TSCA Certification Guide for Importers
General
Key takeaways
TSCA certification is required for chemical substances imported into the U.S.
The EPA enforces TSCA rules and expects full documentation at the border.
Failure to comply can result in fines, delays, and shipment rejections.
Mercury helps clients navigate TSCA regulations for a seamless customs process
TSCA Certification Explained: What Importers Need to Know
The Toxic Substances Control Act (TSCA) plays a key role in regulating chemical imports into the United States. For companies involved in international trade, especially those handling biological materials, reagents, or chemical kits, understanding TSCA requirements is essential.
Missing or incorrect TSCA documentation can result in costly delays or rejected shipments. This article breaks down the basics of TSCA certification, who needs it, and how Mercury helps ensure compliance.
What Is the TSCA Certification?
The TSCA, enacted in 1976 and administered by the U.S. Environmental Protection Agency (EPA), regulates the import and use of chemical substances in the U.S. The goal is to protect human health and the environment from the risks of certain chemicals.
When importing goods into the U.S., importers must certify that the chemical substances are either listed on the TSCA Inventory (positive certification) or are not subject to TSCA (negative certification). Customs requires this certification at the time of entry.
Which Shipments and Products Are Subject to TSCA?
TSCA applies to raw chemicals, mixtures, and products containing regulated chemical substances. Life sciences companies often ship diagnostics kits, reagents, or preservatives that include such substances.
Shipments that may fall under TSCA include:
Laboratory reagents
Medical testing kits with chemical components
Animal byproducts preserved with chemicals
Research-use-only substances
However, not all shipments are covered. TSCA does not apply to food, drugs, cosmetics, or devices regulated under the Food, Drug, and Cosmetic Act.
Who Needs to Comply with TSCA Certification?
Any company or individual importing chemical substances into the U.S. must certify compliance. This includes:
Life science suppliers
Pharmaceutical firms
Biotech research organizations
Importers of diagnostics or specimen kits
Customs clearance depends on submitting the correct TSCA certification statement. Even products that are exempt must be accompanied by a negative certification.
Consequences of Non-Compliance
Non-compliance with TSCA can trigger a chain of problems. U.S. Customs and Border Protection (CBP) can detain or reject shipments that lack the proper certification.
Violators may face civil penalties of up to $50,000 per violation. In serious cases, the EPA may impose criminal charges or injunctions. Beyond the legal risk, delays and rejections disrupt supply chains and jeopardize business operations.
For research-driven companies, delays in receiving critical materials can derail projects, affect trial timelines, and compromise sample integrity.
How to Determine If Your Shipment Needs TSCA Certification
Importers should start by evaluating the product and its chemical content. If the product contains a chemical substance or mixture, determine whether that substance appears on the TSCA Inventory.
For shipments that fall under TSCA, a positive certification must be filed. It should state that the substance complies with all TSCA rules and is listed in the inventory.
If the shipment is exempt, the importer should file a negative certification. This indicates the product is not subject to TSCA regulations, such as biological specimens without chemical preservatives.
Examples:
A diagnostics kit with regulated reagents requires a positive certification.
A dry blood sample without chemical additives may qualify for a negative certification.
How Mercury Helps Clients with TSCA Compliance
Mercury partners with healthcare and life sciences companies to simplify compliance and reduce risk. Our team understands the technical and regulatory requirements involved in international shipments.
We begin by reviewing shipment contents to determine TSCA applicability. If certification is required, we guide clients through documentation and customs requirements.
Mercury collaborates with customs brokers and regulatory experts to ensure each shipment moves efficiently. We flag at-risk shipments before they leave the origin and help prepare correct declarations to avoid delays.
Here's how Mercury supports importers:
Expert Knowledge: Mercury’s team understands the nuances of TSCA and EPA regulations. They guide clients through declaration requirements.
Accurate Documentation: Mercury ensures the right certification statements are submitted via CBP’s ACE system.
Proactive Communication: Mercury coordinates with customs brokers, clients, and regulatory bodies to avoid delays.
Validated Packaging: For sensitive shipments like biological substances, diagnostics kits, or clinical trial samples, Mercury provides compliant containers that maintain product integrity.
Real-Time Tracking: Shipments are monitored 24/7 to ensure temperature compliance and timely delivery.
Record Management: Mercury helps clients retain proper documentation and audit trails for EPA and CBP inspections.
By handling logistics and compliance, Mercury allows clients to focus on research, production, or distribution. Mercury’s services reduce risks, save time, and protect the value of sensitive cargo.
Why Mercury Is a Trusted Partner for Regulated Shipments
Mercury has 40+ years of experience handling time-sensitive, temperature-sensitive, and highly regulated shipments. We serve clients across the life sciences industry, including pharmaceutical manufacturers, clinical trial teams, and diagnostic labs.
We ensure all documentation—TSCA or otherwise—is prepared correctly before shipment departure. With real-time tracking and white-glove service, our logistics experts stay involved at every step.
Our clients trust us to prevent customs issues, minimize delays, and keep critical materials moving on schedule.
Mercury’s proactive compliance support not only protects against penalties but also builds supply chain reliability. Our global network ensures smooth transitions across customs checkpoints and international borders.
Need help with TSCA certification or other compliance challenges? Contact Mercury today to ensure your shipments move quickly, compliantly, and stress-free.
