The Environmental Protection Agency’s inspector general found that the agency didn’t notify test subjects in recent pollutant studies that they were being exposed to cancer-causing chemicals.
At the request of House Science, Space, and Technology Oversight Subcommittee Chairman Paul Broun (R-Ga.), the OIG looked into five research studies the EPA conducted in 2010 and 2011 involving 81 human subjects to test the effects of diesel exhaust.
The OIG found the “consent forms inconsistently addressed the risks of being exposed to [Concentrated Airborne Particles] and diesel exhaust,” with only one of the five studies’ forms providing the test subject “with information on the upper range of the pollutant he or she would be exposed to” and just two of the five “alerted study subjects to the risk of death for older individuals with cardiovascular disease.”
“Only two of the five studies’ consent forms included the risk of death from exposure to high levels of selected air pollutants such as [Particulate Matter] and diesel exhaust, and only one study’s consent form included the upper limits of exposure levels,” the report stated.
“…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. In the future, the EPA should include the long-term risk of cancer to potential subjects in its consent forms so study subjects can make the most informed decisions about whether to participate in a study.”
Six “adverse events” happened with test subjects in the five studies. “The EPA’s clinical follow-up for the six adverse events ranged from 1 day to 3 months after the event and included phone calls and emails by the EPA nurses. While the EPA’s clinical follow-up appeared to be reasonable, the EPA’s policies and guidance do not establish the EPA’s clinical follow-up responsibilities. In our view, the EPA should revise its guidance to establish the agency’s clinical follow-up responsibilities after an adverse event.”
Two of those “adverse events” were reported by the EPA “later than required,” the report noted.
“In addition, when evaluated against the EPA’s [National Health and Environmental Effects Research Laboratory] guidance definition for an adverse event, the EPA did not report two study events to the IRB in which both subjects experienced cardiac arrhythmias. In both instances, the subjects were not allowed to continue participating in the study and were advised to consult their physicians. The EPA should update its NHEERL guidance to make it clear what adverse event definitions and reporting requirements they should use when managing their human subject research studies to ensure the consistent protection of study subjects.”
The IRB refers to the University of North Carolina at Chapel Hill’s (UNC’s) Institutional Review Board.
Other test subjects suffered migraine, persistent cough, and decreased lung function. One with tachycardia and atrial fibrillation required overnight hospitalization for observation.
The EPA classifies diesel exhaust as “likely to be carcinogenic to humans by inhalation.” The agency has been conducting controlled exposure studies on human test subjects for about 40 years.
The Clean Air Act allows the EPA administrator to “conduct a research program on the short-term and long-term effects of air pollutants on human health.”
Broun, a physician, called it “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.”
“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,” the chairman said in a statement. “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.”
Sen. David Vitter (R-La.), the top-ranking Republican on the Senate Environment and Public Works Committee, questioned the studies along with Sen. Jeff Sessions (R-Ala.) in a February 2013 letter to the agency.
“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,” said Vitter. “This is a prime example of how EPA handpicks what scientific information and uncertainties they use to support their overreaching agenda. Discounting the risk involved to human study subjects violates proper scientific protocols and fundamental ethics.”