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Phthalates

Action Plan

I. Overview

This plan explains the U.S. Environmental Protection Agency (EPA)’sAgency’s

(EPA’s) current management plan for 8includes the following eight phthalates: 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). In developing this plan, EPA considered phthalates’the

toxicity, of phthalates, their prevalence in the environment, and their widespread use and human 

exposure. 

Phthalates are produced in high volume. They are used primarily as a plasticizer in 

polyvinylchloride (PVC) products, appear, over 470 million pounds per year (EPA 2006). 

Manufacturers use them in numerous industrial and consumer products, many of which pose 

primarily as plasticizers in poly(vinyl chloride) (PVC) products. Many phthalates can potentially 

lead to high exposure, both individually and in combinationtogether with other phthalates, and 

are. They can often substitutes for each other in products. They are also used in medical 

applications and their presence hashave been detected in food. PhthalatesA number of phthalates

appear in biomonitoring surveys of human tissues, evidencing widespread human exposure.

Phthalate exposures (CDC 2009). Although exposure to phthalates can produce a variety of 

effects in laboratory animals; however, their , for certain phthalates the adverse health effects on 

the development of the male reproductive system are the most sensitive health outcomes.serious.

Several studies have shown associations between phthalate exposures and human health 

(although no causal link has been established). Recent scientific attention is focusing on 

whetherevaluating the cumulative effects of severalmixtures of phthalates may multiply the 

reproductive effects in thean exposed organism exposed. . 

EPA is concerned about phthalates because of their toxicity, and the evidence of 

pervasive human and environmental exposure to these chemicals.them. Thus, the AgencyEPA

intends to initiate action to address the manufacturing, processing, distribution in commerce, 

and/or use of these eight phthalates. The AgencyEPA intends to take action as part of a 

coordinated approach with the Consumer Product Safety Commission (CPSC) and the Food and 

Drug Administration (FDA) to address the concerns associated with these phthalates.).

II. Introduction

As part of EPA'’s efforts to enhance the existing chemicals program under the Toxic 

Substances Control Act (TSCA)1, the Agency identified an initial list of widely recognized 

chemicals, including phthalates, (e.g., see Section VIII of this document), for action plan 

development based on one or more of the following factors their presence in human 

bloodhumans; persistent, bioaccumulative, and toxic (PBT)2 characteristics; use in consumer 

products; production volume; and other similar factors.. This Action Plan is based on EPA’s 

 

1 15 U.S.C. §2601 et seq. 2 Information on PBT chemicals can be found on the EPA website at http://www.epa.gov/pbt/. 
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initial review of readily available use, exposure, and hazard information3 on eight phthalate 

esters. EPA considered which of the various authorities provided under TSCA and other statutes 

might be appropriate to address potential concerns with BPAphthalates in developing the Action 

Plan. The Action Plan is intended to describe the courses of action the Agency plans to pursue in 

the near term to address its concerns. The Action Plan does not constitute a final Agency 

determination or other final Agency action. Regulatory proceedings indicated by the Action Plan 

will include appropriate opportunities for public and stakeholder input, including through notice 

and comment rulemaking processes.

III. Scope of Review

A. Chemical Identity 

Dialkyl ortho-phthalates (or phthalate esters) have the general chemical structure 

shown below: 

O

O

O

O

R

R'

(R, R' groups can be linear, branched, or linear/branched

or cyclic ring)

For purposes of this Action Plan, EPA identified 8eight individual phthalate esters as 

appropriate subjects for a comprehensivedeveloping an assessment and management strategy. 

EPA believes this group is broad enough to provide for a meaningful, extensive approach to 

phthalates management, while remaining manageable in scope. This group of 8eight phthalates 

includes allthe phthalates identified by CPSIA and those being evaluated by CPSC and by EPA 

for the Integrated Risk Information System (IRIS) database. Complete overlap with the work 

being conducted by CPSC), based on advice from the National Academy of Sciences (NAS, 

2008). Four phthalates are common to CPSIA and by EPA forthe IRIS will allow for maximum 

coordination with those efforts.assessment. This phthalates category subject to this Action Plan 

consists ofincludes the following 8eight chemical substances, identified by 10 separate Chemical 

Abstracts Service Registry Numbers (CASRNs): 

No CASRN CA Index Name Acronym Common Name 

1 84-74-2 1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester DBP Dibutyl phthalate 

2 84-69-5 1,2-Benzenedicarboxylic acid, 1,2-bis-(2-

methylpropyl) ester 

DIBP Diisobutyl phthalate 

 

