Executive Summary

Before transgenic plants can be grown outside the laboratory, approval must be obtained from the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). APHIS derives its authority for regulating transgenic plants from the Federal Plant Pest Act (FPPA) and the Federal Plant Quarantine Act (FPQA). As a participant in the U.S. Coordinated Framework for the Regulation of Biotechnology, APHIS developed its first formal procedures for assessing potential environmental effects of transgenic plants in 1987. Currently, APHIS’s Biotechnology, Biologics, and Environmental Protection unit (BBEP) reviews approximately 1,000 applications for field testing and deregulation of transgenic plants each year.

TASK OF THE COMMITTEE

In January 2000 the USDA requested that the National Academy of Sciences examine the scientific basis for and the operation of APHIS regulatory oversight. The specific task set before this committee by the USDA and the NRC (National Research Council) Committee on Agricultural Biotechnology, Health, and the Environment (CABHE) was as follows:

“The committee will review the scientific basis that supports the scope and adequacy of USDA’s oversight of environmental issues related to current and anticipated transgenic plants and their products. In order to address these issues, the committee will:

  1. Evaluate the scientific premises and assumptions underpinning the environmental regulation and oversight of transgenic plants. This evaluation will include a comparison of the processes and products of genetic engineering with those of conventional plant breeding as they pertain



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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation Executive Summary Before transgenic plants can be grown outside the laboratory, approval must be obtained from the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). APHIS derives its authority for regulating transgenic plants from the Federal Plant Pest Act (FPPA) and the Federal Plant Quarantine Act (FPQA). As a participant in the U.S. Coordinated Framework for the Regulation of Biotechnology, APHIS developed its first formal procedures for assessing potential environmental effects of transgenic plants in 1987. Currently, APHIS’s Biotechnology, Biologics, and Environmental Protection unit (BBEP) reviews approximately 1,000 applications for field testing and deregulation of transgenic plants each year. TASK OF THE COMMITTEE In January 2000 the USDA requested that the National Academy of Sciences examine the scientific basis for and the operation of APHIS regulatory oversight. The specific task set before this committee by the USDA and the NRC (National Research Council) Committee on Agricultural Biotechnology, Health, and the Environment (CABHE) was as follows: “The committee will review the scientific basis that supports the scope and adequacy of USDA’s oversight of environmental issues related to current and anticipated transgenic plants and their products. In order to address these issues, the committee will: Evaluate the scientific premises and assumptions underpinning the environmental regulation and oversight of transgenic plants. This evaluation will include a comparison of the processes and products of genetic engineering with those of conventional plant breeding as they pertain

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation to environmental risks. This evaluation may result in recommendations for research relevant to environmental oversight and effects of transgenic plants. Assess the relevant scientific and regulatory literature in order to evaluate the scope and adequacy of APHIS’s environmental review regarding the process of notification and determination of non-regulated status. The committee will focus on the identification of effects of transgenic plants on non-target organisms and the Environmental Assessments (EA) of those effects. The study will also provide guidance on the assessment of non-target effects, appropriate tests for environmental evaluation, and assessment of cumulative effects on agricultural and non-agricultural environments. Evaluate the need for and approaches to environmental monitoring and validation processes.” Previous National Research Council (NRC) committees have examined a number of issues related to the safety of genetically engineered organisms (NRC 1982, 1989, 2000c) but none specifically examined APHIS oversight or how commercial use of genetically engineered crops with non-pesticidal traits could affect agricultural and nonagricultural environments. The task of this committee specifically included provision of guidance for assessment of the cumulative effects of commercialization of engineered crops on the environment. Therefore, the committee examined the potential effects on the environment that could result from the use of engineered crops on large spatial scales over many years. In addition to evaluating the potential direct environmental impacts of single engineered traits within existing agricultural systems, the committee also examined how commercialization of engineered crops with single and multiple traits could actually change farming and thereby impact agricultural and nonagricultural landscapes of the United States. As part of its task, the committee conducted a detailed study of the relevant scientific and regulatory literature and used its findings from this study in developing what the committee considers an appropriate framework for assessing the environmental effects of transgenic plants. The committee used this framework to evaluate the scope and adequacy of the APHIS review process. COMPARISON OF ENVIRONMENTAL ASSESSMENT OF TRANSGENIC PLANTS WITH ASSESSMENT OF OTHER AGRICULTURAL TECHNOLOGIES Risk assessment literature and history demonstrate that environmental regulation of agricultural practices and technologies involves an inter-

