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Policy Issues in Modeling

Putting ecological monitoring of transgenic crops into practice successfully will demand more than an understanding of the scientific underpinnings. Workshop participants found that the designers of such monitoring programs will need to take a number of other issues into account, including existing programs, the availability of resources, and public attitudes.

When developing programs to monitor genetically modified crops, researchers should first recognize that the establishment of such programs will not be written on a blank page. “Many environmental monitoring programs are already under way or have been completed,” said Steve Bartell, of the Cadmus Group, a consulting firm that works on environmental issues. The focus of the existing programs include environmental resources such as agricultural lands, forests, wetlands, estuaries, rivers, streams, lakes, as well as particular groups of organisms for example, birds. “In developing monitoring for genetically modified crops,” Bartell said, “we ought to at least go back and see what those programs are doing—how they are set up, how they identified what to measure in relation to their objectives—and look at some of the statistical design, some of their mechanics of monitoring.”

Beyond that, it is possible that ecological monitoring of transgenic crops might be able to piggyback on—or at least borrow data from—the existing programs. “It's very important to evaluate existing monitoring programs to see which might contribute baseline information, if nothing



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Page 21 Policy Issues in Modeling Putting ecological monitoring of transgenic crops into practice successfully will demand more than an understanding of the scientific underpinnings. Workshop participants found that the designers of such monitoring programs will need to take a number of other issues into account, including existing programs, the availability of resources, and public attitudes. When developing programs to monitor genetically modified crops, researchers should first recognize that the establishment of such programs will not be written on a blank page. “Many environmental monitoring programs are already under way or have been completed,” said Steve Bartell, of the Cadmus Group, a consulting firm that works on environmental issues. The focus of the existing programs include environmental resources such as agricultural lands, forests, wetlands, estuaries, rivers, streams, lakes, as well as particular groups of organisms for example, birds. “In developing monitoring for genetically modified crops,” Bartell said, “we ought to at least go back and see what those programs are doing—how they are set up, how they identified what to measure in relation to their objectives—and look at some of the statistical design, some of their mechanics of monitoring.” Beyond that, it is possible that ecological monitoring of transgenic crops might be able to piggyback on—or at least borrow data from—the existing programs. “It's very important to evaluate existing monitoring programs to see which might contribute baseline information, if nothing

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Page 22 else," Bartell said. "Those programs might also be suitable for modification to use for looking at issues of genetically modified crops.” Two speakers at the workshop described long-running monitoring programs that are carried out by the US government. Each has something to offer those who would design ecological monitoring programs for genetically modified crops. Warren Lee, of USDA, described the natural-resources inventory, begun after passage of the Rural Development Act of 1972, which required USDA to assess the conditions and trends of soil, water, and related resources and report to Congress at intervals not to exceed 5 years. The inventory uses both remote sensing and onsite data collection to gather information about major land-resources areas and watershed levels. Because it is not feasible to track information on every bit of land in the United States, the inventory uses a sampling method that is statistically designed to give representative information about land use from data on a small percentage of the total land. “We have 300,000 primary sample units across the United States,” Lee said, and most of the units contain three sample points at which data is drawn. The data describe the land not just at the point but within a specific distance from the point, and each point is classified into one of 69 categories depending on the use of the land and its cover: water, grass, forest, and so on. In addition, the inventory gathers a huge amount of other information, such as who owns the land, habitat composition, conservation practices, and soil characteristics and erosion. The most important lesson from the natural-resources inventory, Lee said, is the necessity of knowing what you are trying to do before you get started. “We really need to understand what we are trying to understand. We need well-defined needs and well-defined requirements: Where are we going to collect the information? What are we going to collect? How is it going to be collected? How will it be used and analyzed?” Beyond that, he said, paying attention to the specific details of data collection is essential. “We want valid, compatible, and consistent data, and that demands training, technical support, data-collection quality-assurance instructions, checks and evaluations, accurate interpretation and classification, and quality, quality, quality.” USDA also collects data on farms across the United States with its Agricultural Research Management Studies. The surveys have three main objectives, said Jorge Fernandez-Cornejo, an economist at USDA's Economic Research Service: “first, to gather information about agricultural production, resource use, input use, and farm practices; second, to determine the cost of production; and third, to determine farmers' net income and financial situation.” The surveys gather data about farms in nine categories, including

