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By Michael Bastasch
A National Academies of Science (NAS) committee ruled the Environmental Protection Agency (EPA) should continue to conduct studies exposing humans to air pollutants the agency claims causes premature death.
The committee found that “EPA’s procedures are consistent with and indicative of ethical approaches to human-subjects research” and provided “unique information” that’s “important for future” air quality regulations.
EPA asked NAS to review its handling of “Controlled human inhalation exposure” after the agency’s inspector general issued a report on such experiments in 2014. EPA-backed studies exposed subjects, including children, to concentrated levels of pollutants many times higher than the agency says is safe.
Critics are calling the NAS review a “whitewash” that failed to address core problems with EPA science.
“As I predicted, the NAS report of the EPA human experiments program was a complete whitewash,” Steve Milloy, the publisher of the blog Junkscience.com, told The Daily Caller News Foundation.
Milloy has been pushing against junk science for decades as a lawyer, environmental scientist and lobbyist. Milloy has called into question EPA claims that some air pollutants, particularly fine particulate matter, kills people even after short-term exposure.
Through research, Milloy found EPA had been exposing Americans to air pollutants the agency said can cause premature death, including ozone, diesel exhaust and particulate matter. The EPA IG’s 2014 audit of agency-funded human experiments found they broke no laws, but also found “exposure risks were not always consistently represented.”
The IG found that only two of five it reviewed “alerted study subjects to the risk of death for older individuals with cardiovascular disease.” EPA publicly says “particulate matter causes premature death.”
“Like the EPA Inspector General Report that preceded it, the NAS report failed to address the logical box EPA had placed itself in — that is, if PM2.5 is as dangerous as EPA claims then the experiments were illegal,” Milloy told TheDCNF.
Milloy and other scientists opposed to EPA human testing gave presentations to NAS about the problems with agency’s experiments and its claims about fine particulates. NAS doesn’t seem to have taken those presentations into account.
“The only way the experiments aren’t illegal is if EPA was wrong (i.e., lied) about the danger of PM2.5,” Milloy said. “It is unfortunate for the NAS that it has chosen to aid and abet EPA’s corruption of science and/or illegal conduct.”
EPA had conducted human experiments since at least 2003, and from 2009 to 2016 carried out “845 intentional exposures to pollutants” at its Human Studies Facility at the University of North Carolina-Chapel Hill, according to the NAS committee.
NAS found that only one exposure to air pollutants at that facility resulted in hospitalization. NAS reported the “occurrence of one hospitalization, which corresponds to 0.1% of the pollutant exposures, illustrates that, despite substantial efforts to screen potential study subjects, some level of risk is present.”
Though NAS used that statistic to vindicate EPA’s human testing program, arguing “that any increase in chronic disease risk resulting from … exposures in the studies considered by the committee would be vanishingly small.” And that EPA took care to pick subjects unlikely to suffer adverse impacts from inhaling air pollution.
Except the EPA IG found in 2014 the subject who had to go to the hospital was a 58-year-old obese woman with medical problems and a family history of heart disease. She wasn’t alone.
The IG also noted other test subjects experienced health problems during testing. One subject developed a persistent cough after being exposed to ozone for 15 minutes in April 2011.
Two other subjects suffered from “cardiac arrhythmias” during testing in 2010 after being exposed to “clean air,” according to the IG.
The NAS committee concluded continued human studies are “warranted, with improvements in human-subjects oversight, protocols, consent forms, and communication with potential participants during the informed-consent process and improvements in scientific oversight to maximize the potential for the societal benefits of the studies.”
NAS laid out two donations for this approval — “only when a [human] study is expected to provide additional knowledge that informs policy decisions and regulation of pollutants that cannot be obtained by other means” and “when it is reasonably foreseeable that the risks for study participants will not exceed transient and reversible biomarker or physiologic responses.”
But NAS’s approval of continued EPA testing on humans may not amount to much. The White House proposed a 31 percent cut to EPA’s budget, which could include reduced funding or even the complete elimination of the agency’s human testing program.
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