Practices  |  Consumer Product Regulation

Commercial Chemicals and Toxic Substances Control Act (TSCA)

Overview

Wiley Rein is at the forefront of law firms assisting clients with managing the legal, regulatory, and policy issues affecting the manufacture, processing, distribution, and use of chemicals and the products that contain them. We are one of a small cadre of firms known for their strategic expertise in helping clients navigate the regulation of chemicals and toxics in the environment, the workplace, and in consumer products.

We have extensive experience handling matters arising under the Toxic Substances Control Act (TSCA), but we also work with clients on a wider range of issues impacting chemical substances, such as those arising under hazard communication and right-to-know laws (e.g., the federal Emergency Planning and Community Right-to-Know Act and California’s Proposition 65), the Occupational Safety and Health Act (OSHA), importation and Customs law, hazardous materials transportation laws, the Clean Air Act (Title VI) (ozone-depleting chemicals and their substitutes), and the Consumer Product Safety Act (as amended by the CPSIA). We have unique expertise with highly regulated chemical products, such as pesticides, food, drugs, and products of emerging technologies (bio-based substances and products of nanotechnology). We are known for providing effective regulatory strategies and successfully advocating on behalf of our clients before the U.S. Environmental Protection Agency and state-level regulatory agencies involved in regulating chemicals and consumer products.

Our attorneys specializing in TSCA routinely assist clients with matters involving premanufacture notifications (PMNs), significant new use rules (SNURs), chemical testing under TSCA Section 4, Section 8(e) enforcement actions, and issues surrounding the interface between TSCA and other statutes regulating chemical substances (including FIFRA and the FFDCA). Our “chemical team” of attorneys and regulatory analysts are also assisting clients with the sweeping reforms to TSCA enacted in June 2016 by P.L. 114-182, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). We are uniquely positioned to assist companies and trade associations in strategically evaluating and responding to the programmatic rulemakings now underway to implement LCSA reforms.    

Representative Experience

  • Advising a major automobile manufacturer on various regulatory issues involving PMNs and the applicability of the articles exemption.
  • Providing legislative analysis on all aspects of TSCA reform to major trade associations, industrial manufacturers, and major brand owners.
  • Crafting language on specialized aspects such as preemption, Section 8 reporting, and sustainable chemistry for consideration during the legislative process that led to enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
  • Successfully defending the rights of processors and downstream users to immediately commercialize nanomaterials in an EPA’s Section 8(a) notification rulemaking.
  • Successfully representing several manufacturers and importers against proposed regulations by EPA’s new chemical program.
  • Advising on more biotechnology microbial commercial activity notification (MCAN) matters than any other legal service provider.
  • Advising on accurate chemical nomenclature representations for global regulatory compliance.
  • Completing a successful TSCA audit for a multinational company that included a review of numerous toxicological test results for reporting as Section 8(e) substantial risk information.
  • Successfully negotiating alternatives to animal testing to defend a company’s freedom to operate and sell its coating products embedded with carbon nanotubes.
  • Currently serving as primary outside regulatory counsel to numerous industrial manufacturers and consumer products companies impacted by TSCA.

Contact Us

Tracy Heinzman
202.719.7106 | theinzman@wileyrein.com

Martha E. Marrapese
202.719.7156 | mmarrapese@wileyrein.com

Keith A. Matthews
202.719.4462 | kmatthews@wileyrein.com

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