Chemical substance regulation in the United States is primarily governed by the Toxic Substances Control Act (TSCA). By addressing the manufacture, importation, use, and disposal of chemicals, the TSCA seeks to avoid unjustified hazards to the environment and public health.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 was the most notable revision to TSCA, since it increased EPA's power to regulate chemicals.
Expert guidance on understanding TSCA requirements, including amendments from the Lautenberg Act, and developing tailored compliance strategies.
Assistance with preparing and submitting Premanufacture Notifications (PMNs) for new chemical substances.
Helping companies assess and manage risks associated with existing chemicals under TSCA, including responding to EPA information requests (e.g., Section 4, 8(d)).
Assistance with compiling and submitting data for the Chemical Data Reporting rule, which occurs every four years.
Guidance on TSCA compliance for chemicals and products entering or leaving the U.S. market.
Support for various reporting obligations under TSCA Section 8 (e.g., 8(a), 8(e)) for significant adverse reactions.
Helping identify TSCA-regulated substances within products and processes.
Educating teams on TSCA regulations, updates, and compliance best practices.
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Global PCCS has assessed over 2,000 unique chemical substances and 1,500 product formulations for TSCA compliance, helping clients understand their regulatory obligations in the U.S.
Through our comprehensive TSCA screening and compliance strategies, 99.5% of our clients' assessed chemicals and products were confirmed TSCA-compliant, facilitating smooth operations in the U.S. market.
Our expert team has prepared and successfully submitted over 120 PMN and SNUR notifications to the EPA, enabling our clients to introduce new chemicals and products to the U.S. market.
By outsourcing complex TSCA assessments and regulatory filings to Global PCCS, clients typically save an average of 4-6 weeks in regulatory approval time for new chemical introductions.
Our proactive TSCA services contributed to an estimated 95% reduction in potential non-compliance fines and import delays, safeguarding our clients' supply chains and market access in the U.S.
