INTRODUCTION

I. About CIELAP. The Canadian Institute for Environmental Law and Policy (CIELAP) was founded in 1970 as the Canadian Environmental Law Research Foundation. It is an independent, not-for profit, environmental law and policy research and education organization. CIELAP has been involved in environmental law and policy development related to biotechnology over the past 12 years. CIELAP organized the first conference in Canada on environmental law and policy issues regarding biotechnology in 1984 (CELRF, 1984), and has participated in a many consultations with Environment Canada, Health Canada, Agriculture and Agri-Food Canada, and the government of Ontario regarding biotechnology and the environment over the years.

The Institute has produced a number of major publications regarding biotechnology (CIELAP, 1984). These include a major overview study of environmental, social, economic and ethical issues related to biotechnology completed for the Ontario Ministry of Economic Development and Trade, in 1995 (Winfield and Press-Merkur, 1995). The Institute has also published a Citizen's Guide to Biotechnology.

II. Concerns Regarding Biotechnology. This paper provides an overview of the concerns regarding biotechnology which have been raised by members of the academic community and environmental, consumers, agricultural and other non-governmental organizations. These include ethical concerns regarding biotechnology, particularly with respect to the creation of transgenic organisms, the issue of the direct environmental and health impacts of products of biotechnology, and the questions which have been raised regarding the value and purpose of many current applications of biotechnology, particularly in the agricultural field. Potential research priorities and directions for policy reform are outlined.

CONCERNS REGARDING BIOTECHNOLOGY AND THE ENVIRONMENT

I. Ethical/philosophical concerns. Public concerns regarding biotechnology arise from many sources. At most fundamental, many individuals are disturbed by the notion of manipulation of the genetic material of other species, and particularly the movement of genetic material between species. They regard genetic engineering as being a qualitatively different technology from traditional plant breeding or animal husbandry techniques in this sense. Many hold the species barrier to be a law of god or of nature, that species have an inherent integrity, and that the violation of this status is an act of extreme hubris on the part of human beings. Others question, in light of past experiences with eugenics programs and other efforts to "improve" humanity, whether human beings have the wisdom to make appropriate decisions with respect to a technology of this scope and power.

Such perspectives may have no direct bearing on the science of evaluating the potential environmental and human health impacts of products of biotechnology. However, they have significant implications in terms of the acceptability of the risks associated with the creation and use of products of modern biotechnology. They are also critically important to such issues as the labelling of foods derived through genetic engineering.

II. Immediate/direct environmental and health effects. Beyond these philosophical concerns, a number of specific environmental risks have been identified in relation to biotechnology products. These include:

the creation of new pests, such as the escape of a transgenic salt tolerant rice from cultivated fields into estuaries;

the enhancement of the effects of existing pests or creation of new pests through hybridization or gene transfer to related plants or microorganisms;

the enhancement of the effects of existing pests as a result of the selective pressures provided by plants modified for pest resistance or intensified pesticide use arising in conjunction with the modification of plants for pesticide resistance;

infectivity, pathogenicity, toxicity or other harm to non-target species, including humans;

disruptive effects on biotic communities, resulting in the elimination of wild or desirable natural species through competition or interference;

adverse effects on ecosystem processes and functions, such as nutrient cycling;

incomplete degradation of hazardous chemicals by microorganisms employed in such applications as bioremediation, and waste water treatment, leading to the production of even more toxic by-products (Tiedje et al., 1989; Smit et al., 1992; Mellon and Rissler, 1994).

These specific risks sometimes overshadow the more general risk of reducing biological diversity in any given ecosystem. Introduced species may, for example, disturb food-chains or habitats, which in turn will affect biodiversity (Pimentel et al., 1989). Indeed, this risk is explicitly recognized in the United Nations Convention on Biological Diversity (Article 8(g)). Biotechnology also can threaten the biodiversity through its implicit drive to breed uniformity in plants and animals, furthering and encouraging monocultures.

It is important to note that these environmental and health risks are not limited to the introduction of genetically engineered or modified organisms. Naturally occurring organisms can behave as "exotic" species when introduced into ecosystems of which they are not native inhabitants as well. In addition, the introduction of a naturally occurring species into a natural habitat can have disruptive effects if the species is introduced in very high concentrations or quantities. It also has been argued that certain naturally occurring species of microorganisms that have potential to be used in bioremediation and other applications may be opportunistic human pathogens (Ernst et al., 1994).

In this context, there has been growing concern that governments have adopted a "risk-taking" approach to the environmental and health evaluations of products of biotechnology. The risk assessment methodologies employed in such evaluations seem to many to be constructed on assumptions which tend to minimize the apparent potential risk associated with the introduction of products of biotechnology into the environment. Agriculture and Agri-Food Canada, for example, has based its approach to risk assessment on the "familiarity" and "substantial equivalence" of genetically engineered plants to the naturally occurring relatives (RD Dir 94-08).

