Environmental activists have already begun to prime the pump. For example, a Natural Resources Defense Council (NRDC) blog post, titled, “EPA Announces 20 Toxic Chemicals It Won’t Protect Us From,” asserts that the agency is engaged in a ploy “to ensure that they [20 chemicals] are not properly evaluated or regulated.” [Emphasis in original]
According to NRDC, the EPA’s plan to move some chemical assessments from its Integrated Risk Information System (IRIS) program into the Toxic Substances Control Act (TSCA) program is part of a plan to “dismantle” IRIS. Frankly, I hope they are right! As I have documented elsewhere, IRIS is an administratively created program that operates without any congressionally mandated scientific guidelines, and it has a long history of producing junk science.
The TSCA program, on the other hand, has some solid, statutorily mandated requirements designed to promote a rigorous scientific process. TSCA reform passed in 2016 as the Frank R. Lautenberg Chemical Safety for the 21st Century Act and its implementation is only controversial now because of anti-Trump politics. The reform bill was sponsored by eight Republicans and eight Democrats and passed with overwhelming majorities from both political parties.
I admit that I was skeptical of TSCA reform, but the final law still contains some good language to promote the “best available science” and transparency—two cornerstones of the scientific process.
The Trump EPA is simply trying to replace junk science with sound science, but environmental activists don’t want the EPA to deploy scientific principles because it may diminish the agency’s power to regulate. Yet anyone who cares about good public policy should be happy with a law that might prevent needless and counterproductive regulations that result from agency junk science.
For example, formaldehyde is on the EPA’s list of 20 priority chemicals to study under the new TSCA reform law, which means the agency will apply the best science to determine its risk. This is a victory for science because EPA consideration of the chemical under IRIS has proven highly flawed. The Trump EPA has rightly held off on releasing the faulty IRIS assessment, preventing needless media hype, scare campaigns, and faulty regulation.
In 2011, a National Academies of Sciences (NAS) panel report on IRIS’ formaldehyde risk assessment criticized the program for “recurring methodologic problems,” including repeated failures to provide “clarity and transparency of the methods,” along with inconsistencies, poor research documentation, failure to follow EPA research guidelines, and other issues. At the end of its report, the NAS panel included a special section to provide suggestions for IRIS to improve its science for formaldehyde and all other assessments.
The EPA’s IRIS office has allegedly been trying to fix the IRIS program and apply NAS recommendations ever since to no avail. In 2018, the staff held a workshop at which it detailed reform efforts, but it does not appear they have applied these yet to any risk assessments. The report offers a few sentences of praise for some procedural reforms, but the NAS points out that IRIS has not even finalized a handbook outlining its process for staff to apply reforms—which NAS asked for in 2014!
In any case, the debate about IRIS’ formaldehyde assessment has never simply been about its procedural failings. Rather, it strikes at the heart of IRIS’ unhelpful bias toward excessive caution.
To start with, formaldehyde is created by all living organisms—from plants to animals to the human body. Exposure is unavoidable, and the key is finding at what level it poses a risk. It’s reasonable to assume that dangerous levels would greatly exceed that which occurs naturally in the human body and in the foods we consume.
Yet, the draft formaldehyde assessment proposed a reference concentration that is multitudes lower than the amount that humans naturally exhale with each breath. The World Health Organization estimates that humans exhale 8.0 parts per billion (ppb) per breath, while IRIS proposed setting a standard below 0.008 ppb. So if you want to avoid allegedly “dangerous” levels of this chemical, stop breathing. And forget about cooking or eating Brussels sprouts, cabbage, or shiitake mushrooms. The mushrooms alone can contain more than 300 parts per million (ppm) of formaldehyde. Note that’s parts per million is much higher than the parts per billion noted in the IRIS standard. But even then, these exposures pose no significant health concerns.
As a result, the EPA’s suggested reference dose is likely to be too low, as it was in the draft risk assessment. Accordingly, it makes sense that the Trump administration should halt IRIS’ poor work on formaldehyde and address the chemical as part of the new TSCA program. After all, getting the science right is critical for developing sound policies.
An assessment that overstates formaldehyde risks may lead to bans and regulations that would do more harm than good. Formaldehyde has valuable applications for medical purposes that misguided regulation could jeopardize, such as in the manufacture of vaccines. In some cases, it is used to deactivate viruses that cause the flu and to detoxify bacterial toxins necessary to produce safe vaccines for diphtheria and other diseases. The levels of formaldehyde left in these vaccines are low and not dangerous. The FDA explains:
The body continuously processes formaldehyde, both from what it makes on its own and from what it has been exposed to in the environment. When the body breaks down formaldehyde, it does not distinguish between formaldehyde from vaccines and that which is naturally produced or environmental. The amount of formaldehyde in a person’s body depends on their weight; babies have lower amounts than adults. Studies have shown that for a newborn of average weight of 6-8 pounds, the amount of formaldehyde in their body is 50-70 times higher than the upper amount that they could receive from a single dose of a vaccine or from vaccines administered over time.
Formaldehyde is also used as a preservative in personal care products to prevent the development of bacteria, mold, and other dangerous pathogens. It provides these benefits, but exposure remains very low. For example, the tiny trace of formaldehyde released when shampooing your hair is about the same amount as that contained in one medium-sized apple or pear.
Unfortunately, the upcoming congressional hearing is unlikely to provide a balanced overview of the issue because it’s not designed for that purpose. It’s purely political—designed to build on a narrative that the administration is willing to undermine science to help industry peddle toxic chemicals. It’s the left that does not want the best available science to prevail, because it threatens their power.