The U.S. Environmental Protection Agency, and Food and Drug Administration, have had their eyes on formaldehyde for decades, but widespread scientific criticism of the EPA’s latest draft formaldehyde assessment has many worried it’s not using the highest quality methods and evidence to craft its guidance.

Formaldehyde is a widely recognized biologic preservative (think embalming fluid) but it is also used in plastic products, vaccines, medicine, adhesives, paper towels, makeup, insulation, cars, computers, furniture, cabinets and textiles, among hundreds of other products.

According to the Kitchen Cabinet Manufacturer’s 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.

But how safe is formaldehyde for workers who are exposed to it in their daily jobs, and the rest of us who may be exposed in the environment? 

It can be toxic to humans at certain exposure levels when inhaled. However, there is currently no scientific consensus on whether inhaled formaldehyde causes leukemia, including myeloid leukemia and other lymphohematopoietic (LHP) cancers. 

Even so, the EPA released a draft updated review on toxic effects of formaldehyde in April 2022 which claimed a direct causal relationship. The Center identified a number of problems with the agency’s process that led to its conclusion, and many scientific experts have questioned it based on a lack of mechanistic causal evidence. 

This new guidance, the first since 2011, is still being finalized and reviewed by EPA. We believe a strong systematic review, based on advances in the field that have allowed for more rigorous methodologies, including more transparency and replicability, would provide the agency with a better, clearer, picture of what is known. 

In the spirit of gathering better evidence, the Center issued a request for proposals from top researchers to conduct a fully independent, state-of-the-art systematic review of the literature exploring any possible relationship between myeloid leukemia and other LHP cancers, and human exposure to inhaled formaldehyde.

We received several applications from research teams representing top epidemiology and toxicology experts across the United States. Applications were evaluated and scored by an independent five-member panel of scientific experts, including epidemiologists, toxicologists, and risk analysts. It was a tough choice, but we are confident we picked the right team. 

The Center is pleased to announce that an excellent team from ToxStrategies, including experts on systematic review, toxicology, epidemiology, and formaldehyde, will be performing the systematic review, which is expected to be submitted for publication in late summer. The team will be led by Dr. Daniele Wikoff, Director of ToxStrategies’ Health Sciences Practice.

ToxStrategies is a scientific consulting firm with an impressive multidisciplinary team comprised of health scientists, regulatory specialists, and engineers who are recognized as leaders in their respective disciplines, and bring a high level of technical expertise to each project. The firm has extensive experience with systematic review and risk assessment associated with exposures to various consumer products, food ingredients and additives, pharmaceuticals, medical devices, pesticides, industrial chemicals, and environmental contaminants.

The systematic review protocol will be made publicly available either by means of registration on the international prospective register of systematic reviews (PROSPERO), or via posting on the repository, Open Science Framework (OSF), or both, in the next few months.

I have previously written about the importance of a well-executed systematic review, and how to interpret its findings. It is critical to have a review with:

  • A priori research questions
  • Established methodologies for article selection
  • Systematic determination of article quality and forms of bias

Since that blog, I’ve learned that transparency and replicability are necessary additions to this list of critical characteristics. 

The Center is excited to contribute to this area of science by funding such an outstanding group of investigators who will be applying these methods. We hope you will take some time to look at the protocol after it is made public.

We look forward to gaining new information regarding any causal relationship between inhaled formaldehyde and LHP cancers. In addition, we expect the review will identify priority areas for the next round of research needed to further understand the relationship.

In the meantime, we will be attending the 2023 Society of Toxicology annual meeting and expo in Nashville, TN. The event brings together more than 5,000 toxicologists and those working in related areas to share the latest science and technology in the field, including over 70 sessions and more than 2,000 poster presentations. 

Our previously funded research teams have given poster presentations at the conference in the past. We hope to see you there!