3 Information sources used by EPA includes hazard and risk assessments developed by governmental agencies of 

the U.S., Canada, European Union, and Australia. These agencies include; the Australian Government, Department 

of Health and Ageing, the European Chemicals Bureau (ECU), the Chronic Hazard Advisory Panel (CHAP) 

appointed by the U.S. Consumer Product Safety Commission (CPSC), EPA’s Integrated Risk Information System 

(IRIS), and the U.S. National Toxics Program National Reproductive and Developmental Health Effects Panel. In 

addition, robust summaries of studies for the phthalate category submitted by the sponsors to the EPA under the 

Chemical Right to Know High Production Volume (HPV) Challenge Program were also considered 

(http://www.epa.gov/chemrtk/pubs/summaries/benzene/c13467tc.htm). Other governmental and non-government 

sources were used as appropriate.
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3 85-68-7 1,2-Benzenedicarboxylic acid, 1-butyl 2-

(phenylmethyl) ester 

BBP Butyl benzyl 

phthalate 

4 131-18-0 1,2-Benzenedicarboxylid acid, 1,2-dipentyl ester DnPP Di-n-pentyl 

phthalate 

5 117-81-7 1,2-Benzenedicarboxylic acid, 1,2-bis(2-

ethylhexyl) ester 

DEHP Di(2-ethylhexyl) 

phthalate 

6 117-84-0 1,2-Benzenedicarboxylic acid, 1,2-dioctyl ester DnOP Di-n-octyl phthalate 

7 28553-12-0 1,2-Benzenedicarboxylic acid, 1,2-diisononyl ester DINP* Diisononyl phthalate 

 68515-48-0 1,2-benzenedicarboxylic acid, di-C8-C10-branched 

alkyl esters, C9-rich 

(Part of 

DINP)* 

 Di-(C9-rich 

branched C8-C10-

alkyl) phthalate 

8 26761-40-0 1,2-Benzenedicarboxylic acid, 1,2-diisodecyl ester DIDP* Diisodecyl phthalate 

 68515-49-1 1,2-Benzenedicarboxylic acid, di-C9-C11-branched 

alkyl esters, C10-rich 

(Part of 

DIDP)* 

Di-(C10-rich 

branched C9-C11-

alkyl) phthalate 

* Note that each of the commercial products of DINP and DIDP contain is a mixture of two chemicals mixtures in each 

commercial product.

B. Physical/Chemical Property Characterization 

The chemicals in this category are oily liquids at room temperature. They have low to 

moderate vapor pressures, and negligible to moderate water solubility. The water solubility and 

vapor pressure decrease and the octanol-water partition coefficient (log Kow) increases with 

increasing molecular weight (i.e., as the side chain length increases). The vapor pressure ranges 

from 8 x 10-5 to 1.38 x 10-8 mm Hg at 20oC; the water solubility range from 10 mg/L to 3.81 x 

10-5 mg/L at 20oC; and the log Kow ranges from 4.11 (for DIBP) to 9.46 (for DIDP) (Australian 

Government NICNAS, 2008; HSDB 2009; Beilstein 2009; ExxonMobil Biomedical Sciences, 

Inc. 2001). Commonly, the structural characteristics of the ester side chains also affect the 

physical-chemical and toxicological properties of these phthalates; e.g., the phthalates that cause

the most potent reproductive effects are generally those with ester side chains containing 4-8

carbon atoms.

IV. Volumes, Uses and Substitutes Summary

A. Production Volume 

According to the 2006 TSCA Inventory Update Reporting (IUR) database, (EPA, 

2006), reported volume of production (including imports) for the 10 individual phthalates ranged 

from none up to 500 million pounds. DINP had the highest production volume, followed by 

DIDP and DEHP, then BBP, DBP, DnOP and DIBP. There was no production volume data 

reported for DnPP in the 2006 IUR database. 

B. Uses 

The major use of phthalates is as plasticizers (Australian Government, Existing 

Chemical Hazard Assessment Reports, 20082008a-h; HSDB, 2009). A major application of 

plasticizers is in PVC (polyvinyl, [poly(vinyl chloride),)], where they are added to impart 

flexibility and other desirable properties. Phthalated Phthalate-containing PVC products included 

a variety of industrial and commercial products, as well as specialized medical and dental 
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applications. The particular phthalate or combination of phthalates used in a particular product’s 

formulation depends on the properties the phthalates impart, as well as their cost. BBP is the 

most widely used stain-resistant plasticizer in PVC; (Wickson, 1993); vinyl tile represents its 

largest use. (NTP, 2003e). A number of uses of DBP have been identified including the 

manufacture of plastics, paints, wood varnishes and lacquers, use in cosmetics, medical supplies, 

textiles, propellants, food packaging, dental materials, and paper. (OSHA, 2009). More 

