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Phthalates 

I. Overview

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

management plan for 8 phthalates: dibutyl phthalate (DBP), diisobutyl phthalate (DIBP), butyl 

benzyl phthalate (BBP), di-n-pentyl phthalate (DnPP), di (2-ethylhexyl) phthalate (DEHP), di-noctyl phthalate (DnOP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP). EPA 

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

exposure. 

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

polyvinylchloride (PVC) products, appear in numerous industrial and consumer products, many 

of which pose potentially high exposure, both individually and in combination with other 

phthalates, and are often substitutes for each other. They are also used in medical applications 

and their presence has been detected in food. Phthalates appear in biomonitoring surveys, 

evidencing widespread human exposure. Phthalate exposures can produce a variety of effects in 

laboratory animals; however, their adverse effects on the development of the male reproductive 

system are the most sensitive health outcomes. Several studies have shown associations between 

phthalate exposures and human health (although no causal link has been established). Recent 

scientific attention is focusing on whether the cumulative effect of several phthalates may 

multiply the reproductive effects in the organism exposed. EPA is concerned about phthalates 

because of their toxicity, and the evidence of pervasive human and environmental exposure to 

these chemicals. Thus, the Agency intends to initiate action to address the manufacturing, 

processing, distribution in commerce, and/or use of these phthalates. The Agency 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, for action plan development based on their presence in human 

blood; 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 initial review 

of readily available use, exposure, and hazard information3 on eight phthalate esters. EPA 

 

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/. 

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 
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considered which of the various authorities provided under TSCA and other statutes might be 

appropriate to address potential concerns with BPA 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 8 individual phthalate esters as 

appropriate subjects for a comprehensive 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 8 phthalates includes all 

phthalates being evaluated by CPSC and by EPA for the Integrated Risk Information System 

(IRIS) database. Complete overlap with the work being conducted by CPSC and by EPA for 

IRIS will allow for maximum coordination with those efforts. This phthalates category subject to 

this Action Plan consists of the following 8 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 

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

sources were used as appropriate. 
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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 commercial products of DINP and DIDP contain 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, 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, 2008; HSDB, 2009). A major application of plasticizers is in PVC 

(polyvinyl chloride), where they are added to impart flexibility and other desirable properties. 

Phthalated 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; vinyl 

tile represents its largest use. 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. 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. 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 
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polyacrylate and polyacetate dispersions. The major use of DIDP is in PVC as a plasticizer 

(95%). DIDP is extensively used in wire and cable applications, and is, the main plasticizer used 

in this application. Non-PVC uses of DIDP include poly-related uses and nonpolymer uses such 

as anti-corrosion and anti-fouling paints, sealing compounds, and textile inks. DINP is a mixture 

of phthalates and is a commonly used plasticizer. PVC applications account for 95% of the 

volume. There are no known commercial uses for pure DnOP. However, DnOP constitutes 

approximately 20% of the C6–10 phthalate mixtures used in PVC products. 

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 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, 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). 

 In response to a European ban on the use of 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

A. Human Hazard 

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 in animal studies are the phthalate syndrome 

effects, which consist of changes in the fetal development of the reproductive system (NAS 
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2008, NTP-CERHR 2003-2006(all), European Union 2003-2008 (all), Australian Government 

2008 (all)). The phthalates that are the most potent at causing the phthalate syndrome effects are 

generally those with ester side chains having 4-6 carbons. Phthalates with shorter or longer chain 

lengths typically exhibit less severe or no effects; 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. 

 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 

2005). Biomonitoring data from amniotic fluid and urine have demonstrated that humans are 

exposed to phthalates in utero, as babies, 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 phthalates on testosterone production, fetal mortality, 

and male and female reproductive development later in life showed all mixtures were cumulative 

for all endpoints. 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 being conducted by 

the CPSC’s Chronic Hazard Advisory Panel (CHAP) as directed by CPSIA. The anticipated date 

of completion for the CPSC/CHAP activity is 2012. EPA is conducting its own cumulative 

hazard assessment of 6 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 

BBP, DEHP, and DBP elicit the most toxicity to terrestrial organisms, fish, and aquatic 

invertebrates. 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. The other three phthalates which had data: DIBP, 

DINP, and DIDP, exhibited much lower toxicity to aquatic organisms. There are no available 

ecotoxicity data for DnPP or DnOP. 

