Record Display for the EPA National Library Catalog


Main Title Considerations in the U.S. Environmental Protection Agency's Testing Approach for Mutagenicity.
Author Dearfield, K. L. ; Auletta, A. E. ; Cimino, M. C. ; Moore, M. M. ;
CORP Author Health Effects Research Lab., Research Triangle Park, NC. Neurotoxicology Div.
Publisher c1991
Year Published 1991
Report Number EPA/600/J-92/254;
Stock Number PB92-206341
Additional Subjects Mutagens ; Environmental pollutants ; US EPA ; Humans ; Pesticides ; Risk assessment ; Guidelines ; Mutagenicity tests ; Reprints ;
Library Call Number Additional Info Location Last
NTIS  PB92-206341 Some EPA libraries have a fiche copy filed under the call number shown. 07/26/2022
Collation 27p
Historically the U.S. Environmental Protection Agency has used mutagenicity information as part of its weight-of-evidence approach to discern the potential for human carcinogenicity. It is clear from the 1986 Mutagenicity Risk Assessment Guidelines that the USEPA intends to regulate chemicals based on risk of an adverse heritable effect in human germ cells. These Guidelines present a weight-of-evidence scheme for determining if an agent may be a potential human mutagen. Emphasis is placed upon a chemical's intrinsic mutagenic potential, its ability to reach the gonad and interact with germ cell DNA, and its ability to induce heritable mutations in mammalian species. The document summarizes the requirements for mutagenicity testing for submission of data to the USEPA's Office of Pesticide Programs and the Office of Toxic Substances. The rationale and support for the revised guidelines is presented and questions about the revision process and the guidelines themselves are addressed.