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation play of ecological and social factors. Therefore, any analysis of the scope and adequacy of an environmental assessment program must address interaction of these two factors. At the outset of the twentieth century environmental issues were not a dominant public concern, and U.S. farmers were, in general, free to use whatever agricultural practices best suited their needs. As the twentieth century progressed, the impacts of agricultural practices on human health and the environment became a focus of public attention. Regulations and incentive programs were developed for agriculture and now have a major influence on farming, ranging from the choice of tillage practices to the choice of pest control techniques. In the era when the scientific foundation of conventional plant breeding was developed and put in practice, potential for non-target effects and gene flow were not a concern. In contrast, transgenic technology is coming of age during a time when environmental assessments are much more sophisticated and when a growing segment of the public is voicing concern about environmental degradation and lack of faith in government agencies to prevent that degradation. Concern over the impact of transgenic plants on the environment has led governments in a number of countries to raise the standards by which they judge what constitutes a significant negative effect of agriculture on the environment. Environmental standards being developed for transgenic plant varieties consider impacts that were rarely even measured when novel conventional crop varieties or synthetic chemicals were introduced in the 1960s and 1970s. Today, government agencies charged with the regulation of transgenic plants find themselves in the difficult position of enforcing a higher environmental standard for transgenic plants than the standards currently used to regulate the impacts of other agricultural technologies and practices. It is possible that the higher standards being developed for transgenic plants will, in the future, be applied in some fashion to other agricultural technologies and practices. Because decisions that are now being made with regard to transgenic plants could set a precedent for evaluating all agriculture, government agencies and the public must keep this in mind as regulations for transgenic plants evolve. ENVIRONMENTAL EFFECTS OF AGRICULTURAL PRACTICES, NOVEL GENETIC MATERIAL, AND THE PROCESSES USED IN PLANT IMPROVEMENT From a scientific perspective, the committee saw a need to place potential impacts of transgenic crops within the context of environmental effects caused by other agricultural practices and technologies. There is substantial evidence that ecological effects of farming practices exert simplifying and destabilizing effects on neighboring natural ecosystems.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation These effects are of concern because they appear to weaken or destroy ecosystems’ capacity for resilience—that is, an ecosystem’s ability to return to its initial state despite disturbance. Potential ecological effects of transgenic crops, and other crops bearing novel traits, may be heightened in this destabilized ecological milieu. This argues for a cautious approach to the release of any crop that bears a novel trait. Equally, it is an argument for a cautious approach to any extensive change in agricultural practices. The two plant pest statutes (Federal Plant Pest Act and the Federal Plant Quarantine Act), which are used by APHIS to regulate transgenic plants, were originally developed to regulate the introduction of nonindigenous plant species. Because the amount of novel genetic information added to an ecosystem by the introduction of a new species is much greater than that added by a single transgene, the use of these plant pest statutes to regulate transgenic plants has been criticized. On the other hand, the use of these statutes for regulating transgenic but not conventionally improved plants has been defended because the introduced genes in transgenic plants can have a much more distant taxonomic origin (for example, bacterial genes transferred to plants). These arguments are based on a general assumption that the risks associated with the introduction of genetic novelty are related to the number of genetic changes and the origin of the novel genes. The committee compared empirical evidence of environmental impacts involving small to large amounts of genetic novelty from taxonomically related and unrelated sources and found no general support for this assumption. More specifically, it was found that (1) small and large genetic changes have had substantial environmental consequences; (2) the consequences of biological novelty depend strongly on the specific environment, including the genomic, physical, and biological environments into which they are introduced; (3) the significance of the consequences of biological novelty depend on societal values; (4) introduction of biological novelty can have unintended and unpredicted effects on the recipient community and ecosystem; (5) a priori there is no strict dichotomy between the possibility of environmental hazard associated with releases of cultivated plants with novel traits and the introduction of nonindigenous plant species. However, the highly domesticated characteristics of many cultivated plants decrease the potential of certain hazards. The conventional development of semi-dwarf, short-season varieties of rice and wheat that propelled the Green Revolution of the twentieth century clearly exemplifies how a small number of genetic changes to a crop can impact the environment. In the case of rice, a single gene for short stature made rice much more responsive to fertilizer, while a few

