TSCA compliance support - USA

The Toxic Substances Control Act of 1976 (TSCA) grants the US Environmental Protection Agency (EPA) authority to collect data on chemicals used to evaluate, assess, mitigate and control risks that might be posed by their manufacture, processing and use. TSCA provides a variety of control methods to prevent chemicals from posing unreasonable risks, including reporting, recordkeeping and testing requirements and restrictions related to chemicals.

TSG assists clients in all aspects of TSCA compliance, including the notification of new chemicals, compliance audits, data reporting and record keeping.

Understanding the TSCA requirements

The Toxic Substances Control Act (TSCA) gives the Environmental Protection Agency (EPA) the authority to regulate new and existing chemicals. Although initially passed in 1976, the Act was amended in 2016 to include updated provisions that require the EPA to evaluate existing chemicals in a timely fashion, outline new risk-based safety standards, increase public transparency on chemical substances and differentiate chemical risk evaluations based on whether they present a high or low risk. As a result, there are deadlines for manufacturers and importers of chemical substances to meet in 2024 and beyond.

Different sections of TSCA provide EPA with various authorities, a few of which are listed below:

  • Section 5: Require pre-manufacture notification for "new chemical substances" before manufacture/import
  • Section 4: Testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found
  • Section 5: Issue Significant New Use Rules (SNURs) when it identifies a significant new use that could result in exposures to, or releases of, a substance of concern
  • Section 8(b): Maintain the TSCA Inventory
  • Sections 13 and 12(b) respectively: Require importers and exporters of chemicals, to comply with certification reporting and/or other requirements
  • Section 8(a): Require manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce in large quantities
  • 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

TSG can help

We can help with all aspects of chemical compliance under TSCA including:

  • Preparing TSCA compliance manuals
  • Preparing Premanufacture Notices (PMN)
  • Assisting with consent order negotiations
  • Preparing Significant New Use Notices (SNUN)
  • Making polymer exemption determinations
  • Preparing Low Volume Exemption applications (LVE)
  • 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)


TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

Our professionals

TSG's team of chemical experts, regulatory and environmental compliance consultants can help manage all aspects of TSCA compliance. Led by Steven Buchanan, our Washington DC-based team specializing in TSCA includes Manuela Petrisor and Pete Stevenson.

Useful information

Webinar: Mastering TSCA Compliance – Navigating Chemical Data Reporting 2024

Chaired by Senior Regulatory Consultant Pete Stevenson and delivered by Principal Consultant Steven Buchanan and Regulatory...

22 March 2024

Final TSCA fees rule | US EPA

The US Environmental Protection Agency (EPA) has published, on February 21, 2024, a final rule for TSCA fees. The final rule...

07 March 2024

US EPA requires Toxics Release Inventory reporting for seven additional PFAS

For TRI Reporting Year 2024, reporting is required for these seven additional PFAS, bringing the total PFAS subject to TRI...

02 February 2024

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