The Biden administration has begun to reverse a host of policies that could have substantially improved the quality of science produced by government agencies. One recent example involves efforts to rely more on the Environmental Protection Agency’s (EPA) highly flawed research program known as the Integrated Risk Information System or (IRIS).
During the past several years, CEI advocated IRIS reform and called on the agency to move IRIS chemical assessment functions into the office that implements the Toxic Substances Control Act (TSCA) program. TSCA demands that the agency apply some relatively rigorous—and legislatively prescribed—scientific guidelines, which Congress passed with bipartisan support in 2016. IRIS, on the other hand, was created administratively, operates without any congressionally mandated guidelines, and has a long history of issuing highly flawed assessments.
We made headway during the last administration, as some assessments moved from IRIS to TSCA, but the Biden EPA is moving in the opposite direction, suggesting that IRIS could be a model for the TSCA program. Greenwire (June 4, 2021) reports:
EPA issues risk evaluations under the Toxic Substances Control Act (TSCA), and the agency has indicated it will be revamping that process, potentially incorporating approaches taken by IRIS. While the latter program is nonregulatory, it is often held up as a ‘gold standard’ chemical risk assessor.
As I have documented elsewhere, IRIS is anything but the “gold standard” for good science. Instead, it is infamous for cherry picking studies to serve predetermined conclusions, ignoring key science, and producing assessments that deploy highly unrealistic and excessively cautious assumptions. The resulting faulty assessments have created health scares about certain chemicals that undermine critically important uses.
For example, IRIS’ assessment of the chemical ethylene oxide, which is used to sterilize medical supplies, among other things, created an unwarranted health scare about the chemical’s risk, causing closures of medical sterilization plants in late 2019 and 2020. These closures contributed to the medical supply shortages during the COVID-19 pandemic in 2020, until the Food and Drug Administration finally got them to reopen.
The ethylene oxide case shows how dangerous flawed government science can be, and unfortunately, we are likely to see more such problems as the EPA shifts power back to IRIS and tries to incorporate IRIS’ flawed approach to TSCA.
It is not clear how the EPA could use IRIS as a model for TSCA without completely flaunting the law. IRIS is a non-regulatory program created by the agency itself with no statutory authority, while TSCA has congressional mandated guidelines to follow. However, the EPA can shift power to IRIS by giving it authority to review substances that should be assessed under TSCA.
In fact, earlier this year, the Biden EPA resumed the IRIS’ assessment of formaldehyde, which the Trump EPA had moved to the TSCA program. The shift to TSCA made sense given that IRIS had issued a draft assessment for the chemical that was highly flawed. A National Academy of Sciences (NAS) review in 2011 rebuked the IRIS program for its sloppy and poorly designed formaldehyde draft assessment, and the NAS called for the agency to reform the entire IRIS program. The NAS panel noted:
Overall, the committee found that 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. Moreover, many of the general problems with the EPA formaldehyde health assessment have been identified by other Research Council committees that reviewed other EPA chemical assessments in recent years. For instance, there have been recurring problems with clarity and transparency of the methods, even though the documents have grown considerably in length. The committee concluded that if the methodologic issues are not addressed, future assessments may suffer from the same general problems highlighted in this report.
IRIS has since made some procedural reforms that amount to little more than window dressing because they never really addressed the program’s fatal flaws, such as its reliance on unrealistic and excessively cautious assumptions.
By moving the formaldehyde assessment back to IRIS, EPA staff do not have to apply TSCA’s legislatively mandated guidelines, which demand reliance on the best available science. As a result, we can expect the EPA to release an alarmist IRIS assessment on formaldehyde, which will have market implications.
The many valuable uses of formaldehyde will then be placed at risk based on unreasonable fears about its risks. That includes its uses in construction for composite wood products such as kitchen cabinets and flooring, in health care for the creation of vaccines and life-saving drugs, and in personal products as a preservative to protect consumers against injury that could result from spoilage.
As the ethylene oxide case shows, dangerous consequences often result when government research programs like IRIS pervert science. The Biden EPA’s apparent plan to shift assessment backs to IRIS and its interest in incorporating IRIS’ flawed approaches to the TSCA program is disheartening to say the least. Consumers will feel the impacts in the future as valuable products are removed from the market thanks to government-peddled junk science.