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation genes for more rapid maturation allowed farmers to grow one or two extra crops per year. These small genetic changes enabled massive changes in agricultural practices that increased production. However, these changes have increased soil salinity, lowered water tables, and altered wetlands in some regions. Thus, there are tradeoffs between the long-term positive and negative effects of these varieties. The environmental impacts of the genes introduced to Green Revolution varieties and other crops are often indirect, which makes their assessment more complex but no less important. In comparing conventional and transgenic approaches to crop improvement, the committee is in agreement with a previous NRC report (2000c) which found that both transgenic and conventional approaches (for example, hybridization, mutagenesis) for adding genetic variation to crops can cause changes in the plant genome that result in unintended effects on crop traits. Genetic improvement of crops by both approaches typically involves the addition of genetic variation to existing varieties, followed by screening for individuals that have only desirable traits. The screening component will remove many but not all of the unanticipated physical and ecological traits that could adversely affect the environment. Based on a detailed evaluation of the intended and unintended traits produced by the two approaches to crop improvement, the committee finds that the transgenic process presents no new categories of risk compared to conventional methods of crop improvement but that specific traits introduced by both approaches can pose unique risks. There is currently no formal environmental regulation of most conventionally improved crops, so it is clear that the standards being set for transgenic crops are much higher than for their conventional counterparts. The committee finds that the scientific justification for regulation of transgenic plants is not dependent on historically set precedents for not regulating conventionally modified plants. While there is a need to reevaluate the potential environmental effects of conventionally improved crops, for practical reasons, the committee does not recommend immediate regulation of conventional crops. A previous NRC report (2000c) also raised issues related to the lack of rigorous examination of conventionally produced crop varieties. Transgenic and conventional approaches are in a period of rapid change. This makes it difficult to assess the potential risks of specific traits that each approach will be able to alter in the future. While it is not possible to assess the risks of any genetically modified plant without empirical examination, the committee finds that it should be possible to relatively quickly screen modified plants for potential environmental risk and then conduct detailed tests on only the subset of plants for which preliminary screening indicates potential risk.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation RISK ANALYSIS AND THE REGULATION OF TRANSGENIC PLANTS: SCIENTIFIC ASSUMPTIONS AND PREMISES The committee reviewed a number of models for risk analysis, with special attention to those outlined in two previous reports (NRC 1983, 1996). Risk analysis often involves the use of scientific information to provide technical guidance to decision makers about the management of those risks (referred to as the “decision support” role of risk analysis). This decision support role presumes that the decision maker (an individual, a group, or an organization) is well defined and has the legitimate and uncontested authority to make a decision. Traditionally, officials in government agencies have viewed risk analyses as decision support for the exercise of their legislatively mandated authority. However, the assumption that “mandated authority” provides “uncontested authority” does not hold in all cases. Indeed there are many situations in which scientifically rigorous risk analysis and involvement of interested and affected parties in the risk analysis process perform a second, well-recognized role in regulation—that of maintaining the legitimacy of regulatory agencies to exercise such authority. The committee discussed a number of points of tension that arise between the use of risk analysis to create and maintain legitimacy and its use as a decision support tool. It is clear that democracy is best served when people affected by regulatory decision making can be significantly involved in the decision making, and that inclusion of diverse interests in the risk analysis process can be a powerful force to garner legitimacy of a decision. This is especially true because the significance of environmental effects of novel genetic material depends on societal values. However, especially when the decision options under consideration are not well defined, broad public involvement in risk analysis can result in risk management decisions that lack scientific rigor. In the analysis of risks from transgenic plants, APHIS has concentrated on the decision support role of risk analysis. However, it is clear that risk analysis of transgenic plants has played an important role in maintaining the legitimacy of regulatory decision making concerning environmental and food safety in the United States. The committee concludes that risk analysis of transgenic plants must continue to fulfill two distinct roles: (1) technical support for regulatory decision making and (2) establishment and maintenance of regulatory legitimacy. The use of more rigorous methods in decision support are likely to help risk analysis fulfill its role of establishing and maintaining regulatory authority. At least five standards of evidence can be used in a risk assessment for decision support. The scientifically rigorous methods include epidemiological, modeling, and experimental methods. Other meth-

