Washington, D.C. – In response to a request from Oversight Subcommittee Chairman Paul Broun M.D. (R-Ga.), the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) today released a report that examined whether the agency followed applicable laws and procedures when it exposed human subjects to diesel exhaust, particulate matter and ozone.  

The EPA conducted five research studies in 2010 and 2011 involving 81 human subjects during which the OIG determined that “exposure risks were not always consistently represented,” and the agency “did not include information on long-term cancer risks in its diesel exhaust studies’ consent forms.”

In his letter that requested the OIG report Chairman Broun noted that numerous EPA sources, including the agency’s own science, indicate that even at low levels these pollutants can cause death, cancer and other negative health effects.  Despite EPA regulations establishing a presumption against human experiments “involving risk of substantial injury to a human subject” or “irreversible health effects,” the OIG reports that the agency tested extremely high levels of pollutants.  According to the report:

  • “Diesel exhaust is a complex mixture of more than 40 toxic air contaminants. These include 19 known or suspected carcinogens, such as benzene, formaldehyde, and 1,3-butadiene.” (Page 6)
  • “A 2006 EPA assessment document further reports associations between short-term [particulate matter] exposures and mortality and morbidity.” (Page 22)
  • “The EPA classifies diesel exhaust as ‘likely to be carcinogenic to humans by inhalation’” (Page 23)

Chairman Broun: “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. 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 OIG’s report revealed troubling details:

  • “[E]vidence 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.” (Page 25)
  • “[W]e found that the five studies’ consent forms inconsistently addressed the risks of being exposed to [Concentrated Airborne Particles] and diesel exhaust.” (Page 19)
  • “[O]nly 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.” (Page 21)
  • “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.” (Page 24)
  • “The EPA did not report two of the six adverse events it identified in a timely manner…” (Page 29)
  • EPA “defines an adverse event as undesirable and unintended, though not necessarily unanticipated, injury or physical or emotional consequence to a human subject.  These events can be serious and/or unanticipated.”  (Page 5)
  • “An August 2013 article in the Journal of Clinical Best Practices states that ‘most people would want to know whether a medical procedure involves a risk of death, even if the chance of dying is very small.’” (Page 24)

The full report can be found HERE.