U.S. Environmental Protection Agency Revised 03/14/2012 

Phthalates
 

Action Plan1
 

I. Overview 

U.S. Environmental Protection Agency’s (EPA’s) current management plan includes 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 the toxicity of phthalates, their prevalence in the environment and 

their widespread use and human exposure. 

Phthalates are produced in high volume, over 470 million pounds per year (EPA 2006). 

Manufacturers use them in numerous industrial and consumer products, primarily as plasticizers 

in poly(vinyl chloride) (PVC) products. Many phthalates can potentially lead to high exposure, 

both individually and together with other phthalates. They can often substitute for each other in 

products. They are used in medical applications and have been detected in food. A number of 

phthalates appear in biomonitoring surveys of human tissues, evidencing widespread human 

exposure (CDC 2009). Although exposure to phthalates can produce a variety of effects in 

laboratory animals, for certain phthalates the adverse health effects on the development of the 

male reproductive system are the most 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 evaluating the cumulative effects of mixtures of phthalates in 

an exposed organism. 

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

human and environmental exposure to them. Thus, EPA intends to initiate action to address the 

manufacturing, processing, distribution in commerce, and/or use of these eight phthalates. EPA 

intends to take action as part of a coordinated approach with the Consumer Product Safety 

Commission (CPSC) and the Food and Drug Administration (FDA). 

II. Introduction 

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

Substances Control Act (TSCA)2

, 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 humans; persistent, 

bioaccumulative, and toxic (PBT)3

 characteristics; use in consumer products; production volume. 

This Action Plan is based on EPA’s initial review of readily available use, exposure, and hazard 

information 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 

phthalates 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 

1 The Action Plan was originally issued on 12/30/2009.

2 15 U.S.C. §2601 et seq.
 3 Information on PBT chemicals can be found on the EPA website at http://www.epa.gov/pbt/. 

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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 

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

below: 

O 

O 

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

O R' or cyclic ring) 

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

appropriate subjects for developing an assessment and management strategy. This group of eight 

phthalates includes the phthalates identified by CPSIA and those being evaluated by EPA for the 

Integrated Risk Information System (IRIS), based on advice from the National Academy of 

Sciences (NAS, 2008). Four phthalates are common to CPSIA and the IRIS assessment. This 

Action Plan includes the following eight 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 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 DINP and DIDP is a mixture of two phthalates. 

IV. Uses and Substitutes Summary 

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 

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

DnPP in the 2006 IUR database. 

The major use of phthalates is as plasticizers (Australian Government, 2008a-h; HSDB, 

2009). A major application of plasticizers is in PVC, [poly(vinyl chloride)], where they are 

added to impart flexibility and other desirable properties. Phthalate-containing PVC products 

included a variety of industrial and commercial products, as well as specialized medical and 

dental 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). NonPVC uses of DIDP include polymer-related uses and nonpolymer uses such as anti-corrosion 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). 

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; they are acetyl tri-n-butyl citrate (ATBC); di(2-ethylhexyl) adipate (DEHA); 1,2­

cyclohexanedicarboxylic acid, diisononyl ester (DINCH), and di(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); 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; 

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SCENIHR, 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, 

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 

Human 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 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, 2003-4, 2008a-b; Australian 

Government, 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 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 (NAS, 2008). 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 (CDC, 2009). Biomonitoring data from amniotic fluid and urine have demonstrated 

that humans are exposed to phthalates in utero, as infants, 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, 

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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 scheduled 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 

CPSC/CHAP activity is 20124

. EPA is conducting its own cumulative hazard assessment of six 

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. 

Environmental 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. 

Some phthalates studied have been shown to affect reproduction and impair development 

in all studied animal groups. Most phthalates 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 phthalates in laboratory experiments are consistent with 

measured environmental concentrations (Oehlmann, et al., 2008). 

VI. Physical/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 20o

C; the water solubility range from 10 mg/L to 3.81 

10-5 mg/L at 20o

C; 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 

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

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

VII. Exposure Characterization Summary 

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).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 (EPA, 2009) for 

DBP and DEHP show total on-site 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. 

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 a-b; 

CPSC, 2001; 2002). The most studied population and route of exposure 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 for a 

specific list of procedures that were to be performed on high-risk individuals. Depending on the 

procedure, these individuals include male neonates, pregnant women who are carrying male 

fetuses, and 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 of concern in vehicle interiors, particularly 

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

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chemicals (EC, 2003b; EC, 2008a; NTP-CERHR, 2003c). 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 literature indicates that the exposure sources listed from highest to 

lowest are: food, cosmetics, consumer products (other than toys), and toys (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 infants, 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 women 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. 

Environmental Exposure 

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

plastics, many of which contain phthalates, 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. Animal data on the cumulative effect of mixtures of several 

phthalates showed 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, that 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. 

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Potential Impacts on Children 

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 life 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 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 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 that 

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. 

Existing Risk Management Activities 

Federal Government 

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

involved in phthalate management and research include: 

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 pending review by 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 and phthalate 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 phthalate and is reviewing available use and toxicology information associated with 

phthalate exposure from FDA regulated products to better characterize any potential risk from 

these uses. 

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Environmental Protection Agency (EPA) – Existing EPA Actions affecting phthalates 

include: 

 DEHP is regulated under the Safe Drinking Water Act. The highest concentration 

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

	 DEHP and DBP are listed as hazardous air pollutants under the Clean Air Act. 

	 Under the Resource Conservation and Recovery Act (RCRA), phthalates are regulated as 

a hazardous waste if discarded as a commercial chemical product. 

	 DBP and DEHP are reportable to the Toxic Release Inventory (TRI) under section 313 of 

the Emergency Planning and Community Right-to-know Act (EPCRA). 

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

part of the Endocrine Disruptor Screening Program (EDSP). 

	 Phthalates that are listed on the TSCA Inventory are subject to TSCA section 8(e) 

Inventory Update Reporting (IUR) requirements, including production and use 

information for sites having production volumes of at least 25,000lbs/yr. All eight 

Phthalates (10 CASRNs) included in this Action Plan are listed on the TSCA Chemical 

Substance Inventory. 

	 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). 

	 In 2001, under the voluntary HPV Challenge Program, the Phthalate Esters Panel Testing 

Group of the American Chemical Council sponsored a phthalates ester category. The 

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). 

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

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 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 work 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 

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 eight phthalates 

identified in the plan. 

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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 present or may present an unreasonable risk of injury to health or the environment. EPA 

intends to publish a notice of proposed rulemaking 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 eight phthalates in this Action Plan are 

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 consider initiating in 2012 rulemaking under 

TSCA section 6(a) to regulate the eight 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 that will be developed by the CPSC. The cumulative assessment 

approach under development by CPSC, which may be completed in 2012, as well as the ongoing 

review of phthalates at the FDA and the assessment for EPA’s IRIS program, due to be 

completed in 2011, will inform EPA’s determination of the extent of any future TSCA section 6 

action addressing these chemicals. Depending on the nature of its final determination about the 

eight 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 on 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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