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation ods include the judgments of external scientific panels with specific technical expertise, and judgment of experienced regulatory personnel. A consensus of multiple external scientific experts is likely to be more rigorous than regulatory judgments because disagreements among external experts are likely to lead to more robust risk assessments. As indicated above, this committee agrees with previous NRC committees (NRC, 1989, 2000c) that there are no new categories of risk associated with transgenic plants. The categories of risks from transgenic plants include those associated with the movement of the transgenes, impacts of the whole plant through escape, and through impacts on agricultural practices, non-target organism effects, and resistance evolution. For this reason, the process of producing new plant varieties should not enter into the assessment. However, the committee’s analysis indicates that specific traits introduced by either of the two approaches can pose unique risks. For example, within the general category of “risks to non-target organisms,” production of Bt toxins in corn pollen could pose a unique airborne toxin-exposure that was never found in conventional corn varieties. For purposes of decision support this committee agrees with previous NRC reports which conclude that risks must be assessed on a case-by-case basis with consideration for the organism, trait, and environment. Typically there are a number of comparisons that are appropriate for assessing the risks of transgenic crops. For example, the environmental effects of a transgenic crop could be compared to chemically intensive farming practices and to farming practices developed to be more ecologically sustainable. Another obvious comparison is that of a crop variety with a transgenic trait to a similar variety (that is, a near isoline) lacking that trait. Therefore, the maintenance of such varieties is critical for appropriate testing. The committee recognizes that in any attempt to mitigate environmental risk there is a need to be mindful of the fact that avoiding one risk can sometimes inadvertently cause another greater risk. For example, a regulation that discouraged research on pest-specific, plant-produced compounds could in some cases lead to continued use of environmentally disruptive synthetic pesticides. ANALYSIS OF THE APHIS REGULATORY PROCESS The major focus of the committee’s work was on analysis of the scope and adequacy of the APHIS environmental review process for transgenic crops. There were three phases to the analysis. First, the committee examined the general statutes and rules used by APHIS to regulate transgenic plants and the documents that APHIS has developed as guidance for applicants. Next, APHIS assessments of specific applications for testing

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation and commercialization were examined in detail (case studies). During these two phases the committee communicated with APHIS personnel to avoid missing any crucial unpublished information and to learn more about the day-to-day operations of the APHIS-BBEP. Finally, the information gathered was used to determine how well APHIS oversight is meeting the two general roles of risk assessment, and to develop recommendations for specific changes in that oversight. The committee finds that APHIS and other regulatory agencies charged with assessing the safety of transgenic plants face a daunting task. This is so in part because environmental risk assessment of transgenic plants is new and in part because the social context in which regulatory decisions about transgenic organisms must now be made is dramatically different from the one in which these agencies have been accustomed to work. The committee finds that the APHIS regulatory system has improved substantially since it was initiated. For example, in two Bt corn petitions for nonregulated status, one completed in 1994 and one in 1997, the breadth of environmental issues addressed and the degree of rigor with which they were addressed improved with time. Furthermore, the development of a notification process that utilizes ecologically-based performance standards was an important step in effectively streamlining the field-testing process. The learning process at APHIS has not come without missteps, but the agency seems to use them as opportunities for further improvement. In its role of analyzing APHIS environmental reviews the committee mostly searched for problem areas as a means to help improve a functioning system. APHIS has been criticized for regulating transgenic crops with statutes that do not cover all transgenic plants. The committee finds that APHIS currently has the authority to base regulatory scrutiny on potential plant pest status, regardless of the process of derivation, and therefore can theoretically regulate any transgenic plant. However, the only practical trigger used by APHIS is the presence of a previously identified plant pest or genes from a plant pest in the transformed plant. Other operational triggers are needed for transgenic plants that may have associated risks but lack the above characteristics. APHIS jurisdiction and the focus of its Environmental Assessments are confined to the United States, but some APHIS assessments discuss potential environmental effects of specific transgenic plants outside the United States. There is a need to clarify this discrepancy. If APHIS jurisdiction is to remain confined to the United States, Environmental Assessments should clearly state that they do not consider risks beyond United States borders. APHIS documents reviewed by the committee also are inconsistent regarding APHIS authority to deregulate transgenic plants on a limited

