A public interest group has sued the U.S. Environmental Protection Agency (EPA) in federal court in Virginia, alleging that the agency exposed susceptible people to fine particles and diesel exhaust without following the agency’s own rule on conducting studies on human subjects. Am. Tradition Inst. Envtl. Law Ctr. v. EPA, No. 12-1066 (E.D. Va. Filed 9/21/12).
According to the complaint, EPA exposed human subjects to pollutants the agency believes to be lethal without informing the subjects. It seeks an order enjoining EPA from carrying out experiments that expose people to fine particles and staying the agency’s fine particle standards until EPA can ensure that the rules do not rely on illegal human experiments. EPA regulations, which are based on what is known as the Common Rule, prohibit EPA from imposing risks that are not reasonable and prohibit human experimentation “unless the investigator has obtained the legally effective informed consent of the subject.” 45 C.F.R. §46.116 and 40 C.F.R. §26.116.
According to press reports, Senator James Inhofe (R-Okla.) has called for a hearing on the conduct of studies that are the subject of the American Tradition Institute litigation. See FoxNews.com, October 5, 2012.