 All phthalates studied have been shown to affect reproduction and impair development in 

all studied animal groups. Most plasticizers appear to act by interfering with the functioning of 
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various hormone systems, but some phthalates have wider pathways of effects. Effect 

concentrations of plasticizers in laboratory experiments coincide with measured environmental 

concentrations, and thus there is a very real potential for effects of these chemicals on some 

wildlife populations. 

VI. Fate Characterization Summary 

 

 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

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. EPA’s 

Toxics Release Inventory (TRI) data are available only for two phthalates (DBP and DEHP). The 

available release data indicate that releases of phthalates can be expected to all primary 

environmental media. 2007 TRI data (USEPA 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. 

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). The predominant 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. 

 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. 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 
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alternatives to DEHP-containing medical devices if specified procedures were to be performed 

on high-risk individuals. Depending on the procedure, these individuals include infants, boys, 

pregnant or nursing women, and, for some procedures, healthy adults. 

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

inhalation exposure for adults and children could be an issue 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 literature indicates that 

the exposure sources listed from highest to lowest are: food, cosmetics, consumer products 

(other than toys), and toys. While there are limited data on the migration of phthalate from 

plasticized PVC, 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 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 babies, 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 woman having a higher exposure than men. 

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. Aquatic organisms, fish and terrestrial animals have evident exposure to DEHP. 

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 there are implications for 

human health. Data on the cumulative effect of several phthalates indicates 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, evidencing 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, 
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widespread use and human exposure and recent work focusing on the potential cumulative effect 

of mixtures of phthalates. 

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 lifestage 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). Children’s exposures are often greater than those in adults 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 demonstrate that children have the highest 

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

exposures to phthalates. Given the well-characterized health effects of phthalate exposure in 

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

additional 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. 
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 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%: 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 conducted by CPSC 

pursuant to the Act warrants. CPSIA tasks the CPSC with appointing a Chronic Hazard 

Advisory Panel and examining phthalates health effects and exposure. 

 Food and Drug Administration (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 reviewing available use and toxicology information associated 

with phthalate exposure from food contact use to better characterize any potential risk 

from these uses. 

4. EPA. 

 Actions affecting phthalates at EPA include the following: 

 Office of Water DEHP concentration is limited in drinking water 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 Toxic Release 

Inventory (TRI) chemicals under section 313 of the Emergency Planning and Community 

Right-to-know Act (EPCRA). 

 Office of Prevention, Pesticides and Toxic Substances

o Office of Science Coordination and Policy and the Office of Pesticide 

Programs. OPP is conducting an Endocrine Disruptor Screening Program 

(EDSP) under a Congressional mandate in the Food Quality Protection Act. Test 

orders are being issued 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 reporting 
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requirements, including production and use information for sites having 

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

CASRNs) subject to this Action Plan are listed on the TSCA Inventory. 

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

Agreement 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 for a 

phthalates ester category. It 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) 

B. 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 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 approach to address the range of exposures. 

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

toxicity of other phthalate substitutes. Identification of safer and affordable non-phthalate 

substitutes will be an important consideration in any action that would restrict the use of these 

chemicals. 

IX. Next Steps

 

 EPA intends to initiate the following actions to manage the risk that may be presented by 

the 8 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 

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 8 phthalates in this Action Plan are 

currently on this Emergency Planning and Community Right-to-Know Act (EPCRA) § 313 list 

of toxic chemicals. 
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 EPA intends to lay the groundwork to initiate in 2012 rulemaking under TSCA § 6(a) to 

regulate the 8 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 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 to 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 the future TSCA § 6 action addressing these chemicals. Depending on the nature of its 

final determination about the 8 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. 

 Before taking TSCA § 6(a) action respecting DnPP, EPA may consider pursuing 

additional rulemaking under TSCA § 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. 
U.S. Environmental Protection Agency Draft, 12/9/2009 

U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release 

12

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