Practices
Environmental
Industrial and Specialty Chemical Compliance

Industrial and Specialty Chemical Compliance

Shipman’s lawyers in the industrial and specialty chemical compliance practice assist manufacturers, importers, distributors, processors, laboratories and healthcare facilities with placing new and existing chemical substances into the marketplace, keeping the substances in commerce and properly handling and/or disposing of them. We assist clients with ensuring ongoing compliance with evolving state and federal registration, labeling, import/export, hazard communication, hazard response, health and safety laws and regulations, and other requirements. Our attorneys regularly practice before the federal Environmental Protection Agency (EPA), Occupation Safety and Health Administration (OSHA), National Institute of Occupational Safety and Health (NIOSH) and similar state agencies. We also counsel clients on cross-border issues, including in Canada, Mexico, Switzerland, Iran and Costa Rica.

Additionally, our lawyers:

Design and oversee environmental, health and safety assessments/audits
Evaluate and manage compliance programs and environmental management systems
Coordinate safety test consultations
Oversee health hazard evaluations
Design and review workplace health and safety labeling
Represent clients in administrative enforcement proceedings
Defend product liability claims

We assist clients in identifying, managing and applying for regulatory approvals to manufacture or import chemical substances (including biocides), and guide applicants through the administrative process, including through contested cases and litigation support on appeals. During the regulatory approval process, we interface with national and international consultants and laboratories to ensure relevant tests are performed for the pertinent reviewing agency.

We also counsel clients through administrative enforcement proceedings at federal and state levels, as well as in connection with voluntary disclosures and during negotiations of consent agreements and other settlement vehicles.

We advocate for clients throughout all phases of government investigations, including site visits and inspections by government agencies.

Experience

Industrial and specialty chemical compliance

Quarantine, Voluntary Disclosure and Corrective Action Plan

Upon discovery of potential TSCA violations, performed internal investigation and drafted voluntary self-disclosure to EPA on behalf of specialty chemical company. Represented client in meeting with EPA enforcement office, emphasized favorable conditions and behavior, resulting in mutually agreeable Consent Agreement and Final Order with lowest penalty allowed by EPA Audit Policy. Prepared Low Volume Exemption (LVE) application for subject substance in parallel with enforcement proceedings, resulting in sufficient authorized import volumes for client’s business needs. Peripheral support activities included implementation of quarantine and monitoring of affected containers, collaboration with substance manufacturer/supplier, advising on Safety Data Sheet content and documenting waste/release procedures.

Completion of Domestic and Foreign Chemical Substance Notifications

Successfully guided specialty chemical company through EPA Premanufacture Notice (PMN) process, resulting in the substance’s addition to the TSCA inventory. Similarly, guided client through Environment Canada’s New Substance Notification (NSN) Process, resulting in the substance’s addition to the Domestic Substances List (DSL). Peripheral support activities included the filing of a Bona Fide Notice to Import or Manufacture, utilizing Inventory Expert Service (IES) to document CAS Registry Name and Number, evaluating feasibility of Polymer Exemption and Reduced Regulatory Requirement (RRR) Polymer registration paths, arrangement of gel permeation chromatography (GPC) testing, assessment of confidential business information and leading discussions with domestic and foreign partners and governments.

Advised Manufacturer on Domestic and International Specialty Chemical Compliance Matters

Represented an international metalworking fluid developer, manufacturer and service provider. Assisted with registrations and compliance for new products and ingredients under applicable state and federal laws, including the recent substantive amendments to the federal Toxic Substances Control Act (TSCA). Also advised on federal and state hazard warning/labeling requirements and on the regulatory/compliance aspects of potential formula and manufacturing process changes.