Taxpayers are all too familiar with the ancient Roman poet Juvenal’s sage observation that often translates to, “Who watches the watchers?” The question is pertinent when it comes to the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) assessments, along with a critical peer review safeguard that is supposed to keep IRIS’s work scientifically grounded. Fortunately, a U.S. Senator has stepped up to ask that question, and a Freedom of Information Act (FOIA) request has provided some all-too-telling answers.
As a key part of EPA’s system for developing regulations, IRIS is charged with developing toxicity assessments and health risk levels for numerous chemical substances. IRIS is “housed” in its parent agency’s Office of Research and Development to ensure it “can develop impartial toxicity information independent of its use by EPA’s program and regional offices,” according to EPA’s own website. These assessments are supposed to be thoroughly conducted, and subject to outside scientific scrutiny and stakeholder input to ensure the integrity of IRIS’s work.
One big stakeholder to all this is the taxpayer, who not only funds EPA’s $9 billion-plus budget, but who can also shell out more if the cost of government goods or services go up unnecessarily because of flawed regulations based on IRIS findings. Plastics used in health care equipment purchased by Medicaid, military trucks, and flooring materials used in government offices are just a few of hundreds of examples where IRIS missteps could induce regulators into banning or boosting the cost of substances that might actually be safe (and economical) to use.
The latest, but by no means the only, example of potentially flawed oversight in the chemical regulation space involves a contract with the National Academies of Sciences, Engineering, and Medicine (NASEM) to review the 2021 IRIS assessment regarding formaldehyde, a substance common across numerous areas of the economy, from automobile manufacturing to health care. It also occurs naturally in certain foods.
According to a March 2 letter to NASEM from Senator John Kennedy (R-LA), the much-needed review regarding formaldehyde is in danger of being compromised because the officials conducting it were deeply connected with putting together the 2021 IRIS assessment in the first place. And, as Senator Kennedy noted, history is in danger of repeating itself:
This is not the first time the NASEM has been asked to review a draft IRIS formaldehyde assessment. In 2011, prompted by requests from the U.S. Senate, another ad hoc NASEM committee issued a highly critical and hugely impactful report that not only took EPA to task on the draft assessment itself but on the entire IRIS program and its chronic pattern of issuing deficient, inconsistent, and nontransparent chemical assessments.
That NASEM committee report from 2011 quite caustically observed, “EPA's draft assessment was not prepared in a logically consistent fashion, lacks clear links to an underlying conceptual framework, and does not sufficiently document methods and criteria used to identify evidence for selecting and evaluating studies.” Ten years later, little seems to have changed.
As Senator Kennedy further explains, members of the NASEM review team “coordinated closely with” EPA staff that worked on both the current formaldehyde assessment and the one conducted a decade ago, even going so far as to urge downplaying any changes needed to IRIS’s work. As Kennedy observes, one official on the team “is now managing the NASEM review she concluded is not needed.”
Senator Kennedy’s concerns have since been amply validated by media reports on a FOIA request launched by the American Chemistry Council, a broad-based trade association founded 150 years ago. The Council’s inquiry determined that indeed, EPA took undue shortcuts in a process that is supposed to ensure scientific integrity in chemical assessments:
Key officials involved in the National Academy of Sciences’ (NAS) upcoming review appear to have violated basic standards regarding independence, bias, and balance in the peer-review process. For example, the lead NAS staff officer was directly involved in developing the assessment under review while working at EPA.
The FOIA, which produced a large volume of internal communication documents, also shows that the formaldehyde assessment was rushed in 2021, resulting in IRIS “violating its own policies and procedures” by sidestepping normal review processes and by cutting short public input. Given these problems, the Council called for “[r]emoval of any potentially biased panel members and NAS staff who lack independence or objectivity from the panel reviewing the draft IRIS assessment,” as well as an Office of Management and Budget formal interagency review of the assessment, along with other sensible steps.
Clearly, however, this entire area of responsibility for EPA needs a thorough look, and the Government Accountability Office (GAO), Congress’s nonpartisan watchdog agency, concurs. Every other year, GAO publishes a “High Risk List” of “federal programs and operations that are vulnerable to fraud, waste, abuse, and mismanagement, or need transformation.” In 2021, 36 areas were identified, among them “Transforming EPA's Process for Assessing and Controlling Toxic Chemicals,” which has occupied a spot on the High Risk List for 13 years (ironically, another multi-year entry has been the federal government’s own environmental clean-up liabilities, amounting to an estimated taxpayer burden of nearly $600 billion).
Although a variety of subagencies and programs were cited in GAO’s evaluation of EPA’s chemical regulation practices, IRIS has come under particular criticism because it “has not produced timely chemical assessments, and most of its 15 ongoing assessments have experienced delays.” Worse, according to GAO:
[T]he IRIS Program does not publicly announce when assessment drafts move to certain steps in their development process or announce reasons for delays in producing specific assessments. Without such information, stakeholders who may be able to help fill data and analytical gaps are unable to contribute. This could leave EPA without potential support that could help overcome delays.
To add even more insult to injury, GAO’s High Risk scoreboard for IRIS shows that taxpayers have been losing ground. Between 2019 and 2021, IRIS’s ratings for developing capacity and coming up with an action plan to address its problems were unchanged, while three others – commitment from agency leadership to change, monitoring of program deficiencies, and “demonstrated progress” toward remedies – declined. IRIS, and EPA, need to do better now.
Chemical regulation is already badly clouded by poor policymaking, but alas, so is the tax structure. Last year, in spite of a major opposing coalition effort spearheaded by NTU, Congress effectively doubled the Superfund excise tax rate on certain chemicals as a “pay-for” gimmick in its trillion-dollar infrastructure package. The revenues raised won’t go to any new environmental clean-up, but they will be passed along to consumers in the form of higher prices on everything from light trucks to “green energy” devices. As Congress desperately seeks ways to ease inflationary pressures on the economy, revisiting this tax hike should be a no-brainer.
In addition to implementing GAO’s findings and ending discriminatory taxation, EPA needs to focus on what’s already working in chemical regulation. One example is the use of public-private partnerships. Taxpayers cheered EPA’s decision in 2014 to allow the silicones industry to collect data on the impact of one silicone substance called D4.
EPA had initially proposed a massive, scientifically unnecessary project involving 50 water sampling sites that could, by one estimate, have carried a $50 million price tag. Finally, EPA came to its bureaucratic senses and worked with the silicones industry to formulate a carefully overseen monitoring program for numerous sites. Instead of paying for speculative environmental impact models, EPA would be able to get hard data, at no cost to taxpayers, that the agency can rely on to make sound policy decisions about D4.
As this analysis was being written, the IRIS draft assessment on formaldehyde had just been publicly released, prompting (appropriately) a new wave of questions on whether this entire exercise has been tainted and whether IRIS’s value and productivity need to be reexamined. Certainly the draft assessment can’t serve as the basis for regulatory policy.
In anatomy, the iris regulates how much light enters the eye. Unfortunately, the government’s IRIS program will continue to leave taxpayers in the dark without greater oversight from other participants in the chemical evaluation process.