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Federal Regulation of Scientific Research

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The enclosed review of federal regulations of scientific research is a draft and is based on an initial survey of the available information. As such, it is not intended as a final, or authoritative accounting of the web of federal regulations applicable to biotechnology research and development in corporate, academic, or government institutions. I must clarify the overlapping roles USDA and EPA play on plant and animal pathogens and environmental release and the extent of voluntary compliance with the various regulations (especially non-federally funded research).

To the extent that this account is accurate, however, four important implications can be derived. First, a comprehensive government review like that undertaken in 1986 has apparently not been conducted since although the technology has progressed and the scale of work has increased. Second, research with human pathogens seems to require less federal oversight than for plant and animal pathogens. Even for rDNA research that falls under mandatory federal guidelines (e.g. the NIH Guidelines) it is uncertain how rigorous the review process ?" the work of the Institutional Biosafety Committees (IBCs) ?" is. It is at least possible that a large amount of research on human pathogens falls outside mandatory federal oversight. For example, although the Office of Biotechnology Activities (OBA)/NIH has over 400 IBCs registered, their office could not give an approximation as to what percentage of the total rDNA work in the US was thereby covered. (BIO estimates that there are over 1200 biotechnology companies in the US, PhRMA has 67 members, with 24 affiliated research organizations.) Third, because the regulations are based on the products of biotechnology and not the process, oversight increases as an organism moves further from the laboratory (less oversight of research before it is pursued and more of field trials and environmental release). Fourth, non-commercial research that is not federally funded seems to require no regulatory oversight.