Methods of predicting the consequences of the deliberate introduction of new life forms into the environment are still very much under development. Traditional models of chemical toxicology are of only limited use in assessing the potential consequences of exposure to, or consumption of, genetically engineered plants, animals or micro-organisms, and provide no guidance at all in predicting their ecological effects. Indeed, the state of science to assess ecological impacts lags far behind development of new products of biotechnology.

This lag is largely a consequence of public policy decisions regarding the funding of research in universities and governments. In particular, requirements for "partnerships" with the private sector by university researchers has limited the potential for research on the ecological impacts of products of biotechnology (Klicious, 1996). Such research has little commercial value, and therefore is of little interest to private sector sponsors. Research on the development of new applications of biotechnology, on the other hand, attracts a great deal of support, due to the potential for commercialization.

What science has emerged with respect to the potential environmental impacts of the introduction of products of biotechnology appears to confirm the validity of many of the concerns which theorized past. These findings include the following:

that the long term persistence of recombinant organisms and their genetic material in the environment can be expected (Triplett, 1996);

that the commercialization of genetically engineered plants will allow transgenes coding for beneficial traits to be transferred to wild or weedy populations of these plants or their close relatives (Leary, 1996; Rogers and Parkes, 1996; Brown, 1996);

that the emergence of resistent pest populations in response to the commercialization of pesticidal plants is likely (Bergelson and Winterer, 1996; Gould, 1996); and

that transgenic foods may producing allergic reactions (Leary, 1996; Nordless et al., 1996).

More broadly, there are concerns regarding the highly reductionist nature of the current approaches to the environmental assessment of products of biotechnology. In particular, there are concerns regarding the failure to place products in appropriate ecological contexts for assessment (Rissler and Melon, 1993), the failure to consider cumulative effects of commercial scale production (Snow and Palma, 1996), and the failure to assess products as elements of the systems of which they are integral parts (e.g. herbicide resistant crops and herbicide use) (Rissler and Melon, 1993). There are also concerns in Canada regarding the failure of the regulatory system to consider adequately the issue of occupational exposure to biotechnology products (Kohler, 1995).

III. Concerns over the value and purpose of the emerging applications of biotechnology. In addition to the immediate risks which have been identified in relation to the release of biotechnology products into the environment, concerns also have been expressed by a wide range of stakeholders regarding the value and purpose of many of the emerging applications of biotechnology, particularly in the areas of agriculture, fisheries and forestry. Serious questions have been raised as to whether applications of biotechnology which are being developed in these areas are consistent with the principles of environmentally sustainable development. Indeed, it has been suggested that many of the applications appear to treat symptoms of environmentally unsustainable resource management practices, rather than their causes.

With respect to agriculture, for example, the most common modification of field crops currently under development in Canada is for resistance to specific herbicides. This is in response to the increasing resistance of weeds to existing herbicides (AAFC, 1994). The modification of the crop for herbicide resistance permits the use of stronger herbicides to overcome this resistance. However, it has been argued that this approach fails to recognize the causes of these problems, namely inappropriate cropping patterns which promote weed populations, and that it will entrench the dependence of agricultural production on external, capital and energy intensive chemical inputs, further narrow the genetic base employed for agricultural purposes, and increase farmers' dependence on specific agricultural supply firms (Goldburg et al., 1990). In the longer term, the selective pressure of more intensive herbicide use may lead to the emergence of even more resistant pests (Gould, 1991). A better approach might be to emphasize the development of alternatives to chemical pesticides for the control of agricultural pests (NRC, 1989).

These concerns extend beyond Canada. In the developing world, traditional farming methods in the Third World are more often practiced around frequent crop rotation and mixed cropping. It is feared that increased reliance on herbicide and pesticide resistant crops will lead to increased monoculture in areas which have traditionally relied on raising a variety of crops as the basis of a subsistence economy (Shiva, 1993).

In the case of forestry, it has been contended that the development of genetically modified faster growing trees to be used in reforestation efforts fails to address the need to establish sustainable levels of cutting in the first place (Mausberg and Muldoon, 1993). Similar concerns have been expressed regarding the development of fish with accelerated rates of growth to compensate for increased catch levels. Neither application deals with the underlying need to bring harvesting rates into line with the productive carrying capacity of the ecosystems in question or the need to maintain the functional integrity of those systems.

In addition, it has been suggested that some applications of biotechnology do not respond to any identified need at all. Such questions have been raised, for example, in the recent controversy regarding the approval for use of recombinant bovine somatotropin (rbST) or synthetic bovine growth hormone (BGH) in Canada. This synthetic hormone is injected into cows and increases their milk production by about 10%-15%. However, it has been pointed out by, among others, the Canadian House of Commons Standing Committee on Agriculture and Agri-Food, that there is no apparent need for increased milk production in Canada, that the product appears likely to have major disruptive impacts on the structure of the Canadian dairy sector, and that it has been associated with significant animal health effects (SCA, 1994). In sum, it is argued the use of the product would entail significant costs for no public benefit.