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation geographic basis within the United States. This inconsistency is important because in one case the perceived inability of APHIS to set geographic limits led it and the Environmental Protection Agency (EPA) to make different decisions on the planting range of transgenic cotton in the United States. There may be future situations where at least temporary geographic limits would be beneficial. Current APHIS oversight involves three processes: notification, permitting, and petitioning for nonregulated status. It is possible to commercialize the nonliving products of transgenic plants through each of these processes, but petitioning for nonregulated status is currently the predominant mode for commercialization of all transgenic plant products and is the only process for commercialization of living transgenic plants. Initially, all field testing of transgenic plants needed to be approved by the permitting process (see Chapter 3). However, APHIS determined that for some transgenic plants, safety could be assured through a more streamlined approach of having the applicant notify the agency in advance of planting. The notification process was first used for a limited set of crops, but currently almost all field testing is conducted through the notification process that requires APHIS to complete its decision making in less than 30 days. Within this time frame, one APHIS staff member typically determines if the notification process is sufficient for the particular transgenic plant. The applicant must follow general guidelines to ensure that there are no environmental effects from the planting, but the process involves no public or external scientific input. Plants that cannot be grown in the field, based on notification, include those that produce substances intended for use as pharmaceuticals and those that could affect non-target organisms. Some plant products have been commercialized using the notification process, and there is no limit to the acreage that can be planted under the notification system. Commercialization of certain plant products through notification could result in large plantings and increased risks through scale effects. In the committee’s examination of specific cases where commercialization involved only oversight through the notification process, one case was found where it appears that a transgenic plant with toxic properties (avidin-producing corn) was grown under the notification process. The committee finds that the notification process is conceptually appropriate, but there is a need to reexamine which transgenic plants should be tested and commercialized through the notification process. In comparison with the notification process the permitting process requires more detail from the applicant, and if APHIS determines that there is a need for a formal Environmental Assessment of the plant, a description of the application is published in the Federal Register and is open to public comment. The permitting process is not commonly used at

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation present, but as more pharmaceutical-producing plants are developed, it may be used more frequently. The dominant path toward commercialization—petitioning for nonregulated status—is in essence a request for APHIS to determine that there is no plant pest risk (or as commonly understood, no environmental risk) associated with the specific transgenic plant. If APHIS makes this determination, it agrees that the plant no longer needs regulation. As currently implemented, APHIS deregulation is absolute. Once deregulated, the agency does not assume further oversight of the plant or its progeny and descendants. As part of the petitioning process APHIS always conducts a formal Environmental Assessment and publishes this assessment in the Federal Register, providing the public with a 60-day comment period. APHIS personnel are required to respond to each comment received. The committee examined six individual petitions for nonregulated status conducted over a period of four years. Based on these detailed assessments as well as an examination of the general process of APHIS oversight, the committee finds a number of places where APHIS could improve its technical risk assessments and the manner in which it involves the public in policy development and decision making. In general, the committee finds that the APHIS process should be made significantly more transparent and rigorous by enhanced scientific peer review, solicitation of public input, and development of determination documents with more explicit presentation of data, methods, analyses, and interpretations. Such changes are likely to improve the agency’s risk analyses at both the level of decision support and the level of maintenance of regulatory authority. To improve the rigor of decision support, the committee recommends that, whenever changes in regulatory policy are being considered, APHIS should convene a scientific advisory group. This is a common practice of the EPA. Before APHIS first introduced the notification procedure, it formally requested input from the then-active USDA Agricultural Biotechnology Research Advisory Committee (ABRAC). Such formal input has not been sought since that time. The committee recommends that before making specific, precedent-setting decisions, APHIS should solicit broad external scientific review well beyond the use of Federal Register notices. Specific attributes of APHIS’s environmental assessments require comment. The committee recommends that APHIS should not use the term “no evidence” in its environmental assessments. The term “no evidence” can mean either that no one has looked for evidence or that the examination provides contrary evidence. Lack of evidence is not typically

