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6 Postcommercialization Testing and Monitoring for Environmental Effects of Transgenic Plants
Pages 192-219

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From page 192...
... . It also is important to set up long-term, postcommercialization monitoring programs to record trends in predicted effects, and to detect effects that were not predicted by precommercialization testing.
From page 193...
... evaluate the need for and approaches to environmental monitoring and validation processes and, if deemed necessary, to include recommendations for postcommercialization monitoring of transgenic plants and (2) provide guidance on the assessment of non-target effects, appropriate tests for environmental evaluation, and assessments of cumulative effects on agricultural and nonagricultural environments for transgenic plants.
From page 194...
... Because it is not clear that these protocols are completely appropriate for transgenic plants, postcommercialization validation testing is especially important. If evidence is collected over time that confirms the accuracy of precommercialization testing protocols, the need for validation testing would decrease, but due to the uniqueness of new products its utility is unlikely to disappear.
From page 195...
... As noted above, this complexity stems from interannual variations and indirect effects. Because laboratory and small-scale field experiments do not adequately replicate all the interactions that occur in an ecosystem, the only way to observe the full range of ecological effects of a transgenic crop is to observe it in actual ecosystems.
From page 196...
... Validation testing must always be based on testing specific hypotheses related to the accuracy and adequacy of precommercialization testing. In some past cases, precommercialization tests have identified potential risks and restrictions that have been imposed on commercialization to limit these risks.
From page 197...
... Recommendation 6.2: Postcommercialization validation testing should be conducted at spatial scales appropriate to evaluate environmental changes in both agricultural and more natural ecosystems. A funding mechanism for postcommercialization testing will need to be established.
From page 198...
... Validation testing grant proposals could fall between the main objectives of both of these programs. Present public research programs, such as the Biotechnology Risk Assessment and Risk Management Programs will need to be expanded substantially to meet this need for postcommercialization testing.
From page 199...
... In addition, lack of consistent standards for data collection across agencies makes it difficult to increase statistical power by combining data. Monitoring programs associated with agriculture have a more extensive history.
From page 200...
... and thus fall short of a comprehensive assessment of natural resources (see BOX 6.1~. Despite the information available from the NRI and NASS, there are substantial gaps in current monitoring data from agricultural systems in the United States (The Heinz Center 1999~.
From page 201...
... Finding 6.2: Our ability to assess the impacts of large-scale planting of transgenic crops is hampered in part by the lack of baseline or comparative data on the environmental impacts of agriculture. Finding 6.3: The data provided through the NRI or the NASS are not sufficiently detailed to allow an independent assessment of the environmental effects of transgenic plants.
From page 202...
... Hunters (via their purchase of duck stamps) pay for many of these monitoring programs, and spend about $1 billion for hunting and related activities.
From page 203...
... , again highlighting the need for long-term data collections. Another challenge in determining what to monitor comes from the potential for strong indirect effects in ecosystems.
From page 204...
... DEVELOPMENT OF MONITORING PROGRAMS FOR TRANSGENIC CROPS The effects of commercialization of transgenic crops can range from a change in the state or dynamics of an organism, a population, or an ecological system. These effects can be characterized as either direct or indirect.
From page 205...
... Monitoring for novel or acute ecological effects, such as detection of a new nonindigenous invasive species, has relied on such a system for several decades (Kim 1983~. Detecting new effects of transgenic plants, such as a pathogen of herbicide-tolerant soybean or a decline in bird populations in areas planted with certain transgenic crops, would also require a network of trained observers who have an incentive for detecting such unexpected effects.
From page 206...
... In addition, crop consultants and farmers themselves may notice environmental changes associated with transgenic crops. Building and maintaining the capacity to detect new acute ecological effects is paramount to an effective monitoring system.
From page 207...
... But because they are trained observers of agriculture, it is possible that while they are conducting their normal activities they could be on the watch for potential environmental effects of transgenic crops. This may be facilitated by a short half-day or one-day workshop on the potential environmental hazards of transgenic crops, so that these extension service personnel can understand better the types of effects that might occur.
From page 208...
... Ecological effects with a low frequency of occurrence will probably occur in a spatially heterogeneous pattern, and the probability of occurrence will be predicted to be proportional to the area of the transgenic crop planted. Information on the planting pattern will permit use of epidemiological methods (Waggoner and Aylor 2000)
From page 209...
... The criteria recognize that some ecological indicators have been less useful than anticipated because they have not been clearly linked to underlying ecological processes or because the data requirements are overly complex and extensive. The criteria provide a framework for evaluating indicators to assess the potential importance of a proposed indicator, its properties, its domain of applicability, and its limitations: 1.
From page 210...
... This committee is not charged with and will not provide detailed guidance on organismal groups/taxa for monitoring. However, the committee encourages further research into the potential use of indicator or umbrella species to assess ecosystem health or changes associated with the commercialization of transgenic plants (see BOX 6.2~.
From page 211...
... Recommendation 6.6: There should be an open and deliberative process involving stakeholders to establish criteria for environmental monitoring programs. The committee follows the arguments for a common currency developed by the indicators committee (NRC 2000a)
From page 212...
... For the National Marine Fisheries Service, credibility is a major concern. Many stakeholders mistrust data that are collected and analyzed by the same agency that makes policy recommendations, conducts stock assessments, and enforces fishery regulations.
From page 213...
... The 17 federal agencies that make up the FGDC are developing the NSDI in cooperation with organizations from state, local, and tribal governments; the academic community; and the private sector in an effort to improve the quality of the collected information while minimizing the burden for individual agencies through the use of information technologies. Recommendation 6.8: The establishment of long-term monitoring efforts is recommended to permit assessment of potential environmental changes associated with the commercialization of transgenic plants.
From page 216...
... Long-term monitoring programs are expensive and labor intensive, and require standardization of monitoring units and verification of data collected. Society will benefit only if timely responses become part of the framework for evaluating the environmental impacts of transgenic plants.
From page 217...
... For verification of precommercialization risk assessment testing, this type of testing would provide feedback on effects at larger spatial scales that would either confirm the validity of current risk assessment procedures or suggest that they should be modified. In the latter case, a formal response to the results of validation testing would be a change in the type or extent of precommercialization testing that an applicant would need to conduct before a permit would be issued or a petition approved.
From page 218...
... Major monitoring programs such as the NRI and the NASS provide valuable long-term datasets relevant to agriculture, but they are not sufficiently detailed or focused to allow an independent assessment of the environmental effects of transgenic plants. Currently the environmental monitoring of agricultural and natural ecosystems in place in the United States is inadequate for assessing the potential impacts of commercialized transgenic crops.
From page 219...
... long-term monitoring would help identify and distinguish patterns of biotic and abiotic variation in natural and agricultural ecosystems from impact events due to transgenic crops. In order for the findings of such monitoring efforts to be useful, a clear and coordinated regulatory response must be in place.


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