Formaldehyde is in the news again, because of a report made public by the National Academies of Sciences, Engineering, and Medicine (NASEM) that evaluates the methods used by the EPA in its latest draft assessment on the health hazards of formaldehyde. 

The EPA released the draft assessment in April of 2022. Criticism of that report, along with NASEM’s contracted evaluation of its methods, has resulted in a lawsuit filed by the American Chemistry Council.

The negative health effects of formaldehyde exposure, especially inhaled formaldehyde, aren’t new. They have been studied since the mid-1800s when the industrial and commercial uses of formaldehyde began, and have been noted to occur at established exposure levels. 

However, in its draft review, EPA states for the first time that inhaled formaldehyde even at low levels causes myeloid leukemia and other lymphohematopoietic (LHP) cancers. This is new, and it’s in contrast with other U.S. program assessments, most notably the National Toxicology Program which notes an association but does not claim that formaldehyde is a cause of LHP cancers or leukemia.

Formaldehyde is a focus of the Center for Truth in Science, especially since EPA first released its draft review last April. It has been the subject of more than one CTS blog post (such as this one and this one), as well as the funding of a state-of-the-art systematic review of the literature. We will continue to follow this issue closely and provide scientific clarity where possible.

After the release of its draft assessment, the EPA held a public comment period, at the end of which it announced that it had contracted with the NASEM to conduct an external peer review of the process used to develop the draft report. Notably, the NASEM had criticized the process used by the EPA on its formaldehyde review back in 2011, especially as it applied to leukemia.

What is the National Academies of Sciences, Engineering, and Medicine (NASEM)? 

The NASEM is a “quasi-governmental organization” that advises the federal government on important scientific and technical issues. It was started by President Lincoln who was looking for the best scientists in the U.S. to give his administration independent, accurate, advice on technical questions that arose during the Civil War (e.g., how to make a compass work in a submarine, or how to tax alcohol content of different beverages).

It does not receive funding directly from Congress. Instead, individual federal agencies set up contracts with NASEM to answer specific questions. These contracts make up 70% of NASEM’s budget. The other 30% comes from private donations, which sometimes causes controversy (such as when the Sackler family donated millions of dollars to NASEM’s work on opioids). 

What did the NASEM peer review conclude?

The NASEM’s peer review of the EPA’s draft report was largely positive. It concluded the EPA’s draft “… follows the advice of prior National Academies reports and that its findings on hazard and quantitative risk are supported by the evidence identified.” 

Not surprisingly, this has not been well received by many who work in the industry sectors that rely on formaldehyde in their products, and who had submitted critical comments to the EPA regarding its process during the public comment period.

Most notably, the American Chemistry Council (ACC) stated in a press release:

“NASEM did not address the validity of the toxicity values in EPA’s 2022 draft IRIS assessment. These values are significantly out of step with international authorities, such as global health agencies and regulators, including the World Health Organization (WHO) and the European Chemicals Agency, which have used decades of scientific evidence by universities and independent scientists to support a safe threshold for formaldehyde exposure and no causal association with leukemia.”

In fact, ACC has been so critical of the EPA evaluations on formaldehyde over the years, and the recent report from NASEM, that it filed a lawsuit against the two organizations in July 2023. As Susan Goldhaber of The American Council on Science and Health describes it

“The ACC claims improper EPA control over the NASEM review violated the Federal Advisory Committee Act (FACA) [under which NASEM operates]. FACA requires that members of federal advisory committees be ‘fairly balanced’ in views represented and that ‘the advice and recommendations of the advisory committee not be inappropriately influenced by the appointing authority or by any special interest but will instead be the result of the advisory committee’s independent judgment.’

“The ACC lawsuit claims that EPA violated FACA by impermissibly controlling who was on the committee, and the issues allowed for discussion – only considering EPA’s view of the evidence. During ‘open sessions’ to solicit public comment on scientific matters, NASEM stated that its true goal is ‘to engage in a question-and-answer session with EPA’ and that ‘the committee’s view is that the sponsor, EPA, is best positioned to …. answer questions on the assessment of formaldehyde.’

“The ACC lawsuit concludes that ‘unreliable reports on formaldehyde promoted by the federal government create concrete and particularized injuries to members of ACC that regularly use the chemical to create products that modern society is dependent upon, [posing] unjustifiable hurdles and restrictions on all companies that use formaldehyde.”

Ms. Goldhaber ends with an important reflective question: Are these laws simply check-the-box activities, or do federal agencies need to implement them as they were intended, i.e., to provide real public input and diverse opinions on rule making that has the potential to affect the lives of every American?

Legal Newsline also wrote on the lawsuit and accusations on NASEM’s review committee, one of which is that the NASEM study director was previously a career scientist with the EPA’s IRIS program, and “… was actively involved in developing the agency’s formaldehyde assessment in 2012.” The ACC contends this conflict of interest was not disclosed as it should have been, as it was not included on the study director’s biography provided on NASEM’s website. It is possible the director’s own work on formaldehyde would be under review by the committee. 

Why should we care about formaldehyde?

The toxic effects review of formaldehyde is a good issue to use to evaluate EPA’s (and NASEM’s?) process because of its reach into so many products made, sold, and used in modern life. The chemical is found in many building materials, such as composite wood products and many everyday paper and household products. 

Formaldehyde is also used as a preservative in medicines, cosmetics, and dishwashing liquid. According to the Kitchen Cabinet Manufacturers Association, a trade group, formaldehyde is critically important across the economy. It directly impacts the employment of about 600,000 U.S. workers, and indirectly impacts an additional 3 million U.S. jobs. 

There are health concerns with exposure, especially when inhaled at high concentrations. However, this has been known for a long time and EPA has worked over its history to provide guidance on the levels of formaldehyde that workers and consumers can be safely exposed to.

The new concerns about formaldehyde that EPA is raising must be substantiated in sound, replicated science that is conducted in the most transparent manner possible. It is important to question and assess methods to be sure as much bias as possible is removed. And there is bias on all sides. While industry bias seems to be most often mentioned, there is also bias from anti-industry groups and individuals. 

We are all human and susceptible, often unconsciously, to the roots of our own influences. The scientific process is meant to overcome this as much as possible. 

What is the best science telling us, and do we need more quality studies before an objective judgement can be made? In order to retain public trust in their actions and guidance, both the EPA and the National Academies need to humble themselves and be open to what influences they may be working under.

There is good reason to follow this science closely to ensure it leads to accurate conclusions.