UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA
THE AMERICAN TRADITION ) INSTITUTE ENVIRONMENTAL LAW ) CENTER, )
UNITED STATES ENVIRONMENTAL ) PROTECTION AGENCY, et al., )
Civil Action No. I: 12-cv-1066 (AJT/TCB)
Before the Court is the defendant Environmental Protection Agency's ("EPA") Motion to Dismiss("the Motion"), pursuant to rule 12(b)(l) or alternatively 12(b)(6) [Doc. No. 22). 1 Upon consideration of the Motion, the memoranda and exhibits in support thereof and in opposition thereto, and the arguments of counsel at a hearing on January 3, 2013, and for the reasons contained in this Memorandum Opinion, the Court finds that Plaintiffs Complaint fails to state a claim on which relief may be granted and the Court will GRANT the Motion to Dismiss...
In its complaint, the American Tradition Institute ("ATI")2 alleges that the defendant, EPA, failed to adequately inform participants in a study known as the CAPTAIN study of the life-threatening health risks associated with their exposure to particulate matter ("PM") air pollution, all in violation of what is referred to as the Common Rule, which regulates human experimentation.3 Based on this claim, the plaintiff seeks a wide range of declaratory and injunctive relief, including an immediate halt to the EPA's CAPTAIN study "and any other EPA human experimentation which intentionally exposes human subjects ...to 'fine particles' ...."4
2 There are two plaintiffs listed the caption.One is the Environment Law Center, about which nothing is allegedin the Complaint, and appears to be the advocacyarm for the other named plaintiff, ("ATI"), which is allegedto be a 501(c)(3) organization and whichdescribes its
3 The Common Rule is a set of regulations promulgated by the EPA, as well as other federal department and agencies, that govern the ethical and scientific conduct of government sponsored research with human participants. EPA has codified the Common Rule in its regulations at 40
C.F.R. § 26.101 et. seq. Among its core requirements are:
1. That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent; and
2. That proposed research be reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.
See EPA, Human Subjects of Research (the "Common Rule"), at
http://www .epa.gov/oppfead 1/guidance/cr-require.htm (last visited Jan. 31, 2013).
4 ATI also seeks the following additional relief:
• A declaration that EPA failed to provide legally effective informed consent to subjects participating in PM 2.5 studies.
• A prohibition on any further use of expenditures to conduct the CAPTAIN study.
• An Order that EPA to suspend use of the University of North Carolina Medical Institutional Review Board ("IRB").
• A prohibition on EPA's relying on data resulting from any research involving intentional exposure of any human subject to PM 2.5.
• A stay of any implementation of Clean Air Act ("CAA") rules regulating fine particulate matter until the Agency can review its processes for promulgating rules to ensure that "EPA does not rely in any fashion upon illegal human experimentation."
• An Order for follow-up monitoring of all human subjects that have been exposed to PM
2.5 (requested for the first time in Plaintiffs Reply).