TSCA Risk Evaluation

Sahar Osman-Sypher

ACC Statement on EPA’s TSCA Risk Evaluation Framework Rule

ACC has issued the following statement in response to the EPA's release of the Risk Evaluation Framework Rule under TSCA.

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Cutting-Edge University Research

UNC Research Study Confirms Safe Levels of Exposure for Formaldehyde

Strengthen Transparency

EPA’s TSCA risk evaluation process provides a critical opportunity to strengthen the transparency, credibility, and quality of the science used to make regulatory decisions regarding the use of formaldehyde.

EPA’s Formaldehyde Risk Evaluation Puts Critical Industries in Jeopardy

The U.S. Environmental Protection Agency (EPA) has released its proposed risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA). We have substantial concerns with several aspects of EPA’s draft and believe these restrictions could jeopardize access to formaldehyde. In proposing unrealistic toxicity values for formaldehyde based on flawed data and science, the EPA is targeting a building-block chemistry essential to producing many of the products we rely on every day. If EPA continues on its current path, formaldehyde manufacturing and many of its downstream uses would be severely restricted or banned in the U.S.

Aerospace: Chemicals and polymers derived from formaldehyde are used in aerospace applications because of their flame resistance, thermal protection, and impact resistance. Learn more in our aerospace infographic
Agriculture: Formaldehyde helps American families access safe meat, poultry, and aquaculture products. Learn more in our agriculture infographic
Automotive: Formaldehyde-based technologies are used to make interior molded and under-the-hood components. Learn more in our automotive infographic
Building & Construction: Formaldehyde-based resins are used to make plywood, particleboard, and fiberboard along with numerous other applications for the housing industry. Learn more in our building and construction infographic
Medicine: Formaldehyde is used in the influenza, polio, and hepatitis vaccines to inactivate viruses and detoxify bacterial toxins. Learn more in our medicine infographic
National Security: Formaldehyde is used to make munitions and ballistics along with lightweight durable military equipment. Learn more in our national security infographic
Science & Preservation: Formaldehyde is used in biological research, microscopy, anatomical and forensic studies along with the preservation of specimens in museums. Learn more in our science and preservation infographic

Many recently completed peer-reviewed studies 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 numerous peer-reviewed scientific articles that have already been published and chemical reviews that have been conducted by federal and international agencies, evaluations must rely upon the highest quality and most relevant, recent 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 it will find that the responsible uses of formaldehyde, and any potential exposures, continue to be properly managed.

ACC Comments on EPA’s Draft Formaldehyde TSCA Risk Evaluation

Evaluation Not Based On Best Science And Sets Up Unachievable Workplace Limits That Threaten Vital Industries

Over 200 Comments Submitted

A diverse group of stakeholders, experts, and peer reviewers have identified major issues with EPA’s draft Formaldehyde Risk Evaluation under TSCA.

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EPA Formaldehyde TSCA Risk Evaluation 2024 Key Dates

May 7, 2024

Virtual Meeting on SACC Charge Questions

(May 3 at Noon Registration Deadline)

May 14, 2024

60-Day Comment Deadline for Draft TSCA Risk Evaluation

May 20-23, 2024

4-Day SACC Peer Review

December 2024

Projected Final Risk Evaluation Including "Unreasonable Risk" Determinations

TSCA Timeline

Completion/ Projected Completion		TSCA Risk Evaluation Element
Released on March 20, 2019		Preliminary TSCA High Priority Designation
December 2019		Final TSCA High Priority Designation • The Official Start of the Risk Evaluation Clock
April 2020		Draft TSCA Scoping Document • 90 Days After Final High Priority Designation • 45 Day Public Comment Period
August 2020		Final TSCA Scoping Document • 180 Days After Final High Priority Designation
September 2020		Publication of a Final List of Manufacturers Responsible for Payment
November 2020		Payment of TSCA Risk Evaluation Fees • 120 Days After Final Scoping Document
June 2021		Publication of a Revised Final List of Manufacturers Responsible for Payment
June 2021		Publication of TSCA Health and Safety Data Reporting Rule - Addition of 20 High-Priority Substances
December 2021		Submission Deadline for Unpublished Studies Pursuant to TSCA Health and Safety Data Reporting Rule
March 14, 2024		Draft TSCA Risk Evaluation Released • 60 Day Public Comment Period
May 7, 2024		Virtual SACC Meeting on Charge Questions • May 3rd comment deadline
May 14, 2024		Comment Deadline for Draft TSCA Risk Evaluation
May 20-23, 2024		4-Day Virtual SACC Peer Review • Opportunity for Public Comment
August 2, 2024		Final SACC Report Issued
August 20, 2024		Final IRIS Assessment Issued
Estimated by December 2024		Projected Final TSCA Risk Evaluation • Will include risk determination of whether formaldehyde constitutes an “unreasonable risk”
Estimated by December 2025		Propose risk management rule(s) for any unreasonable risk determinations found in the final risk evaluation • Due within 1 year after publishing a final risk evaluation
Estimated by December 2026		Finalize risk management rule(s) for any unreasonable risk determinations found in the final risk evaluation • Due within 2 years after publishing the final risk evaluation • EPA may extend these deadlines for up to two years provided the aggregate length of extensions for the section 6(a) rulemaking and the risk evaluation does not exceed 2 years.
Estimated December 2026-2031 Within 5 Years of Risk Management Rule		Establish mandatory compliance date(s) for restrictions or the start of a ban or phase-out based on final risk management rules. • Due within 5 years after a risk management rule is promulgated

FAQs

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.