TSCA Section 6(h) & PBT Compliance: What Manufacturers Must Know

What Is TSCA Section 6(h)?

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted in 2016, includes a provision under TSCA section 6(h) that requires the U.S. Environmental Protection Agency (EPA) to take expedited action on specific Persistent, Bioaccumulative, and Toxic (PBT) chemicals to address risks and reduce exposures to the extent practicable.

In 2016, the EPA identified five PBT chemicals for expedited action and issued a proposed rule in 2019.

In January 2021, the EPA finalized rules restricting five specific PBT substances—known collectively as the TSCA PBT 5.

Under the Toxic Substances Control Act (TSCA), the EPA has the authority to regulate chemicals that are persistent, bioaccumulative, and toxic in order to protect human health and the environment. These chemicals can build up in the environment over time and can have potential risks for exposed populations, including the general population, consumers and commercial users, and susceptible subpopulations (such as workers, subsistence fishers, tribes, and children).

The TSCA PBT 5 Substances

These substances have widespread industrial applications and are now regulated:

Who Is Affected by TSCA 6(h)?

Even if you're not manufacturing these chemicals, your company may be impacted if you:

• Import parts or finished goods containing these substances
• Assemble products with flame retardants, plasticizers, or specialized rubber components
• Ship products into the U.S. market

This affects industries like electronics, automotive, machinery, and industrial equipment.

Compliance Responsibilities in a Manufacturing Company

For a non-chemical manufacturer, TSCA 6(h) compliance involves several teams:

• Compliance/Regulatory Affairs: Lead the program, supplier outreach, and documentation
• Procurement: Engage suppliers for declaration collection
• Engineering/R&D: Approve material changes or substitutions
• Legal: Review exemptions, ensure documentation meets audit standards
• Product Stewardship: Maintain BOM integrity, update PLM/ERP systems

TSCA Section 6(h) Compliance Checklist

1. Substance Screening

   • Review BOMs, SDSs, FMDs for the 5 PBT substances
   • Focus on plastic, rubber, and electrical components

2. Supplier Declarations

   • Distribute TSCA PBT declaration templates
   • Collect CAS number confirmations and usage declarations

3. Documentation

   • Maintain signed declarations, screening reports, exemption justifications

4. Exemption Review

   • Check for EPA exemptions (especially PIP 3:1 deadline extensions)
   • Record decisions and justifications

5. Internal Coordination

   • Share findings with sourcing, engineering, legal teams
   • Update material approval workflows

6. Monitoring & Training

   • Subscribe to EPA updates
   • Recertify suppliers annually or with product changes
   • Conduct internal training on TSCA fundamentals

Managing Supplier Declarations

Use IPC-1752A XML or Excel-based declaration forms to collect:

• Internal Item Number
• Manufacturer Name and Part Number
• Presence of PBT (Yes/No/Unknown)
• Specific PBT (e.g., PIP 3:1, DecaBDE)
• CAS Number
• Reason for use or exemption
• Supporting documents (FMD, SDS, CoC)

TSCA 6(h) Exemptions & Deadline Updates

EPA granted extensions for PIP 3:1 due to its prevalence in electronics and manufacturing:

• Updated enforcement deadlines (2022 and 2024 amendments)
• Workplace use exemptions
• Phased-out use timelines (check EPA rule notices)

Risk of Non-Compliance

• EPA fines up to $50,000 per day
• Shipment holds at U.S. customs
• Business disruption with major OEMs or government contracts

Tools to Simplify Compliance

• Use compliance management software like Acquis Compliance Tool or IPC-1752A XML
• Automate BOM screening and declaration workflows
• Integrate with REACH, RoHS, Prop 65 tracking

Need help streamlining TSCA 6(h) compliance? Contact us to explore how Acquis automates supplier declarations and substance tracking.