Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on July 6, 2022, that it is inviting small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel that will focus on EPA’s development of a proposed rule to collect data to inform each step of the Toxic Substances Control Act (TSCA) risk evaluation and risk management process. EPA states that the proposed rule would establish a framework of reporting requirements based on a chemical’s status in the TSCA Section 6 Risk Evaluation/Risk Management Lifecycle. Additionally, the new data reporting rule would enhance the exposure-related data collected through the TSCA Chemical Data Reporting (CDR) process. According to EPA, collecting data geared specifically towards prioritization, risk evaluation, and risk management would help ensure that EPA has relevant and timely data to inform each step of the process for reviewing potential risks from existing chemicals. Self-nominations are due July 20, 2022.

The data reporting rule, including changes to CDR, is tiered to specific stages of the TSCA Section 6 existing chemicals program:

  • Identifying a pre-prioritization pool of substances as potential candidates for prioritization;
  • Selecting candidate chemicals and completing the prioritization process; and
  • Assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation).

According to EPA, tying specific reporting requirements to the activities that make use of reported data will also reduce the burden related to data collection efforts while ensuring that EPA has the information it needs to fulfill its risk evaluation and risk management responsibilities. EPA intends the proposed rule to create a framework to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA’s ability to collect data under this proposed rule would derive from authorities in TSCA Sections 8(a) and 8(d), which give EPA authority to require:

  • Manufacturers and processors to provide known or reasonably ascertainable information, including chemical identity, production volumes, uses, byproducts, and worker exposure; and
  • Manufacturers, processors, and distributors to submit health and safety information.

EPA states that the potentially regulated community consists of entities that manufacture, import, or process chemical substances, potentially including when the chemical substance is manufactured as a byproduct or is part of a formulated product or article (including import and processing). According to EPA, it anticipates most respondents affected by this collection activity to be from the manufacturing sectors, including chemical manufacturing; petroleum and coal product manufacturing; chemical, petroleum, and merchant wholesalers; paper, plastics, paint, and printing ink manufacturing; electronic product and component manufacturing; or other activities, including utilities and construction.

The Panel, convened under the authority of the Small Business Regulatory Enforcement Fairness Act, will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. The Panel members ask a selected group of SERs to provide advice and recommendations on behalf of their company, government, or organization to inform the Panel members about the potential impacts of the proposed rule on small entities. EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.

More information on EPA’s July 27, 2021, webinar on the development of the rule is available in our July 29, 2021, memorandum.

Tags: CDR, SBAR, SER, tiered