specifically, it is used as a plasticizer in uses such as nail polishes, explosives, and solid rocket 

propellants. Nearly half of DEHP consumption in the United States occurs in medical devices, 

such as intravenous (IV) tubing and blood bags. The rest is split between consumer products and 

construction-related products. (TURI, 2006). DIBP is considered a specialty plasticizer, too 

volatile to be used in PVC, and is often combined with other phthalates. As such, it is used in 

nitrocellulose, cellulose ether, and polyacrylate and polyacetate dispersions. (ECPI, 2009). The 

major use of DIDP is in PVC as a plasticizer (95%).%) (EC2003b). DIDP is extensively used in 

wire and cable applications, and is, the main plasticizer used in this application. (TURI, 2006).

Non-PVC uses of DIDP include polymer-related uses and nonpolymer uses such as anticorrosion and anti-fouling paints, sealing compounds, and textile inks. (EC2003b). DINP is a 

mixture of phthalates and is a commonly used plasticizer. (TURI, 2006). PVC applications 

account for 95% percent of the volume. There are no known commercial uses for pure DnOP. 

However, DnOP constitutes approximately 20% percent of the C6–10 phthalate mixtures used in 

PVC products. (NTP, 2003a).

C. Substitutes 

There are various possible alternatives for phthalates in plasticized PVC (Biron, 

2009; SCENIHR, 2007). Four chemicals have been cited as already being used in various 

children’s products: Acetyl; they are acetyl tri-n-butyl citrate (ATBC); Didi(2-ethylhexyl) 

adipate (DEHA); 1,2-Ccyclohexanedicarboxylic acid, diisononyl ester (DINCH), and Didi(2-

ethylhexyl) terephthalate (DEHT or DOTP). Citrate-based plasticizers, like ATBC, are drop-in 

substitutes for DEHP made from citric acid and have been available for years as plasticizers in 

medical devices (Tickner, 2001). DINCH is an alternative for applications such as medical 

devices (SCENIHR, 2007). Another chemical, trioctyltrimellitate (TOTM) performs as a 

plasticizer in PVC and it has potential to be used commercially. Promising non-phthalate 

substitutes for DEHP in vinyl flooring material include DGD (dipropylene glycol dibenzoate) 

and DEHA (di(2-ethylhexyl) adipate). Other possible phthalate substitutes include: phosphate 

esters (e.g., tris(2-ethylhexyl)phosphate, and diphenyl cresyl phosphate); sebacate and azelate 

esters (e.g., diisodecyl sebacate (DIDS), di-butyl sebacate, and di(2-ethylhexyl) azelate (DOZ)); 

isosorbide esters (made from renewable resources), and other organic esters such as isobutyrate 

trimethylpentanediol, and diethyl succinate. In addition, low-molecular-weight polymeric ester 

plasticizers that are derived from polymeric multifunctional alcohols and adipic, sebacic or 

glutaric acid; polymeric rubbers and plastics; and reactive plasticizers may also be potential 

substitutes for phthalates (Biron, 2009; SCENIHR 2007)., 2007). As part of its inquiry, EPA 

will explore the potential risks as well as costs presented by phthalate substitutes.

In response to a European ban on the use of some phthalates in toys and personal care 

products for children, plasticizers based on isosorbide esters were developed (Roquett, 2009). 

These plasticizers can cover a broad range of phthalate applications, such as adhesive, sealants, 
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inks, floor coverings, wall paper, and medical disposables. It is worth noting that isosorbide 

esters could be prepared under solvent-free conditions (Chalecki, 1997), providing an 

environmentally friendly approach to manufacturing. 

V. Hazard Identification Summary

A. Human Hazard Health Effects

A comparison of toxicity information from laboratory animal studies for phthalates as a 

chemical group allows generalizations to be drawn with respect to certain health endpoints. For 

example, acute toxicity, skin and eye irritation and sensitization potential are low for all 

phthalates tested, and the majority of the phthalates were not genotoxic. The most sensitive 

health outcomes following phthalate exposures of some phthalates in animal studies are the 

phthalate syndrome effects, which consist of changes in the fetal development of the 

reproductive system (NAS, 2008,; NTP-CERHR, 2003a-e, 2006; EC, 2003a-b, 2003-2006(all), 

European Union 2003-2008 (all),4, 2008a-b; Australian Government 2008 (all))., 2008a-h). The 

phthalates that are the most potent at causing the phthalate syndrome effects are generally those 

with linear ester side chains having 4-6 carbons. Phthalates with shorter or longer chain lengths 

typically exhibit less severe or no effects; however, branching of the ester side chain is also

important. It appears that the age of the animal at the time of exposure is critical with respect to 

the severity of the effects; pubertal animals show effects at doses lower than those in the 

corresponding studies in adult animals. The fetus is the most sensitive life stage. (NAS 2008).

