Chemical Management and Compliance
Our global environmental team helps clients navigate the complexities of chemical and environmental management systems, regulations and statutes. In the U.S., this includes advising on the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act, ISO 14001, the Federal Insecticide, Fungicide, and Rodenticde Act and the Responsible Care Management System and RC 14001 standards, as well as similar programs in California. In Europe, our team of seasoned lawyers and litigators counsels multinational clients on the development and application of several environmental protection laws. This includes the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, the Classification, Labelling and Packaging (CLP) Regulation, the Biocidal Products Regulation and legislation on plant protection products to ensure continued market access, commercial operations and regulatory compliance.
Clients turn to our lawyers for innovative solutions to their most pressing chemical management issues in the U.S., Europe and around the world. Based in the U.S. and Brussels, our team works together across Sidley’s global offices to advocate on behalf of clients in a wide variety of sectors. Together with our international trade team, we represent clients in transactional, regulatory and litigation matters at the intersection of regional and international environmental law, including World Trade Organization rules and the Technical Barriers to Trade Agreement.
We bring value to our clients in the following ways:
- In-depth TSCA insight: Since its enactment in 1976, the TSCA has been the primary chemical regulatory regime in the U.S., governing how chemicals are brought into the market and establishing extensive reporting and data collection requirements. Our lawyers were directly involved in the successful efforts to substantively reform the TSCA in 2016, allowing us to provide clients with strategic advice on a range of TSCA regulations and proposals, including pre-manufacture review and notice for new chemicals, as well as options for the review and regulation of existing and new chemicals. Our advice also covers:
- TSCA Section 4 and 5 rules, as well as voluntary initiatives.
- Information collection and reporting under TSCA Section 8, including allegations of adverse effects, reporting substantial risk information and submitting human health studies.
- Chemical import certification and export notifications, including coordination with U.S. customs regulations.
- Rulemakings for the implementation of the new TSCA provisions.
- Legislative, regulatory and judicial advocacy: Our lawyers have been involved in efforts to adopt various international chemical agreements into U.S. law, including the Stockholm Convention on Persistent Organic Pollutants, the Rotterdam Convention on Prior Informed Consent and the Convention on Long-Range Transboundary Air Pollution. In addition, we have:
- Participated in rulemaking related to polychlorinated biphenyls (PCBs) and have led several successful appellate challenges to the EPA’s PCB regulations. Our experience also includes advising clients in cases involving several of the major PCB cleanup sites in the U.S.; allegations of the illegal disposal, use or transportation of PCBs; and maintaining compliance with PCB regulations.
- Extensive experience and a multifaceted team that includes lawyers who are government relations and advocacy experts. The team has a strong record of success in working on behalf of clients, both formally and informally, to advance policy priorities and navigate the federal interagency process at the EPA, other relevant agencies and within the Executive Office of the President.
- Risk assessment and counseling: We work closely with technical experts on the risks posed by chemicals, including toxicity (both human and eco-toxicity), exposure, environmental fate and transport. Our cross-functional environmental crisis management team assists clients on the range of issues associated with major incidents involving chemical security. In addition, we provide regulatory advice related to pesticide registrations, as well as toxic tort and product liability enforcement defense. We also have teams dedicated to advising on leading-edge issues such as sustainable development, climate change and biotechnology.
- Chemical safety and security: Our lawyers have been engaged in advising clients on compliance with the various regulatory programs related to safety and security at facilities that handle and use chemicals, such as the Clean Air Act’s Risk Management Plan program, the Chemical Facilities Antiterrorism Standards and OSHA’s Process Safety Management standard. We have provided both compliance counseling and policy guidance to help the implementing agencies change program elements.
- California Proposition 65, CARB and Green Chemistry: We routinely advise clients on a range of issues in connection with the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), including regulatory compliance, submittal of public comments on rulemaking, chemical listing evaluations, consumer and worker exposure assessments and the defense of 60-Day Notice of Intent to Sue letters. We also engage with the Office of the Attorney General, whether in defending a matter or in seeking or developing policy positions. We have successfully conducted a partial trial under Proposition 65, as well as an appeal, and secured the first alternative form of settlement under Civil Code Section 998. We aim to provide customized, innovative approaches to Proposition 65 litigation defense and compliance challenges to achieve the client’s priorities. We also handle enforcement proceedings under the consumer product regulations of the California Air Resources Board (CARB) and counsel clients on the evolution of California’s signature Safer Consumer Products Law (commonly known as the Green Chemistry Initiative). In addition, we advise on many California chemical content and product stewardship laws, ranging from pharmaceutical and electronics “take back” rules, to recycled content plastic container standards, to lead limits in toys, jewelry and other consumer products, to one-off legislation adopted to manage a single chemical, often after publicity. We also have resolved enforcement actions under California’s pesticide laws, which supplement the federal regime.
- State chemical content laws: With offices in the key environmental rulemaking jurisdictions of California, Illinois, Massachusetts, New York, Texas and Washington D.C., we are able to assist on a range of state proceedings. Our knowledge of the laws in these key jurisdictions, combined with our federal experience, enables us to help develop compliance systems for our clients that meet national and international standards, as well as varying state requirements.
In Europe, some of our focus areas include:
- Chemicals – authorizations, restrictions and bans: European policymakers are at the forefront of chemical rules and policy. We regularly update and advise clients on EU law and regulation, from early planning, legislative lobbying and day-to-day counseling to challenging decisions in the EU and national courts. We counsel clients and trade associations on all aspects of the chemical supply chain, including manufacturing, distribution and use, as well as transportation and disposal. We have deep experience on a number of EU regulatory frameworks, including REACH, Biocidal Products Regulation, Cosmetics Regulation, Plant Protection Products Regulation, Restriction of Hazardous Substances (RoHS) Directive, Water Framework Directive, pharmaceutical and medicinal products rules, food safety legislation and various climate change-related regulations.
- Chemical hazard classification: Significant legal consequences can be triggered by hazard classifications assigned under the EU’s CLP Regulation. We help clients identify those consequences, advocate for sound science through risk-based regulation and, when necessary, litigate unacceptable classifications. We also assist our clients with practical compliance matters caused by gaps and overlaps between the CLP Regulation and other labeling requirements, including under international transportation codes.
- Challenging EU regulations and decisions in the Court of Justice of the European Union: Our team handles some of the most high-profile regulatory litigation in the EU courts in Luxembourg. This includes litigating EU restrictions on the use of neonicotinoid substances in plant protection products on behalf of Bayer CropScience; representing CropLife America, the American Chemistry Counsel, and the National Association of Manufacturers in a joint intervention in the Court of Justice regarding access to regulatory information under the EU’s Aarhus Regulation; representing the global nickel industry in appealing the EU’s classification of virtually all known nickel substances; and acting on some of the first appeals regarding candidate listing and substance evaluation decisions under REACH.