EPA Ordered to Do Outside Reviews of Toxicology Database

Staff Writer

When the Environmental Protection Agency (EPA) crafts a regulatory standard—how much arsenic is safe in drinking water, for example—its staff members rely on scientific assessments of the chemical's toxicity. The quality of these agency reviews have been criticized by industry and on Capitol Hill—criticisms that were backed up earlier this year in a study by the National Academies' National Research Council (NRC). Now Congress has directed EPA to document improvements to the process and to ask the academies to review up to three of its toxicity assessments.

The chemical assessments, held in a database called the Integrated Risk Information System (IRIS), can be quite controversial. EPA's assessment of formaldehyde, an important ingredient for the chemical industry, was so politically charged that Senator David Vitter (R-LA) in 2009 held up the confirmation of EPA's science adviser until the agency agreed to have an NRC expert panel evaluate the assessment. That review found technical problems, such as inadequate evidence for the conclusion that formaldehyde causes leukemia, as well as more general shortcomings in the clarity and transparency of the assessment. The panel made a host of recommendations, including standardizing descriptions of the strength of evidence and uncertainty.

The new requirements, described in a few paragraphs within a $915 billion 2012 spending bill for several federal agencies that the president is expected to sign tomorrow, directs EPA to adopt these recommendations. The agency is already taking steps toward that goal, says a spokesperson. "EPA continues to strengthen the Integrated Risk Information System Program (IRIS), as part of an effort to ensure that the best possible science is used to protect human health and the environment. EPA is enhancing this important program to be more responsive to the needs of the agency and its government partners."

To double check the progress, EPA must ask the academies to review its draft assessment of inorganic arsenic and up to two other chemicals. The draft assessment of arsenic has raised fears that it would be "extremely burdensome and expensive" for drinking water treatment. Scott Jensen, a spokesperson for the American Chemistry Council in Washington, D.C., says "Overall, we're pleased that Congress has taken on the ongoing issues with IRIS." But Jennifer Sass of the Natural Resources Defense Council disagrees in an e-mail. "Overall, sending reviews to the National Academies is a terrible idea that is unnecessary, costly, and will lead to lengthy delays. EPA IRIS assessments are subjected to Agency staff review, interagency review, public comment, and expert peer review. There is nothing magical about the NAS review that could add to an already years' long process of review."

This particular review may not necessarily slow down the IRIS process. The budget language specifies that the academies' report should take no longer than 18 months, and, in contrast to an earlier version of the bill, does not prevent EPA from finalizing its assessment while the review is underway. At the moment, EPA is reviewing feedback from its Science Advisory Board and plans to release a final version "as soon as it is ready," according to the spokesperson.

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