Several human studies have reported associations of exposure of some phthalates with 

adverse reproductive outcomes and developmental effects similar to those in the rat, although no 

causal link has been established (Swan et al, 2005; Huang et al., 2009). The reproductive 

developmental effects observed in humans include shortened anogenital distance observed in 

newborn boys; and shortened pregnancy, lower sex and thyroid hormones, and reduced sperm 

quality observed in adults. Since the pathway for sexual differentiation in the fetus is highly 

conserved in all mammals, the reproductive developmental effects observed in the rat studies are 

potentially relevant to humans. Data from the National Health and Nutrition Examination survey 

(NHANES) indicates widespread exposure of the general population to phthalates (NHANES 

2005CDC, 2009). Biomonitoring data from amniotic fluid and urine have demonstrated that 

humans are exposed to phthalates in utero, as babiesinfants, during puberty, and in adult life, and 

that people are exposed to several phthalates at once. In addition, recent studies in animals 

evaluating the cumulative effects of mixtures of several active phthalates on testosterone 

production, fetal mortality, and male and female reproductive development later in life showed 

all mixtures were cumulative for all endpoints. (Rider et al., 2008, 2009; Howdeshell, et al., 

2007, 2008a, 2008b; Gray et al., 2006; Hotchkiss et al., 2004). In conclusion, taken together, the 

reproductive effects observed in animal studies and in humans, the human biomonitoring data, 

and the data on cumulative effects of mixtures support EPA’s concern for potential human health 

hazard following exposure to phthalates. 

A major cumulative hazard assessment of phthalates is currently beingscheduled to be

conducted by the CPSC’s Chronic Hazard Advisory Panel (CHAP) as directed by the Consumer 

Product Safety Improvement Act of 2008 (CPSIA.). The anticipated date of completion for the 
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CPSC/CHAP activity is 20124. EPA is conducting its own cumulative hazard assessment of 6six

of the phthalates in this Action Plan as part of the updating of the IRIS database. In a separate 

effort EPA is screening certain phthalates to assess their endocrine disrupting properties. 

B. Environmental Hazard Effects

Of the 8 phthlates, BBP, DEHP, and DBP elicit the most toxicity to terrestrial 

organisms, fish, and aquatic invertebrates. (EC, 2008a,; Staples et al. 1997). Ecotoxicity studies 

with these phthalates showed adverse effects to aquatic organisms with a broad range of 

endpoints and at concentrations that coincide with measured environmental concentrations. 

Toxic effects were observed at environmentally relevant exposures in the low ng/L to μg/L 

range. (Oehlmann et al. 2008). The other three phthalates which had data: DIBP, DINP, and 

DIDP, exhibited much lower toxicity to aquatic organisms. (Staples et al. 1997). There are no 

available ecotoxicity data for DnPP or DnOP. 

AllSome phthalates studied have been shown to affect reproduction and impair 

development in all studied animal groups. Most plasticizersphthalates appear to act by interfering 

with the functioning of various hormone systems, but some phthalates have wider pathways of 

effects. (Jobling et al. 1995). Effect concentrations of plasticizersphthalates in laboratory 

experiments coincideare consistent with measured environmental concentrations, and thus there 

is a very real potential for effects of these chemicals on some wildlife populations. (Oehlmann, 

et al., 2008).

VI. FatePhysical/Chemical Properties andFate Characterization Summary

The chemicals in this category are oily liquids at room temperature. They have low to 

moderate vapor pressures and negligible to moderate water solubility. The water solubility and 

vapor pressure decrease and the octanol-water partition coefficient (log Kow) increases with 

increasing molecular weight (i.e., as the side chain length increases). The vapor pressure ranges 

from 8  10-5 to 1.38 10-8 mm Hg at 20oC; the water solubility range from 10 mg/L to 3.81

10-5 mg/L at 20oC; and the log Kow ranges from 4.11 (for DIBP) to 9.46 (for DIDP) (Australian 

Government, 2008a-h; HSDB, 2009; Crossfire Beilstein, 2009; ExxonMobil Biomedical 

Sciences, Inc., 2001). 

The chemicals in this category have moderate volatility from moist soil surfaces and 

water. They have low to moderate mobility in soil and water systems. They are expected to be 

readily biodegradable and the rate of abiotic hydrolysis is considered negligible to slow under 

environmental conditions. Based on available data, the phthalates are ranked low for persistence 

and low for bioaccumulation although bioconcentration factors for DEHP in freshwater shrimp 

were moderate (HSDB., 2009,; NITE, 2002). 

