Reply to Professors Purchase and Gelbke.
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Biomedical subjects
Publications and source records attributed to S O Hansson.
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Ideally, one might wish to reverse the burden of proof in the regulation of chemical substances, so that a substance is regarded as hazardous unless proven non-hazardous. Due to the structure of toxicological knowledge, a full reversal is not practicable. Nevertheless, important steps in the direction of a reversal are both possible and desirable.
The use of critical effects in the determination of occupational exposure limits (OELs) in Sweden is subjected to a statistical study. Many of the present OELs are high in relation to known no-effect levels and effect levels, and the degree of protection has a surprisingly weak correlation with the seriousness of the adverse effect. Several proposals for improved procedures are put forward. One of these is to supplement the concept of critical effects with that of dominant effects. A dominant effect of a substance is a health effect that is at some concentration the most serious health effect.
A statistical measure, the detection level, that conveys information about the risk of type II errors in a way that is easily understandable to the statistically unsophisticated decision maker is proposed. The detection level answers the question: "How big should an effect have been in order to be detected in this way?" Given a statistical test with the critical level (size) alpha*, the detection level of this test is the smallest effect that would, with at least probability 1-alpha*, lead to a significant outcome (P < alpha*) of the test. It is proposed that detection levels should be calculated as a standard procedure in toxicity reviews, and in particular in reports from toxicologists to decision makers.
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