Safety in applying genetic engineering to agriculture

Background

As biotechnology advances, it is providing the knowledge and techniques of genetic engineering that can be used to modify all forms of life: human, animal and plant. As a result, much attention is now being given to genetic modification of crops and livestock in order to improve productivity and nutritional value of foods. Thus, biotechnology is furthering the scientific approach to agriculture and food that started with Pasteur and Mendel in the nineteenth century.

The goal of genetically modifying a crop such as corn or soy is to enhance an existing characteristic of the crop, such as improving its nutritional value, or to endow the crop with a new attribute, such as making it resistant to insect pests or drought. The means of achieving such a goal for a particular crop involve the splicing of selected genetic material from other species into the genome of the targeted crop.

Unlike conventional agricultural practice of creating hybrid crops through cross-breeding, a process which only works within a narrow range of related species and takes generations of experimentation, genetic modification enables the splicing of genes from totally unrelated species for the rapid production of hybrids which could never occur otherwise in nature. Well known examples involve the splicing of selected genes from fish into tomato crops to enable the tomato crops to withstand frost, and the splicing of bacteria genes into corn and cotton to enable these crops to resist insect pests. Since each modified crop is unprecedented in nature, it presents uncertainty as to whether it will endanger the environment, other conventional crops, and the health of humans and animals.

A small group of very large multinational corporations based in the US and the EU dominate this new agricultural enterprise, from the product design and testing stages to the large scale production and marketing of the genetically modified seeds. Agencies in developed nations are authorized to regulate these corporate activities so they do not endanger human or animal health, other agriculture, and the natural environment. These risk regulators are therefore responsible for assuring that corporate pre-market testing will be done and that test results and other studies indicate that the new products can be safely grown and consumed.

But the stringency of the regulatory approval process differs across nations because national policies, regulations, public values and cultural attitudes about farming, foods and risk differ in many respects. For example, the US is considered to be extremely permissive because regulators waive several test requirements and do not require labeling of the new products, and much of the public is unconcerned. To the contrary, most EU nations are viewed as being extremely obstructionist because they require stricter testing, comprehensive risk assessments, crop tracking and food labeling, and citizens remain strongly opposed.

This is a very broad topic raising many issues with scientific, environmental, economic, cultural & political feature for these and other reasons, the planting, harvesting, distribution, processing and consumption of genetically modified crops such as wheat, soy, canola, and corn is a growing enterprise in the US, Canada, Argentina, Australia, China, Brazil, and Spain, but are not conducted in Germany, France, Italy, Greece, Denmark, Japan, and other countries.

According to proponents, it is inevitable that the growing capability to splice together genetic material from many different species will progressively transform agriculture, livestock production, fish farming, and forestry and the downstream industries which use plants and animals as materials for the production of foods, medications, building materials and many other products. Their optimistic view is that these developments pose minimal risk, that such risk will be manageable (e.g. by buffer zones around planting areas, etc.), and that the new crops and foods will provide health, environmental and economic benefits for developed nations, and even greater benefits for developing nations: e.g. ability to prevent crop destruction and increase food supply by designing crops to withstand drought, pests and other naturally occurring adversities; ability to improve the nutritional quality of basic foods and diminish traditional illnesses due to dietary deficiencies; ability to improve public health and workforce health by substituting new pest resistant crops and modified micro-organisms for conventional chemical pesticides and other toxic agrochemicals; and ability to achieve sustainable agriculture.

Opponents offer many reasons for opposing biotech agriculture: that growing and consuming a food crop containing genes from unrelated species violates nature, conflicts with religious and other dietary rules, poses risk that the new genetic material will flow into other plants and cause loss of biodiversity and other irreversible ecological harm. Other risk scenarios that have been presented include the potential of newly pest-resistant crops for killing off insects which are vital elements of the food chain for birds and other animals, and for accelerating the evolution of super-resistant insect pests. Many also fear that genetic agriculture will cause social dislocation in agrarian regions by displacing small farms with high tech agribusinesses, and that consumers of the new foods will be exposed to allergenic risks over the short term, and various illnesses over the long term. Finally, there are deep fears in third world nations that the multinational firms which dominate genetic agriculture will inevitably take control of their national food supply systems. Although opponents often lack conclusive scientific support, a number of recent incidents have served to make their concerns plausible. And their opposition, translated into market forces, has thus far slowed the genetic agriculture enterprise in many parts of the globe.

Finally, it should be noted that biotechnology is also being applied for other purposes related to agriculture: for developing genetically engineered micro-organisms for pest killing purposes, as substitutes for chemical pesticides; and for growing genetically modified crops which produce pharmaceuticals and other non-food products. Much of the discussion above is relevant to these other uses of genetic modification.

The practice of genetically modifying crops is entering its second decade, and the questions and conflicts remain. Is it morally wrong to mix disparate species? To what extent should cultural attitudes and perceptions shape public policy or should we trust technical expertise and the assurances of companies and regulators? Is it irresponsible or dangerous to proceed given current uncertainty about risks and the limitations of risk assessment and testing methods as means of reducing this uncertainty? Will commercial experience produce learning about risks which will enable biotech agriculture to be more safely managed over time by the companies, regulators and growers of the new crops? Can the promised benefits for human wellbeing be achieved without destabilizing agrarian societies and producing bio colonialism by multinational firms? Are existing corporate practices, legal and regulatory safeguards, and international treaties sufficient to provide bio safety and protect biodiversity or should more precautionary principles be followed? These are only a few of the issues confronting nations as this powerful technology progresses.

Challenges

For NeTWork 2006, the main theme is the familiar challenge of how to manage a new technology safely, with the technology in question being the genetic modification of crops and foods.

