Biotechnology:

Delays in and Status of EPA's Efforts to Issue a TSCA Regulation

RCED-92-167: Published: Jun 12, 1992. Publicly Released: Jul 14, 1992.

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Pursuant to a congressional request, GAO provided information on the development and potential issuance of a biotechnology regulation under the Toxic Substances Control Act (TSCA), focusing on: (1) the Environmental Protection Agency's (EPA) efforts to issue a TSCA biotechnology regulation; and (2) the impact of not having a TSCA biotechnology regulation on the biotechnology industry.

GAO found that: (1) EPA has worked since 1984 to issue a TSCA biotechnology regulation, but has been unsuccessful, primarily because of disagreement within the executive branch over the scope of the regulation; (2) in 1988, EPA developed a proposed regulation and sent it to the Office of Management and Budget (OMB) for review, but the Office of Science and Technology Policy (OSTP) raised concerns that the proposal would subject more microorganisms to regulation than was warranted by their probable risk to the environment, and EPA withdrew its proposal; (3) in July 1990, OSTP issued new guidance defining the scope of biotechnology products to be considered for regulation, and EPA completed a revised regulation based on the new guidance; (4) in February 1992, OSTP eliminated the definition of the scope of the 1990 guidance, and advised agencies to oversee the introduction of only biotechnology products that posed an unreasonable risk to the environment; (5) the guidance did not provide any specific direction on how agencies were to implement the risk-based approach, and it was unclear whether the proposed EPA regulation would be acceptable; and (6) the biotechnology industry is concerned that the extended debate over a final regulatory process inhibits investment in new biotechnology products.

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