General Industry News

IRIS Assessment of MTBE, Others, Put on Hold

The EPA announced on Tuesday, June 15, 2010, that it is holding four of its ongoing IRIS (Integrated Risk Information System) assessments pending a review of some of the underlying studies used in the assessments. Reviews of methanol, MTBE, ETBE and acrylonitrile were halted pending review of a potentially sketchy scientific resource that was providing the basis for linking these chemicals to cancer.

The agency is holding these assessments due to a report from the National Toxicology Program (NTP) that outlines a recent review of a research study completed by the Ramazzini Institute, a lab in Italy that conducts animal testing to evaluate the potential cancer-causing effects of chemicals. The report discusses findings from a recent assessment by NTP pathologists of an animal study on methanol. NTP's report recommends that further pathology reviews be carried out to resolve differences of opinion between NTP scientists and the Ramazzini Institute in the diagnoses of certain cancers reported in the study.

Out of an abundance of caution and to ensure the agency's chemical assessments are grounded in the soundest possible science, the EPA undertook a thorough review of all ongoing and previous chemical assessments to determine which, if any, relied substantially on cancer testing from the Ramazzini Institute.

The agency found six assessments that significantly rely on data from Ramazzini cancer studies, four of which were currently in progress, and were thus halted. Those four,on methanol, MTBE, ETBE and acrylonitrile, have been placed on hold and will determine whether the questions raised by NTP will require the agency to revise the assessments or take additional action to verify the data used in these assessments. The EPA also postponed an August 23 meeting of the agency's Science Advisory Board, which had been previously scheduled to review the draft methanol assessment.

Two previously completed assessments, Vinyl Chloride and 1,1- Dichloroethylene also relied substantially on findings from Ramazzini Institute cancer studies. The EPA is reviewing these assessments as well to determine what action is needed to assure their scientific integrity.

The EPA said it will continue its review to determine if any other assessments are significantly impacted.

SOURCE: EPA Press Release

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