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Potential SBAR Panel: TSCA Section 8 Rule: Tiered Data Reporting (TDR) and Recordkeeping Requirements for Manufacturing (including Importing) and Processing of Certain Chemical Substances

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About the Rule

  • Title: Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management under the Toxic Substances Control Act (TSCA)
  • RIN: 2070-AK62
  • Docket: EPA-HQ-OPPT-2021-0436
  • Publication Date for Notice of Proposed Rulemaking (NPRM): The projected publication date will be available in the upcoming semiannual regulatory agenda

What is the Implication of the Proposed Rulemaking on Small Entities?

EPA is developing a rulemaking under sections 8(a) and 8(d) of the Toxic Substances Control Act (TSCA) to establish a framework of reporting requirements based upon a chemical’s status in the Risk Evaluation/Risk Management Lifecycle. Currently, the agency primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that its data collection strategies provide information to better meet the agency's basic chemical data needs, such as information related to exposure, health, and eco-toxicity.

To this end, EPA is developing a data reporting rule, including changes to CDR, that is tiered to specific stages of the TSCA existing chemicals program:

  • Identifying a pre-prioritization pool of substances as potential candidates for prioritization;
  • Selecting candidate chemicals for and completing the prioritization process; and
  • Assessing 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 proposed rule is intended to create a framework to obtain information about potential hazards and exposure pathways related to certain chemical substances, particularly occupational, environmental, and consumer exposure information. The subject chemical substances can vary, but initially may be those identified as a high-priority chemical substance, those listed on the 2014 workplan, or others that are of interest to EPA.

EPA’s ability to collect data under this proposed rule would derive from authorities in TSCA sections 8(a) and 8(d):

  • TSCA section 8(a) provides EPA the authority to require manufacturers and processors to report certain information known to or reasonably ascertainable by them, including information relating to chemical identity and structure, manufacture, use, disposal, worker exposure, and health and environmental effects, and to maintain records of such information.
  • TSCA section 8(d) provides EPA the authority to require manufacturers, processors, and distributors to submit certain health and safety study information to the agency. This information is needed to inform prioritization, risk evaluation, and risk management of chemical substances under TSCA section 6.

For chemicals that are actively being evaluated by EPA for potential risk management rulemaking actions, the agency is interested in obtaining information that will identify all conditions of use for the chemicals and the details needed for a risk evaluation. This may include information related to the manufacturing (including importing), processing, and use of certain chemical substances, including as byproducts, impurities, or as part of an article. The subject chemical substances can vary, but initially may be those identified as priority chemical substances, those listed on the 2014 workplan, or others that are of interest to EPA.

Tying specific reporting requirements to the activities that make use of such reported data will also help reduce the burden related to data collection efforts while ensuring that the agency has the information it needs to fulfill its risk evaluation and risk management responsibilities.

The potentially regulated community consists of entities that manufacture (including import) or process chemical substances. EPA’s previous experience with TSCA section 8(a) collections has shown that most respondents anticipated to be affected by this collection activity are from the following North American Industrial Classification System (NAICS) code categories:

  • NAICS 325 - Chemical Manufacturing;
  • NAICS 324 - Petroleum and Coal Product Manufacturing; and
  • NAICS 424 - Chemical, Petroleum and Merchant Wholesalers.

In addition to the anticipated respondents from the NAICS codes listed previously, the potentially regulated community includes manufacturers of byproducts that are required to report under certain TSCA section 8(a) rules, including CDR. Byproduct manufacturers may be listed under a different primary activity for a site, such as NAICS codes 22, 322, 327310, 331, 334, and 335, representing utilities, paper manufacturing, cement manufacturing, primary metal manufacturing, computer and electronic product manufacturing, and electrical equipment, appliance, and component manufacturing, respectively.

The potentially regulated community also includes processors of the subject chemicals. Processors may be listed under a different primary activity for a site, such as NAICS codes 11, 23, 32591, and 32551, representing agriculture forestry fishing and hunting, construction, printing ink manufacturing, and paint and coating manufacturing, respectively. The listed NAICS codes are examples and not a complete list.

Additional information related to this proposed rule is available on EPA’s web sites:

  • How EPA Evaluates the Safety of Existing Chemicals
  • 2014 TSCA Workplan Chemicals
  • 2021 Public Webinar on Proposed TSCA Data Reporting Rule

How Can I Learn More?

While the opportunity to participate on this Panel may have passed, you will have the chance to submit comments concerning this rulemaking during the standard public comment period commencing after publication of the notice of proposed rulemaking in the Federal Register.

Semiannual updates about the development status of the rulemaking are available on:

  • RegInfo.gov
  • EPA's Regulatory Agendas and Plans page

Regulatory Flexibility for Small Entities

  • Learn About the Regulatory Flexibility Act
  • Small Business Advocacy Review (SBAR) Panels
  • Small Entity Compliance Guides
  • Section 610 Reviews
  • Frequent Questions for Small Entities
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Last updated on June 24, 2024
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