Phthalates Action Plan Summary
- What chemicals are addressed in the Action Plan?
- Why is EPA concerned about these chemicals?
- What action is EPA taking?
What chemicals are addressed in the Action Plan?
Eight chemicals are included: dibutyl phthalate (DBP), diisobutyl phthalate (DIBP), butyl benzyl phthalate (BBP), di-n-pentyl phthalate (DnPP), di (2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP). Phthalates are high production volume chemicals used primarily as plasticizers in polyvinylchloride (PVC) products.
Why is EPA concerned about these chemicals?
EPA is concerned about phthalates because of their toxicity and the evidence of pervasive human and environmental exposure to these chemicals.
Phthalates are used in many industrial and consumer products, many of which pose potentially high exposure. Phthalates have been detected in food and also measured in humans.
Adverse effects on the development of the reproductive system in male laboratory animals are the most sensitive health outcomes from phthalate exposure. Several studies have shown associations between phthalate exposures and human health, although no causal link has been established. Recent scientific attention has focused on whether the cumulative effect of several phthalates may multiply the reproductive effects in the organism exposed.
What action is EPA taking?
On the basis of existing information, EPA included the the following actions in its Action Plan:
- EPA intends to initiate rulemaking in autumn 2010 to add these eight phthalates to the Concern List under TSCA section 5(b)(4) as chemicals that present or may present an unreasonable risk of injury to health or the environment.
- EPA also intends to initiate rulemaking in late 2010 to add the six phthalates not already on the Toxics Release Inventory (TRI).
- In preparation for rulemaking in 2012 under TSCA section 6(a), EPA intends to cooperate with the Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA) to more fully assess the use, exposure and substitutes for these chemicals. EPA plans to consider the results of the cumulative assessment currently being developed and due to be completed by CPSC in 2012 pursuant to the Consumer Product Safety Improvement Act of 2008 (CPSIA), as well as the ongoing review of phthalates at FDA and the assessment for EPA’s IRIS program, due to be completed in 2011. These assessments will inform EPA’s decision on future action to address these chemicals. EPA’s potential control measures may include a ban of all or several of these chemicals, as appropriate.
- EPA may consider pursuing additional rulemaking under TSCA section 5(a)(2) in late 2010 or early 2011 to require manufacturers and processors of DnPP to notify EPA before manufacturing or processing DnPP for a significant new use. The most recent Inventory Update Reporting (IUR) data contains no reports of this phthalate being produced or imported into the United States, and thus it is possible that any use of DnPP may be a significant new use.
- EPA intends to conduct a Design for the Environment and Green Chemistry alternatives assessment by 2012. The information developed could be used to encourage industry to move away from phthalates in a non-regulatory setting to expand risk management efforts beyond whatever regulatory action might be taken under TSCA, or it could be used as input to a regulatory action. The alternatives assessment would build upon existing knowledge and would consider exposures to all human subpopulations, including children, as well as environmental exposure.
- August 2011: EPA began the DfE alternatives assessment.
Download the complete Phthalates Action Plan (PDF), 16 pages, 80 KB, About PDF