TSCA Lookahead for 2024

The Toxic Substances Control Act (TSCA) will continue to have an impact on chemicals imported and manufactured in 2024. TSCA forms the backbone of regulatory oversight for chemicals in commerce within the United States, aiming to ensure their safe production, importation, and use. The quadrennial Chemical Data Reporting (CDR) window opens later this year for the 2020-2023 reporting period. While there are no significant rule changes to date, minor changes which were optional, carried over from 2020, and improvements to the 2024 CDR Tool will require careful review. More importantly to your company’s long-term strategy, U.S. EPA has continued its process to evaluate the safety of existing chemicals. Many of these compounds are used every day in industry as feedstocks, intermediates, and various consumer uses. Proposed risk mitigation regulations resulting from this process aim to reduce chemical exposure, in some cases placing restrictions on production or importation in as little as 18 months after the rule becomes final.

Reporting

The CDR Rule under 40 CFR Part 711, mandates that manufacturers and importers report information about the quantities and uses of chemical substances on the TSCA Inventory they produce or import if the quantities exceed the set thresholds. It operates on a four-year reporting cycle, where entities must report if they exceed the thresholds in any one year from the current cycle (2020-2023). There are currently more than 42,000 active chemicals in the inventory. The standard reporting requirement kicks in for manufacturing or importing 25,000 pounds or more of a TSCA-listed chemical at a single site within the current reporting cycle. A reduced threshold of 2,500 pounds applies to substances that are subject to certain TSCA actions. The TSCA action may also limit certain exemptions or limit the use of the small manufacturer exemption.

In the 2024 CDR cycle, the primary focus is on the calendar year 2023, for which manufacturers and importers are required to provide comprehensive manufacturing, processing, and use details. Additionally, they must report production volume data for each year from 2020 through 2023. Regularly, the largest CDR reporters are in the Petrochemical, Chemical, Pulp and Paper Manufacturing, and Oil and Gas Extraction Industries. It is never too early to dust off your 2020 report and begin reviewing your data sources for the 2024 report.

Look for a future 4 the Record article with more details about the 2024 CDR Tool and tips and tricks for collecting, summarizing, and reporting the data. This allows U.S. EPA to collect data to support chemical prioritization, risk assessment, and risk management activities, which have ramped up in recent years. Facilities will want to ensure the best information is available to U.S. EPA. ALL4 can assist your facility in preparing and submitting your CDR.

U.S. EPA Actions

TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21^st Century Act, requires U.S. EPA to evaluate the safety of existing chemicals via a three-stage process. The three stages of U.S. EPA’s process for ensuring the safety of existing chemicals are prioritization, risk evaluation, and risk management. The prioritization process considers the hazard/exposure, persistence, and bioaccumulation. However, the prioritization is not to consider non-risk factors (cost/benefits) in the prioritization process. At least 50% of the chemicals evaluated must come from the 2014 TSCA Work Plan, but others can be put into the que for review.  The 2014 update to the plan has 90 chemicals.

High-Priority designation of a chemical then initiates a risk evaluation. The evaluation must determine if the chemical presents an unreasonable risk to health or the environment under its “conditions of use.”  Again, U.S. EPA is not permitted under TSCA to consider non-risk factors as in the prioritization stage. Chemicals that are deemed to pose an unreasonable risk then move to the risk management process. In the final stage, U.S. EPA is required to implement by regulation, restrictions on the manufacture, processing, distribution, use, or disposal of a chemical. The risk management tools are broad from labeling up to and including a ban of the chemical or certain uses.

At each stage of the process there are avenues for public input. Public dockets have been opened for each chemical in the 2014 work plan. This allows for input by industry and end users to be submitted during a 90-day comment periods. To date 33 chemicals have ongoing or completed risk evaluations under TSCA. Of those, five have had proposed risk management rules published.

In December 2023, U.S. EPA announced it was beginning the prioritization process for five additional chemicals from the work plan: Acetaldehyde, Acrylonitrile, Benzenamine, MBOCA, and Vinyl Chloride. The publication in the Federal Register on December 18, 2023 initiated the 90-day comment period to supply data related to the hazard, exposure, and bioaccumulation. Their focus will be on exposure potential, build up in the environment, if the chemical is stored near significant drinking water sources among other evaluation points. Minimal comments have been received to date. It is imperative that U.S. EPA receive quality data to complete the prioritization evaluation. We see 2024 as a year of steady progress at all three stages of the regulatory process. If you manufacture or use these chemicals it will be important to track the progress because the recent U.S. EPA proposals for other chemicals include nearly complete bans.

Where do we go from here?

The three-step process of prioritization, risk evaluation, and risk management is a multi-year process. With opportunities to comment and provide valuable data to U.S. EPA at each stage, it is imperative to become part of the process early and often to influence the regulatory outcome for each of these chemicals. ALL4 can assist in identifying upcoming actions, evaluating data sets related to exposure and safety incidents, help suggest areas to bolster data collection, and provide comprehensive comments on risk evaluations and proposed risk management rules. For further assistance, please reach out one of ALL4’s EHS specialists or Scott Kirkpatrick at skirkpatrick@all4inc.com.