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Contracts and registration studies

Authors
  • Elias, Donald J.
  • Sterner, Ray T.
  • Savarie, Peter J.
Publication Date
Jan 01, 1994
Source
eScholarship - University of California
Keywords
License
Unknown
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Abstract

Public and governmental concerns about the health, safety, and environmental impacts of pesticides have led to increased regulatory requirements to determine the hazards and risks associated with their manufacture, distribution, and use. Vertebrate pesticides are regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. Much of the data required for registration of these pesticides will be generated by commercial testing laboratories under contract to the product registrants or sponsors. In this paper, we address aspects of the contract research process including: 1) an overview of FIFRA requirements, 2) the nature of the contract research process, 3) guidelines for setting up and administering a contract for this type of work, and 4) several case studies to illustrate some of the "pitfalls" that may be encountered. The information presented is based on the collective experience of the authors' involvement with 49 contracted studies over a three-year period.

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