Toxic Substances Control Act (TSCA)

Steptoe’s Environment & Life Sciences Group has broad experience with the Toxic Substances Control Act (TSCA).  Our attorneys assist clients with TSCA regulatory and litigation matters, including compliance assistance and enforcement defense.  In addition, our integrated team includes scientists and consultants with technical backgrounds that make them invaluable in assisting clients with the scientific and technical questions that often arise under TSCA.  We work closely with chemical manufacturers, producers, importers, and exporters, as well as key trade associations.  We are active on many developing issues under TSCA, including Nanotechnologies, EPA’s Chemical Data Reporting (CDR) Rule, and TSCA legislative reform. 

Steptoe’s attorneys assist clients on the interface between TSCA and REACH.  The firm’s Brussels office has been actively involved in the implementation of the European Union’s REACH (EC Regulation 1907/2006 – the Registration, Evaluation, Authorisation and Restriction of Chemical substances) since its inception.  With its team of specialized lawyers (chemicals, life sciences, intellectual property, contract, competition, trade), and highly professional technical support, Steptoe offers a comprehensive chemical regulatory compliance solution to a broad spectrum of companies for both TSCA and REACH. 

Steptoe has substantial experience in assisting clients on a wide array of issues arising under TSCA, including specific experiences with:

  • EPA’s Nanoscale Materials Stewardship Program (NMSP)
  • High Production Volume (HPV) Chemical Challenge Program
  • Regulation of intergeneric microorganisms under TSCA
  • TSCA compliance audits and self-reporting of TSCA violations
  • Section 8(a), (d), and (e) recordkeeping and reporting requirements
  • PMN/Microbial Commercial Activity Notice requirements
  • Section 5 Significant New Use Rules (SNUR)
  • TSCA exemptions, including polymers, R&D chemicals, and articles
  • Providing advice and counsel on TSCA Imports and Exports by drawing on Steptoe's International Trade Group, which has extensive experience in customs law and assists importers and exporters on issues regarding US customs
  • Providing advice on potential overlap between TSCA, FIFRA and FFDCA regulation for multi-use products
  • TSCA preemption
  • Chemical Data Reporting (CDR) Rule (previously Inventory update rule)

 Representative Engagements

  • Developed a TSCA compliance system for a client that imports and exports intergeneric microorganisms
  • Assisted in self-reporting TSCA violations under EPA’s “Audit Policy” to avoid significant potential penalties
  • Developed and implemented a comprehensive TSCA compliance audit for a large, multinational chemical manufacturing client
  • Assisted with submission of information under the Nanoscale Materials Stewardship Program
  • Assisted with submission of comments to EPA policy decisions regarding nanotechnology