Biotechnology:

Managing the Risks of Field Testing Genetically Engineered Organisms

RCED-88-27, Jun 13, 1988

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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.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Agriculture

    Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Not Implemented

    Comments: 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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