TSCA Draft Findings on BBP Risks

🪵 Floor coverings
🎨 Paints and coatings
♻️ Plastics and rubbers
🧵 Vinyl flooring, toys, and synthetic leather

EPA data reports annual production/import volumes between 10–50 million pounds, though later reports (2016–2019) suggest this may have declined to 1–20 million pounds.

Why EPA Is Reviewing BBP—and What They Have Found

TSCA Section 6 requires EPA to evaluate "high‑priority substances" to determine if they pose an unreasonable risk under current conditions of use (COUs). BBP’s scope covers:

🏭 Manufacturing
⚙️ Processing
🚚 Distribution
🧰 Industrial, commercial, and consumer uses
🗑️ Disposal
📝 Draft Risk Evaluation: August 1, 2025.

EPA released its draft risk evaluation of BBP in August 2025. The major findings:

⚠️ Unreasonable human health risk for workers in 16 specific COUs, especially in manufacturing and formulation processes.
🌿 Unreasonable environmental/ecological risk in 4 COUs, some of which overlap with worker exposure risks.
✅ No unreasonable risk found for general consumers or the public.
🛡️ Personal protective equipment (PPE) effectiveness was not assumed in the risk calculation, meaning actual risk could be mitigated through proper controls.

BBP: Hazards, Exposure & Effects Human Health Hazards

Key findings from animal and occupational studies:

🧪 Workers exposed to BBP showed elevated metabolite levels and a potential link to multiple myeloma.
👶 Reproductive/developmental toxicity: Animal studies report decreased fetal weight, developmental abnormalities in reproductive organs, and impaired fertility.
🧠 Human studies suggest links between BBP exposure and language delays, asthma, and eczema in children.

BBP is classified as:

i. Possibly carcinogenic to humans (EPA)
ii. Reproductive/developmental toxicant (EU, California)

Environmental Effects

BBP is moderately water-soluble and subject to biodegradation but is:

🐠 Highly toxic to aquatic organisms such as algae, daphnia, and fish.
🌬️ Released into the environment via wastewater, indoor air, and product disposal.
💧 Partially removed in some wastewater treatment facilities (~90%), but persistence remains an issue.
🔄 Exposure Routes

Human exposure happens through:

🏭 Occupational inhalation and skin contact in workplaces
🍽️ Oral ingestion, typically through contaminated food or hand-to-mouth transfer from dust
🧴 Dermal absorption—animal studies show ~27% skin absorption
🌬️ Inhalation of indoor air and dust from treated materials
📊 Average daily intake for U.S. adults: ~2 µg/kg bodyweight/day

EPA’s Risk Evaluation Process Peer Review and Science Advisory Council on Chemicals (SACC)

While BBP’s draft is not directly reviewed by the SACC, its technical support documents (on hazard/exposure models) are being evaluated in the broader phthalate reviews (e.g., DBP, DEHP, DCHP). The SACC peer review meeting is scheduled for August 4–8, 2025.

Public Participation

EPA will open a 60-day public comment period once the draft is published in the Federal Register, under Docket ID: EPA-HQ-OPPT-2018-0501.

Public comments may address:

i. Real-world exposure and monitoring data
ii. PPE effectiveness and engineering controls
iii. Environmental fate and wastewater treatment data

BBP in Context: Phthalate Group Risk Evaluations

Butyl Benzyl Phthalate (BBP) is part of a broader group of seven high-priority phthalates that the U.S. Environmental Protection Agency (EPA) is evaluating under the Toxic Substances Control Act (TSCA). These chemicals are widely used as plasticizers—additives that increase the flexibility, transparency, and durability of plastics, particularly in consumer products, construction materials, and medical devices.

1. BBP – Risk to workers/environment from use in vinyl flooring, sealants, adhesives.
2. DBP – Reproductive toxicity in cosmetics, inks, paints; risks to consumers/workers.
3. DEHP – Found in PVC; poses developmental and endocrine risks to all user groups.
4. DIBP – Structurally like DBP; likely endocrine disruptor in coatings and plastics.
5. DCHP – Used in rubber/plastics, risk of reproductive toxicity and organ effects.
6. DINP – Milder toxicity; under review for chronic risks in insulation, toys, flooring.
7. DIDP – Low acute toxicity; long-term environmental risk from plastic applications.

Implications and Next Steps Workplace Controls

Employers using BBP in manufacturing or formulation should:

💨 Implement ventilation and engineering controls
🧤 Use and enforce PPE (e.g., gloves, masks)
🎓 Train workers and monitor workplace air and surfaces
📢 Environmental Reporting

Companies must:

📝 Document release pathways
📈 Track treatment efficiency
🔄 Improve product lifecycle assessments
⚖️ TSCA Risk Management Rule

If EPA finalizes its “unreasonable risk” conclusion, it must proceed to propose a Section 6(a) rule, which may include:

a. Use restrictions or phase-outs
b. PPE/labelling requirements
c. Product-specific prohibitions

Takeaways

i. BBP poses unreasonable risk to workers and the environment in multiple COUs.
ii. EPA’s draft risk evaluation excludes assumptions about PPE use.
iii. No unreasonable risk was found for consumers or the general population.
iv. Public and industry input is vital during the 60-day comment period.
v. EPA is evaluating BBP as part of a larger group of phthalates under TSCA.

What Can be done?

🔍 Review the draft risk evaluation and submit public comments.
📤 Share data on actual exposure conditions, workplace protections, and environmental releases.
🤝 Engage in the SACC peer review process if you are a stakeholder or expert.
⚠️ Prepare for potential regulatory restrictions or alternatives development.

Resources and References

1. EPA Risk Evaluation for BBP
2. Federal Register Docket: EPA-HQ-OPPT-2018-0501
3. EPA Press Release – August 2025