Chemical Regulation

"The firm’s work ranges from occupational exposure and residential contamination of dwellings, to claims involving superfund sites."

The Legal 500 US 2020

Baker Botts environmental lawyers work with clients to comply with the network of federal and state laws regulating the manufacturing, processing, storage and use of chemical substances. We regularly advise and defend clients in connection with regulatory compliance and enforcement matters, as well as their obligations arising under U.S., foreign and international requirements for chemical products and hazardous, toxic and/or radioactive materials.

Toxic Substances Control Act (TSCA). Our environmental lawyers work with chemical producers, processors, importers and other clients on a wide variety of issues relating to chemicals management, import/export, hazard and risk analyses, supply chain, risk management planning, chemical reporting, test orders, premanufacture notices, protection of confidential business information, product stewardship, and other matters arising under TSCA and related environmental laws.

Emergency Planning and Community Right-to-Know Act (EPCRA). We have substantial experience assisting clients with EPCRA’s requirements for planning and coordination with local first responders, addressing accidental and emergency releases, maintaining effective hazard communication programs and satisfying applicable Tier II Chemical Inventory and annual Toxics Release Inventory reporting. We work with clients to protect trade secrets and confidential commercial information when complying with EPCRA. We also defend clients against EPCRA enforcement actions.

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Our FIFRA work includes advising clients on the applicability of the Act and compliance with the registration and use requirements of the Act, as well as related state statutes. We work with clients on the full range of pesticides – antimicrobials, fungicides, insecticides, and herbicides – and on products for large scale agriculture as well as for household and consumer use. We also advise clients on requirements and policies associated with pesticidal devices, emerging biotechnology products, and biostimulants, and on marketing claims that may implicate pesticide registration requirements. We defend against FIFRA enforcement actions, such as those alleging product misbranding or adulteration.

Emerging Issues. Our lawyers closely monitor and advise clients with regard to federal and state initiatives targeting emerging chemical contaminants, such as per- and poly-fluoroalkyl substances (PFAS), 1,4-dioxane and others. These activities have included, among other things, preparing comments on regulatory proposals, developing risk communication strategies, chemical fingerprinting, assisting with registration of products effective against SARS-CoV-2 (the novel coronavirus that causes COVID-19), analyzing the legal and regulatory risks associated with continued (or legacy) use of such substances, and advising on effective corporate programs to manage such risks.

Featured Experience

We advise clients on:

  • EPA stakeholder sessions in connection with the agency’s ongoing risk evaluation process for several designated high priority chemical substances
  • Completing the registration process under FIFRA, including addressing compensation requirements and technical consultations with EPA
  • Administrative EPCRA enforcement cases involving alleged failure to timely report accidental releases, complete necessary corrective actions, and/or file required follow-up reports federal and state authorities
  • Compliance obligations under TSCA § 12(b) for export notices, and under TSCA § 13 with respect to import certifications
  • Developing and filing “Premanufacture Notifications” (PMNs) for new chemical substances that have not yet entered commercial production
  • Compliance with Chemical Data Reporting (CDR) requirements established under TSCA § 8
  • Developing product claims and assessing product mode of action to ensure proper classification under FIFRA as a pesticide or device
  • Interpreting TRI reporting requirements for chemical use and disposal, including those for incidental byproducts
  • Preparing voluntary disclosures under EPA’s Audit Policy, including submissions under the Agency’s eDisclosure portal, regarding potential noncompliance with TSCA, EPCRA and FIFRA
  • EPA regulatory enforcement actions under TSCA, including alleged CDR noncompliance (and under the prior Inventory Update Rule (IUR) program) and violations of applicable import/export requirements
  • Regulatory compliance obligations under EU Directive 2002/95/EC on the Restriction of Hazardous Substances (RoHS) and EU Directive 2012/19/EU on Waste Electrical & Electronic Equipment (WEEE) (including recent amendments to these directives)
  • Key policy/regulatory ramifications associated with the European Union REACH program, including advice about substance information exchange forums (SIEFs) activities, and developing upstream and downstream hazard communication systems
  • FIFRA enforcement actions and “stop sale” orders
  • Assisting with regulatory agency interface on the full range of pesticides – antimicrobials, fungicides, insecticides, and herbicides – and on products for large scale agriculture as well as for household and consumer use