Chemical Aspects of Compliance with Good Laboratory Practices
1988; American Chemical Society; Linguagem: Inglês
10.1021/bk-1988-0369.ch003
ISSN1947-5918
Autores Tópico(s)Chemistry and Chemical Engineering
ResumoCurrent Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) apply only to health effects studies. The Toxic Substances Control Act (TSCA) GLPs already include both health effects, ecotox and chemical fate studies. To provide consistency in inspections and enforcement, an extension of the regulations is in development. These are designed as "generic" GLPs, that is, they are intended to be sufficiently broad to cover any test being submitted for regulatory purposes to the EPA without writing new GLP regulations for each new type of study as it becomes accepted by the scientific and regulatory community. Since not all GLP elements apply to all studies the proposed regulations are based upon those principles of GLPs that are applicable to that type of study.
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