EPA Announces Intent to Regulate Dozens of Uses of Five Phthalate Chemicals to Protect Workers and Environment

WASHINGTON - U.S. Environmental Protection Agency (EPA) announced today that it will move to regulate dozens of applications of five widely used phthalate chemicals to address environmental and workplace risks. This decision is based on final risk evaluations, released today, for each of these chemicals: Butyl Benzyl Phthalate (BBP), Dibutyl Phthalate (DBP), DicyclohexylPhthalate (DCHP), DiethylhexylPhthalate (DEHP), and DiisobutylPhthalate (DIBP),commonly used to make plastics more flexible in everything from building materials to industrial applications. EPA used gold standard science and tapped independent peer reviewers to reach its conclusions that all five chemicals it reviewed pose unreasonable risks to workers and to the environment. EPA's regulatory focus will target the specific uses that harm workers or threaten the environment.

"Our gold standard science delivered clear answers that these phthalates pose unreasonable risk to workers in specific industrial settings and to the environment," said Administrator Lee Zeldin. " We'll work directly with stakeholders to develop targeted protections that keep workers safe and protect our environment. This is exactly what science-based environmental protection should look like."

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 levels that could cause health problems. Under the Toxic Substances Control Act (TSCA) risk evaluation process, EPA focuses specifically on uses regulated under the federal chemical safety law. EPA's TSCA risk evaluation does not analyze exposures from food, food additives, food packaging, medical devices, cosmetics and otherconsumer productsthat 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 with exposure levels that are causing unreasonable risk to the general population. In pursuit of gold standard science, dermal modeling was enhanced based on peer review feedback and public comment, especially with the replacement of rodent data with actual human data.

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 will next develop rules to eliminate the identified unreasonable risks to workers and the environment. The agency will conduct extensive consultation 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.

• BBP: Unreasonable risk to workers (2 conditions of use); environmental risks (7 conditions of use)

• DBP: Unreasonable risk to workers (5 conditions of use); environmental risks (1 condition of use)

• DCHP: Unreasonable risk to workers (2 conditions of use);

• DEHP: Unreasonable risk to workers (10 conditions of use); environmental risks (20 conditions of use)

• DIBP: Unreasonable risk to workers (4 conditions of use); environmental risks (7 conditions of use)

When 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.