conditions, decisions about the permissibility of the introduction, and the permit restrictions that will be imposed in order to minimise the risk of environmental or other harm caused by the introduction, can indirectly determine whether GMOs can be used at all. For example, a common requirement is to require the maintenance of a “buffer zone” around the GMO area, so that invasions of the GMO species or of unexpected characteristics or other impacts, can be detected before they extend to surrounding lands, affect organic agricultural products, or otherwise exert an unexpected impact. Reportedly, in many cases these buffer requirements effectively eliminate any possibility of introduction of the GMO.

38Canadian Food Inspection Authority, 1994

39World Health Organisation, 2000.

40Commoner, 2002, at 46; see also Royal Society of Canada, 2001.

41Young, 1992.

42See, generally, Mulder and Ree, 1996; and more specifically to GMOs, Bearano, 1999; BioTIK Expert Group, 1999; and Christensen, 2001.

43Kapuscinski, 2003.

44Formal Statement of the US, at 34.

45Our Common Future, at 118.

46Id at 120.

47Mead, 19__ (citations omitted.)

48Marion Nestle, 2001

49McNeely, 2001

50Wambugu (1999)

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