Phthalates

EPA Phthalates Risk Evaluations

Comprehensive Toxic Substances Control Act (TSCA) scientific assessments protect American families, workers, and the environment through gold standard science and rigorous peer review.

Page Navigation

• Protecting American Health
• Understanding Phthalates
• Gold Standard Science
• Transparent Review Process
• Key Findings
• Next Steps

PROTECTING AMERICAN HEALTH

EPA conducted the most comprehensive evaluation ever of five widely used phthalate chemicals. Using gold standard science and extensive public input, we examined these chemicals' potential for health effects. 

 EPA's comprehensive TSCA evaluations examined Butyl Benzyl Phthalate (BBP), Dibutyl Phthalate (DBP), Dicyclohexyl Phthalate (DCHP), Diethylhexyl Phthalate (DEHP), and Diisobutyl Phthalate (DIBP), and identified specific workplace exposures that create unreasonable risks for workers, primarily from inhalation during spray applications and manufacturing processes. Additionally, four of the five chemicals pose unreasonable risks to aquatic life from certain industrial releases to surface water.  

UNDERSTANDING PHTHALATES

Phthalates are chemicals that make plastics more flexible and durable. They are found in building materials, paints, adhesives, sealants, and various industrial applications. EPA evaluated five specific phthalates with widespread uses.

GOLD STANDARD SCIENCE

EPA's evaluation employed the most rigorous scientific methods available, using the best available data and conservative assumptions to protect public health, especially for vulnerable populations. 

Phthalates have the potential to cause human health abnormalities that EPA is seriously concerned with, including hormone deficiencies and endocrine disruption. It’s also important to note that gold standard science also shows that these health impacts do not occur at all exposure levels. The key factor in determining risk is whether people are exposed to amounts above safe levels that could cause health problems. Under the court-ordered TSCA risk evaluation process, EPA focuses specifically on uses regulated under federal chemical safety law. EPA’s TSCA risk evaluation does not analyze exposures from food, food additives, food packaging, medical devices, cosmetics, and other consumer products that are under the purview of the Food and Drug Administration or Consumer Product Safety Commission. For the consumer uses that are part of this TSCA risk evaluation, EPA found no products creating exposure levels that are causing unreasonable risk to consumers or the general population.  

The agency's cumulative exposure analysis, which examined exposure to multiple phthalates simultaneously, was based on available data for individuals aged four years and older. While no national-scale biomonitoring data exists for children under four, EPA used conservative modeling approaches to specifically assess toy mouthing behaviors in infants (less than one year), as well as two- and three-year-olds, ensuring that even the most vulnerable young children were included and protected in the evaluation.  

EPA improved the evaluation based on new scientific data, public comments, and independent peer review. Based on peer review feedback, EPA included a sensitivity analysis to update the characterization of impacts to surface water by evaluating variable flow rates and wastewater treatment removal levels to inform risk determinations. In response to peer review feedback and public comment, EPA refined the dermal modeling approach to use a more realistic exposure scenario and replaced rodent data with human dermal absorption data. Additionally, based on public comment and stakeholder engagement, EPA refined the inhalation assessment for some worker scenarios and incorporated more representative workplace monitoring data. Making these science-based improvements demonstrates EPA's commitment to using the best available data and methodologies. These changes resulted in more accurate and defensible risk assessments. 

When the EPA determines whether a chemical poses unreasonable risk, the agency must consider several key factors: 

• Health impacts: How the actual, real-world level of chemical exposure is affecting people's health, including cancer risks and other negative health impacts, based on how the chemical is being used 
• Environmental impacts: How the chemical is affecting the environment and how much exposure is occurring in real-world conditions 
• Who gets exposed: Which groups of people are being exposed to the chemical above levels that cause health impacts, paying special attention to vulnerable populations (like children, pregnant women, or people with existing health conditions) 
• How dangerous the chemical is: The severity and type of harm it can cause 
• What we don't know: Any gaps or uncertainties in the scientific data 

EPA considers all of these factors together when determining a chemical's risks. 

 Our Scientific Approach 

• Comprehensive Data Collection: Gathered exposure data from manufacturing, processing, distribution, and disposal of these chemicals 
• Toxicity Assessment: Evaluated health effects 
• Exposure Modeling: Used conservative assumptions to estimate exposures for workers, consumers, and the general population  
• Cumulative Analysis: First-of-its-kind assessment considering exposure to multiple phthalates and background exposures simultaneously 

TRANSPARENT REVIEW PROCESS

EPA's evaluation underwent extensive review to ensure scientific rigor and that diverse perspectives were incorporated, directly responding to Make America Healthy Again (MAHA) Commission calls for transparency and stakeholder engagement. 

1. Independent Peer Review: External scientific experts reviewed methodology, data interpretation, and conclusions 
2. Public Comment: Extensive public participation with comments from industry, advocacy groups, and scientific experts 
3. Draft Improvements: Significant refinements based on new data, public input, and peer review recommendations 

KEY FINDINGS

⚠ Worker Exposures 

Unreasonable risks identified for workers in specific industrial applications, primarily from inhalation during spray applications and manufacturing processes. 

 ⚠ Environmental Concerns 

Risks to the environment identified for four of the five chemicals, specifically threats to fish and other aquatic life. 

 ⚠ Health Impacts 

Above certain exposure levels, Phthalates have the potential to cause human health abnormalities that EPA is seriously concerned with, including hormone deficiencies and endocrine disruption. 

NEXT STEPS

The agency will confer with workers, businesses, labor groups, and communities to develop targeted, practical protections that ensure worker safety and environmental protection. Personal protective equipment, engineering controls, and alternative approaches will be carefully evaluated to create effective, implementable solutions that protect those most at risk. 

 EPA commits to keeping Americans informed with radical transparency about chemical safety decisions that affect their health and communities. 

Read Full Risk Evaluations: BBP, DBP, DCHP, DEHP, DIBP, DIDP, and DINP.