VII. Exposure Characterization Summary

 

4

 CPSIA gives the CHAP 18 months to complete its evaluation, and 6 months to complete its final report, for a total 

of 24 months. Previous CHAPs have requested additional time. The CPSC staff estimates that the CHAP will begin 

work in early calendar year 2010. Thus, for planning purposes, the staff estimates that the report will be completed 

in 2012
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A. Releases

Phthalates are released to the environment from multiple sources including industrial 

releases, the disposal of manufacturing, processing and industrial wastes, municipal solid waste, 

land application of sewage sludge, and release from products containing phthalates. Only two 

(DBP and DEHP) of the 8 phthalates are listed on EPA’s Toxics Release Inventory (TRI) data 

are available only for two phthalates (DBP and DEHP).).list of toxic chemicals. The available 

release data for these two phthalates indicate that releases of phthalates can be expected to all 

primary environmental media. 2007 TRI data (USEPA, 2009) for DBP and DEHP show total onsite and off-site releases of more than 336,000 pounds from 134 sites and 1,229,000 pounds from 

251 sites, respectively; however, under TRI, some volume of releases are not reported by some 

facilities. These data also indicate that the volume of releases to particular media generally ranks 

in the following order (from highest to lowest release volume): land, air, water. Some facilities 

report relatively high releases and may create potentially high localized environmental 

concentrations of phthalates. Based on a comparison of TRI releases to IUR data, production and 

import volumes indicate that the vast majority (likely between 95% and 99.9%) of phthalates can 

be expected to be incorporated into plastics and other products. 

B. Human Exposure 

People may be exposed to phthalates from multiple sources, (including air, water, food, 

soil, sediments, and biota) and in multiple environments (including home, work, and when 

undergoing medical procedures).) (Babich, 2004; Clausen 2004; EC, 2003 a-b; 2003-04; 2008 ab; CPSC, 2001; 2002). The predominantmost studied population and route of exposure that has 

been studied for this class of chemicals has been direct exposure via ingestion by small children 

and infants from the mouthing of toys, teethers, or other children’s products made of flexible 

PVC. (Babich, 2004; EU 2003 a,b; 2003-04; 2008 a,b; CPSC 2001, 2002). Exposures have also 

been shown to occur via prenatal exposures. (Adibi et al., 2004)

Medical device assessments for DEHP have been developed by FDA, Health Canada 

Medical Devices Bureau and the European Union Scientific Committee on Medicinal Products 

and Medical Devices. (FDA, 2002a; Health Canada, 2002; EC 2002). The overarching 

conclusion is that premature infants are the population most highly exposed to phthalates via 

these uses. In 2002, the FDA recommended the use of alternatives to DEHP-containing medical 

devices if specifiedfor a specific list of procedures that were to be performed on high-risk 

individuals. Depending on the procedure, these individuals include infants, boysmale neonates, 

pregnant or nursing women who are carrying male fetuses, and, for some procedures, healthy 

adults. peripubertal males (FDA, 2002b).

Exposure routes of concern will depend on the product and its use patterns. For example, 

inhalation exposure for adults and children could be an issueof concern in vehicle interiors, 

particularly in summer due to elevated temperatures in vehicles given the vapor pressure range of 

these chemicals. Exposure to phthalates can occur from releases that result from the 

manufacturing, processing or industrial use of phthalates as well as contamination of air, water, 

food, and dust from the use or disposal of products containing phthalates. The published 
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literature indicates that the exposure sources listed from highest to lowest are: food, cosmetics, 

consumer products (other than toys), and toys. While there (NTP-CERHR, 2003 a-e, 2006;

HSDB, 2009). There are limited data on the migration of phthalate from plasticized PVC into 

environmental media. However, due the total volume of plasticized PVC produced, it is possible 

that PVC or other polymer/polymeric-like materials containing phthalates may be long-term and 

dispersive sources of human and environmental exposures to phthalates. 

Data from the NHANES (CDC, 2009) indicates widespread exposure of the general 

population to phthalates. Biomonitoring data from amniotic fluid and urine have demonstrated 

that humans are exposed to phthalates in utero, as babiesinfants, during puberty, and in adult life, 

and that people are exposed to several phthalates at once. For example, NHANES detected a 

DEHP urinary metabolite in 78% of the 2541 samples tested with womaen having a higher 

exposure than men. (CDC, 2009). Children have been reported as having the highest exposures; 

specifically to DEHP, DBP, BBP and DnOP. 

