STP1115

    Role of Plant Bioassays in FDA Review: Scenarios for Terrestrial Exposures

    Published: Jan 1991


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    Abstract

    Plant bioassays are used to predict the effects of chemicals on terrestrial systems. However, in tiered-testing schemes, plants are tested only when introduction and fate information suggest that terrestrial exposure is probable. In this paper we discuss how information on chemical introduction and fate may trigger the need for plant toxicity tests, and how terrestrial exposure estimates are obtained and used at the U.S. Food and Drug Administration (FDA). FDA regulates chemicals used for food additives, food packaging and processing, and animal drugs and feed additives. These materials may be introduced into the environment as a result of their manufacture, use, or disposal. Information on introduction rates, environmental partitioning, and transformation is used to estimate the potential for terrestrial exposure. Described in detail are two scenarios for terrestrial exposure from application of wastewater treatment plant sludges to soils and one scenario for direct introductions of animal wastes to soils.

    Keywords:

    terrestrial effects, environmental assessment, plant toxicity, agricultural soil amendment, sludge, food additives, animal drug wastes


    Author Information:

    Harrass, MC
    Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Washington, DC,

    Eirkson, CE
    Center for Veterinary Medicine, U.S. Food and Drug Administration, Rockville, MD

    Nowell, LH
    Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Washington, DC,


    Paper ID: STP19500S

    Committee/Subcommittee: E47.11

    DOI: 10.1520/STP19500S


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