1
Setting the Stage

Less than two decades ago, genetically engineered organisms (GEOs) were the subject of much scientific study, but not part of everyday life. By 2006—eleven years after the first commercial introduction of corn plants engineered to produce their own insecticide (the delta endo-toxin gene of the bacterium Bacillus thuringiensis, or Bt)—more than 123 million acres of land in the United States were planted with genetically engineered crops. Today, 89 percent of all soybeans, 83 percent of cotton, and 61 percent of corn grown in the United States are the products of genetic engineering (Fernandez-Cornejo and Caswell, 2006). Other GE plants, trees, microbes, insects, and fish are on the horizon.

A key question related to GE crops has been their potential and actual effects on the environment, and numerous studies have been conducted to assess the risks and examine the outcomes of transgenic crops. Those studies have generally informed and strengthened the regulatory oversight of GEOs, but questions still linger in the scientific community about whether GE crops have been evaluated in a broad, long-term ecological context that might expose more subtle effects over time. Those questions also apply to the next generation of GEOs that are in development or poised for field study. Given the diversity of taxa involved and novel traits contemplated, ecologists wonder how the environmental effects of the new GEOs might be manifested, if at all, and how such effects can be detected.

With those concerns in mind, research leaders at the U.S. Geological Survey’s (USGS) Biological Resources Division (BRD) asked the National



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1 Setting the Stage L ess than two decades ago, genetically engineered organisms (GEOs) were the subject of much scientific study, but not part of everyday life. By 2006—eleven years after the first commercial introduction of corn plants engineered to produce their own insecticide (the delta endo- toxin gene of the bacterium Bacillus thuringiensis, or Bt)—more than 123 million acres of land in the United States were planted with genetically engineered crops. Today, 89 percent of all soybeans, 83 percent of cotton, and 61 percent of corn grown in the United States are the products of genetic engineering (Fernandez-Cornejo and Caswell, 2006). Other GE plants, trees, microbes, insects, and fish are on the horizon. A key question related to GE crops has been their potential and actual effects on the environment, and numerous studies have been conducted to assess the risks and examine the outcomes of transgenic crops. Those studies have generally informed and strengthened the regulatory over- sight of GEOs, but questions still linger in the scientific community about whether GE crops have been evaluated in a broad, long-term ecological context that might expose more subtle effects over time. Those questions also apply to the next generation of GEOs that are in development or poised for field study. Given the diversity of taxa involved and novel traits contemplated, ecologists wonder how the environmental effects of the new GEOs might be manifested, if at all, and how such effects can be detected. With those concerns in mind, research leaders at the U.S. Geological Survey’s (USGS) Biological Resources Division (BRD) asked the National 

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 GENETICALLY ENGINEERED ORGANISMS, WILDLIFE, AND HABITAT Research Council (NRC) to organize a workshop of developers of GEOs, ecologists, land managers, and others to discuss GEOs in the context of ecological research. Rather than assessing the potential environmental risk of any particular transgenic organism, the USGS was interested in identifying different research approaches that could be useful in anticipat- ing, understanding, and detecting effects of GEOs on wildlife and natural habitats. This report is a summary of the discussions that emerged from that workshop, held in Irvine, California, on November 6 and 7, 2007. POTENTIAL TRAITS AND EFFECTS Almost all currently produced GE (also known as genetically modi- fied, or GM) crops contain genes for herbicide tolerance, Bt production, or both. But beyond these crops, research and testing are under way in a large variety of plants (including trees), microorganisms, and animals (including insects and aquatic species) to introduce a much broader range of traits with potential benefits for farmers, consumers, and other users of GE products (see Box 1-1). These traits include resistance to disease, drought tolerance, greater nutritional content, production of pharmaceu- tical products, and altered starch structure for industrial uses such as in biofuels. Transgenic plants and animals engineered to produce vaccines and human proteins already have been created and some are being field- tested. The potential to genetically engineer insect and aquatic species for the purpose of developing effective biocontrol agents is another subject under active investigation—for example, a GEO that can help control a non-native aquatic species—yet at much earlier stages of development. One of the primary reasons that most GEOs have not been commer- cialized or even extensively field-tested is the continued uncertainty about their risks to the environment, both managed and wild. In a number of reports published by the National Research Council (NRC 2000, 2001, 2002a, 2002b, 2004), potential environmental impacts identified included the following: • Direct and indirect effects on plant and animal species coexisting with transgenic plants and animals. • Interbreeding or hybridization with and horizontal gene transfer to species related to the GEO, creating novel organisms in the ecosystem that are potential pests, competitors, or that depress the fitness of wild relatives. • Spread of biologically active agents, such as viruses, to non- transgenic species, and the emergence of recombinant viruses. • Spread of novel proteins produced by the GEO to the air, water, or soil in which plants and animals live.

