Ethylene Oxide Cancer Risk Assessment Based on Epidemiological Data: Application of Revised Regulatory Guidelines

Risk Analysis - Tập 19 Số 6 - Trang 1135-1155 - 1999
M. Jane Teta1, Robert L. Sielken2, Ciriaco Valdez‐Flores2
1Union Carbide Corporation, 39 Old Ridgebury Road K3, Danbury, CT 06817–0001.
2Sielken, Inc., 3833 Texas Avenue, Suite 230, Bryan, TX 77802

Tóm tắt

Ethylene oxide (EO) research has significantly increased since the 1980s, when regulatory risk assessments were last completed on the basis of theanimal cancer chronic bioassays. In tandem with the new scientific understanding, there have been evolutionary changes in regulatory risk assessment guidelines, that encourage flexibility and greater use of scientific information. The results of an updated meta‐analysis of the findings from 10 unique EO study cohorts from five countries, including nearly 33,000 workers, and over 800 cancers are presented, indicating that EO does not cause increased risk of cancers overall or of brain, stomach or pancreatic cancers. The findings for leukemia and non‐Hodgkin's lymphoma (NHL) are inconclusive. Two studies with the requisite attributes of size, individual exposure estimates and follow up are the basis for dose‐response modeling and added lifetime risk predictions under environmental and occupational exposure scenariosand a variety of plausible alternative assumptions. A point of departure analysis, with various margins of exposure, is also illustrated using human data. The two datasets produce remarkably similar leukemia added risk predictions, orders of magnitude lower than prior animal‐based predictions under conservative, default assumptions, with risks on the order of 1 × 10−6 or lower for exposures in the low ppb range. Inconsistent results for “lymphoid” tumors, a non‐standard grouping using histologic information from death certificates, are discussed. This assessment demonstrates the applicability of the current risk assessment paradigm to epidemiological data.

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Risk Analysis

Tập 19 Số 6

1135-1155

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