General provisions for the use of human and animal data.

§ 1990.143 General provisions for the use of human and animal data.

Human and animal data which are scientifically evaluated to be positive evidence for carcinogenicity including the following policies shall be uniformly relied upon for the identification of potential occupational carcinogens. Arguments challenging the following provisions or their application to specific substances will be considered in individual rulemaking proceedings only if the evidence presented in support of the arguments meets the criteria for consideration specified in § 1990.144 or § 1990.145.

(a) Positive human studies. Positive results obtained in one or more human epidemiologic studies will be used to establish the qualitative inference of carcinogenic hazards to workers.

(b) Positive animal studies. Positive results obtained in one or more experimental studies conducted in one or more mammalian species will be used to establish the qualitative inference of carcinogenic hazard to workers. Arguments that positive results obtained in mammalian species should not be relied upon will be considered only if evidence is presented which meets the criteria for consideration specified in § 1990.144(c) or 1990.144(f).

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