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Formaldehyde and the Need for Best Available Science

As we move forward in our series on the importance of the 2016 TSCA amendments, the next chemical we are going to focus on is one that you may be somewhat familiar with, formaldehyde. Formaldehyde is a critical building block chemical, but you may have heard mixed messages about this chemical compound. This blog dives into the science surrounding this naturally-occurring chemical, highlights the importance of integrating all the lines of scientific evidence and discusses how open, science-based, transparent discussions with all stakeholders are critical to understanding and determining the risks associated with formaldehyde.

Will Science Win the Day?

What do you think of when you hear the word “formaldehyde?” Do you think of the human body, trees, fruits, vegetables and meats? Do you know that formaldehyde is naturally present in all of these things? In fact, formaldehyde is naturally produced in the human body through a variety of normal metabolic functions.

Formaldehyde is also used in the production of hundreds of items and plays an important role in everyday life. Not only is the generation of formaldehyde essential for human metabolism, but it is also used as part of the manufacturing process for many materials that we depend upon regularly. Take, for example, plywood, medical devices, and seat belt buckles, where little or no formaldehyde is present in the final products.

Science shows that everyday exposures to inhaled formaldehyde do not reach the lungs or other distant sites in the body. Yet, media stories continue to allege dangerous effects from these low level exposures, and a meaningful segment of the public continues to be misinformed about the science.

This isn’t to say exposure to high levels of formaldehyde is completely harmless. In fact, at very high concentrations it is used by morticians to preserve bodies. However, decades of peer reviewed formaldehyde scientific studies continue to reinforce a threshold mechanism for this chemical compound. Published scientific studies indicate that lifetime exposure to high levels of formaldehyde in air can cause nasal cancer in laboratory animals, however these levels are well above workers’ and the public’s every day exposure. A threshold is the amount of something that humans can be exposed to on a typical basis without experiencing adverse health effects. According to the large body of research available, the low levels of formaldehyde to which workers and the public are exposed are highly unlikely to lead to any adverse health effects.

Science is ever-evolving; research that was once relevant may now be obsolete or disproved by new, more advanced science. That’s why EPA must adhere to the 2016 TSCA amendments for current and future risk evaluations. These amendments require the use of the best available science and weight of scientific evidence when it comes to evaluating risk. The 2016 TSCA amendments also establish a transparent systematic review process, a clearly defined approach to identifying relevant scientific information, evaluating the quality of data, and weighing the information.  

Formaldehyde Has a Threshold Mechanism, and Recent Studies Agree

There are safe exposure levels of formaldehyde, otherwise our bodies wouldn’t rely on it to survive. That is why accurate evaluation of formaldehyde and determining the levels at which formaldehyde from occupational, commercial and consumer exposures might cause adverse effects is critical. Central to this challenge is proper evaluation and integration of the entire body of scientific evidence, including human, animal and mechanistic information to draw conclusions regarding risk.

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. In 2010, the World Health Organization (WHO) established indoor air quality guidelines for short-term and long-term exposures to formaldehyde using a threshold. The WHO evaluated potential non-cancer and cancer effects and noted that its threshold value would be protective of all adverse human health effects.

As mentioned earlier, 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 (external) and endogenous (internal) exposures and those exposures that could meaningfully alter normal human processes.

There are a number of recently completed, peer-reviewed studies that have meaningfully advanced the body of scientific evidence related to understanding formaldehyde produced by the body versus inhaled formaldehyde generated from other sources.  More than a decade’s worth of research from scientists at the University of North Carolina at Chapel Hill (UNC) has characterized the difference between exogenous and endogenous formaldehyde. For example, a 2019 peer reviewed scientific research publication that focused on low dose exposures found that those low doses of exogenously produced formaldehyde (i.e., inhaled formaldehyde from the environment) did not cause any measurable change in the concentrations of formaldehyde naturally found in the body.

Given the thousands of peer reviewed scientific articles that have been published, and dozens of chemical reviews that have been conducted by federal and international agencies, it is crucial for evaluations to rely upon the highest quality and most relevant information when determining risk. This is done through a systematic review process, which is required by the 2016 TSCA amendments. A systematic review process is a pre-established set of protocols that comprehensively, objectively, transparently, and consistently identifies and evaluates evidence based on quality and relevance.   

ACC Supports 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. The safety of the general public and workers is a top priority, which is why industry supports an updated formaldehyde review under TSCA. ACC is confident that when EPA follows the required science protocols in conducting a risk evaluation of formaldehyde, using the best available, highest quality and most relevant data will demonstrate that the responsible uses of formaldehyde, and any potential exposures, continue to be properly managed.

Are you interested in the impact of the TSCA risk evaluation process on other chemicals? Check out the rest of our four-part blog series here: 1,4-dioxane and 1,3 butadiene.

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