Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management under TSCA

Rule Summary 

EPA is developing a proposed rule for implementing a tiered data collection strategy to help inform the agency's prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). EPA wants to improve data collection strategies to better meet the agency's basic chemical data needs, such as information related to exposure, health, and eco-toxicity. Currently, EPA primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process.  

EPA is developing a proposed data reporting rule tiered to these specific stages of the TSCA existing chemicals evaluation process:  

• Identification of a pool of substances as potential candidates for prioritization; 

• Selection of candidate chemicals from the pool and completing the prioritization process; and  

• Assessment of high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). 

The agency held a public webinar on July 27, 2021 on the development of this proposed rule.  

EPA intends to convene a Small Business Advocacy Review (SBAR) Panel on this rulemaking. The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. Learn more about the SBAR panel.  

EPA anticipates publishing a proposed rule about six months after the SBAR panel is completed. 

Rule History 

A. Why is EPA developing this rule? 

TSCA requires EPA to evaluate the safety of existing chemical substances via a three-stage process comprised of prioritization, risk evaluation, and risk management. Under TSCA, EPA is required to have at least 20 chemical risk evaluations in progress at any given time on substances designated as high-priority substances. To do this, EPA needs to maintain a pool of potential candidate chemicals to ensure there are enough substances ready to be prioritized and—if designated a high-priority substance—to be evaluated for risk under TSCA. 

EPA is developing this framework rule to collect information targeted to the specific analyses completed by EPA at each stage of the existing chemicals evaluation process. Currently, the agency relies on CDR data to provide exposure-related information from chemical manufacturers (including importers). CDR information is submitted every four years and helps EPA to understand the types, amounts, end uses, and possible exposures to chemicals in commerce.  

The CDR database is the most comprehensive source currently available to EPA of basic screening-level, exposure-related information on chemicals. To meet its TSCA obligations to evaluate chemicals identified for the existing chemicals evaluation process, however, EPA needs additional, more detailed information. EPA would continue to use CDR to identify the chemicals that are potential candidates for prioritization and for other purposes. 

The proposed rule is expected to establish a framework of data reporting requirements to: 

• Collect information beyond the basic screening-level CDR data, including health and safety studies and exposure monitoring data; 

• Provide a more robust description of the supply chain, potentially including information from processors and about other situations (e.g., articles, byproducts) exempted from CDR, with the intent to more comprehensively identify the conditions of use to be evaluated for each chemical; and 

• Provide more detailed information needed for risk evaluations associated with the manufacture, processing, use, and disposal of each chemical. 

The proposed rule’s framework is expected to establish a series of reporting obligations for a limited number of chemicals based on their position in the existing chemicals evaluation process. As chemicals move through the existing chemicals evaluation process, other chemicals would be made subject to the appropriate reporting requirement, while chemicals that are determined to not be high priority or that have completed the evaluation process would be removed. 

B. What TSCA authorities is EPA considering using? 

Under TSCA section 8, EPA is authorized to collect certain information about chemical substances. EPA is considering using the authorities under TSCA sections 8(a), 8(c), and 8(d) to develop a framework rule that can be used to trigger the need to report information for each stage of the existing chemicals evaluation process. 

TSCA section 8(a)(1) authorizes EPA to promulgate rules under which manufacturers (including importers) and processors of chemical substances (other than small manufacturers or processors) must maintain such records and submit such information as EPA may reasonably require. The information includes, to the extent that it is known or reasonably ascertainable: chemical identity and related information; manufacturing (including importing) and processing information, including concerning byproducts; exposure-related information; and existing information concerning environmental and health effects. CDR, described above, is an example of a TSCA section 8(a)(1) rule. 

TSCA section 8(c) requires manufacturers, processors and distributors to maintain and, upon request, submit to EPA information such as: significant adverse reactions to health or the environment; consumer allegations of personal injury or harm to health; reports of occupational disease or injury; and reports of complaints of injury to the environment. 

TSCA section 8(d) requires manufacturers, processors and distributors to submit to EPA lists of health and safety studies that have been conducted or initiated by such persons or that are known or reasonably ascertainable, and, upon request, copies of such studies. The studies do not need to be published to be included in the submission. 

Additional Resources 

Review documents and other information associated with this rulemaking at docket EPA-HQ-OPPT-2021-0436 on www.regulations.gov. 

Read about EPA’s Existing Chemicals Program. 

Read about Chemical Data Reporting (CDR).