Available information indicates that workers may be exposed to phthalates by inhalation 

and dermal routes, with the dermal route seeming to be more prevalent. The Occupational Safety 

and Health Administration (OSHA) has established Permissible Exposure Limits (PELs) of 5 

mg/m3

 time-weighted average (TWA) for both DBP and DEHP (OSHA, 2006). According to the 

IUR data, industrial workers exposed to these phthalates number in the thousands. 

C. Environmental Exposure 

Due to their pervasive use and release, as well as its propensity for global transport, 

phthalates are found in most environmental media, for example ambient air, surface water, soil, 

sediment, etc. (EC, 2003a-b; 2008a-b; NTP-CERHR, 2003 a-e; 2006). Aquatic organisms, fish 

and terrestrial animals have evident exposure to DEHP. (EC 2008a; Staples et al. 1997).

VIII. Risk Management Considerations

Phthalate exposures can produce a variety of adverse effects in laboratory animals; 

especially on the development of the male reproductive system, and therefore there are 

implications for human health. DataAnimal data on the cumulative effect of mixtures of several 

phthalates indicatesshowed an increase in the reproductive effects in the organism exposed. 

Phthalates are produced in high volume and they are used in numerous industrial and consumer 

products. Phthalates appear in biomonitoring surveys, such as NHANES, evidencingthat provide 

evidence of widespread human exposure. Phthalates are also found in the environment and 

wildlife species. EPA is concerned with phthalates based on toxicity, particularly to the 

development of the male reproductive system, prevalence in the environment, widespread use 

and human exposure and recent work focusing on the potential cumulative effect of mixtures of 

phthalates. 

Potential Impacts on Children 
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Phthalate exposures are a potential concern for children’s health. In animal studies, 

exposure to phthalates during fetal development results in adverse effects on the male 

reproductive system. The timing of exposure is critical to the severity of effects. The fetus is the 

most sensitive lifestagelife stage for male reproductive effects, and pubertal animals show effects 

at lower doses than those showing effects in adult animals. Children are exposed to phthalates 

through a number of consumer products (e.g., toys, infant feeding products), as well as 

environmental sources (e.g., air, water, food).) as well as consumer products (e.g., toys)..

Children’s estimated exposures are often greater than those in adults which may be due to 

increased intakes of food, water, and air on a bodyweight basis, as well children’s unique 

exposure pathways such as mouthing of objects and ingestion of non-food items. The 1999-2000 

and 2001-2002 NHANES biomonitoring data in the Third National Report on Human Exposure 

to Environmental Chemicals demonstrate that children have the highest exposures to phthalates 

of all groups monitored, and other biomonitoring data indicate in utero exposures to phthalates.

(CDC, 2005). Given the well-characterized health effects of phthalate exposure in animals in 

conjunction with the demonstrated widespread phthalate exposure in children, EPA believes 

additionalthat the cumulative health risks of phthalates should be assessed to determine what

actions are warranted to insure protection of children’s health from this group of chemicals. 

A. Existing Risk Management Activities 

1. Foreign Governments. 

A number of nations have taken steps to manage risk associated with phthalates or further 

assess those risks. For example, in 2005, the European Commission banned DEHP, DBP and 

BBP in all toys and childcare articles. DINP, DIDP and DnOP were banned from use in toys and 

childcare articles, if they can be put in the mouth by children. Canada proposed in June, 2009 to 

harmonize their phthalate requirements with those already in effect in the EU and US, ensuring 

the same level of protection as children in the US and the EU. In 2006, the Australian 

Government declared the phthalates DEHP, DIDP, DMP, DINP, DBP, BBP, DnOP, DEP and 

bis(2-methylethyl) phthalate as Priority Existing Chemicals and initiated health risk assessments 

for these phthalates, which were concluded in 2008.

2. State Governments. 

Several states, such as California and Washington, have proposed or enacted legislation

regarding phthalates, including prohibiting the sale of children's products containing phthalates, 

investigating the risks involved in the use of phthalates, and requiring manufacturers to use the 

least toxic alternative. Some of these state provisions have been superseded by the federal bans 

in CPSIA. 

3. Federal Government Outside EPA. 

The federal government both regulates and continues to study phthalates. Federal entities 

involved in phthalate management and research include: 
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Consumer Products Safety Commission (CPSC) – Among other provisions, the 

Consumer Product Safety Improvement Act of 2008 (CPSIA) banned the use of six phthalates in 

toys and child care articles at concentrations greater than 0.1%: percent: DEHP, DBP, BBP, 

DINP, DIDP and DnOP. The use of three of these banned phthalates, DINP, DIDP, and DnOP 

may be reinstituted by CPSC if scientific research conductedpending review by CPSC pursuant 

to the Act warrants.the Chronic Hazard Advisory Panel. The CPSIA tasks the CPSC with 

appointing a Chronic Hazard Advisory Panel and examining the cumulative health risks of 

phthalates health effects and exposurephthalate substitutes. The CHAP will recommend to the 

Commission whether to continue the ban of DINP, DIDP, and DnOP and whether any other 

phthalates or phthalate substitutes should be banned. 