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Page 23 field characteristics, seed, fertilizer applications, pesticide applications, pest-management practices, use of machinery, and irrigation. Recently, the surveys have begun to collect data on the use of genetically modified crops. “We like to answer three types of questions,” Fernandez-Cornejo said. “First, what factors led the farmer to adopt genetically modified crops? Second, what is the impact of adoption on pesticide use, on yields, and on farm profits? And finally, what is the suspected diffusion pattern of the adoption?” Besides government monitoring programs, companies that sell genetically modified seed often carry out their own monitoring programs, which might also be useful in setting up monitoring for ecological effects of transgenic crops. Aventis sees such monitoring as part of its stewardship of its products, MacDonald said. “Stewardship is viewed as a business responsibility that extends beyond regulatory requirements,” he said, "and that is why we often voluntarily conduct monitoring after commercialization. It is in the company's interest to ensure the sustainability of this technology.” "Product stewardship also involves the development of good agricultural practices for using the technology,” MacDonald explained. “We have a benefit-risk assessment during the safety evaluation of the product, which leads to a recommendation for managing the benefits and the risks. And that is where monitoring comes in. Monitoring is an effective way to assess the efficacy of your management program. We can take the information from monitoring and update our guidance so that the outcome is best agricultural practices, or we can use the information to update our monitoring efforts to refine and focus the activities that we are looking at.” Any ecological monitoring scheme should start with an understanding of what has already been done, from government surveys to industry stewardship programs, and work from there. A second factor to take into account will be the availability of resources. If time and money were no object, it might be possible to design near-perfect monitoring programs, but time and money are always limited, so the design of the program will always demand tradeoffs. “For a successful monitoring effort,” Lee said, “you need to have a clear purpose, well-defined needs, well-defined requirements, and—I cannot emphasize this enough—adequate resources. Everyone I talk to says, ‘Gee, I would sure like to have those statistically reliable data at my county level.' Well, I say, ‘Give me the money, and we can do it.' But although most people in Congress like to have the information, they don't necessarily like to pay for it. The conflict that everyone in this room will face is getting adequate resources to get quality data. So I cannot emphasize enough: You must define the needs well so that you can target resources to get the job done.”

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Page 24 BOX 4: Understanding Public Attitudes Toward Transgenic Crops To be effective, any ecological monitoring of genetically modified crops will have to take public attitudes and opinions into account. To do that, one must know what those attitudes are and how they are developed. Hallman studies just those issues. The first thing one must understand about how people think about genetically modified crops, Hallman told the workshop, is that people actually don't think or know much about them. “The latest data suggest that 50% of Americans have read little or nothing about biotechnology. Only about 10% report that they have heard or read a great deal about biotechnology." Surprisingly, the level of public awareness has not grown a great deal over the last decade, even as biotechnology has made its way from the laboratory to the farm. “One of the first good studies done on awareness of biotechnology in the United States was done by the Office of Technology Assessment and released in 1987. It found at that time that 63% had heard relatively little or almost nothing about biotechnology and 6% had read or heard a lot.” This relative unfamiliarity with biotechnology offers both an opportunity and a danger, Hallman said. "Relatively uninformed opinions are what we call uncrystallized; that is, they are not well thought through. They are not necessarily strongly held. They are subject to change." In short, he said, biotechnology is not something that Americans have made up their minds about. “If you look at the opinion polls that ask people to rank the hot political issues, genetically modified crops are not high on the list. It's not something about which people have been forced to make personal decisions, by and large. “I want to emphasize that: It's not something that people have had to make personal decisions about. That is important because once people make decisions, their opinions become more crystallized. When that happens, they adjust their attitudes and opinions to support their decisions. They pay much more attention to confirming information. They discount inconsistent information. And, more maddeningly, they reinterpret disconfirming information to support their decisions.” Thus, Americans are open to being convinced that genetically modified foods are a good thing; but they could also decide that genetically modified foods are something to be avoided. “Given the current state of uncrystallized opinion, at least in the United States and in other parts of the world, when do you begin communicating about this? Clearly, the answer is now, while people's opinions are still uncrystallized, while people are still relatively open to new information, and before people are forced to make a decision about genetically modified crops.” Hallman listed several factors that could make people turn against biotechnology in agriculture. So far, people haven't thought much about transgenic products, Hallman suggested, because they seem to represent incremental advances over familiar products. A truly novel product, however, would make people pay attention, and the wrong product could crystallize their opinions against genetically modified organisms. “Once we start creating things like glow-in-the-dark grass or

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Page 25 other kinds of products that are seen as trivial by the public, that will force some people to make some decisions,” Hallman said, and those decisions might not be approving. Any sort of accident or adverse event, particularly one that threatened what are perceived as vulnerable populations, could also set people against genetically modified foods. “If there is ‘genetic contamination' of baby food, for example, it would cause people to re-evaluate their positions. In general, anything that happens to babies, to kittens, to bunnies, to butterflies, or to old people will get people's attention and cause them to make decisions.” Various social factors could also play a role. “Perceived injustice, perceived unfairness, or perceived lack of control can make people come down on one side or another,” Hallman said. “There are some social conformity pressures as well: people who are perceived leaders or respected persons come down on one side or another, and it then becomes socially acceptable to be for or against.” Perhaps the most important thing for biotechnology scientists to understand, he said, is that if people are to be convinced to favor transgenic foods, it will have to be on their terms, not on the scientists' terms. "People see a fundamental difference between genetically modified crops and traditional crops. One of the implications of this concerns the argument, We don't monitor traditional crops, so why should we monitor genetically modified crops, when they are functionally equivalent? But that argument doesn't resonate with people. People think that the two are fundamentally different.” Scientists and others who would communicate with members of the public about genetically modified crops should first understand the framework that people have for understanding such things and then work within that framework. “It is important to find out the right starting points for folks,” Hallman said. “We need monitoring data about public opinions, just as we need environmental monitoring data. In the United States, we lack good data on this.” Whatever people think and however poorly informed they are, scientists should not make the mistake of concluding that the public is irrational, Hallman said. “There are several real dangers in believing that the public is irrational. One is concluding that because the public is irrational, efforts to provide information and education are a waste of time and money. They can't make good decisions, so why educate them? Another is concluding that because the public is irrational, they can't make good decisions about biotechnology. It would follow that those of us who are rational, the experts, and those who agree with us should make the decisions that are ‘good' for the public. The first assumption ensures that the public will not have the tools needed to make informed decisions, and the second ensures that the public will become angry that decisions about the acceptability of a perceived risk are being made for them. “I beg you not to treat the public as irrational. Treat them with respect, and give them the information that they need to participate in this process.”

