Field Testing Genetically Modified Organisms Framework for Decisions (1989) / Chapter Skim
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Appendix - Historical Overview of Nucleic Acid Biotechnology: 1973 to 1989
Appendix - Historical Overview of Nucleic Acid Biotechnology: 1973 to 1989
Pages 133-142
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From page 133... ...
Oversight mechanisms tailored to the methods and products of biotechnology began to emerge in 1974, when the National Academy of Sciences (NAS) , responding to a letter from the attendees at the 1973 Gordon Conference on Nucleic Acids, convened a committee to evaluate the safety of research on recombinant DNA.
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From page 134... ...
Ultimately, a statement of principles outI~n~ng a proposed set of standards for recombinant DNA research was drafted, and researchers agreed to control their own research stringently until the safety of the new recombinant DNA technology could be ensured. FORMATION OF NIB GUIDELINES A second stage ~ the development of an oversight mechanism began when a committee of scientists appointed by NTH, known as the Recombinant DNA Advisory Committee (RAC)
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From page 135... ...
These groups provide advice on scientific and policy issues ~nvolv~g agency oversight of a broacI range of technologies, in addition to recombinant DNA. ENVIRONMENTAL RELEASES The modification of the guidelines to address the planned introduction into the environment of certain genetically manipulated orgamstns triggered another stage in the development of an oversight system and a new debate about hazards.
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From page 136... ...
NEPA establishes procedures obligating many federal agencies to take environmental values into account for all major activities. It requires most federal agencies to conduct an environmental assessment and perhaps to prepare an environmental unp act statement for each major action that may significantly Erect the environment.
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From page 137... ...
Senate, 1984~. The report also questioned the ability of federal agencies to regulate planned mtroauctions in light of the unquantifiable nature of the risks, and it concluded that more information on the environmental fate of these introduced organisms was needed to ascertain whether such releases posed a risk to the ecosystem.
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From page 138... ...
Since the possibility of regulatory overlap exists, particularly among EPA, FDA, and USDA, the document identifies which regulatory bodies have been designated ~ lead agencies for particular biotechnology products or their uses. Although the current oversight framework Is still evolving, the regulatory agencies continue to rely on existing laws for oversight of biotechnology activities.
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From page 139... ...
Recurrent difficulties In the oversight of planned Introductions have involved a variety of considerations, including whether adequate scientific bases exist for the federal agencies to differentiate releases of greater and lesser concern, whether data requirements are am propriate, and whether emerging regulatory approaches (which tend to be product- rather than process-based) will extend the reach of oversight to areas not traclitionaDy subject to federal review.
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From page 140... ...
concluded that there is no evidence that the introduction into the environment of organisms modified by recombinant DNA present unique hazards, but rather that the risks are the same that as incurred in the introduction into the environment of unmodified organis~. Consistent with the oversight approaches sometimes utilized by the regulatory agencies and others, the white paper concluded that dectsion-mak~ng on the environmental use of genetically manipulated organisms should be based on the organisms' relevant properties and not on the process by which the organisms were produced.
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From page 141... ...
The report evaluated the scope of regulatory policies applicable to smaD-scale releases, reviewed the adrn~nistrative procedures for ~rnplementing policies, and identified technical methods available to control and monitor risks posed by field testing. It states that the probability of ecological disruption from introductions ~ low, but the magnitude of the impact may be extremely severe.
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