Food and Drug Administration (FDA) – The FDA regulates phthalates in food contact 

substances (such as plastic wrap), cosmetics, pharmaceuticals and medical devices. FDA 

announced in June 2008 that it is conducting a comprehensive inventory of regulated products 

that contain phthalates and is reviewing available use and toxicology information associated with 

phthalate exposure from food contact useFDA regulated products to better characterize any 

potential risk from these uses. 

4. 

Environmental Protection Agency (EPA. 

) – Existing EPA Actions affecting phthalates at EPA include the following: 

 Office of Water DEHP concentration is limited in drinking waterDEHP is regulated 

under the Safe Drinking Water Act. The highest concentration allowed, the maximum 

contaminant level (MCL), is 0.006 mg/L. 

 Office of Air and Radiation DEHP and DBP are listed as hazardous air pollutants 

under the Clean Air Act. 

 Office of Solid Waste and Emergency Response Under the Resource Conservation and 

Recovery Act (RCRA), phthalates are regulated as a hazardous waste if discarded as a 

commercial chemical product. 

 Office of Environmental Information DBP and DEHP are listed as reportable to the

Toxic Release Inventory (TRI) chemicals under section 313 of the Emergency Planning 

and Community Right-to-know Act (EPCRA). 

 OfficeBBP, DBP and DEHP are included in the first group of 67 chemicals to be 

screened as part of Prevention, Pesticides and Toxic Substances

 Office of Science Coordination and Policy and the Office of Pesticide Programs.

OPP is conducting anthe Endocrine Disruptor Screening Program (EDSP) under a 

Congressional mandate in the Food Quality Protection Act. Test orders are being issued 
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for the first group of 67 chemicals (74 FR 54422), including three phthalates in this 

Action Plan: BBP, DBP and DEHP. ).

o Office of Pollution Prevention and Toxics:

 TSCA Section 8(a) Inventory Update Reporting (IUR) Phthalates that are listed on 

the TSCA Inventory are subject to TSCA IUR reportingsection 8(e) Inventory Update 

Reporting (IUR) requirements, including production and use information for sites having 

production volumes of at least 25,000lbs/yr. All 8eight Phthalates (10 CASRNs) subject 

toincluded in this Action Plan are listed on the TSCA Chemical Substance Inventory. 

 TSCA Section 4 Testing In 1989, EPA entered an Enforceable Consent Agreement

under TSCA section 4 with six companies to perform certain chemical fate and 

environmental effects on certain Alkyl Phthalates (54 FR 618). 

 High Production Volume Challenge Program In 2001, under the voluntary HPV 

Challenge Program, the Phthalate Esters Panel Testing Group of the American Chemical 

Council submitted a test plan forsponsored a phthalates ester category. ItThe panel has 

submitted to EPA robust study summaries or other information for 26 phthalates, 

including several of those being considered in this Action Plan (BBP, DEHP, DINP, 

DIDP and DnOP) 

State Governments

California, Vermont and Washington have established standards for the content of certain 

phthalates in children’s articles. California prohibits the manufacture, sale, or distribution in 

commerce of any toy or child-care article that contains DEHP, DBP, or BBP at greater than 0.1% 

and of any toy or child-care article, intended for use by children under three years of age that can 

be mouthed, that contains DINP, DIDP or DnOP at greater than 0.1%. Vermont prohibits the 

manufacture, sale, or distribution in commerce of any toy or child-care article intended for use 

by a child younger than three years old that contains DEHP, DBP, or BBP in concentrations 

greater than 0.1% and of any toy or child-care article intended for use by a child under three 

years of age that can be placed in the mouth and that contains DINP, DIDP, or DnOP in 

concentrations greater than 0.1% (CRS, 2008).

As part of a statute concerning chemicals in children’s products generally, Washington 

prohibits a manufacturer, wholesaler, or retailer from manufacturing, knowingly selling, offering 

for sale, or distributing for sale or for use in the state a children’s product or product component 

containing phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) individually or in combination, 

at a concentration exceeding 0.1% by weight (CRS, 2008). Other States such as Hawaii have 

introduced legislation to prohibit the manufacture, sale, or distribution of certain toys and child care 

articles containing certain types of phthalates (Hawaii House of Representatives, 2009; CRS, 2008)

Foreign Governments

A number of nations have taken steps to manage risk associated with phthalates or further 

assess those risks.B. For example, in 2005, the European Commission banned DEHP, DBP and 
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BBP in all toys and childcare articles (Directive 2005/84/EC). DINP, DIDP and DnOP were 

banned from use in toys and childcare articles, if they can be put in the mouth by children. 

