Risk assessment and risk management of transgenic fish
by Anne R. Kapuscinski and Kelly M. Pennington, University of Minnesota, St. Paul, MN 55108, USA. E-mail: kapus001@umn.edu
Research and development of genetically modified or transgenic fish is underway for intended uses in aquaculture. There is a need for systematic and broadly accepted methodologies to assess and manage environmental risks of this biotechnology. There is very little experience in environmental risk assessment of transgenic fish using case-specific and ecologically relevant data. Methodologies do exist for this task but have not been fully utilized. To address this need, a team of 40 co-authors from 19 countries wrote a peer-reviewed book,
Environmental Risk Assessment of Genetically Modified Organisms: Methodologies for Transgenic Fish (see the
Selected Readings page and note by the author
below). This book synthesizes the best science-based methodologies that countries can apply to conduct their own ecological risk assessments and develop risk management measures for proposed uses of transgenic fish on a case-by-case basis. The authors discuss the flexibility, utility, and limitations of these methodologies. The methodologies are also relevant to transgenic crustaceans and mollusks, as well as to aquaculture lines produced by traditional selective breeding.
Any risk assessment process based on scientific analysis should be linked with transparent involvement of relevant stakeholders at key points. This “analytic-deliberative” process recognizes the need for both high-quality science and the input of affected parties. One particular method for involving stakeholders is Problem Formulation and Options Assessment (PFOA), a process for science-guided multi-stakeholder involvement in environmental risk assessment in which stakeholders identify what societal need may be addressed by the transgenic fish, consider other technology options, deliberate on benefits and risks of the identified options and develop recommendations for decision makers.
Potential environmental hazards associated with escape or intentional release of a specific line of transgenic fish range from changes occurring at the molecular level to the ecosystem level. Therefore, methodologies from molecular biology, population genetics, ecology, and other scientific fields all must be applied to risk assessment of transgenic fish. A complete environmental risk assessment estimates the probability and magnitude of gene flow from transgenic to wild relatives; and the probability, magnitude and severity of ecological effects, with or without gene flow. To understand whether or not a specific environmental harm will occur, care must be taken to identify traits of the fish and components of the ecosystem which are feasible to measure and are reliable indicators of the ecological change that is of concern. Risk assessments need to openly treat the uncertainty that exists at each step in the environmental risk assessment process, by using uncertainty analysis methods from a range of available qualitative and quantitative tools.
Risk management of transgenic fish is currently focused on two methodologies: physical and biological confinement of fish to minimize their entry into and spread in nature; and monitoring to detect presence, establishment and ecological effects of escaped or intentionally released fish. Risk management practices should be based on conclusions from a risk assessment and not replace the need to conduct a science-based and transparent risk assessment.
Gaps remain in human and institutional capacity needed to conduct science-based and socially robust risk assessments of transgenic fish. Large gaps exist in data for assessing effects on specific ecosystems. Major needs are to: (a) fill key gaps in baseline ecological data on aquatic ecosystems and improve access to databases; (b) establish confined facilities with semi-natural conditions for conducting risk assessment tests, ideally as international cooperative research facilities in different ecological regions; (c) fill major gaps in public data on ecologically relevant traits of transgenic fish lines, especially for those closer to seeking commercial approval; and (d) develop in-depth risk assessment training programs for key participants in the process of risk assessment of transgenic fish and other genetically improved lines. Human capacity building should target aquatic scientists, from molecular biologists to community ecologists, who produce research data that can inform government-mandated risk assessments or who conduct the risk assessments; as well as regulatory affairs and biotechnology staff in public and private sector organizations which inform the ultimate decision-makers.
Note by the author: Courtesy copies of this cited book were distributed to developing-country scientific libraries and various entities involved with aquaculture and fisheries. A very small number of courtesy copies remain. To request a copy, write an email message that confirms you are from a developing country, gives your current job title and full work address, and explains why you need this book; and send to
isees@umn.edu, with subject line “book request to Anne Kapuscinski”.
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