The power of the European Union protocol to test for carcinogenicity of inhaled fibers

We evaluate the power of a recent protocol proposed by the European Union (EU) for testing the carcinogenicity of inhaled fibers. We assume that every fiber has oncogenic potential determined by its biopersistence. We use a recently estimated potency for the oncogenic potential of fibers together with experimentally determined "weighted" half-lives (WHL) of a dozen fibers to generate simulations of long-term bioassays conducted according to the EU protocol. We analyze these experiments using standard statistical techniques and determine the number of tests that would have yielded significant results. We conclude that the EU protocol will readily detect the carcinogenic effect of long-lived fibers, such as amosite with a WHL of more than 450 days, and usually detect the effect of fibers, such as RCF1a, with WHL of about 40-50 days. However, the EU protocol has very low power to detect effects of short-lived fibers, such as X607,with WHL of about 10 days. (C) 2001 Academic Press.