The U.S. Environmental Protection Agency (EPA) invited on July 6, 2022, small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) panel. The EPA seeks self-nominations directly from entities that may be subject to the rule requirements; self-nominations were due July 20, 2022. The panel focuses on the agency’s proposed rule to collect data to inform each step of the Toxic Substances Control Act (TSCA) risk evaluation and risk management process. Participating in the SBAR, or at least tracking its activities and engaging as much as possible, is encouraged. The reasons for engagement are discussed below.
Background
Chemical information is mission critical for the EPA. Data-gathering provisions, however, must be carefully calibrated to elicit useful information and not unnecessarily burden small businesses. This balance is tricky, given the growing complexity of chemical regulation, EPA’s enhanced authority under TSCA, and its requirement to complete risk evaluations to establish risk management controls.
The proposed rule would create a framework of reporting requirements based on a chemical’s status in the TSCA Section 6 risk evaluation/risk management lifecycle. The new data reporting rule also would enhance the exposure-related data collected through the TSCA Chemical Data Reporting (CDR) process. According to the EPA, collecting data geared specifically toward prioritization, risk evaluation, and risk management would help ensure it has relevant and timely data to inform each step of the process for reviewing potential risks from existing chemicals.
The data reporting rule, including changes to CDR, is tiered to specific stages of the TSCA Section 6 existing chemicals program and covers:
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 the EPA, tying specific reporting requirements to the activities that make use of reported data also will reduce the burden related to data collection efforts while ensuring the EPA has the information needed for its risk evaluations. The proposed rule will help to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. TSCA Sections 8(a) and 8(d) authorize the EPA 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.
The EPA states the potentially regulated community consists of entities that manufacture, import, or process chemical substances, including when the chemical substance is manufactured as a byproduct or is part of a formulated product or article (including import and processing). This collection activity will affect 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 will include federal representatives from the Small Business Administration, the Office of Management and Budget, and the EPA. Panel members will ask a selected group of SERs to provide advice and recommendations on behalf of their companies, levels of government, or organizations to inform them about the potential impacts of the proposed rule on small entities.
Discussion
The ongoing TSCA Section 6 risk evaluations significantly impact stakeholders in the industrial chemical community. The risk evaluations and subsequent risk management results will make or break the chemical substances being reviewed. The EPA is required by law to assess the chemical, its attributes, conditions of use, and potential for human health and environmental exposure. CDR information will be a critical component of the analysis. Stakeholders are urged to work closely with the EPA to ensure the correct information is submitted and that small business entities’ interests are well served.