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation useful in making regulatory decisions about risk. The committee also recommends that APHIS not use general weediness characteristics in its assessments because these characteristics have no predictive value. APHIS must instead use criteria specific to the regulated article and the environments to which it could be exposed. Until recently it was difficult or impossible to determine the full sequence of an inserted gene. Therefore, APHIS’s past acceptance of partial sequence data was reasonable. At this time the agency should require reporting of full DNA sequences of transgenes as they are integrated into the plant genome unless the applicant can provide scientific justification not to do so. Data on flanking sequences also would be useful to determine the exact insertion site of the transgene APHIS’s environmental assessments of transgenic plants with pesticidal properties include assessment of effects on non-target organisms as well as assessment of the risk posed by the potential of pests to evolve resistance to the pesticidal substance. The treatment of these two issues in APHIS’s Environmental Assessment documents is generally superficial. The committee recommends that for pesticidal plants APHIS should either increase the rigor of assessments of resistance risk and non-target impacts, or it should completely defer to the EPA, which also assesses these risks. The committee commends APHIS for developing and making available guidelines for applicants who are using any of the three APHIS processes. These guidelines clearly are helpful, especially to small companies and scientists who are generally not familiar with regulatory processes. One way in which these guidelines could be improved would be for APHIS to provide information about what types of evidence it considers necessary for each of the characteristics listed in the guidelines. Without such information it is difficult for applicants to determine the degree of rigor required by the agency in making its assessments. The committee recognizes that APHIS staff are open to personal interaction with applicants, but more detailed published guidance still would be useful. All of these changes would increase the utility of APHIS risk assessments in decision support. The increased rigor provided by these changes also could increase public confidence. There are a number of aspects of APHIS oversight that bear directly on public confidence. The committee finds that the extent of confidential business information (CBI) in registrant documents sent to APHIS hampers external review and transparency of the decision-making process. Indeed, the committee often found it difficult to gather the information needed to write this report due to inaccessible CBI. It is not clear that APHIS has the power to decrease the unwarranted use of CBI. However,

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation regulatory agencies of other countries receive documents with less CBI than does APHIS. A previous NRC report (NRC 2000c) raised similar concerns about CBI. In the committee’s review of public participation in the review process it was apparent that the number of comments on Federal Register notices has declined almost to zero. Committee discussions with representatives of public interest groups indicate that this decline in responses to APHIS-BBEP Federal Register notices is at least in part due to a perception that APHIS is only superficially responsive to comments. The committee finds that there is a need for APHIS to actively involve more groups of interested and affected parties in the risk analysis process while maintaining a scientific basis for decisions. As indicated above, there is a tension between use of the risk analysis process for decision support and maintenance of authority. APHIS could benefit from more attention to maintaining a balance between these two roles of its risk analyses. In examining its day-to-day operations the committee finds that APHIS-BBEP is understaffed and questions the match between the scientific areas of staff training and their responsibilities. The committee specifically noted understaffing in the area of ecology. The committee recommends that APHIS improve the balance between the scientific areas of staff training and job responsibilities of the unit by increasing staff and making appropriate hires. In making this recommendation the committee is aware that APHIS needs help in making its hiring practices and salary ranges more flexible. Because of the large number of applications for field testing, more resources are needed in order to maintain a suitable number of well-trained APHIS officers for field inspection. As pointed out above, the committee commends APHIS for maintaining an environment in which the decision-making process can be adjusted based on knowledge gained from past risk assessments and regulatory decisions. The committee thinks APHIS would profit from formalizing its learning process. A fault-tree analysis is one approach to such a formalized learning process. POSTCOMMERCIALIZATION TESTING AND MONITORING Environmental testing of transgenic plants prior to commercialization can be effective in screening plants for many types of risks, but the committee finds there are several compelling arguments for validation-testing and ecological monitoring after commercialization of these plants. Because APHIS has considered deregulation absolute, it does not currently conduct postcommercialization monitoring unless commercializa-