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 SETTING THE STAGE BOX 1-1 Genetically Engineered Traits in Experimental Development Crops Drought and salt tolerance Nitrogen and water use efficiency Nutritional amendments—oils and proteins/amino acids Herbicide tolerance mechanisms (novel) Disease and pest resistance (plant insecticides, lectins) Biofuels (cellulosic digestion; carbohydrate storage) Senescence/ripening/phenology Industrial uses—starches/oils/fibers Microorganisms Fungi and bacteria with enhanced virulence characteristics for insect control Fermentation of substrates, antimicrobial producers, probiotics for “active” foods, attenuated vaccines (bacterial and viral) Phage for plant disease control Biofuels related (cellulose, lignin degradation) Nitrogen fixation in non-traditional plants Insect symbionts for paratransgenic control Animals Growth promotion—(growth hormone) cattle, fish, shellfish Medically valuable proteins in milk Disease resistance (antimicrobial peptides, viral resistance, BSE) in cattle, swine, poultry, fish, bivalves Insects—disease resistance and pharmaceutical production Vector disruption—(Malaria, Dengue) Product quality—(silk, high value proteins) Viral resistance in honey bees Source: Chris Wozniak (workshop presentation) • Indirect effects on wildlife and habitat ecosystems because of changes in the management of agriculture, forestry, and fisheries related to GEOs. The ability to understand the potential for these effects to occur on a large scale over a long time period—particularly in the cases of trees, aquatic species, and microbes—is confounded by regulatory requirements for the confinement of an experimental GEO during testing. That poses a difficult challenge for GEO developers and evaluators. There is little known about the likelihood or magnitude of impact of GEOs, so they can- not be released into the environment for research purposes. Yet, a better

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 GENETICALLY ENGINEERED ORGANISMS, WILDLIFE, AND HABITAT understanding of the potential and actual effects of GEOs relative to other influences on the environment (for example climate change, invasive spe- cies, or land use changes) requires approaches that take into account both the specific characteristics of GEOs and the character and resilience of the environment, as well as the extent of the interaction between the GEO and the environment. That understanding could be best achieved by observa- tion in an actual environmental setting. How will this impasse be overcome? In her welcoming presentation, Anne Kapuscinski described the role of ecological research in informing the decision-making process of risk assessment. That role includes gather- ing information, identifying the appropriate parameters for consideration, and analysis of complex systems. Because interest in the development and implementation of GEOs with a variety of traits is likely to increase in the future, concerns about potential environmental hazards need to be translated into specific research questions that produce data to inform those who evaluate and manage the risks of GEOs. That does not mean that ecological research is necessarily narrow; it may be focused on how natural systems operate more generally to elucidate more general prin- ciples. But that information is also relevant to work of risk assessors in the federal agencies with regulatory authority and the agencies tasked with overseeing the integrity of publicly owned land. FEDERAL RESPONSIBILITIES In 1986, the Coordinated Framework for the Regulation of Biotechnol- ogy defined roles for federal agencies in regulating the products of bio- technology. The framework focused on products being developed at the time, mainly transgenic microbes and plants, and did not focus on taxa of other GEOs or on the effects of GEOs on wildlife and their habitats. In order to address uncertainties about these issues and other emerg- ing products of biotechnology, in May 2000, the White House Office of Science and Technology Policy and the Council for Environmental Quality undertook a review of the relevant agencies and statutes for regulating biotechnology products. This review, completed in January 2001, along with a number of federal and state laws, covers oversight of GEOs today (CEQ/OSTP 2001). Under this policy, the U.S. Department of Agriculture (USDA) (and particularly its Animal and Plant Health Inspection Service [APHIS]), the U.S. Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) share responsibility for regulating GEOs. USDA has the authority to provide permits for testing of GE plants and some animals, for regulating their production, including an assessment of envi- ronmental risks. EPA has authority over plants and microorganisms that

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 SETTING THE STAGE produce pesticides (such as the Bt crops). FDA must approve the market- ing of GEOs as food, and under the National Environmental Protection Act, FDA may also consider the environmental effects of production of transgenic animals. Among many federally funded research programs on GEOs, the USDA Biotechnology Risk Assessment Grants (BRAG) Program was established in 1992 by an act of Congress. Through the Farm Security and Rural Investment Act of 2002, the BRAG Program funds “research designed to identify and develop appropriate management practices to minimize physical and biological risks associated with genetically engineered ani- mals, plants and microorganisms.” According to Chris Wozniak, who presented information about BRAG, approximately 140 projects have been funded (maximum award of $400,000) since 1992, with an emphasis on studies that “will provide information useful to regulators for mak- ing science-based decisions in their assessments of genetically modified organisms” (USDA, 2008). Other agencies also become involved as GEOs interact—or have the potential to interact—with the environment. For example, the Department of Interior’s Fish and Wildlife Service and Bureau of Land Management (BLM) and the Department of Commerce’s National Marine Fisheries Ser- vice may assert the authority of the Endangered Species Act, the National Invasive Species Act of 1996, and other federal legislation. In addition, most oversight authority for wildlife and fisheries resources rests with the states, six of which, as of this publication, have issued regulations prohibiting releases of aquatic or marine GEOs. WORKSHOP PURPOSE AND ORGANIZATION The Department of Interior’s USGS does not have regulatory or over- sight authority over GEOs, but its mission to provide reliable scientific information to other agencies and to the public gives it an important role in strengthening the information base about the effect of GEOs on the environment. The USGS BRD, one of the agency’s four broad topical dis- ciplines, “works with others to provide the scientific understanding and technologies needed to support sound management and conservation of our Nation’s biological resources” (USGS, 2008). Bob Szaro (USGS) explained that the USGS is a scientific advisor to several federal agencies with stewardship responsibility for public lands, including the BLM, the National Park Service, and other agencies. In that capacity, the BRD requested that the NRC organize a workshop to fur- ther approaches to understanding the effects of GEOs on terrestrial and aquatic ecosystems. The workshop’s expected outcome was to identify fundamental information needs and prioritize research directions. It also

