TSCA Risk Evaluation
EPA’s Formaldehyde Risk Evaluation Must Be Transparent and Science Based
Formaldehyde was identified as a high-priority candidate chemical for TSCA risk evaluation. It is important to note that a designation of formaldehyde as a high-priority chemical “does not constitute a finding of risk” and should not be cause for concern. A high-priority designation simply means the EPA has nominated formaldehyde for risk evaluation.
In order to complete an accurate TSCA risk evaluation of formaldehyde, 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. 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.
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. 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.
If EPA follows the required science protocols in conducting a transparent 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.
TSCA requires the use of the best available science, meaning that information must be of the highest quality 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.
EPA has made clear that designation as a high priority chemical “does not constitute a finding of risk” and should not be cause for concern. Formaldehyde plays an integral role in a wide variety of industrial applications across the automotive, aviation, textile, energy, and building and construction sectors. The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) has standards for workplace exposures to formaldehyde. These comprehensive health standards include limits on permissible exposures, requirements for monitoring employee exposures in the workplace, protective measures—including engineering controls, medical surveillance and communication—and training about hazards. Current standards, such as the OSHA Formaldehyde Standard, 29 C.F.R. § 1910.1048, protect the health of millions of workers and provide effective workplace controls for the production, storage, handling, and use of this important chemical.
A $1.35 million fee for each EPA-initiated risk evaluation will be divided among companies that have manufactured or imported the chemical substance in any volume in the past five years, including companies that have imported articles containing that substance.
After years of study, and hundreds of peer-reviewed scientific publications, the weight of the scientific evidence supports the conclusions that formaldehyde does not cause leukemia and there are clearly defined safe thresholds for formaldehyde exposure. These thresholds have been utilized by international scientific and regulatory bodies to develop risk-based exposure levels.