The Toxic Substances Control Act (TSCA)
The Toxic Substances Control Act (TSCA) is the primary U.S. law regulating chemicals. Whether you are manufacturing a new substance or importing an existing one, you must ensure it is either on the TSCA Inventory or qualifies for an exemption. Navigating these requirements is essential to keep your products on the market and avoid significant legal or financial penalties.
Our Offerings
We verify the status of your substances and assist with the mandatory "positive" or "negative" import certifications required for every chemical shipment.
Our experts prepare and submit Premanufacture Notifications (PMNs) and manage communication with the EPA to expedite your product's commercialization.
We manage the complex collection and submission of data for substances manufactured or imported above specific volume thresholds, typically every four years.
We conduct in-depth reviews of your internal processes to identify gaps, mitigate risks, and develop robust Standard Operating Procedures (SOPs).
TSCA Deadlines
New chemicals require a PMN at least 90 days before you intend to manufacture or import.
Large-volume manufacturers must report data during the designated four-year cycles (e.g., the 2024 CDR period).
Importers of specific high-priority chemicals may be subject to strict data submission deadlines (often within 60 days of a rule's finalization).
Related Services
Helix Digital Intelligence
Use our proactive software to monitor regulatory changes and manage your chemical data in real-time.
TSCA Training & Workshops
Specialized training for your staff to master TSCA fundamentals and stay updated on evolving EPA rules.
Uninterrupted Market Access
Prevent costly shipment delays or seizures at the border.
Risk Mitigation
Reduce the likelihood of EPA enforcement actions and civil penalties.
Resource Efficiency
Free up your internal teams by leveraging our specialized regulatory and scientific staff.
Our Process
Unlike firms that focus solely on the law or only on data, we bridge the gap between science and regulation. Our unique approach combines technical chemical assessments with strategic advocacy, ensuring that your compliance strategy is both scientifically sound and commercially viable.
Discovery & Scoping
We assess your product portfolio to determine applicable TSCA sections and reporting requirements.
Data Collection & Review:
We gather necessary chemical identity, volume, and toxicity data, ensuring all information is "reasonably ascertainable" for EPA submission.
Submission & Advocacy
We file notifications (like PMNs or CDRs) through the EPA’s Central Data Exchange (CDX) and advocate on your behalf during the review period.
Ongoing Maintenance
We provide long-term support for recordkeeping, Significant New Use Rules (SNURs), and inventory updates.