Ä¢¹½tv

Agency proposes data reporting rule for unpublished health and safety studies as part of risk evaluation process under Toxic Substances Control Act

On March 25, the Environmental Protection Agency proposed a rule under the Toxic Substances Control Act (TSCA) that would require manufacturers and importers of  to report data from unpublished studies of health and safety; occupational, general population, and consumer exposures; and environmental effects. The proposed rule includes the five chemicals currently under EPA's prioritization process (acetaldehyde, acrylonitrile, benzenamine, MBOCA, and vinyl chloride) and 10 chemicals under consideration for prioritization action next year, including bisphenol A, ethylbenzene, hydrogen fluoride, and naphthalene. 

Chemical industry stakeholders will have 60 days following publication of the Federal Register notice to submit comments on the proposed rule at  under docket EPA-HQ-OPPT-2023-0360. Under the proposed data reporting rule, chemical manufacturers would need to refine or update exposure monitoring studies to meet the requirements EPA has developed for worker and consumer exposure data under their review.

Use of exposure data in TSCA's chemical risk evaluation process

Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to TSCA, EPA conducts risk evaluations for existing chemicals using a three-step approach: prioritization, risk evaluation, and risk management. Chemicals designated as high-priority substances undergo risk evaluation and, if unreasonable risk is determined, risk management. 

Throughout the risk evaluation process for a given chemical, EPA may request or accept industry-provided health and safety data, including occupational and consumer exposure studies, for consideration when identifying or evaluating high-priority substances or in setting final risk management regulations. Understanding how EPA has historically assessed exposure data in the risk evaluation process can help industry stakeholders better anticipate how additional data may be used and interpreted in future assessments. 

Data required under the proposed rule

Under the , EPA would require manufacturers who meet the defined criteria to submit a copy of existing or ongoing health and safety studies in the manufacturer's possession or any that are known to them. Among other data, the required information would include unpublished studies on occupational (inhalation and dermal), general population, and consumer exposures; toxicity studies; and environmental monitoring data. The submitted health and safety data would be used to inform all three steps in EPA's risk evaluation process for existing chemicals.

In December 2023, EPA announced it was beginning the . Going forward, the agency expects to initiate prioritization on five additional chemicals each year. EPA's approach to the risk evaluation process highlights the potential impact of the agency's proposed data reporting rule for health and safety studies and some of the challenges that manufacturers may face when collecting and evaluating exposure monitoring data.

As EPA is expected to incorporate the unpublished health and safety data into their risk evaluation process, chemical manufacturers will want to try to confirm that their exposure studies are sufficiently representative of relevant worker processes and activities under evaluation by EPA and that appropriate supporting documentation and context are provided with the data. Manufacturers may need to update existing exposure studies under the guidance of trained industrial hygienists so that the data meet EPA requirements for occupational exposure assessments and are properly interpreted by the agency.