According to Chemical Watch, the Trump administration proposed significant budget cuts for the EPA’s “chemical safety and sustainability research” budget, which includes IRIS spending within the agency’s Office of Research and Development (ORD). The Senate omnibus spending bill proposed elimination of IRIS completely. Yet the compromise bill that landed on President Trump’s desk last Friday continues to fund ORD at 2017 levels, and report language directs the administration to fund IRIS at its 2017 levels.
IRIS funding was restored after E&E News featured an interview with Obama administration holdover Kristina Thayer, who is in charge of IRIS and has been working to address past problems associated with low productivity, questionable scientific practices, and the lack of transparency. Thayer’s background includes working for environmental activist groups, such as World Wildlife Fund and the Environmental Working Group (EWG). She works under former American Chemistry Council scientist Tina Bahadori, who started her career at EPA during the Obama years. Bahadori recently arranged for a National Academy of Sciences (NAS) workshop to review progress on IRIS program improvements, with the apparent hope that the NAS will provide some praise for recent reforms and support continued funding of IRIS.
But even if IRIS has made some progress addressing past scientific transgressions, that should not be enough to save it. IRIS’s failures go beyond delays and sloppy research; they stem from IRIS’s excessively precautionary and unbalanced approach. Its assessments vastly overstate risks by design. And the IRIS process is easy to abuse because it lacks scientific standards that are grounded in law—there is little means to hold it accountable. To top that off, Thayer’s affiliation with the activist EWG alone should raise eyebrows about whether her reforms could shift the direction of the program toward more balanced science. EWG has a long history of exaggerating risks and pushing junk science to make a host of unfounded claims, all designed to support regulations that raise prices and deny consumer choice.
For nearly a decade, congressional oversight committees, the Government Accountability Office, and the National Research Council (NRC) have all urged the EPA to reform the IRIS process to address ongoing and serious scientific and procedural deficiencies. A 2011 NRC review of the IRIS assessment for formaldehyde noted “recurring methodologic problems” that were “similar to those which have been reported over the last decade by other NRC committees.” It also noted that the assessment included “[p]roblems with clarity and transparency of the methods” that “appear to be a repeating theme over the years.” The committee provided advice on ways to reform the system, but problems persist.
Formaldehyde may be the poster child of IRIS’s junk science approach, but it’s just one of many questionable assessments. For example, attorneys at Pepper Hamilton provide an excellent case study on IRIS’s junk science approach to assessing risks associated with the chemical trichloroethylene (TCE), which is a solvent used in industrial processes and in dry cleaning. They point out that the IRIS risk assessment for TCE was largely based on one 2003 study—referred to as the “Johnson study”—which was of highly questionable value. Half of the data from the Johnson study was pulled from another study conducted in 1993, a study that actually had the opposite conclusion: It found no statistically significant connection between TCE exposure in rats and heart issues. Pepper Hamilton’s case study explains:
On the face of EPA’s own 2014 review, there are six published studies reporting “the results of oral administration of TCE to rodents during fetal developmental,” but only the Johnson study reports a statistically significant increase in fetal malformations. The Dawson 1993 study (which includes the data later used in the Johnson study) found no statistically significant increase. The Fisher 2001 rat study (whose authors include the lead author of the Johnson study) failed to detect any effects, as do the two other rat studies and one mouse study. In addition, “none” of the five separate inhalation studies of TCE exposure to rats reported cardiac effects in fetuses (including the Carney study, a well-done study performed in 2006, but not reviewed in the 2006 National Academy of Sciences [NAS] report). No laboratory has replicated the Johnson study results.
Yet some may say, “Who cares if IRIS to too precautionary? After all, why take unnecessary risks?” Such a philosophy ignores risks created by regulations themselves and the risk associated with crippling innovation and consumer freedom. For those reasons, excessive precaution is bound to do more harm than good. For example, excessively precautionary policies can contribute to malnutrition and hunger around the world by preventing agricultural innovations.
IRIS assessments have tremendous influence on myriad EPA policy decisions. Indeed, these assessments impact decisions related to clean-up of hazardous waste sites, drinking water standards, and clean air rules.
IRIS’s critics, rightly maintain that the program is highly flawed, has a long history of producing junk science, and its functions more rightly belongs within the EPA’s Toxics Substances Control Act (TSCA) program. The recently reformed TSCA outlines some basic scientific standards for researchers to use for chemical risk assessments. IRIS, on the other hand, was created administratively, without any congressional mandate or scientific guidelines. While it’s not clear how well TSCA will actually perform in the long run, the law at least requires that this program apply much stronger and congressionally-mandated standards designed to promote scientific integrity as well as transparency.
Given the fact that TSCA passed with broad bipartisan support in Congress, it’s shouldn’t even be controversial to make this organizational change, but there are other political factors in play. Key supporters of IRIS don’t want power to shift from the program—which has Obama holdovers in place—to the more accountable TSCA program led by Trump-selected staff, particularly Deputy Assistant Administrator Nancy Beck.
Beck has been criticized for having worked for the American Chemistry Council (ACC), but ironically, one of IRIS’s key supporters, Tina Bahadori, also worked for ACC.
The real issue isn’t where these two individuals worked before they arrived at EPA; it is the direction chemical research should move in the future. Are we going to continue to allow regulators to use junk science in the name of “precaution,” or are we going to at least try to start holding them more accountable?