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6. Biological and Operational Considerations for Bioconfinement
Pages 180-198

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From page 180...
... . WHAT BIOLOGY TELLS US ABOUT CONFINEMENT AND BIOCONFINEMENT As explained in Chapters 3­5, a wide array of bioconfinement measures has been proposed for limiting the movement of transgenes.
From page 181...
... Early evaluation permits the consideration and comparison of simpler, traditional confinement techniques alongside the more complex, and sometimes more expensive, bioconfinement options. The constant and iterative evaluation of confinement options during
From page 182...
... In other cases, it may be possible to combine two barriers of the same type but whose failures would be independent events, such that a failure of one barrier does not trigger a failure of the other. This does not necessarily require using different bioconfinement methods, as long as the measures are independent.
From page 183...
... Experimental Information on Efficacy The discussion of redundancy implies that some information should be available on how well a confinement method works. The effectiveness of many confinement methods, particularly bioconfinement methods, will depend on the genotype and the environment.
From page 184...
... Recommendation 5. Bioconfinement techniques should be assessed with reference to the temporal and spatial scales of field release.
From page 185...
... Options Based on Technology and Gene-Specific Compounds Bioconfinement methods that are based on transgenic technology have received considerable recent attention (e.g., Daniell, 2002) , and this committee also has identified the potential of bioconfinement by external administration of gene-specific compounds (Chapter 4)
From page 186...
... Similarly, the reproductive biology of the novel genotype should be compared with that of its progenitor before field release to evaluate changes in reproductive biology. Integrated Confinement System If the tests of the proposed confinement technique suggest that it will be successful, it will still be necessary to establish an integrated confinement system (ICS)
From page 187...
... For example, a standard tool for amplifying a specific DNA segment (polymerase chain reaction, or PCR) facilitates testing for the presence of specific transgene constructs in the genotype of an organism.
From page 188...
... . Likewise, insertion of DNA sequences that can be used as "bio-barcodesTM" to identify specific transgene constructs has been proposed (Gressel, 2002)
From page 189...
... The analysis associated with selection of confinement methods for GEOs­­including the decision to proceed or not­­would benefit from having a public component. Public participation can identify hazards, raise important questions, and provide information about specific conditions that can lead to more realistic assumptions (NRC, 1996; Hails and
From page 190...
... Transparency and public participation should be important components in developing and implementing the most appropriate bioconfinement techniques and approaches. Compliance Compliance is critical to the success of confinement.
From page 191...
... Some bioconfinement methods are more amenable than others to verification and monitoring. It is easier to verify a bioconfinement technique that has an obvious physical manifestation, such as one that involves a visually identifiable phenotype, than it is to verify a bioconfinement technique that does not.
From page 192...
... The possibility of human error should be taken into account as a factor when determining bioconfinement methods and evaluating their efficacy. Natural Events Compliance also can be affected by natural events.
From page 193...
... Compliance also can be affected by private suits that are brought to enforce federal laws or to challenge the way federal agencies respond to citizen petitions regarding GEO confinement. Increases in Spatial and Temporal Scale Increases in the spatial and temporal scale of GEO production and the use of bioconfinement techniques could affect the incidence of compliance.
From page 194...
... Chapter 2 discusses the points to consider: the desired or mandated level of protection; the organism; the novel trait; the available confinement techniques, biological and otherwise; the relevant genomic, physical, and biotic environment; behavioral factors; social values; the resources potentially available for prevention or remediation of bioconfinement failure; and the competing demands for those resources. In addition, the applicable regulatory regime could impose requirements or constraints regarding what confinement techniques may be used.
From page 195...
... defines publicly funded agricultural research as any agricultural research performed with financial or material support from the public sector. For agricultural research in general, the reasons given for public support include · To improve human health and well-being through advances that lead to higher quality and nutritional value in the food supply and greater food safety · To sustain the quality and productivity of natural resources · To preserve biological resources that are the endowment for future generations Publicly funded research on bioconfinement methods is needed for all of these reasons.
From page 196...
... Of necessity, industrial research is primarily market-driven, whereas publicly funded research need not be. Long-range and non-market-driven publicly funded research can help ensure the continuation of the fundamental biological discoveries that will lead to innovative bioconfinement methods not envisioned today.
From page 197...
... Specific issues on which research could shed useful light include social factors that affect the significance of potential hazards; behavioral patterns of those who grow or use GEOs with respect to the willingness or ability to apply appropriate bioconfinement techniques; ways to reduce human error and instill a strong confinement ethic in those engaged in bioconfinement; and ways the federal regulatory system could be simplified, strengthened, and made more credible. · develops a better understanding of the dispersal biology of organisms targeted for genetic engineering and release, where sufficient information does not exist or where questions have arisen (Recommendation 17)
From page 198...
... , and research on bioconfinement methods is no exception. Indeed, development of bioconfinement methods to protect investment by preventing unlicensed use of GEOs has spurred much industry research in recent years (Chapter 3)


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