Latham’s Chemical Regulation & Product Defense Practice addresses the full range of challenges facing manufacturers, processors, and users of chemicals, worldwide. Latham lawyers guide clients through the regulations, politics, and potential liabilities arising throughout a chemical’s lifecycle — from new product approvals to product compliance, strategy and defense.
The firm regularly advises clients across the chemicals value chain, from chemical manufacturers to their downstream customers who rely on chemicals to produce an array of products, including: batteries, biocides, clothing, crops, cosmetics, drugs, engines, food, fuels, medical devices, pesticides, plastics, semiconductors, toys, vehicles, and other consumer products.
With a “follow the molecule” approach, Latham partners with clients to implement integrated technical and legal strategies to protect the company’s reputation and the commercial viability of its chemicals and products. Latham develops chemical and product defense strategies on a variety of fronts for new and existing products, including strategies for:
- Obtaining new product approvals and registrations, which may include removing barriers posed by lack of data or existing laws, regulations or policies
- Navigating the regulatory process to protect existing products, comply with conditions of approval and avoid supply chain disruption
- Responding to recalls and product claims
- Addressing compliance vulnerabilities through auditing and self-disclosure, and defending against enforcement actions
- Responding to or bringing litigation, with the defensive and offensive objectives and the potential regulatory and business interplay also in mind
- Evaluating potential indemnities that could enable or derail a merger or acquisition
Providing Integrated Solutions Across Jurisdictions
As chemical regulatory regimes vary widely across the globe, Latham regularly advises clients active in multiple regions — for example, with supply chains originating in Africa or Latin America, manufacturing in China, and industrial and retail product sales in heavily regulated markets in California or Europe. The firm helps clients develop effective business strategies to address the myriad and varying regulations in an integrated manner. Latham Chemical Regulation & Product Defense lawyers also frequently team with Latham litigators to serve clients seamlessly, thus ensuring that regulatory matters do not create litigation vulnerabilities and vice versa.
Latham lawyers are well-versed in a broad array of laws, regulatory programs, international agreements and voluntary programs governing chemical substances. Latham’s team has deep experience working with an array of prominent chemistries, and our team includes partners and associates with the know-how to navigate the intersection of the technical aspects of these chemistries with the various legal regimes.
Latham has long-standing experience advising clients regarding the following:
- International treaties and programs such as the Basel, Rotterdam, LRTAP, Stockholm, Chemicals Weapon, Drug Precursor and SAICM Conventions, and UN model rules for classification and labeling (GHS) and transport of dangerous goods.
- Statutes and initiatives implemented by the US Environmental Protection Agency (EPA), including Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the chemical aspects of nearly every other statute implemented by EPA such as Clean Air Act Hazardous Air Pollutants, and the Emergency Planning and Community Right to Know Act (EPCRA).
- Chemical and product regulatory programs of many other US agencies, including those under the Food, Drug and Cosmetic Act, Consumer Product Safety Act, Hazardous Materials Transportation Act, Occupational Safety and Health Act (OSHA), Vehicle Safety Act, and Federal Trade Commission (FTC) Act.
- US State laws governing chemicals, including California Proposition 65, California’s “Green Chemistry” program, and numerous others.
- Chemical management programs of the European Union, including Biocides Directive, Plant Protection Products Directive, REACH Regulation, Waste Electrical and Electronic Equipment (WEEE) Directive and Restriction of Hazardous Substances (RoHS) laws.
- Other chemical regulatory programs around the globe, including in Canada, Japan, China, Korea.
Developing Insightful Solutions
As one of the largest Chemical Regulation & Product Defense practices in the world, Latham draws on the insight of lawyers across the globe with backgrounds as in-house counsel, government regulators, and chemists. With more than 30 years of experience, often handling matters of first instance and advising on complex cross-border issues that defy bright-line answers, Latham Chemical Regulation & Product Defense lawyers draw on an immense work product library covering many specific chemicals to efficiently develop creative, sophisticated, and comprehensive solutions for market-leading global companies.
From traditional chemical regulatory issues to the new science around endocrine disruptors, biomonitoring and emerging contaminants, Latham has helped clients across the globe. Representative work includes:
- Handled a business-critical issue for a large automotive OEM concerning whether a chemical (developed and patented jointly by the OEM and the chemical’s manufacturer) was legal under TSCA to import and process in the United States. Latham developed and executed a multi- pronged approach that allowed EPA to make the regulatory chemistry judgments about TSCA Inventory status without supply disruption.
- Worked with a paints and coating manufacturer in responding to a FTC investigation of multiple companies into “VOC-free” and “low VOC” claims; because Latham also had advised the client at the front end on the substantiation required for making these claims and because the client had followed this advice, the client — in contrast to several other companies also under investigation — was able to avoid adverse action by the FTC.
- Assisted various chemical producers and consumer product manufacturers on numerous occasions in defending a product on multiple fronts at the same time, including one or more US federal agencies, the US Congress, class action/product liability litigation, media, and activists groups.
- Worked with semiconductor manufacturers to develop and implement short and long term Environmental Social Governance (ESG) and sustainability initiatives, including the metrics necessary to measure progress against those initiatives.
- Assisted numerous clients who manufacture, process and/or use chemicals in developing and implementing complex auditing programs to discover, correct, and disclose chemical regulation violations without enforcement penalties, including programs to perform strategic assessments for the Board of Directors and senior management regarding legal and technical trends that could impact a client’s core businesses and products.
- Represented a client in conjunction with an investigation by the US Chemical Safety Board following an explosion at a facility allegedly caused by improper handling of the client’s product.