The Control of Environmental Hazards

The relevance of environmental concerns to the issue of patenting is not obvious. Granting a patent does not imply approval of any particular use of the patented product or process, or indeed approval of any use at all. Consequently, any argument linking the environmental implications of genetically modified organisms (GMOs), be they microbes, plants or animals, to patenting must run as follows. Patenting will create incentives for biotechnology research and development (precisely the claim made by firms and researchers in the field). The effect will be to create a client group of investors with an economic stake in recovering their investments through commercialization of the patent, and therefore with an interest in playing down the potential envi ronmental consequences of commercialization. Normally, we would expect the environmental implications of the release of GMOs to be addressed through environmental protection statutes and regulations, just as we would expect the safety implications of other kinds of patented devices to be addressed through appropriate statutes and regulations. However, opponents of patenting might respond with an argument that the regulatory regime is either (a) inherently incapable of dealing with the hazards posed by GMOs, or (b) incapable of dealing with them at present. In either instance, the potential hazards may be serious enough that, in the absence of promising alternatives, the patent system should be used to check the development of the technology.

Just such an argument was made by Margaret Mellon of the [U.S.] National Wildlife Federation in the 1989 Congressional hearings on transgenic animal patenting. Warning that we need to "look before we leap" into biotechnology, she went on to say:

In a nutshell, patenting will encourage scientists to produce large numbers of genetically engineered animals and we believe that the release of those animals, either accidentally or intentionally, poses uncertain but real environmental risks. It is our view that we are not ready to stimulate the engineering of animals; that is, we are not ready for patenting until we have in place a system of laws and regulations to oversee the environmental releases of the organisms the technology will produce.⁽¹⁷⁶⁾

For one thing, "the products of biotechnology are often living organisms themselves. They are consequently capable of movement and reproduction. This makes an accurate prediction of the likely level of exposure," a standard and indispensable element of conventional risk assessment methodology, "extremely difficult."⁽¹⁷⁷⁾ Increasing the number of carefully monitored experimental field trials is unlikely to reduce that difficulty.⁽¹⁷⁸⁾ Mellon asks what might happen if fish that have been genetically engineered to grow faster or to survive in extremely cold water escape from their holding tanks. Will the faster-growing fish

... displace native species? Will the extra hormones have altered the nutritional quality of their flesh? Will the novel fish breed with other fish and transfer the new gene into wild populations with further and even more unpredictable effects?

What about warm-water fish that are newly equipped with anti-freeze genes? Will they be able to survive in waters where they previously might have died? Will they displace existing populations of cold-water fish?⁽¹⁷⁹⁾

An additional difficulty is the possibility of gene transfer among organisms, which, according to Mellon, "poses a particularly important issue in the risk assessment of genetically engineered organisms released to the environment:"

For example, genes for antibiotic resistance engineered into one bacterium may, under certain circumstances, be transferred to animal or human pathogens. Our ability to combat these pathogens would be compromised if the antibiotics to which they had become resistant were the same ones used to control them. Similarly, it would be a problem if genes for pest resistance introduced into bacteria associated with crops were transferred into bacteria that became associated with weeds. The results could be `superweeds' which would require ever higher doses of chemical herbicides to control.⁽¹⁸¹⁾

Environmental health and safety concerns constitute a good reason for proceeding cautiously with particular applications of any new technology, quite independently of the issues surrounding patenting. One way of approaching the implications of those concerns for patenting, as we have suggested in other sections of the report, is to ask whether these concerns are serious enough, and difficult enough to deal with in other ways, that they justify replacing the presumption in favour of patenting with a presumption against patenting, until and unless certain conditions can be met. Since neither zero risk nor definitive proof of safety is attainable in practice, risk-benefit comparisons are a crucial and unavoidable component of environmental regulation.⁽¹⁸⁶⁾ They are also ultimately subjective even when not bedeviled by highly incomplete information. Even more than the hazards with which environmental policy and law have generally dealt, the hazards associated with genetic engineering are a matter of profound disagreement, and the topic of much informed but necessarily inconclusive scientific debate.

What is the appropriate response to such profound uncertainty on the part of experts? The choice of approaches is likely to be a function of one's more general attitude towards risk, which may in turn be associated with an optimistic or pessimistic view of the relative hazards and benefits of technological innovation.⁽¹⁸⁷⁾ According to some social theorists, such views are closely connected with competing conceptions of the social system and social interactions as a whole.⁽¹⁸⁸⁾ Responses to uncertainty and risk, in other words, can be interpreted as manifestations of global moral conceptions of the nature of society and the place of science and technology in it. This line of reasoning suggests that conflicts about the environmental risks associated with biotechnology are likely to be both ethically and politically intractable, regardless of what presumptions are adopted about patentability of higher life forms.

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