Divine Right of EPA: Agency says it's above the law on human testing

EPA tells the federal court hearing the illegal human testing suit that the agency answers to nothing and no one — i.e., no law and no judge.

Check out this passage from EPA’s memo in support of its motion to dismiss our claim:

D. EPA’s Decision to Study PM2.5 with Human Participants Is a Decision Committed to Agency Discretion by Law.

Even if some element of EPA’s program of controlled human exposures studies involving PM2.5 could be considered a final agency action, Plaintiff’s claim still must be dismissed because EPA’s decision regarding what studies it chooses to conduct is committed to agency
discretion by law and, therefore, is not subject to review under the [Administrative Procedures Act (APA)]. See 5 U.S.C. §701(a)(2). The APA bars judicial review of discretionary agency action where the statute “is drawn so that a court would have no meaningful standard against which to judge the agency’s exercise of discretion.” Heckler v. Chaney, 470 U.S. 821, 830 (1985).

Here, Congress directed EPA to study the causes and effects of air pollution. 42 U.S.C. § 7403. Nothing in the [Clean Air Act (CAA)] provides a meaningful standard” to evaluate what air pollution EPA chooses to study or how. To the contrary, the CAA gives EPA broad discretion in the subject matter of its research program. The only CAA provision applying to EPA’s research is CAA Section 103, 42 U.S.C. § 7403, where Congress broadly mandated that EPA study the health effects of air pollution. But no CAA provision tells EPA what air pollutants to study, with the exception of ozone and wood smoke. 42 U.S.C. § 7403(c)(3), (d)(1). Nor does it provide any standard or direction for how EPA must decide what to study or not, when to conduct studies, what kinds of studies to conduct, how to set and when to shift research priorities. The specific methods for EPA’s research are likewise not specified, i.e., whether EPA involves human participants in its research; although, as mentioned above, the involvement of human participants was known to Congress when debating the CAA. Congress prescribed certain timelines for the prioritization of environmental health assessments of hazardous air pollutants, id. §7403(d)(2)(B)-(C), but did not address any of the issues involved in developing and implementing a research program for any other air pollutant.

Deciding what research program to pursue and how to pursue it “involves a complicated balancing of a number of factors which are peculiarly within [the Agency’s] expertise.” Heckler, 470 U.S. at 831. EPA must determine whether its resources are best spent in the study of certain types of pollutants, whether such studies will be fruitful, and whether such studies best fit with the Agency’s statutory mandates. Because “no judicially manageable standards are available for judging how and when [EPA] should exercise its discretion” in deciding what research to undertake, EPA’s decision to study the health effects of PM2.5 using controlled human exposure studies was a decision committed to EPA’s discretion and immune from review under the APA. Id. at 830… [Emphasis added]

But in the August 2001 Maryland Court of Appeals decision in Grimes et al. v. Kennedy Krieger Institute (a case involving EPA-funded study of children intentionally exposed to lead paint), the Court stated:

It is clear to this Court that the scientific and medical communities cannot be permitted to assume sole authority to determine ultimately what is right and appropriate in respect to research projects involving young children free of the limitations and consequences of the application of Maryland law.[Emphasis added]