One of the central features of the Canadian and U.S. federal governments' approach to the regulation of biotechnology products has been their refusal to address these wider issues within their regulatory systems. Rather, these have been narrowly focussed on the direct effects of the introduction of genetically engineered plants, microorganisms and other products of modern biotechnology into the environment. Nor have the Canadian or U.S. federal governments indicated any willingness to see these questions raised in other forums, such as studies or investigations by Parliamentary committees.

IV. Determining what is "acceptable" risk with respect to products of biotechnology. A final area of serious concern regarding products of biotechnology is the complete failure of governments to establish appropriate processes and procedures for determining what constitute "acceptable risk" with respect to products of biotechnology. This is a political, social, economic and ethical question. Given that society is asked to bear significant risks with respect to the products of biotechnology, it seems that there must be appropriate mechanisms for public participation and public accountability in decision-making. However, in Canada the decision-making processes around products of biotechnology have been completely closed and public accountability mechanisms almost totally absent. The need for reform in this area is particularly acute, given that the societal benefits of many applications of biotechnology are, in the eyes of many, open to such serious question.

DIRECTIONS FOR REFORM

There are a number of steps which should be taken to improve the situation with respect to the environmental and health impacts of products of biotechnology which may enter the environment. They include the following.

1. Substantially increased funding from government for science on ecological impacts in universities and within governments. It is clear in Canada and the United States that there is not shortage of government funds to support research and development activities with respect to biotechnology products. Indeed, a representative of Environment Canada indicated to the "Risk Assessment at the Crossroads" conference that the Canadian federal government intended to make $100 million available for the support of biotechnology this year. However virtually none of these funds will be available to support research on ecological or human health impacts.

Given the growing gap between the development of products of biotechnology and our ability to assess their likely long-term effects resulting from these funding priorities, serious consideration should be given to the dedication of a substantial portion of these funds to research on the ecological and health impacts of biotechnology. These funds should not be tied to "partnership" requirements with the private sector. The goal should be to support high quality, independent research.

2. Regulators must provide for the monitoring of environmental effects of products in commercial use. In Canada, little or no provision appears to be being made for this kind of work. Given our limited knowledge regarding the likely long-term consequences of commercial scale releases, this seems an essential step. embarking on a vast ecological experiment and need to know what is happening.

3. Regulators should adopt a more precautionary approach to assessments. The limits of the current science on ecological impacts releases must be recognized. We must proceed with caution where we don't know.

4. Regulators should seek to evaluate products in an appropriate ecological context and in the context of the systems of which they are integral parts. The likely long-term effects of herbicide resistant crops, for example, cannot be meaningfully assessed in isolation from the agricultural practices and patterns of herbicide application associated with their use.

5. Explicit consideration must be given to the cumulative effects of the use of products of biotechnology in the environment, particularly on commercial scale, on human health, environment, biodiversity.

6. The regulatory process must provide for explicit consideration of the health effects of occupational exposure to products of biotechnology.

7. The regulatory process should include consideration of the availability of alternative means of achieving a product's purpose which may present lower potential for harm to the environment and human health.

8. The regulatory process should consider the availability and likely effectiveness of monitoring, control, waste treatment and emergency response plans with to products.

9. Governments must provide for more open and transparent decision-making processes regarding products of biotechnology including:

notice and comment on major regulatory decisions, such as approvals of field tests and product approvals;

improved access to information and;

appeal procedures related to major regulatory decisions.

Many of these are proposals contained in the reply of the Biotechnology Caucus of Canadian Environmental Network (Winfield and Kneen, 1996) to the government of Canada's proposals for the regulation of biotechnology contained in the December 1995 response (Canada, 1995) to the June 1995 report of the House of Commons Standing Committee on Environment and Sustainable Development (SCESD, 1995).

Ultimately, the only way in which many of the questions regarding the long-term ecological impacts of products of biotechnology, and the value and purpose of these products will be to subject them to a full environmental assessment such as a comprehensive study under the Canadian Environmental Assessment Act. This would provide for an open and public examinations of the rationale for, and availability of alternatives to, these products, and the cumulative effects of their commercial scale use.

CONCLUSIONS

With the approval by the Canadian and U.S. federal governments of the commercial scale use of genetically engineered crops, and other biotechnology products, we find ourselves on the verge of a vast ecological experiment, involving the large scale introduction of a large number of species never before seen in nature. Yet our capacity to assess likely impacts remains in its early stages. If we proceed, we should do so with the utmost caution. If something goes wrong, it is likely to be very expensive, if not impossible, to control or correct.

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