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EPA use of in vivo germ cell mutagenicity data
Author(s) -
Cimino Michael C.
Publication year - 1991
Publication title -
environmental and molecular mutagenesis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1
H-Index - 87
eISSN - 1098-2280
pISSN - 0893-6692
DOI - 10.1002/em.2850180416
Subject(s) - hazard , in vivo , toxicology , agency (philosophy) , chemical safety , hazard analysis , biochemical engineering , chemistry , risk analysis (engineering) , biology , business , genetics , reliability engineering , engineering , philosophy , organic chemistry , epistemology
The Toxic Substances Control Act (TSCA) provides the U.S. Environmental Protection Agency, Office of Toxic Substances (EPA, OTS) with the authority to regulate chemical use by requiring testing and use restrictions as appropriate to protect human health. Regulation on the basis of heritable mutation induction is specifically mentioned in the Test Rule section of the law and has also been pursued for new chemical substances. A tiered scheme of mutagenicity testing has been employed and recently revised to assess mutagenicity hazard. In vivo assay systems play key roles at all three levels in the scheme, beginning with the first level of determining intrinsic mutagenicity hazard. Once intrinsic mutagenicity has been identified, the revised scheme requires an assay or assays to assess chemical interaction with gonadal DNA. Finally, the scheme contains tests that permit risk assessment for a chemical. The recently‐revised Office of Pesticide Programs (OPP) mutagenicity lest‐ing requirements closely parallel those of OTS.