In part I of our look at upcoming changes to the regulation of formaldehyde in the US, we saw that the EPA has two separate but related review processes underway for this essential chemical, and that there was a risk that the review processes could put into place restrictions that would eventually disrupt access to a product which the feed industry relies on as a disinfectant.
At the foundation of the EPA’s work on formaldehyde is what is called its IRIS assessment, a concept which was introduced in the previous article. There is some concern that an ill-conceived IRIS assessment could ultimately restrict the use of formaldehyde in the US by setting an extremely low risk value level which would be referred to in regulation about the safe use of the chemical.
To quote one industry expert consulted for this piece, “because IRIS documents can be relied upon to inform legislation and regulation, it’s vital that the science and process are robust.”
Unfortunately, as we will see, stakeholders have been sounding the alarm over perceptions that the EPA’s science and process are not as robust as one should hope.
ACC concerned about process
In July of last year, the American Chemistry Council (ACC) brought a legal challenge alleging that the IRIS process, and particularly step 4 involving the external peer review requested of NASEM, had been conducted incorrectly. In its press release at the time, the ACC claimed that “this review process has included numerous FACA violations, including improper EPA influence, conflicts of interest on the committee, a lack of technical balance, and failure to meet transparency obligations or provide meaningful opportunities for public comment.”
Meanwhile, in comments to Feedinfo in January, the industry association painted a more detailed picture of its concerns (although it should be noted that not all of the points raised are necessarily part of its legal challenge).
Skipped procedural steps
To quote Sahar Osman-Sypher, ACC Senior Director, Chemical Products and Technology Division, “As the ACC has noted in numerous comments and letters to U.S. EPA and NASEM over the last 18 months, the key steps required under its stated process and IRIS Handbook were skipped ahead of developing the draft assessment. In developing the 2022 draft assessment, EPA failed to implement Step 1 of the IRIS process; EPA never released an IRIS assessment plan, which would have included scoping and problem formulation materials. As EPA’s most recent IRIS Program Update from Oct 2023 shows, formaldehyde is the only of the 17 chemicals being reviewed under IRIS for which EPA has not (or does not plan to) taken public comment on an IRIS assessment plan or systematic review protocol prior to developing the assessment and releasing a draft.”
NASEM scope of review limited, leaving out relevant peer-reviewed studies
Meanwhile, she adds, “NASEM has indicated that its ability to provide a comprehensive review of the body of scientific literature was constrained by EPA, which imposed a narrow and rigid set of charge questions for NASEM to answer and constrained its ability to exercise independent scientific judgment or consider contrary evidence. This narrow scope precluded any consideration of the best available science. The Federal Advisory Committee Act prohibits EPA from using the advice of NASEM unless the report is ‘the result of the Academy’s independent judgment’ and the review process is not under the control and management of the sponsoring agency. Furthermore, NASEM followed EPA’s lead and ignored or dismissed over 70 key peer-reviewed studies, most international formaldehyde assessments, and comment from authors of key studies.
“Significantly, NASEM also fails to fully address the validity of the toxicity values in EPA’s 2022 draft IRIS assessment, stating ‘the committee did not conduct an independent hazard evaluation or dose-response assessment, and therefore does not recommend alternative hazard identification conclusions or toxicity values.’ This limitation is a significant failure and disregards the scientific evaluations from global health agencies, regulators, and other international authorities who have used decades of scientific evidence by universities and independent scientists to support a safe threshold for formaldehyde exposure.
“Despite these limitations, and lack of peer review of the science by NASEM, EPA has indicated that the SACC [Science Advisory Committee on Chemicals] will not be reviewing the chronic inhalation exposure and the cancer inhalation unit risk (IUR) because it was peer reviewed by NASEM .”
Unchecked IRIS process demands levels out of touch with reality
“EPA’s concerns stem from one flawed evaluation conducted by the IRIS program. While EPA’s IRIS has never been authorized by Congress, IRIS assessments form the basis for “safe” levels for regulatory and enforcement action at EPA as well as state and federal agencies. This is the case even though they are not designed to look at actual risk or exposure and are developed without going through the process for regulation (notice-and-comment, interagency review, response to public and scientific comments).
“EPA’s IRIS assessment suggests a ‘safe’ level for formaldehyde in a range that defies reality - in the same ballpark as the amount of formaldehyde in exhaled human breath, and well below levels that exist in outdoor air, our homes, or background levels in nature. This assessment is also out of step with the rest of the world like the European Union, which recently reviewed the science on formaldehyde and established workplace standards,” Ms. Osman-Sypher states.
What does the EPA say?
Consulted about these issues, an EPA spokesperson told Feedinfo: “IRIS assessments are the premier source of toxicity information used by EPA, state and local health agencies, Tribes, other federal agencies, and international health organizations. IRIS assessments are subject to a rigorous review process that includes independent external peer review, public review and comment, and interagency review. EPA follows well-established policies, procedures, and practices related to the development and review of IRIS assessments. Because this is pending litigation, EPA has no further information to add.”
What’s next?
It is important to note that the regulatory processes under discussion here are far from terminated. As was pointed out in the previous INSIGHT on formaldehyde, these documents have not yet been finalised, and therefore nothing is certain about the route that EPA will take. Moreover, even in the worst-case scenario of an IRIS assessment which sets a very low threshold for human exposure to formaldehyde which then requires EPA to restrict its use under the TSCA, rulemaking is not expected to begin until 2025.
In other words, formaldehyde is not about to imminently disappear in the US market, nor is it certain that it will ever do so. Nonetheless, given how these various regulatory processes interact, with later steps building upon earlier work, and periods for public comment quite short, it is probably in the interest of those who rely on formaldehyde – including the feed additives industry – to keep an eye on how these slow-moving developments are progressing and to think about how their conclusions might impact access to an important tool in keeping animals healthy and productive.
