化学物質の管理とコンプライアンス

Our U.S. team is distinguished by:

• Market-Leading TSCA Insight: Our team is particularly adept in helping clients — from multinational corporations to emerging startups — efficiently navigate U.S. Environmental Protection Agency (EPA) requirements for chemicals. Since its enactment in 1976, 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 TSCA in 2016, as well as in representing challengers to later EPA regulations based on those amendments. We provide clients with strategic advice on a range of TSCA requirements and proposals, such as:
  • Manufacturing and importing new chemical manufacturing, including filing bona fide notices of intent, pre-manufacture notifications, and import certifications
  • Data collection and reporting under EPA’s Chemical Data Reporting rule
  • Engaging with EPA on its evaluation, and proposed restrictions, of existing high-priority chemicals
  • Compliance with TSCA Title VI requirements for composite wood products (and related requirements from the California Air Resources Board)
• Federal and California Pesticide Law Compliance:
  • Our team, which includes a former U.S. EPA official who oversaw federal pesticide enforcement actions, advises clients on the full spectrum of federal pesticide law compliance issues under FIFRA. This includes:
    • Advising manufacturers of conventional, antimicrobial, and biopesticidal pesticides on registration with U.S. EPA, including expedited pathways
    • Antimicrobial surface and air disinfectant pesticide registration and regulatory compliance
    • Virucidal disinfectant efficacy claims, including for emerging viral pathogens, such as SARS-CoV-2, the virus that causes COVID-19
    • Pesticidal device compliance issues, including labeling review and laboratory testing to support on-label efficacy claims
    • Pesticide product and device import and export matters, including representing clients where U.S. EPA or U.S. Customs and Border Protection has detained a pesticide import and issued a notice of refusal of admission
    • Advising sellers and distributors of pesticides and pesticide devices on regulatory compliance questions
    • Defending against U.S. EPA enforcement actions alleging violations of federal pesticide law, including alleged sale or distribution of unregistered or misbranded pesticides, as well as negotiating administrative settlement agreements with the EPA
    • EPA establishment registration, labeling compliance, and annual reporting requirements
  • Sidley’s pesticide law compliance team is well-versed in advising on California pesticide law compliance, including navigating Department of Pesticide Regulation audits, the state pesticide mill assessment program, and enforcement actions alleging sale or distribution of unregistered or misbranded pesticides into the state.
  • We routinely advise clients on issues that cut across federal pesticide laws under FIFRA and U.S. Food and Drug Administration jurisdiction under the Federal Food, Drug, and Cosmetics Act.
• Diverse Experience in California Proposition 65: We advise many clients on a range of issues in connection with the California Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65, including regulatory compliance, comments on rulemaking, chemical listing evaluations, and consumer and worker exposure assessments. We regularly represent manufacturers and retailers in defending 60-Day Notice of Intent to Sue letters and facing Proposition 65 claims in California state courts. 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 negotiated numerous Proposition 65 settlements and represented clients in trials conducted under Proposition 65. We aim to provide customized, innovative approaches to Proposition 65 litigation defense and compliance challenges to achieve our clients’ goals in the most efficient and cost-effective manner.
• Waste Management and Chemical Safety and Security: Our lawyers advise clients on compliance with the various regulatory programs related to safety and security at facilities that handle and use chemicals. We provide both compliance counseling and policy guidance to help the implementing agencies change program elements. Members of our team focus on:
  • Waste management and disposal under the Resource Conservation and Recovery Act and analogous state laws
  • The Clean Air Act’s Risk Management Plan program
  • The Department of Homeland Security’s Chemical Facility Antiterrorism Standards
  • Reporting for hazardous substances under EPCRA and CERCLA
  • OSHA’s Process Safety Management regulations
• Environmental Marketing and Consumer Protection: We counsel e-commerce companies, manufacturers, and retailers on environmental and sustainability claims in marketing under the U.S. Federal Trade Commission regulations and related consumer protection laws. Our team advises companies on complying with the Guides for the Use of Environmental Marketing Claims at 40 C.F.R. Part 260, also known as the “Green Guides.”
• State Chemical Control and “Green Chemistry” Experience: With offices in the key environmental rule-making 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, helps us develop compliance systems for our clients that meet national and international standards, as well as varying state requirements. We handle compliance counseling and enforcement proceedings under:
  • California’s signature Safer Consumer Products Law (commonly known as the Green Chemistry Initiative) and related initiatives from other states
  • Children’s products chemical restrictions issued by various states, as well as overlap with U.S. Consumer Product Safety Commission requirements
  • Pharmaceutical and electronics “take back” rules
• Navigating Enforcement and Voluntary Disclosures: Sidley’s team advises clients facing information requests and enforcement investigations from federal and state agencies on regulated chemicals and products, including imported high-risk chemicals and products containing emerging contaminants, such as per- and polyfluoroalkyl substances. We also devise strategies for dealing with potential noncompliance situations, engaging with agencies in order to mitigate penalties and other risks, including under EPA’s Audit Policy. Our team includes a former senior official at U.S. EPA who oversaw large enforcement actions, as well as the EPA Audit Policy while at the agency.
• Guiding Legislative and Regulatory Advocacy: Our multifaceted team includes lawyers who are leading practitioners in federal and state government relations and advocacy. Working on behalf of our clients, both formally and informally, we have a proven record of advancing policy priorities and navigating the federal interagency process at the EPA, other relevant federal agencies, state agencies, and within the Executive Office of the President. More broadly, 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. We also advise clients on:
  • Filing comments on proposed rule-makings
  • Challenging new rules under the Administrative Procedure Act or on other grounds

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 laws and regulations — 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 in-depth knowledge of a number of EU regulatory frameworks, including REACH, Biocidal Products Regulation, Cosmetics Regulation, Plant Protection Products Regulation, Restriction of Hazardous Substances 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, advocating for sound science through risk-based regulation and, when necessary, litigating 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.