I. Introduction
Formaldehyde is normally present in all tissues, cells and bodily fluids and that natural occurrence complicates any formaldehyde risk assessment.
National Academies of Sciences, Engineering, and Medicine (2011).
Throughout our daily lives, all of us are exposed to formaldehyde and always will be. After all, formaldehyde is an integral part of normal metabolism in humans and other animals; a product of all sorts of combustion, including wildfires; a natural decomposition byproduct of organic matter; and a product of the degradation of other chemicals. Formaldehyde is also a remarkably versatile chemical used to make a multitude of industrial and consumer products that we all rely on, from composite wood products to electronics.
EPA recognizes the ubiquitous nature of formaldehyde and that conducting a TSCA risk evaluation of formaldehyde poses unique challenges. Not only must EPA overcome the challenge of distinguishing formaldehyde exposures traceable to certain conditions of use (COUs) from all other sources, but it must evaluate the hazards from these exposures, all of which must be based on the best available science and the weight of scientific evidence. EPA fails to meet these challenges as made abundantly clear in the draft risk evaluation for formaldehyde (hereinafter “Draft RE”).
EPA confidently asserts that formaldehyde as a whole chemical presents unreasonable risk. In rendering this unreasonable risk determination, EPA clearly failed to assess potential risk from conditions of use of formaldehyde “within the broader context of all sources of 3 formaldehyde, some of which people have been exposed throughout the course of human existence.”
In the Draft RE, EPA did not separate background combustion sources from the TSCA COUs, nor was EPA able to distinguish formation of formaldehyde as a result of the degradation of other chemical compounds from the COUs. In its evaluation of specific COUs, EPA’s exposure estimates are riddled with uncertainties and unrealistic assumptions that only serve to exaggerate the estimated exposures and exacerbate the challenges of assessing and addressing unreasonable risk. Similarly, EPA’s overly conservative interpretation of the available hazard information – repeatedly criticized upon review by various scientific bodies – further obfuscates the Agency’s evaluation of real-life, actual risks associated with the COUs.
The Draft RE is plagued by fatal scientific and procedural deficiencies that cannot be corrected during the risk management phase as EPA appears to signal in an appendix tucked away in one of the documents that constitute the sprawling Draft RE. Indeed, TSCA’s legislative history makes clear that demonstrating “the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture,” which is a required element of any risk management rule under TSCA Section 6(c)(2)(A), does “not require EPA to conduct a second risk evaluation-like analysis to identify the specified information, but rather, can satisfy these requirements on the basis of the conclusions regarding the chemical’s health and environmental effects and exposures in the risk evaluation itself.” EPA cannot abdicate its duty to accurately evaluate the risks associated with each COU during risk evaluation, in hopes that the Agency will develop “new information collection or development” during the risk management stage.
The stakes could not be higher. EPA’s preliminary determination that formaldehyde presents unreasonable risks, if left unaltered, will have profound impacts on the entire economy as EPA unleashes its regulatory arsenal to address those unreasonable risks, however unreal. EPA recognizes it is at a critical juncture in the development of the Draft RE, as it awaits public and peer review comments on both the formaldehyde hazard and exposure assessments, the two key ingredients of any risk evaluation. In finalizing the formaldehyde risk evaluation, EPA has the choice to either fulfill its obligations under TSCA and ensure that the risk evaluation truly reflects the TSCA scientific standards of best available science and weight of the scientific evidence, or to hold fast to its current approach that EPA rightly fears “compounds conservative assumptions, leading to unrealistic or un-addressable outcomes.”4
Comments on Draft Formaldehyde Risk Evaluation under the Toxic Substances Control Act (TSCA)
I. Introduction
Formaldehyde is normally present in all tissues, cells and bodily fluids and that natural occurrence complicates any formaldehyde risk assessment.
National Academies of Sciences, Engineering, and Medicine (2011).
Throughout our daily lives, all of us are exposed to formaldehyde and always will be. After all, formaldehyde is an integral part of normal metabolism in humans and other animals; a product of all sorts of combustion, including wildfires; a natural decomposition byproduct of organic matter; and a product of the degradation of other chemicals. Formaldehyde is also a remarkably versatile chemical used to make a multitude of industrial and consumer products that we all rely on, from composite wood products to electronics.
EPA recognizes the ubiquitous nature of formaldehyde and that conducting a TSCA risk evaluation of formaldehyde poses unique challenges. Not only must EPA overcome the challenge of distinguishing formaldehyde exposures traceable to certain conditions of use (COUs) from all other sources, but it must evaluate the hazards from these exposures, all of which must be based on the best available science and the weight of scientific evidence. EPA fails to meet these challenges as made abundantly clear in the draft risk evaluation for formaldehyde (hereinafter “Draft RE”).
EPA confidently asserts that formaldehyde as a whole chemical presents unreasonable risk. In rendering this unreasonable risk determination, EPA clearly failed to assess potential risk from conditions of use of formaldehyde “within the broader context of all sources of 3 formaldehyde, some of which people have been exposed throughout the course of human existence.”
In the Draft RE, EPA did not separate background combustion sources from the TSCA COUs, nor was EPA able to distinguish formation of formaldehyde as a result of the degradation of other chemical compounds from the COUs. In its evaluation of specific COUs, EPA’s exposure estimates are riddled with uncertainties and unrealistic assumptions that only serve to exaggerate the estimated exposures and exacerbate the challenges of assessing and addressing unreasonable risk. Similarly, EPA’s overly conservative interpretation of the available hazard information – repeatedly criticized upon review by various scientific bodies – further obfuscates the Agency’s evaluation of real-life, actual risks associated with the COUs.
The Draft RE is plagued by fatal scientific and procedural deficiencies that cannot be corrected during the risk management phase as EPA appears to signal in an appendix tucked away in one of the documents that constitute the sprawling Draft RE. Indeed, TSCA’s legislative history makes clear that demonstrating “the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture,” which is a required element of any risk management rule under TSCA Section 6(c)(2)(A), does “not require EPA to conduct a second risk evaluation-like analysis to identify the specified information, but rather, can satisfy these requirements on the basis of the conclusions regarding the chemical’s health and environmental effects and exposures in the risk evaluation itself.” EPA cannot abdicate its duty to accurately evaluate the risks associated with each COU during risk evaluation, in hopes that the Agency will develop “new information collection or development” during the risk management stage.
The stakes could not be higher. EPA’s preliminary determination that formaldehyde presents unreasonable risks, if left unaltered, will have profound impacts on the entire economy as EPA unleashes its regulatory arsenal to address those unreasonable risks, however unreal. EPA recognizes it is at a critical juncture in the development of the Draft RE, as it awaits public and peer review comments on both the formaldehyde hazard and exposure assessments, the two key ingredients of any risk evaluation. In finalizing the formaldehyde risk evaluation, EPA has the choice to either fulfill its obligations under TSCA and ensure that the risk evaluation truly reflects the TSCA scientific standards of best available science and weight of the scientific evidence, or to hold fast to its current approach that EPA rightly fears “compounds conservative assumptions, leading to unrealistic or un-addressable outcomes.”4