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 GENETICALLY ENGINEERED ORGANISMS, WILDLIFE, AND HABITAT was designed to identify existing research and monitoring that could pro- vide a platform for GEO-related research on the ecological effects of GEOs and lead to new partnerships, projects and resources for these complex and critical areas of inquiry. BRD asked the workshop planning commit- tee and workshop participants to focus on approved GEOs already in the environment and those that may reasonably be expected to be developed within the next five to ten years (see Box 1-2). In early 2007, a committee of nine scientists was appointed to plan the workshop. An in-person meeting and numerous conference calls cul- minated in the two-day Workshop on Genetically Engineered Organisms, Wildlife, and Habitat at the Arnold and Mabel Beckman Center in Irvine, California, November 6 and 7, 2007. The workshop involved federal, university, and other scientists who conduct research on GE plants, trees, microbes, insects, and fish, as well as those who focus on the ecosystems that these GEOs might affect. Representatives of federal agencies involved in regulatory oversight also participated. The workshop began with some basic information on GEOs, including an overview of what GEOs exist and what new GEOs are planned for development in the next five to ten years, and an overview of the USGS and specifically, the BRD. The information from the introduc- tory session has been summarized in this chapter. The workshop continued with presentations on the status of current research—and, as importantly, on current research gaps—on the effects of GEOs on terrestrial and aquatic wildlife and habitats. These presenta- BOX 1-2 Statement of Task An NRC committee will organize a public workshop of experts, resource man- agers, and others to identify research activities with the greatest potential to pro- vide scientific information and data that would improve the ability to assess the ecological risks and impacts of genetically engineered organisms (GEOs) on ter- restrial and aquatic wildlife and their habitats in the United States. The workshop will be organized around key concerns related to the interaction of GEOs with natural environments and consider the specific types of data needed to evaluate the risk and impact of GEOs on wildlife and their habitat. In addition to identifying various scientific approaches to obtaining the necessary data, the workshop will consider whether and how research needs and approaches for evaluating the risk and impact of GEOs might complement or build on existing research, surveillance, and monitoring activities in natural areas. A rapporteur will produce an individually- authored summary of the workshop.

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 SETTING THE STAGE tions describing current GEO research were organized by taxa, and were followed by presentations of potential models which could be used to study GEOs in the environment. Models presented included invasion ecology, gene flow, and landscape analysis. These presentations helped inform the breakout discussions and are summarized in Chapter 2 of this publication. The plenary presentations and group discussions did not evaluate the potential risks of GEOs to the environment or the methodologies for risk assessment. Instead, discussions within the workshop explored how GEOs could be studied in the context of natural habitats, what some of the interactions of GEOs with the environment could be, and what research questions related to environmental interactions would be important to consider. In keeping with the statement of task, the heart of the workshop, as reported in Chapter 3, focused on breakout sessions to identify research that could be pursued to better understand GEO-ecosystem interactions. For the breakouts, participants were divided by ecosystem type: two groups focused on the agriculture/wildland interface, and one each on the silviculture/wild forest and on the aquaculture/aquatic habitat inter- face. These groups identified several broad research priorities for “their” interface, and then reported back in a plenary session for clarification and discussion. In a second round of breakouts, participants began to develop research proposals to address the research topics identified. Although time constraints made detailed proposals impossible, they serve as a start- ing point for funding and regulatory agencies, particularly as they seek to fill information gaps in assessments of the risks of GEOs to wildlife and habitat. As additional input to USGS and others, the final thoughts on the workshop by committee members and participants are contained in Chapter 4. The agenda for the workshop can be found in Appendix A. Short biographies of the committee members and workshop participants are contained in Appendix B. The role of the workshop planning committee was to develop the agenda for the meeting, invite speakers, and recruit participants. This report, which is meant to present a factual summary of what occurred at the workshop, was prepared by a rapporteur, indepen- dent of the committee, and was reviewed for accuracy by several partici- pants who were in attendance.

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