TSCA FAQ

Navigating chemical regulations is essential for companies aiming to maintain compliance and protect public health. The TSCA FAQ addresses one of the most impactful components of U.S. chemical control laws—specifically, restrictions on Persistent, Bioaccumulative, and Toxic substances. These rules, established under the Toxic Substances Control Act (TSCA), not only impose strict obligations on businesses but also require proactive measures to reduce environmental and human exposure to hazardous chemicals.

I. Regulatory Framework & Substance Identification - TSCA FAQ

Under what authority does EPA regulate PBT chemicals?

The Environmental Protection Agency (EPA) exercises its authority primarily through:

Toxic Substances Control Act (TSCA) Section 6(h) (15 U.S.C. §2605)
January 2021 PBT Final Rule (40 CFR Part 751, Subpart E)
2023-2024 Revisions (Notably for PIP 3:1 enforcement discretion)

Key Distinction from Other TSCA Rules:
Unlike standard TSCA chemical evaluations, Section 6(h) is unique because it:

Expedited 3-year review timeline
Stricter “unreasonable risk” threshold
Fewer exemption opportunities

What scientific criteria define PBT substances?

EPA applies rigorous quantitative thresholds:

Property	Measurement Method	Threshold Level
Persistence	Soil/water half-life	>2 months
Bioaccumulation	BCF/BAF testing	≥1,000
Toxicity	EC50/LC50 assays	≤1 mg/L (aquatic)

Example Substance Profile – DecaBDE:

Environmental persistence: 5.7 year soil half-life
Bioaccumulation: BCF of 6,800 in rainbow trout
Chronic toxicity: LOEC of 0.1 mg/kg/day in mammals

Why are these specific chemicals targeted in TSCA compliance?

The selection process involved multiple factors:

Initially, 2014 TSCA Work Plan prioritization
Then, 2016 Risk Evaluations showing unreasonable risk
Finally, International Alignment with:
- Stockholm Convention (DecaBDE)
- UNEP HCBD listings
- OECD PBT screening criteria

II. Compliance Requirements & Implementation - TSCA FAQ

What are the current substance-specific restrictions?

Chemical	Key Restrictions	Exemptions	Enforcement Status
DecaBDE	Total ban	Military/Nuclear uses	Full enforcement
PIP 3:1	Prohibited in consumer goods	Aviation hydraulics until 9/2024	NAA in effect
HCBD	Byproduct controls	None	Case-by-case

Importantly, PIP 3:1 No Action Assurance (NAA) for electronics expires September 2024 – prepare for full compliance.

What compliance documentation is mandatory?

Businesses must maintain:

Supplier Certifications with:
- Full material declarations
- Testing methodology documentation
Laboratory Reports from ISO 17025 accredited facilities
Downstream Notifications including:
- Customer acknowledgment receipts
- Safety data sheet updates
Exemption Justifications with:
- Technical support documents
- Use-case evidence

What testing protocol should we implement?

A phased approach is recommended:

First, Initial Screening ($200-500/sample)
- XRF for brominated flame retardants
- FTIR for polymer identification
Then, Confirmatory Testing ($800-1,500/sample)
- GC-MS for volatile organics
- HPLC for phenolic compounds
Finally, Ongoing Monitoring
- Quarterly batch testing
- Supplier audit program

Best Practice: Allocate 0.5-1.5% of product cost for compliance testing.

III. Global Compliance Strategy - TSCA FAQ

How do international regulations compare?

Region	Regulation Region	Key Differences from TSCA
EU	REACH Annex XIV	28 PBTs vs 5, authorization process
China	MEP Order 38	DecaBDE only, no PIP 3:1 restrictions
Canada	CEPA 1999	Similar substances but delayed timelines

Compliance Impact Analysis:

Consequently, 72% of EU-compliant products require reformulation for US market
Asian imports show 3× higher violation rates (EPA 2023 data)

What emerging global trends should we monitor?

2024 Regulatory Developments:

South Korea: K-REACH amendments adding PBT categories
United Kingdom: UK REACH consultation on PBT thresholds
MERCOSUR: Proposed harmonization with EU standards

Strategic Recommendation:
Implement a “Global Highest Standard” policy using:

EU REACH as baseline
TSCA PBT for US market
China GB standards for Asian exports

Therefore, companies should monitor these changes closely.

IV. Enforcement & Risk Management - TSCA FAQ

What are the real-world enforcement consequences?

Recent cases demonstrate:

2023 Automotive Case: $3.2M penalty for DecaBDE in wiring harnesses
2024 Electronics Import: 100% shipment rejection for PIP 3:1 violations
Ongoing: EPA Region 5 targeting plastic component manufacturers

Compliance Risk Matrix:

Risk Factor	Probability	Impact
Civil Penalties	High	$50k/day/violation
Product Seizure	Medium	Full shipment value
Reputational Harm	Very High	Stock price impact

How should we structure our compliance program?

An effective framework includes:

Governance
- Designated PBT compliance officer
- Board-level reporting
Technical Controls
- SAP EHS module implementation
- Automated SDS management
Supply Chain Management
- Tier 1-3 supplier audits
- Contractual penalty clauses
Testing Regimen
- 10% random sample rate
- Annual method validation
Training
- Certified specialist program
- Quarterly workforce updates

V. Supply Chain & Due Diligence

How can we ensure suppliers comply with TSCA rules?

Action Steps:
- Include PBT compliance clauses in supplier contracts (reference 40 CFR §751.407).
- Require third-party lab certifications for high-risk materials (e.g., plastics, lubricants).
- Conduct annual audits of Tier 1 and 2 suppliers.
Red Flags: Suppliers refusing to disclose full material compositions or citing “proprietary blends.”

What if a supplier provides non-compliant materials?

Immediate steps:
1. Quarantine affected inventory.
2. Notify the EPA via CDX portal within 15 days (per TSCA §8(e)).
3. Seek indemnification per contractual terms.
Mitigation: Maintain a 10% financial reserve for supply chain contingencies.

VI. Exemptions & Alternatives

How do we apply for a TSCA exemption?

Process: Submit a “Critical Use Exemption” petition (40 CFR §751.413) with:
- Technical justification (e.g., no feasible alternatives).
- Exposure mitigation plan.
- Phase-out timeline (max 5 years).
Success Rate: <15% approved (EPA 2023 data).

What are safer alternatives to restricted PBTs?

PBT Substance	Common Alternatives	Trade-offs
DecaBDE	Aluminum trihydroxide, Phosphinates	Higher cost (20–30%)
PIP 3:1	Pentaerythritol tetrastearate	Reduced thermal stability
HCBD	Catalytic recycling processes	Energy-intensive

VII. Testing & Certification

Are "homogeneous materials" exempt if under 0.1% concentration?

No: Unlike EU REACH, TSCA prohibits PBTs at any concentration in articles unless specifically exempted (e.g., PIP 3:1 in aviation until 2024).

How often must we retest products?

Frequency:
- Annual testing for high-volume products (>10,000 units/year).
- Biannual if supply chain changes occur.
Cost-Saving Tip: Use “group testing” for products with identical material profiles (EPA-accepted since 2022).

Conclusion - TSCA FAQ

Complying with the EPA’s Toxic Substances Control Act (TSCA) PBT regulations is not just a legal obligation—it’s a critical step toward responsible business operations and environmental stewardship. As these rules continue to evolve, companies must stay proactive to avoid costly penalties, supply chain disruptions, and reputational damage.

Contact Enviropass to learn more about TSCA and how to assess your products against it.