The Toxic Substances Control Act (TSCA) gives the U.S. Environmental Protection Agency (EPA) the authority to evaluate and regulate chemicals to protect human health and the environment. Whether you’re introducing a new chemical or managing an existing one, understanding your obligations and responsibilities under TSCA is essential to maintaining compliance and avoiding costly regulatory delays.
TSCA covers a wide range of regulatory requirements, including reporting, recordkeeping, testing, and restrictions related to chemical substances used in manufacturing, processing, distribution and disposal.
Understanding TSCA requirements
Originally enacted in 1976 and significantly amended in 2016, TSCA now requires the EPA to:
- Evaluate existing chemicals using risk-based safety standards
- Increase transparency around chemical data by improving public access to these data while protecting confidential business information
- Prioritize chemicals for risk evaluation based on potential hazards and exposures
- Set and enforce compliance deadlines for manufacturers and importers to meet requirements related to chemical testing, reporting, and risk management
As of 2025, manufacturers and importers Are subject to new requirements under the amended TSCA provisions. These include stricter substantiation requirements for Confidential Business Information (CBI) and new risk management rules for certain high-priority chemicals identified through EPA’s risk evaluation process.
Key TSCA sections and what they mean for you
TSCA is structured into several sections, each granting the EPA specific regulatory authority:
- Section 4: Testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found
- Section 5: Require pre-manufacture notification (PMN) for “new chemical substances” before manufacture or import
- Section 5: Issue Significant New Use Rules (SNURs) when EPA identifies a significant new use that could result in exposures to, or releases of, a substance of concern
- Section 8(a): Require manufacturers (including importers) to report information on the production, use, exposure and disposal of chemicals in commerce Section 8(b): Maintain the TSCA Inventory, a comprehensive list of all existing chemical substances manufactured or processed in the US
- Section 8(c): Requires manufacturers (importers) and processors to keep records of significant adverse reactions to health or the environment that are reported to them
- Section 8(d): Requires manufacturers (including importers) of certain chemicals to report data from unpublished health and safety studies to the EPA, as determined by the EPA
- Section 8(e): Require that any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture, and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment, to immediately inform EPA, except where EPA has been adequately informed of such information
- Section 12(b): Requires exporters of certain chemical substances to notify the EPA when those substances are being exported, particularly if they are subject to specific TSCA rules or orders
- Section 13: Requires importers of chemical substances to certify compliance with TSCA regulations at the time of importation, typically through a TSCA import certification statement submitted to U.S. Customs and Border Protection
PFAS reporting and compliance
Under Section 8(a)(7) of TSCA, the EPA now requires manufacturers and importers of PFAS or PFAS-containing articles to report detailed information on these substances. This includes data on their uses, production volumes, byproducts, disposal practices, worker exposures, and environmental or health effects.
Any company that has manufactured or imported PFAS at any time between January 1, 2011 and December 31, 2022, must submit this information electronically through the EPA’s Central Data Exchange (CDX). The reporting period begins April 13, 2026, with a deadline of October 13, 2026, for most entities. However, small manufacturers reporting solely as article importers have until April 13, 2027, to submit their data.
Sagentia Regulatory supports clients in navigating these complex PFAS reporting requirements by:
- Identifying PFAS substances and uses subject to TSCA reporting
- Gathering and organizing historical data from 2011 – through 2022
- Preparing and the reports via EPA’s CDX system
- Providing guidance on effective recordkeeping and documentation practices
- Ensuring compliance with evolving PFAS-related rules and reporting deadlines
- Assisting with the protection of Confidential Business Information (CBI)
How Sagentia Regulatory supports TSCA compliance
Sagentia Regulatory provides end-to-end support for companies navigating TSCA regulations. Our services include:
- Preparing TSCA compliance manuals
- Preparing TSCA Section 5 applications (Premanufacture Notices (PMN), Significant New Use Notices (SNUN))
- Preparing TSCA exemption applications (Low Volume Exemption (LVE))Assisting with TSCA Section 5(e) consent order negotiations
- Making polymer exemption determinations
- Providing chemical import/export advice
- Assisting with chemical data reporting (CDR)
- Performing TSCA compliance audits
- Preparing TSCA inventory NOA Form B
- Preparing Microbial Commercial Activity Notices (MCAN)
- Preparing TSCA Environmental Release Application (TERA)
- Assisting with Confidential Business Information (CBI) substantiation
- Assisting with microbial characterization for MCAN and TERA
- Assisting with genetic manipulation data per requirements
- Assisting with production process and determine the Quality Control (QC) check points
- Determining if client qualifies for Tier I and Tier II exemptions
- Determining whether client qualifies for biotechnological Test Market Exemption Applications (TMEAs)
- Supporting PFAS reporting under TSCA Section 8(a)(7), including data collection, historical use analysis, and electronic submission via EPA’s CDX system
Why work with Sagentia Regulatory for TSCA compliance?
Our team combines regulatory insight with scientific expertise to help you meet TSCA requirements efficiently and confidently. We take the time to understand your goals, anticipate compliance challenges, and develop a strategic path forward. Our consultants are responsive, deadline-driven, and committed to long-term partnerships built on trust and confidentiality.
Meet our TSCA experts
Led by Steven Buchanan, our Washington, DC-based TSCA team includes Manuela Petrisor and Pete Stevenson – seasoned professionals with deep experience in chemical regulatory compliance.
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