STP921

    Evaluating Risks of Genetically Engineered Products Under the Toxic Substances Control Act

    Published: Jan 1986


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    Abstract

    This paper describes the Office of Toxic Substances' plans for evaluating the risks of genetically engineered organisms subject to the Toxic Substances Control Act. The events in the risk assessment process, the categories of information needed for the assessment, and underlying principles are identified and discussed. Major features of the plans are: (1) the overall components of the review, such as hazard, exposure, and benefit assessment, are analogous to those for conventional products; (2) despite the lack of standardized risk assessment techniques, sufficient information exists to conduct case-by-case reviews; (3) until standardized techniques are developed, each product will be subject to a detailed review on a case-by-case basis; (4) data needs will be flexible and will depend upon the characteristics of the particular product under review; (5) due to the interdependence of information, trade-offs can be made; (6) prenotice consultations will significantly expedite the review process; and (7) different combinations of nonagency experts will assist in each product assessment.

    Keywords:

    risk assessment, regulations (federal), biotechnology research and development, Toxic Substances Control Act, environmental issues, biotechnology overview, policy planning (federal), aquatic toxicology


    Author Information:

    Hollander, A
    Biotechnology project manager and biotechnology science advisor, Office of Toxic Substances, U.S. Environmental Protection Agency, Washington, DC,

    Rissler, J
    Biotechnology project manager and biotechnology science advisor, Office of Toxic Substances, U.S. Environmental Protection Agency, Washington, DC,


    Paper ID: STP29024S

    Committee/Subcommittee: E47.04

    DOI: 10.1520/STP29024S


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