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Page 26 Resource limitations will force researchers to make choices about which sorts of monitoring they will do. For example, Schaal noted, “if we are going to begin looking at ecosystems, then things become very complicated. It seems to me that the farther away we get from the farmer's field, the more complex the monitoring is, the more expensive it is, and the less likely there are to be funds to do it.” “It will be important,” Bartell added, “to select ecological effects that are compatibly scaled with the monitoring resources. It doesn't make sense to choose a measurement that requires 50 years of monitoring to demonstrate an impact if the necessary resources to perform such longer term monitoring cannot be reliably committed.” A third issue that will affect monitoring programs is the question of who will carry out the monitoring. The answer is not obvious, said Neal Stewart of the University of North Carolina at Greensboro. “Should it be the primary industry? Should it be someone like Cadmus? And how much can we involve farmers in monitoring, inasmuch as they seem to be the closest to the situation?” In many ways, the individual farmer is a natural choice to do much of the monitoring, noted Jeremy Sweet, of the National Institute of Agricultural Botany in the UK. “Who is going to see the unexpected first? It's most likely to be the person growing the crop. So the main thing is to engage the farmer in this program as much as possible and to have the farmer, if you like, as a partner in this, being involved in the development and the stewardship of the crops, and see that the farmer is contributing.” Other speakers, however, questioned whether farmers could be trusted with the monitoring, given that their self-interest might be in conflict with the interest of accurate monitoring. “There is a disjunction between assumptions made by the scientific community and the reality of what is going on with farms and farmers,” said Lipson. “Compliance with refuge-area requirements, for example, deserves a great deal more independent scrutiny than it has been given. Frankly, it is not what it is purported to be according to my experience in the farm community. Likewise, the reliance on farmers to report anomalies in the performance of crops is questionable. I heard several times that this is what the scientific community is relying on in order to determine what questions it should be asking or where it should be making investigations. I think that is highly problematic." With regard to monitoring for the spread of herbicide-resistant weeds, Steven Duke, a USDA researcher, said this is already being done by farmers, extension agents, and weed scientists. “There has been a lot of monitoring already. There are herbicide-resistance action committees that are organized to glean all the data they can from all over the world on herbicide resistance and report it as quickly as possible,” said Duke.

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Page 27 The question remains: Who should do the monitoring? And if it is the farmers, how can researchers be assured that their monitoring reports are accurate and unbiased? Several speakers made the point that no monitoring system that is designed without keeping the public in mind can expect to be successful, at least in a public-policy sense. “One of the dilemmas facing the European Union right now,” MacDonald said, “is a lack of confidence in the regulatory system, and in the government in general, as to its ability to safeguard the food supply. This has been driven by a number of tragic food crises that the EU has faced, which have shaken public confidence. We have to identify strategies that can improve public confidence, and monitoring can go a long way to achieving that goal.” “Trust is emerging as a very important issue,” said Lynne Frewer, of the UK's Institute of Food Research, in Norwich. “Increasing trust means increasing the transparency of the whole risk-management process, which means laying bare the uncertainties that are inherent in that process.” Hallman added, “giving people a sense of control is key to this. It is not enough to have scientists saying, ‘Trust me, trust me, trust me.' People don't respond to that well. Instead, it is important to have a process that is open and to do things like monitoring, even when you don't have to, so that people don't have to trust the opinion of an expert.” Those who design ecological monitoring programs for genetically modified crops could learn something, Bartell suggested, from the US national laboratories run by the Department of Energy, which have had to regain public trust as they clean up a variety of sites that have been contaminated by nuclear wastes and other hazardous materials. “One of the ways that they have effectively addressed those problems,” Bartell noted, “is to allow the development of local stakeholder committees so that the public can introduce what it thinks are the important issues in relation to the cleanup and associated risk-assessment and risk-management issues.” Finding ways for the public to have input into the design and oversight of monitoring operations would make it much more likely that the public would trust the results of monitoring.

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