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Biotechnology: Managing the Risks of Field Testing Genetically Engineered Organisms

RCED-88-27 Published: Jun 13, 1988. Publicly Released: Jul 12, 1988.
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Highlights

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.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Agriculture To ensure that microorganisms formed by the transfer of "well-characterized noncoding regulatory sequences" of genetic material from plant pests to nonplant pests receive review prior to release, the Secretary of Agriculture should direct the Administrator of the Animal and Plant Health Inspection Service to revoke the exemption for such organisms in regulations governing genetically engineered plant pests.
Closed – Not Implemented
USDA claims that it narrowed the gap in regulatory coverage between its proposed and final rules and that the limited exclusions which remain are both safe and appropriate. Although GAO found no evidence of such narrowing, it does not intend to pursue this at this time.
Environmental Protection Agency To ensure effective regulatory coverage of genetically engineered microorganisms, the Administrator, EPA, should make all microorganisms covered by the Toxic Substances Control Act subject to either the premanufacture notice or significant new use rule regulations prescribed by section 5 of the act. To avoid overregulation of lower-risk organisms that could result from this action, EPA could revise section 5 regulations to establish a multilevel review system with less stringent requirements for organisms believed to be of relatively lower risk.
Closed – Not Implemented
In September 1990, the EPA Biotechnology Science Advisory Committee met to discuss proposed guidance, published in the Federal Register. EPA has not taken final action 7 years after this report was issued.

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Topics

Natural Resources and Environment
Agricultural researchBiological researchBiomedical researchEnvironmental monitoringFood and drug lawHealth hazardsPlants (organisms)Product safetyResearch program managementToxic substancesBiotechnology