Legislative and technical aspects of mutagenicity testing.

Mutation Research
V W Mayer, W G Flamm

Abstract

A brief account is given of the history of the legislative acts that give responsibility to the U.S. Food and Drug Administration (FDA) for ensuring the safety of foods, drugs, and cosmetics. Within the present legislative framework the FDA has the authority to impose regulations which are designed to ensure the safety of all foods, drugs, and cosmetics. The existing legislative authority is adequate for this purpose; however, the difficulty lies instead with technology and the inadequacy of scientific perspective in the emerging area of mutagenicity testing. Earlier efforts in development of mutagenicity screening systems culminated only a few years ago in the proposal to use the host-mediated assay, somatic cell cytogenetics, and dominant lethal tests collectively. Subsequent research efforts indicated that there were serious practical and scientific deficiencies in using this approach. More recently a new proposal, the tier system, has been suggested as an alternative measure. The proposed tier system at FDA consists of three testing levels of increasing complexity. The first tier is an initial screening effort using techniques having maximum sensitivity that are also useful for large-scale, rapid testing. The second tier is...Continue Reading

References

Mar 29, 1974·Archives of Toxicology·H Frohberg, M S Schencking
Dec 1, 1973·Environmental Health Perspectives·D J Brusick, V W Mayer
Aug 1, 1974·Mutation Research·W G Flamm
Jan 1, 1973·Mutation Research·K W Petersen, M S Legator
Feb 1, 1973·Food and Cosmetics Toxicology·K A PalmerM S Legator
Jun 1, 1972·Toxicology and Applied Pharmacology
Oct 1, 1972·Toxicology and Applied Pharmacology·S S EpsteinY Bishop
Jul 6, 1971·Annals of the New York Academy of Sciences·M S Legator

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Citations

Nov 1, 1976·Mutation Research·U H Ehling
Jan 1, 1980·Journal of Environmental Science and Health. Part. B, Pesticides, Food Contaminants, and Agricultural Wastes·M D WatersR Valencia

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