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation tion has been conducted through the process of notification (or permitting) and the extent of monitoring for notifications is dependent on APHIS staffing levels and priorities. The committee finds that APHIS assessments of petitions for deregulation are largely based on environmental effects considered at small spatial scales. Potential effects from “scale-up” associated with commercialization are rarely considered. A good example of this is the use of toxicology-type testing of transgenic plants with pesticidal traits. These toxicology tests on a limited set of organisms are certainly helpful in preliminary assessment of hazards from effects on non-target organisms, but these acute toxicity tests might miss potential chronic effects that occur within field environments or effects that are not possible with the model organisms tested. The committee recommends that postcommercialization validation testing be used to assess the adequacy of precommercialization environmental testing. This validation testing should involve testing specific hypotheses related to the accuracy and adequacy of precommercialization testing. This testing should be conducted at spatial scales appropriate for evaluating environmental changes in both agricultural and adjacent, unmanaged ecosystems. This validation testing could be funded and managed through programs such as the USDA Biotechnology Risk Assessment and Risk Management Program, which primarily sponsor university researchers. However, to meet the needs of products being commercialized, these programs will have to be expanded substantially. The committee recommends that two different types of general ecological monitoring be used to assess unanticipated or long-term, incremental environmental impacts of transgenic crops. One type of monitoring involves use of a network of trained observers to detect unusual changes in the biotic and abiotic components of agricultural and nonagricultural ecosystems. The second involves establishment of a long-term monitoring program that examines the planting patterns of transgenic plants, and uses a subset of species and abiotic parameters as indicators of long-term shifts in an ecosystem. While validation testing can be put in place using the existing public research infrastructure, it will be much more difficult to institute an effective system of trained observers, and to develop a long-term program for monitoring indicators of ecosystem change. The committee finds that there already are groups of individuals available who could be trained as observers, but it would be inefficient to have these observers assess only the effects of transgenic plants. The committee recognizes that the ability to monitor impacts of largescale planting of crops with new traits is hampered by the lack of baseline data and comparative data on environmental impacts of previous agricultural practices. The committee finds that the United States does not

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation have in place a system for environmental monitoring of agricultural and natural ecosystems that would allow for adequate assessment of the status and trends of the nation’s biological resources. This problem encompasses much more than concerns about transgenic crops. The committee endorses the development of ecological indicators, as proposed by the NRC (2000a), for both agricultural and nonagricultural environments. Without systematic monitoring data, it will not be possible to separate coincidental anecdote from real ecological trends. The same NRC report recommended development of indicators based on the assumption that monitoring them is more cost effective and accurate than monitoring many individual processes or species. This approach also simplifies communication of findings. Transgenic plants should be one component of such a monitoring system. One essential monitoring requirement will be the spatial distribution of transgenic crops. The committee recommends that a body independent of APHIS be charged with the development of an indicator-monitoring program. This monitoring program/database should allow participation by agencies, independent scientists, industry, and public-interest groups. The database depository should be available to researchers and the interested public. A scientifically rigorous design modeled after the National Resources Inventory, and with cost sharing among agencies should reduce the burden of costs for such a program. More research is needed to identify organisms and biological processes that are especially sensitive to stresses and perturbations. Finally, there should be an open and deliberative process involving stakeholders for establishing criteria for this environmental monitoring program. The committee recommends that a process be developed that allows clear regulatory responses to findings from environmental monitoring. Although monitoring may detect some unexpected effects in a time period that allows action to be taken to prevent or ameliorate those effects, in other cases, monitoring may detect such effects so late that environmental damage may be irreversible (e.g., extinction). Therefore, the committee finds that monitoring cannot substitute for precommercialization regulatory evaluation. LOOKING TOWARD THE FUTURE The significance of biotechnology to environmental risk resides primarily in the fact that a much broader array of phenotypic traits can now potentially be incorporated into plants than was possible two decades ago. The array of traits is likely to increase dramatically in the next two decades. As such, our experience with the few herbicide-tolerant and insect- and disease-resistant varieties that have been commercialized to

