Travis 1987 EPA Cancer Risk - Cancer risk management A...

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Cancer risk management A review of 132 federal regulatory decisions Curtis c. navis Samantha A. Richter Oak Ridge Natiowl Laboraso~ Oak Ridge, Enn. 37831 Edmund A. C. Crouch Richard Wilson Hamrd University Cambridge, Mass. 02138 Ernest D. Klema nj?s University Medford, Mass. 02155 Various federal agencies are responsi- ble for promulgating regulations and standards to protect the public from ex- posure to environmental carcinogens. Althmgh many factors are considered in the decision to regdate a carcinogen, one important issue concerns the prob- ability that individuals in an exposed population will develop cancer. What has not been clear, however, is the level of cancer risk that triggers regulation, or whether there is consist- ency withii and between agencies in arriving at the risk decisions that under- pin regulatory action. We have r&c- sptively reviewed the use of cancer risk estimates in prevailing federal standards and in withdrawn regulatory initiatives to determine whether any simple patterns emerge to correlate risk level with regulatory action. Our results show that there are definite pat- terns and a surprising degree of consist- ency in the federal regdatov process. The sources of the data reviewed are notices of proposed or fii regulations found in the Fedeml Register and in published and unpublished regulatory support documents, all of which are in the public domain. Three measures of risk are considered: Individual risk is measured as an upper-limit estimate of the probability that the most highly ex- posed individual in a population will develop cancer as a result of a lifetime of exposure. The size of the population RIN CORN CO 5 GRAIN GASOLIN I- E STAllONS COFl exposed to the hazards is considered. Fix population risk is measured as an upper-limit estimate of the number of additional incidences of cancer in the exposed population. Federal agencies compute population risks (as measured by the number of cancer deaths per year) by one of two methods: by multi- plying maximum individual risk by population size or by accounting for variations in individual exposure levels and adding up the resulting figures for an entire population. Almost one-thii of the population risk estimates re- viewed here were calculated using the first method, although the second method is preferable. Knowledge of two additional terms, de manifestis and de minimis, is impor- tant to understanding the patterns that emerge from the data. De manifestis risk, literally a risk of obvious or evi- dent concern, has its roots in the legal definition of an “obvious risk”; one that is instantly recognized by a person of ordinary intelligence. De minimis risk bas been used for a number of DOG DIPS PE AEROSOL SI years by regulators to define an accept- able level of risk that is below regula- tory concern. This term stems from the legal principle, de minimis non curaf lex; “the law does not concern itself with trifles.” Table 1 lists 132 regulatory decisions
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Travis 1987 EPA Cancer Risk - Cancer risk management A...

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