Biotechnology

Managing the Risks of Field Testing Genetically Engineered Organisms Gao ID: RCED-88-27 June 13, 1988

In response to a congressional request, GAO reviewed federal risk management of genetically engineered organisms intended for agricultural and health uses in the environment, focusing on Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) policies.

GAO found that: (1) because no laws specifically regulate genetically engineered organisms, the agencies apply existing laws based on product usage; (2) although USDA, EPA, and FDA generally used a case-by-case approach in reviewing proposed field tests, USDA and EPA exempted certain categories of organisms from regulatory review; (3) the agencies perform prerelease reviews to determine whether to allow field tests and what controls to impose; (4) the agencies' advisory groups reflect a wide range of relevant disciplines; (5) agency approvals are contingent upon specific field conditions, generally require plans to mitigate unexpected harm, and have the authority to terminate an experiment, if necessary; and (6) methods to control the dispersal and impact of microorganisms require minimizing risk while maximizing field test usefulness.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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