Rep. Broun: EPA ‘Despicable’ For Not Informing Human Test Subjects of Risks
(CNSNews.com) – The Environmental Protection Agency’s (EPA) failure to fully inform study volunteers about the risks involved in exposing them to high levels of particulate matter is “despicable,” House Science Subcommittee on Investigations and Oversight Chairman Paul Broun (R-Ga.) said Wednesday.
EPA subjected human test subjects to concentrated levels of particulate matter the agency itself considers to be harmful and even fatal, a just-released report by the agency’s inspector general confirmed. (See EPA IG Human Study Subjects.pdf)
“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 testified before Congress in 2011.
“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,” Broun said in a statement.
“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. 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,” the subcommittee chairman added.
Broun asked EPA Inspector General Arthur Elkins, Jr. to investigate in October 2012, five months after JunkScience.com founder Steve Milloy sent Elkins a letter asking him to determine whether EPA intentionally exposed human subjects “to potentially lethal and/or disease-producing levels of airborne fine particulate matter” in five studies done between Jan. 5, 2010 and June 9, 2011 at the agency’s National Health and Environmental Effects Research Laboratory in Research Triangle Park, N.C. (See Junk Science letter to EPA IG.pdf)
Milloy, a lawyer and Johns Hopkins-trained biostatistician, was the first to report about EPA’s human experimentation after reading about it in an obscure government-subsidized scientific journal.
Participants were paid $12 an hour to inhale diesel exhaust fumes containing 19 known or suspected carcinogens piped in from an idling truck parked outside the lab. They included an asthmatic college student and an obese 58-year-old woman who had to be hospitalized for an irregular heartbeat before the experiment was over.
Although Elkins concluded that “the EPA followed applicable regulations when it exposed 81 human study subjects to concentrated airborne particles or diesel exhaust emissions,” he also noted in his March 31 report that “exposure risks were not always consistently represented.”
“The EPA’s diesel exhaust studies did not include language about the long-term cancer risks of diesel exhaust,” the IG report stated, adding that “evidence suggests that at least some human study subjects would like to know if a study involves risk of death, even if the risk is very small.”
“Only one of five studies’ consent forms provided the subject with information on the upper range of the pollutant he or she would be exposed to and only two of five alerted study subjects to the risk of death for older individuals with cardiovascular disease,” the IG report noted.
Table 5 of the report (“Statements made in consent forms of the five studies reviewed”) documents that not all study volunteers were fully informed of the risks involved.
“There should be five ‘no’s’ there,” Milloy told CNSNews.com, pointing out that Table 5 is “contradictory” to Table 4, which states that all five studies provided participants with “a description of any reasonably foreseeable risks or discomforts.”
“A year and a half later, we have this report, which basically agrees with what I said,” Milloy noted, adding that Elkins never contacted him during his investigation. “EPA was not disclosing the risk of death, and it was not disclosing the risk of cancer in contravention of basic human research protocols.”
The first sentence of the report states that “the EPA followed applicable regulations when it exposed 81 human study subjects to concentrated airborne particles or diesel exhaust emissions in five EPA studies conducted during 2010 and 2011.”
But Milloy says that is an attempt to “sweep the issue under the rug,” as evidenced by the IG’s own findings. “If that first sentence is true, you wouldn’t need the rest of the 42-page report, which agrees with me. It’s a non-sequitur,” Milloy told CNSNews.com.
Milloy also pointed out that the IG report does not address the question of whether it is legally, ethically or morally acceptable to expose human beings to high levels of the same pollutants EPA regularly cites to regulate air quality, and to which EPA Administrator Gina McCarthy says there are “no safe levels of exposure.”
“If what EPA says is true, how can you expose elderly and sick people to this stuff?” he asked. “If you’re a cancer patient, you can choose to put your life at risk because there’s a trade-off: the experimental treatment might work. But you cannot risk your life to determine safe levels of exposure for the purposes of EPA’s public policy.”
And the IG report only covered a fraction of EPA’s ongoing human experiments, Milloy told CNSNews.com.
“Keep in mind that the five studies and 81 subjects constitute a very small part of the human testing program. EPA admitted in court that there were 6,000 or so test subjects,” he said.
EPA is currently proposing new regulations governing ozone, which will cost the U.S. economy an estimated $90 billion annually – the most expensive government regulations in U.S. history. (See EPA Proposed ozone standards.pdf)
“EPA claims ozone can kill you, and then they expose people to incredibly high levels of ozone (400 parts per billion) not found in nature or in any American city. If ozone is so dangerous, EPA has no business exposing anybody to it,” Milloy said.
“This is really about saying this stuff is deadly, and then testing it on people,” he continued, adding that the studies’ conclusions form “the basis for the destruction of much of the coal industry and major new rules issued by the Obama administration.
“If what EPA says in regards to particulate matter and ozone is true, EPA should have civil and criminal liability” for not informing test subjects of the dangers, Milloy pointed out.
“EPA says particulate matter kills. The only way EPA is not in serious trouble is because it lied to somebody, either the test subjects or Congress and the public. There’s no third possibility.”