Background - Practices (Details)

Chemicals

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Crowell & Moring's chemicals team helps companies to bring their chemical products to market and keep them there. We also work closely with our clients to anticipate, prepare for, and respond to challenges and threats to the chemistries they rely on.

Our chemicals team includes lawyers with technical backgrounds and provides broad-based and industry-focused assistance to leading multinational companies, smaller chemical companies, trade associations, and testing consortia with operations and interests in North America, Europe, Asia, and Australasia. We provide practical advice at every stage of a chemical product's lifespan, from intellectual property and risk management issues that arise during a product's development to regulatory approvals required to bring a product to market, as well as advising companies about ongoing compliance issues and defending companies and chemical products against regulatory challenges, litigation, and activist-driven campaigns.

Our chemicals team includes former government regulators and other practitioners with decades of experience in the regulation of chemical products. We regularly represent clients before the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC), Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration (DEA), and other federal and state regulatory agencies, including California's Department of Toxic Substances Control (DTSC) and California’s Office of Environmental Health Hazard Assessment (OEHHA).

Three pillars support the success of our chemicals practice: (1) we listen to our clients, strive to understand their objectives and needs, and work closely with them, as partners; (2) we have a deep and sophisticated understanding of the laws and regulations that impact the chemicals industry; and (3) we have built longstanding, trusting relationships with the relevant regulators over 30 years of practice.

Visit the TSCA Modernization Resource Center

Representative Engagements

  • We advised several global manufacturers and represented their interests on Capitol Hill during negotiations on TSCA modernization and the debate and discussions leading up to enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
  • We have assisted many clients in understanding and complying with the requirements of “New TSCA,” including "Inventory reset" reporting and reporting on nanoscale materials.
  • We regularly assist clients in obtaining new product clearances under TSCA, including novel product categories such as biotechnology products and products employing nanotechnology. We also have negotiated multiple TSCA section 5(e) consent orders and section 5(a)(2) significant new use rules for new chemicals, when needed to secure their access to the U.S. market.
  • We routinely counsel clients on labeling and testing requirements, import and export requirements, new product development, reporting and recordkeeping requirements, and the applicability of new regulations and evolving agency guidance.
  • We advise companies on legislative and regulatory initiatives at the state, federal and international levels concerning various chemicals of concern, including perfluorinated compounds, brominated flame retardants, bisphenol-A, and others.
  • We assist clients in preparing for and complying with emerging state regulatory programs governing chemical products, such as California’s Safer Consumer Product Regulations and Maine’s Act to Protect Children’s Health and the Environment from Toxic Chemicals in Toys and Children’s Products.
  • We often assist companies to defend themselves against enforcement actions brought by EPA and state regulatory agencies, and we frequently help companies to mitigate their risk of civil commentary penalties under TSCA by effectively using EPA’s Audit Policy, New Owner Policy, and Small Business Compliance Policy.
  • We have performed product regulatory due diligence in connection with many acquisitions and sales of chemical companies, business units, and product lines.
  • Finally, because the chemical industry is global, we assist clients through our Brussels office in identifying and complying with their obligations under the European Union’s Regulation Concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and related legislation in the EU.