Canada proposed in June, 2009 to harmonize their phthalate requirements with those already in 

effect in the EU and U.S., ensuring the same level of protection as children in the U.S. and the 

EU (Canada Consumer Product Safety Act). In 2006, the Australian Government declared the 

phthalates DEHP, DIDP, DMP, DINP, DBP, BBP, DnOP, DEP and bis(2-methylethyl) phthalate 

as Priority Existing Chemicals and initiated public risk assessments for these phthalates. Phase 1 

the development of the public health hazard assessments was concluded in 2008 (Australian 

Government, 2008a-h). Phase 2 the development of the risk assessments is currently in progress 

(Australian Government, 2009). 

Risk Management Approach 

Phthalates are used in products that are subject to EPA, FDA, and the CPSC. People may 

be exposed to phthalates from a variety of product uses, as well as from industrial releases and 

environmental exposures; these exposure pathways should be assessed together to appropriately 

characterize exposures and avoid underestimating risk. The assessment of combined exposure is 

important to determine the potential impacts of these chemicals. Focusing individually on these 

phthalates would very likely underestimate their impact since they appear to produce similar 

adverse effects. Also, many phthalates are interchangeable in their uses as plasticizers for 

flexible PVC products, so restrictions on one could simply shift use to another of similar toxicity. 

Given this cumulative impact, the management of the risk from combined exposure requires a 

coordinated approach by all three agencies, and, as appropriate, additional federal agencies. 

Therefore, EPA intends to participate in a coordinated approachwork closely with CPSC and 

FDA to address the range of exposures. 

In assessing potential restrictions on certain phthalates, EPA plans to weigh the relative 

toxicity and feasibility of other phthalate substitutes. Identification of safer and affordable nonphthalate substitutes will be an important consideration in any action that would restrict the use 

of these chemicals. 

IX. Next Steps

EPA intends to initiate

On the basis of existing information, the Agency believes that the following regulatory 

actions would be warranted to manage the risk that may be presented by the 8eight phthalates 

identified in the plan. 

EPA intends to initiate rulemaking to add the 8 phthalates to the list under TSCA section 

5(b)(4). Section 5(b)(4) authorizes the EPA to compile and keep current a list of chemicals it 

finds presents or may present an unreasonable risk of injury to health or the environment. A 

EPA intends to publish a notice of proposed rulemaking is intended to publish in autumn, 2010. 

EPA intends to initiate rulemaking in late 2010 to add the six phthalates not listed on the 

Toxics Release Inventory to that list. Only two of the 8eight phthalates in this Action Plan are 
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currently on this Emergency Planning and Community Right-to-Know Act (EPCRA) §section

313 list of toxic chemicals. 

EPA intends to lay the groundwork to initiateconsider initiating in 2012 rulemaking 

under TSCA §section 6(a) to regulate the 8eight phthalates . In preparation for rulemaking, EPA 

intends, in cooperation with CPSC and FDA, to continue its work to more fully assess the use, 

exposure and substitutes for these chemicals. In its further review, EPA plans to consider the 

future results of the cumulative assessment currently being that will be developed by the 

Consumer Product Safety Commission (CPSC), pursuant to the Consumer Product Safety 

Improvement Act of 2008 (CPSIA).. The cumulative assessment approach under development by 

CPSC, due towhich may be completed in 2012, as well as the ongoing review of phthalates at the 

Food and Drug Administration (FDA) and the assessment for EPA’s IRIS program, due to be 

completed in 2011, will inform EPA’s determination of the extent of theany future TSCA 

§section 6 action addressing these chemicals. Depending on the nature of its final determination 

about the 8eight phthalates, EPA’s potential control measures may include a ban of all or several 

of these chemicals. EPA expects to exercise its risk management authorities in coordination with 

CPSC, FDA and, as appropriate, other agencies. EPA will develop more detailed assessments to 

support the TSCA section 6(a) “presents or will present an unreasonable risk” findings. If these 

more detailed assessments indicate that a different approach to risk management is appropriate, 

EPA will consider additional approaches.

Before taking TSCA §section 6(a) action respectingon DnPP, 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 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 effects beyond 

whatever regulatory action might be taken under TSCA or could be used as input to a regulatory 

action. The alternatives assessment would build upon existing knowledge and would consider 

exposures for all human subpopulations, as well as environmental exposure. 

As part of the Agency's efforts to address phthalates, EPA also intends to evaluate the 

potential for disproportionate impact on children and other sub-populations. 
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