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EPA Failed to Disclose Cancer Risk to People in Studies

The U.S. Environmental Protection Agency failed to disclose cancer risks to volunteers used in research studies on harmful pollutants, a government watchdog says.

Mark Drajem, Businessweek, Apr 3, 2014

The EPA, which warns of dangers from diesel exhaust and tiny particles in its rules to cut pollution, recruited people for tests on those pollutants in 2010 and 2011. Consent forms they got didn’t mention cancer because the agency considered the risks minimal from short-term exposure, the agency’s Office of Inspector General said in a report yesterday.

“When justifying a job-killing regulation, EPA argues exposure to particulate matter is deadly, but when they are conducting experiments, they say human exposure studies are not harmful,” Louisiana Republican Senator David Vitter said in a statement, reacting to the report.

The EPA’s test practices have been criticized by Republicans who say the agency contradicts itself in explaining its rules and testing safety, and called for the human testing to be shut down. The watchdog said the EPA followed “applicable regulations,” and proposed procedural changes, not a shuttering of the research.

“The agency should inform study subjects of any potential cancer risks of a pollutant to which they are being exposed,” according to the report, conducted after complaints from the lawmakers.

The agency pledged to improve its consent forms and set up better plans for reacting to “adverse events and unanticipated problems” in response to the watchdog’s recommendations.

13 Studies

In the past decade, the EPA did 13 studies of particulate matter and four studies on diesel exhaust at its North Carolina laboratory, the report said. Each study would include 20 to 40 people in a chamber where pollution is set to levels similar to Los Angeles or New York. Blood, heart and lung functions are monitored for about two hours. Long-term effects are unlikely because the tests are so short, according to the agency.

The exposures “reflect a balance between being high enough to produce biological responses but not so high as to produce clinical responses,” the report said.

The EPA said its studies on people, which have been conducted for more than 40 years, provide detailed biological information on how pollutants affect individuals.

“We are in the process of embracing their recommendations,” Bob Kavlock, deputy assistant EPA administrator for science, said in a blog post today. “Thanks to their generous spirit and contribution of time, our research volunteers play a vital role in helping EPA scientists advance the cause of protecting the health of all Americans.”

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