Cancer hazard identification and qualitative risk assessment

Abstract

This paper focuses on the ethical aspects of the process of identifying environmental carcinogens. Qualitative risk assessment is particularly relevant to carcinogens acting through a mutation, a circumstance in which no-effect doses cannot be postulated. Further, different ethical and/or regulatory approaches to agents producing cancer in humans versus those producing cancer in laboratory animals would be unfair given the low sensitivity of many epidemiologic studies. These practicalities, among others, make the assessment of cancer risk difficult. Therefore, national and international agencies commonly rely on experts in order to evaluate the strength of the scientific evidence concerning the carcinogenicity of a given agent. Ethical issues may arise at different stages in the evaluation process, including the selection of the scientific data for evaluation, the preparation of the report and the evaluation itself. Clarity of language, consistency in the use of terms and explicitness of subjective interpretations of data are proposed in this paper as being consistent with the ethical principle of autonomy, thereby making the evaluation process and its conclusions more transparent to the reader of the report.