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation date provides a very limited basis for predicting questions needed to be asked when plants with very different phenotypic traits are assessed for environmental risks. For example, the production of non-edible and potentially harmful compounds in crops such as cereals and legumes that have traditionally been used for food creates serious regulatory issues. With few exceptions, the environmental risks that will accompany future novel plants cannot be predicted. Therefore, they should be evaluated on a case-by-case basis. In the future many crops can be expected to include multiple transgenes. The current APHIS approach for deregulation does not assess the environmental effects of stacking multiple genes into single-crop varieties. There are at least two levels at which scientists and regulators must look for interactions between such inserted genes with regard to environmental effects. The first level is interactions of genes and gene products that affect the individual plant phenotype. The second is the whole-field or farming systems level. One of the case studies examined by the committee finds early indications that gene stacking can have environmental effects at the farming systems level. The types of new transgenic crops that are developed, as well as the rate at which they appear, will be affected by the interaction of complex factors including public funding and private financial support for research, the regulatory environment, public acceptance of the foods and other products produced from them, and the resolution of debates over need- versus profit-driven rationales for the development of transgenic crops. For future novel products of biotechnology, adequate risk analysis for decision support and maintenance of authority will depend on a regulatory culture that reinforces the seriousness with which environmental risks are addressed. Public confidence in biotechnology will require that socioeconomic impacts are evaluated along with environmental risks and that people representing diverse values have an opportunity to participate in judgments about the impact of the technology. Currently, APHIS environmental assessments focus on the simplest ecological scales, even though the history of environmental impacts associated with conventional breeding points to the importance of large-scale effects. The committee recommends that in the future APHIS should include any potential impacts of transgenic plants on regional farming practices or systems in its deregulation assessments. APHIS has been constrained in its risk analysis and decision-making process by the statutes through which it may regulate transgenic plants. In May 2000, the U.S. Senate and House of Representatives agreed in a conference report on a new Plant Protection Act (PPA). The new regulations that will be used to enforce the PPA have not yet been developed.

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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation The committee recommends that the regulations to enforce the PPA be developed in a manner that will increase the flexibility, transparency, and rigor of APHIS’s environmental assessment process. APHIS jurisdiction has been restricted to the U.S. borders. However, in an era of globalization, environmental effects of transgenic crops on the ecosystems of developing countries will be an important component of risk analysis. As exemplified by the effects of Green Revolution varieties of wheat and rice, novel crop genes often have indirect effects on the environment. These indirect effects can occur because the new crop traits enable changes in other agricultural practices and technologies that impact the environment. They also can indirectly affect vertical integration of agriculture and equality of access to food. Society cannot ignore the fact that people who lack food security often cause major effects on both agricultural and nonagricultural environments, so in a broad context the positive or negative effects of transgenes on human well-being can be seen as an environmental effect. Environmental concerns raised by some of the first transgenic crops (e.g., gene flow, disruption of the genome, non-target effects) could be ameliorated by expanding our knowledge base in specific areas of molecular biology, ecology, and socioeconomics. Furthermore, such an expanded knowledge base could lead to the production of transgenic plants that would improve the environment. To increase knowledge in relevant areas the committee recommends substantial increases in public-sector investment in the following research areas: (1) improvement in precommercialization testing methods; (2) improvement in transgenic methods that will minimize risks; (3) research to identify transgenic plant traits that would provide environmental benefits; (4) research to develop transgenic plants with such traits; (5) research to improve the environmental risk characterization processes; and (6) research on the social, economic, and value-based issues affecting environmental impacts of transgenic crops.