The workshop will bring safety management knowledge from various disciplines and nations to address the known risks and current uncertainties posed by the planting, harvesting, distribution, processing and consumption of genetically modified crops. Participants with safety management experience and expertise, drawn from academia, industry and government, will apply their knowledge and analytic methods to this sequence of activities involving genetically modified crops. In this manner, it is hoped that the broad range of safety science expertise will be thoughtfully applied and contribute to improving safety management and minimizing the risks of biotechnological agriculture. Participants will also illuminate promising research areas.

As discussed previously, genetically modified crops are being grown, processed, and consumed in several nations, and efforts are being made to expand this development across the globe. But despite corporate testing and regulatory oversight, and assurances of safety, there is substantial uncertainty about the short and long term impacts of these crops on ecosystems, biodiversity, consumer health, and the structure and stability of agrarian societies.

This situation seems analogous to the introduction and dispersion of other uncertain technologies into society where operating experience, mishaps, near misses, & other developments continuously reduce uncertainties, clarify risks, and shape public perceptions, and where the flow of such information to corporations and regulators causes them to take the actions needed to make the technologies safer (or more acceptable) over time. Examples include new uses of nuclear technology, new chemical process activities, new ventures by extractive industries, the deployment of high speed rail and air transport systems, and the introduction of new pharmaceuticals and medical devices.

Some salient issues are:

1. Is this an appropriate analogy or are there some very important differences between genetic engineering in agriculture and the other technologies that have been addressed by safety experts? The question raises some interesting socio-technical, behavioral, and public policy issues.

2. If it is a plausible analogy, are there special features which make the societal “learning from experience” approach to safety management too slow, harmful or otherwise inadequate? In other words, do features like the rapid spread of biotech agriculture and the irreversibility of some of its potentially harmful consequences make the need for safeguards more urgent? If there is urgency, can the process of reducing uncertainties and developing safeguards for environmental and health protection be accelerated? Can risk assessment be improved to serve these needs? Would information systems and electronic communications be of value? (knowledge about systems analysis, organizational and societal learning, information management, experience sharing, risk assessment and risk communication seems relevant).

3. If it is not an analogous situation but a very different one (e.g. due to inability to contain, manage, mitigate or reverse potential harmful consequences, or to reduce uncertainty over the foreseeable future, or due to irreparable conflict with deeply held beliefs, values and culture), then “learning from experience” may be insufficient and different approaches to safety need to be considered. Does this require that more be done before growing a genetically modified crop species or introducing it into food systems? If so, then more of what? More regulation (e.g. more testing, more risk assessment, more precaution about uncertainty)? More corporate self regulation (e.g. codes of conduct, certification procedures, etc.)? More public education for self protection and informed participation? New regulations or more fearsome liability for growers and distributors to prevent mishaps by these downstream parties? Incentives to bring about more corporate attention to safety when conceptualizing and designing a genetically modified crop? More development and implementation of the precautionary principle in all decision-making? Clearly, this scenario requires consideration of various social controls and of socio-technical and behavioral issues relevant to implementation of the controls.

4. What is the relevance of national culture to the conceptualization of risk and safety in agriculture and food systems, and to the design and implementation of a safety management approach to genetically modified agriculture? For our meeting, the interface between universal principles for safety management and cultural influence is particularly important because biotech agricultural activities and their consequences for the environment and consumers transcend borders. Thus, knowledge gained from comparative studies of safety management and the regulation of agriculture and food in different countries will be very helpful. Similarly, comparative studies of public values and attitudes about agriculture and food, media influence, and the marketing of new products, will be illuminating. Is there a different portfolio of arguments when you live in Brazil or in France? Moreover, who’s shaping the debate? Who’s setting the agenda?

5. Further examination of national experience may also be helpful. For example, what has been learned about cultural reactions and means of coping with invasive species? Has the setting of safety boundaries for prior innovations in agriculture and food had unforeseen consequences on food supply and the economic structure of farming and food systems, as safety bounding of transport systems has caused congestion and other societal problems?

6. What can be learned from best practices employed in other industrial sectors to introduce new activities into sensitive environments and risk-averse societies? Firms engaged in the development of oil resources use a phase model to assess environmental and social impacts at varying degrees of depth, depending on where they are in the developmental process. To do these assessments, knowing the environmental and social parameters (including value systems) and having dialogue with stakeholders is considered essential. Is this approach adaptable to biotech agriculture? Would there be any special problems in defining the parameters or baselines and identifying the stakeholders? These firms also use risk assessment to estimate accident risk, longer term environmental risk, and business risk, and have gone beyond conventional concepts of risk to also address risks defined by natural hazards, public perception and ethics. What can be learned from this experience? To what extent is it adaptable to biotech agriculture? Finally, these firms have learned that their activities have secondary environmental and social effects over which they do not have direct control, for example, the completion of an oil installation infrastructure which inadvertently enables others to access, develop and degrade a sensitive area. Because biotech agriculture is likely to have an even broader range of secondary effects beyond the direct control of its practitioners, it seems to be especially important to determine what lessons can be learned from oil industry experience.

Experience gained in other technological sectors is likely to have value for improving safety in biotech agriculture.

Workshop organizers

• Michael Baram, Boston University School of Law

• Mathilde Bourrier, University of Geneva

Outputs

The papers presented during the workshop and the following discussions led to the production of a book, titled Governing Risk in Genetically Modified Agriculture.

• Baram, M. & M. Bourrier (Eds) 2010. Governing Risk in Genetically Modified Agriculture. Cambridge, MA: Cambridge University Press. ISBN: 978-1107001473.

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