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In October, 2003, the National Academy of Sciences/National Research Council (NRC) issued a report entitled "Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma". The NRC report proposed a new system for reviewing proposed biotechnology research for its bioterrorism potential. The proposed system would build upon the currently existing system of 400 or so Institutional Biosafety Committees (IBCs) around the country that were established originally by the National Institutes of Health for reviewing recombinant DNA (rDNA) research. CSREES, in its assurance process for agency-sponsored research, currently relies on IBCs for reviewing the possible agricultural and environmental impacts of rDNA research. The NRC report specifically identified seven classes of experiments that may pose a terrorist threat to human, plant, and animal well-being. The NRC Committee that developed the report included a number of highly qualified experts in the life sciences and other fields, but no agriculturalists. The NRC report is likely to have direct impacts on the research and extension work of plant pathologists and veterinary scientists across the country. There is therefore an opportunity to factor input from these stakeholders into the long-term Federal response to the NRC report, to develop defensive measures against threats to agricultural biosecuity, and to update CSREES policy and procedures for assuring that biotechnology research in agriculture is performed in a safe and appropriate manner.
NON-TECHNICAL SUMMARY: To examine USDA procedures in light of biosecurity aspects of agricultural biotechnology research and experimentation. To develop defensive measures against threats to agricultural biosecuity, and to update CSREES policy and procedures for assuring that biotechnology research in agriculture is performed in a safe and appropriate manner.
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APPROACH: The Information Systems for Biotechnology (ISB) program at Virginia Tech will organize a one to two day meeting of 20 to 30 selected plant pathologists, veterinary scientists, and government and IBC officials. Participants will be provided with a copy of the NRC report and asked to flesh out its implications for their specialty areas and for agricultural biosecurity. Issues to be addressed include unique features of agriculturally important pathogens that may determine if or how they should be handled differently from human pathogens, similarities and differences between plant and animal select agents as they pertain to agricultural biosecurity, and IBC review of proposed agricultural rDNA research for its destructive potential.
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PROGRESS: 2004/06 TO 2006/05 <BR>
On March 3-4, 2005, the U.S. Department of Agriculture (USDA) and Information Systems for Biotechnology at Virginia Tech, in cooperation with the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA), convened a one-time workshop on Biotechnology Research and Agricultural Biosecurity in Arlington, Virginia. Active participants included 30 invited experts from academia, industry, non-profits, and government on microbiology, plant science, animal/veterinary science, and Institutional Biosafety Committee (IBC) operations. The workshop organizers provided each participant with a copy of the 2003 National Research Council (NRC) report entitled Biotechnology Research in an Age of Terrorism. The NRC report identified seven classes of experiments of concern that may pose a terrorist threat to human, plant, and animal well-being. The report also proposed a new system for reviewing proposed biotechnology research for its bioterrorism potential. This would be based on the existing system of IBCs around the country that were established originally for reviewing the biosafety of recombinant DNA (rDNA) research. The USDA biosecurity workshop focused on the agricultural dimensions of biosecurity, and the workshop planners coordinated with the staff of the NSABB which will address the full range of national biosecurity issues. The purpose of the USDA workshop was to examine: 1) agency policies, processes, and procedures for oversight of agricultural biotechnology research; and 2) the intersection between agricultural biotechnology research, regulation/oversight, and biosecurity in the United States. Workshop participants heard plenary presentations on the NRC recommendations and agricultural research, an overview of issues in agricultural biotechnology research, biosafety and biosecurity issues in agricultural research, and issues in plant and animal biotechnology research. Workshop participants discussed existing strengths, gaps/issues, and best practices for biosecurity in agricultural biotechnology research and formed small groups to discuss the scope of biosystems for NSABB to address, IBC biosecurity responsibilities and enabling tools, risk assessment including biosecurity, training and education of researchers, and coordination and cooperation of agencies and organizations with interests in biosecurity. The results were: a) recommendations were provided to the NSABB on issues, concerns, and options for biosecurity and agricultural biotechnology research and b) feedback was provided to USDA on revision of forms and procedures to assure the biosecurity and biosafety of agricultural research involving biotechnology and biological agents that may pose a biosecurity risk.
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IMPACT: 2004/06 TO 2006/05 <BR>
The workshop examined the mutual interactions between agricultural biotechnology research and agricultural biosecurity in the U.S. Reactions of the agricultural research community to the NRC report were recorded, and recommendations put forth on the potential impact of new IBC review procedures recommended by NRC and possible new information restrictions on the conduct of biotechnology research in agriculture. The workshop also provided insight and direction for revised CSREES assurance procedures for recombinant DNA (rDNA), animal care, and human subjects to enable the agency and local IBCs to limit the destructive potential of rDNA research without overly restricting the conduct of rDNA research for beneficial purposes.