This week marked the four-year anniversary of the Toxic Substances Control Act (TSCA) as reformed by the Lautenberg Chemical Safety for the 21st Century Act (LCSA). This significant update created clear and enforceable requirements and deadlines for EPA to assess both new and existing chemicals through a risk-based review process and increased public transparency for chemical information.
In 2019, formaldehyde was identified as a high-priority candidate chemical for TSCA risk evaluation. It is important to note that a designation as a high-priority chemical “does not constitute a finding of risk” and should not be cause for concern.
The safety of formaldehyde products and addressing potential risks of exposure are important, and formaldehyde stakeholders have taken this responsibility seriously for years and continue to do so today. This is why formaldehyde stakeholders have, for decades, committed significant resources to scientific research in order to improve understanding of formaldehyde uses, exposure potential and risk. The results of this research have led to numerous peer-reviewed scientific publications.
Objective, Transparent and Sound Science
TSCA requires the use of the best available science, meaning that information should be of the highest quality and relevant to the evaluation in order to be included in the review. This type of evidence includes information on the hazard and exposure potential of the chemical substance; persistence and bioaccumulation; potentially exposed or susceptible subpopulations; the conditions of use or significant changes in the conditions of use of the chemical substance; and the volume or significant changes in the volume of the chemical substance manufactured or processed.
The importance of objective, transparent and sound science underpinning U.S. regulations cannot be overstated.
EPA’s implementation of TSCA is based on chemical evaluation tools and guidance documents that rely upon the best available science and weight of the scientific evidence. Accurate evaluation of formaldehyde and determining the levels at which formaldehyde from occupational, commercial and consumer exposures might cause adverse effects are absolutely critical. Central to this challenge is proper evaluation and integration of the entire body of scientific evidence, including human, animal and mechanistic information.
One critical element for the formaldehyde risk evaluation will be understanding formaldehyde’s role as a naturally occurring chemistry and how that may impact the assessment of human health risk from other sources. Given formaldehyde’s ubiquitous presence in air and its use as a building block chemistry to create materials present in homes and buildings, it is not surprising it can be detected at very low concentrations in indoor environments. A World Health Organization evaluation noted ambient air concentrations of formaldehyde in the range of 1.5ug/m3 – 16.4ug/m3 and indicated US indoor concentrations of formaldehyde were in the range of 21ug/m3 – 46ug/m3. However, formaldehyde is also produced naturally in the human body as a part of normal metabolic functions and is naturally present in a wide variety of fruits, vegetables, meats, fish and beverages. For example, a 2014 evaluation by the European Food Safety Authority found that human intracellular steady state concentrations of formaldehyde were estimated to be around 12mg/L and background levels in food products of formaldehyde ranged from 0.1mg/kg – 0.3mg/kg in milk to over 200mg/kg in some fish species. As EPA undertakes its evaluation of the available formaldehyde literature and potential risks, it will be critically important to adequately consider and integrate knowledge about exogenous and endogenous exposures and those exposures that could meaningfully alter normal human processes.
There are a number of completed, peer-reviewed studies that contribute to the body of scientific evidence related to understanding formaldehyde produced by the body versus formaldehyde generated from other sources. For example, a 2019 peer reviewed scientific research publication from the University of North Carolina (UNC) provides a recent example in a series of research studies conducted over the past decade. The study focused on low dose exposures and found that those low doses of exogenously produced formaldehyde (i.e., inhaled formaldehyde from the environment) did not cause health effects.
Furthermore, a recent article published by Frank Schnell on Science 2.0 also notes the need for increased emphasis on scientific data, especially when it comes to formaldehyde. Dr. Schnell notes risk assessments need to be based on scientific evidence rather than emotionally charged rhetoric. Risk assessments based on emotion and politics, instead of science, only create unwarranted regulations that are unlikely to result in additional health benefits.
Supporting Formaldehyde’s Review under TSCA
We appreciate the progress EPA has made identifying the conditions of use and exposure scenarios it will focus on for the formaldehyde risk evaluation. As a constructive public participant in the risk evaluation process, industry stakeholders submitted comments to the draft formaldehyde scoping document and are assembling the most relevant and best available scientific information that can inform the Agency throughout this process. This science continues to demonstrate that safe exposure thresholds to formaldehyde exist and uses are well managed.
The safety of the general public and workers is one of our top priorities, which is why industry supports formaldehyde’s review under TSCA. Numerous federal standards and regulations are in place to minimize formaldehyde emissions and any potential human health risks. For example, EPA’s regulations under TSCA Title VI, Formaldehyde Standards for Composite Wood Products, provide the most stringent formaldehyde product emissions standard in the world today.
Even though formaldehyde is already highly regulated by a number of agencies and exposures are generally low and controlled, it is understandable that the public may still have questions. EPA’s review of formaldehyde under the TSCA program will hopefully reassure workers and consumers that uses of formaldehyde chemistry are effectively managed using transparent, science-based standards.
 World Health Organization (WHO). 2010 Formaldehyde. In: Selected pollutants. WHO Guidelines for Indoor Air Quality. WHO, Regional Office for Europe, Copenhagen, Denmark, pp. 103-156.
 European Food Safety Authority (EFSA). 2014. Endogenous formaldehyde turnover in humans compared with exogenous contribution from food sources. EFSA Journal;12(2):3550