The Environmental Protection Agency is saying that it followed “all laws and regulations” when testing the effects of harmful pollutants on humans.
“The findings of the Office of Inspector General’s March 31 report confirm that EPA followed all laws and regulations concerning human studies research, and has internal guidelines in place that exceed those normally required by universities, industry and other government agencies conducting human studies research,” the EPA told The Daily Caller News Foundation in an emailed statement.
The first line of EPA IG’s report said the agency “followed applicable regulations when it exposed 81 human study subjects to concentrated airborne particles or diesel exhaust emissions” in five studies done in 2010 and 2011.
But while the IG’s report absolves the agency of breaking any rules, it notes that the EPA did in fact expose human test subjects to air pollutants, which the agency has publicly said cause premature death.
The IG report found that “exposure risks were not always consistently represented and that “the EPA did not include information on long-term cancer risks in its diesel exhaust studies’ consent forms.”
The report added that “only one of five studies’ consent forms provided the subject with information on the upper range of the pollutant” they would be exposed to, and that only “two of five alerted study subjects to the risk of death for older individuals with cardiovascular disease.”
The IG even noted that the lack of warning about the risks associated with PM are contrary to what the agency has publicly said about the air pollutant. A 2003 EPA document says even short-term exposure to PM can result in heart attacks and arrhythmias for people with heart disease. Long-term exposure can result in reduced lung function and even death. A 2006 review by the EPA reiterates that short-term PM exposure can cause “mortality and morbidity.”
“Particulate matter causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you should,” former EPA administrator Lisa Jackson told Congress on Sept. 22, 2011. “If we could reduce particulate matter to healthy levels it would have the same impact as finding a cure for cancer in our country.”
The EPA still claims that short-term exposure to PM that is 2.5 microns in diameter can cause “mortality” and that long-term effects include mortality and is “suggestive of lung and other cancers and reproductive and developmental effects.”
Some Republicans have repeatedly called for investigations into the EPA’s human testing procedures.
“It is abhorrent for EPA to be conducting these human experiments without providing robust information and notification to the patients about the risks of death and following the strictest protocols,” said Georgia Rep. Paul Broun, who sparked the EPA IG’s investigation.
“While the EPA champions protecting human health, in one case, EPA doubled the amount of particulate matter it was exposing individuals to without fully informing the participants or all the proper ethical review boards,” Broun added. “This blatant disregard for the safety and well-being of others is despicable, and the proper steps must be taken to ensure that such carelessness does not occur again.”
Last year, Republican Sens. David Vitter of Louisiana and Jeff Sessions of Alabama wrote to the EPA over concerns the agency was not being honest about the health effects of exposing people to PM2.5.
“It is a concern that EPA would assert in the rulemaking process that PM2.5 exposure is deadly while simultaneously asserting in the waivers signed by participants in EPA human exposure studies that these exposures are not harmful,” Vitter and Sessions wrote to the EPA in February 2013. “Furthermore, there are valid questions about the quality or usefulness of the exposure studies actually relied upon by EPA.”
But the EPA says that protecting human health in its studies is a top priority and that the agency adheres to rigorous scientific standards.
“EPA is one of many federal departments and agencies, in addition to other research institutions and industry members, which conduct or support research with human subjects under the governance of the Common Rule,” the EPA said. “All human exposure studies conducted by EPA scientists are independently evaluated for safety and ethics, and the results are peer-reviewed. EPA is committed to ensuring the protection of study participants.”
The agency contended that the IG’s report was mainly related to “updating EPA’s internal policies and procedures to further improve its human studies research program.”
“The report recognized the importance and efficacy of such high standards, and identified opportunities to strengthen our internal procedures even further,” the EPA wrote in a blog post in the wake of the IG report. “We are in the process of embracing their recommendations, including incorporating extra levels of feedback and review as study procedures are changed through the review process, strengthening how we communicate internally, and sharing even more information about exposure risks with study volunteers, even when these risks are minimal.”
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