US EPA to resume chem risk assessments despite research scepticism

11 April 2011 21:38  [Source: ICIS news]

HOUSTON (ICIS)--The US Environmental Protection Agency (EPA) will take up again three draft chemical risk assessments it had placed on hold in June 2010 amid scepticism of some underlying research, the agency said Monday.

In June 2010, the EPA had placed on hold assessments of methanol, methyl tertiary butyl ether (MTBE), ethyl tertiary butyl ether (ETBE) and acrylonitrile (ACN) while it examined the validity of data from Italy’s Ramazzini Institute.

The agency was assessing the chemicals as likely human carcinogens.

The hold came after a team of pathologists from the US National Toxicology Program (NTP) visited Italy and examined a research study from Ramazzini on methanol.

The NTP said its scientists disagreed with the institute on the diagnoses of certain cancers reported in the study, adding that further reviews were necessary to confirm or deny the reports.

The EPA and the National Institute of Environmental Health Services (NIEHS) are in the midst of an ongoing independent Pathology Working Group (PWG) review, in cooperation with the Ramazzini Institute, of several studies, including the methanol cancer assessment study.

The PWG review is expected to continue for several months. The cancer assessment for methanol will remain on hold until the review is completed, the EPA said.

However, the EPA determined that reliance on Ramazzini Institute study results are not necessary to continue with the assessment for MTBE, ETBE and ACN. Work on those assessments will continue during the PWG review.

The Methanol Institute, a trade group for the US methanol industry, described Monday’s announcement as good news, adding that it expects the PWG review will confirm problems with Ramazzini Institute data.

“If the pathology working group does in fact confirm the preliminary results, we believe the Ramazzini study cannot be used for health assessment purposes,” said Greg Dolan, vice president of the Methanol Institute.

Once the Ramazzini data is excluded, Dolan said his organisation expects no case could be made that methanol is a likely human carcinogen.

In addition to the four draft assessments, the EPA also found that two completed risk assessments – on vinyl chloride monomer (VCM) and 1,1-dichloroethylene (EDC) – also relied substantially on findings from Ramazzini cancer studies. The EPA said it would evaluate those results.

Methanol is used in paints, varnishes, wiper fluid and adhesives. MTBE and ETBE are gasoline additives, and ACN is used to make certain plastics and fibres.

Additional reporting by Joe Kamalick

For more on methanol, MTBE, ACN and VCM, visit ICIS chemical intelligence


By: Michelle Klump
+1 713 525 2653



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