U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

1 Phthalates

I. Overview

This plan explains the U. S. Envir onmental Protection Agency (EPA)’s current management plan for 8 phthalates: dibutyl phtha late (DBP), diisobutyl phthalate (DIBP), butyl benzyl phthalate (BBP), di-n-pentyl phthalate (D nPP), di (2-ethylhexyl) phthalate (DEHP), di-noctyl phthalate (DnOP), diisonony l phthalate (DINP), and diis odecyl phthalate (DIDP). EPA considered phthalates’ toxicity, prevalence in th e 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 nu merous industrial and consumer products, many of which pose potentially high e xposure, both individually and in combination with other phthalates, and are often substitu tes 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, thei r adverse effects on the developm ent of the male reproductive system are the most sensitive health outcomes. Se veral studies have shown associations between phthalate exposures and human health (although no causal link has been established). Recent scientific attention is focusing on whether th e 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 addr ess 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 th e existing chemicals program under the Toxic Substances Control Act (TSCA) 1 , the Agency identified an ini tial list of widely recognized chemicals, including phthalates, for action plan development based on their presence in human blood; persistent, bioaccum ulative, 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 information 3 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 ri sk assessments developed by governmental agencies of the U.S., Canada, European Union, and Australia. These agencies include; the Austra lian Government, Department of Health and Ageing, the European Chemicals Bureau (ECU), the Chr onic 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 Re productive 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 consideredU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

2 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 stak eholder input, incl uding 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 iden tified 8 individual pht halate esters as appropriate subjects for a comprehensive asse ssment and management strategy. EPA believes this group is broad enough to provide for a m eaningful, extensive approach to phthalates management, while remaining manageable in scop e. This group of 8 phthalates includes all phthalates being evaluated by CPSC and by EPA fo r 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 coordi nation 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-C 8 -C 10 -branched alkyl esters, C 9 -rich (Part of DINP)* Di-(C 9 -rich

branched C 8 -C 10 - alkyl) phthalate

( http://www.epa.gov/chemrtk/pubs/summaries/benzene/c13467tc.htm ). Other governmental and non-government sources were used as appropriate.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

3 8 26761-40-0 1,2-Benzenedicarboxylic acid, 1,2-diisodecyl ester DIDP * Diisodecyl phthalate 68515-49-1 1,2-Benzenedicarboxylic acid, di-C 9 -C 11 -branched alkyl esters, C 10 -rich (Part of DIDP)* Di-(C 10 -rich

branched C 9 -C 11 - alkyl) phthalate

* Note that commercial products of DINP and DIDP cont ain 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 ne gligible to moderate water solubility. The water solubility and vapor pressure decrease a nd the octanol-water part ition coefficient (log K

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

from 8 x 10 -5 to 1.38 x 10 -8 mm Hg at 20 o C; the water solubility ra nge from 10 mg/L to 3.81 x

10 -5 mg/L at 20 o C; and the log K

ow ranges from 4.11 (for DIBP) to 9.46 (for DIDP) (Australian Government NICNAS, 2008; HSDB 2009; Beilste in 2009; ExxonMobil Biomedical Sciences, Inc. 2001). Commonly, the structural characteristics of the ester si de 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 U pdate Reporting (IUR) database, reported volume of production (including imports) for th e 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 ma jor application of pl asticizers is in PVC (polyvinyl chloride), where they are added to im part flexibility and othe r 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 formul ation depends on the properties the phthalates impart, as well as their cost. BBP is the most wide ly 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 lac quers, use in cosmetics, medical supplies, textiles, propellants, food packaging, dental materi als, and paper. More sp ecifically, it is used as a plasticizer in uses such as nail polishes, explosives, and solid rock et 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 a nd construction-related products. DIBP is considered a speci alty plasticizer, too volatile to be used in PVC, and is often combined with other phthalates. As such, it is used in nitrocellulose, cellulose ether, andU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

4 polyacrylate and polyacetate dispersions. The majo r use of DIDP is in PVC as a plasticizer (95%). DIDP is extensively used in wire and cable appl ications, and is, the ma in plasticizer used in this application. Non-PVC uses of DIDP in clude poly-related uses and nonpolymer uses such

as anti-corrosion and an ti-fouling paints, sealing compounds, a nd textile inks. DINP is a mixture of phthalates and is a commonly used plastici zer. PVC applications acc ount 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 fo r 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-buty l citrate (ATBC); Di(2-eth ylhexyl) adipate (DEHA); 1,2- Cyclohexanedicarboxylic acid, diisononyl ester (D INCH), and Di(2-ethylhexyl) terephthalate (DEHT or DOTP). Citrate-based plasticizers, lik e ATBC, are drop-in substitutes for DEHP made

from citric acid and have been available fo r 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. Promisi ng non-phthalate substitutes for DEHP in vinyl flooring material include DGD (d ipropylene glycol dibenzoate ) and DEHA (di(2-ethylhexyl) adipate). Other possible phthalate substitute s include: phosphate esters (e.g., tris(2- ethylhexyl)phosphate, and diphenyl cresyl phos phate); sebacate and aze late esters (e.g., diisodecyl sebacate (DIDS), di-butyl sebacate, a nd di(2-ethylhexyl) azelate (DOZ)); isosorbide esters (made from renewable resources), a nd other organic esters such as isobutyrate trimethylpentanediol, and diethy l succinate. In addition, low mo lecular weight polymeric ester plasticizers that are derived from polymeric multifunctional alcohols and adipic, sebacic or glutaric acid; polymeric rubbers and plastics; and reactive plas ticizers may also be potential substitutes for phthalates (Biron, 2009; SCENIHR 2007).

In response to a European ban on the use of pht halates in toys and personal care products for children, plasticizers based on isosorbide esters were developed (Roquett, 2009). These plasticizers can cover a broad rang e of phthalate applications, such as adhesive, sealants, inks, floor coverings, wall paper, and medical disposable s. 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 la boratory animal studies for phthalates as a chemical group allows generalizations to be draw n with respect to certain health endpoints. For example, acute toxicity, skin and eye irritati on and sensitization potential are low for all phthalates tested, and the majority of the pht halates 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 feta l development of the re productive system (NASU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

5 2008, NTP-CERHR 2003-2006(all), European Uni on 2003-2008 (all), Australian Government 2008 (all)). The phthalates that ar e the most potent at causing th e phthalate syndrome effects are generally those with ester side chains having 4-6 carbons. Phthalates with shorter or longer chain lengths typically exhibit less seve re or no effects; branching of the ester side chain is also important. It appears that the age of the animal at the time of expos ure is critical with respect to the severity of the effects; pube rtal 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 associ ations of exposure of some phthalates with adverse reproductive outcomes and developmental e ffects 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 in clude shortened anogenita l distance observed in newborn boys; and shortened pregnancy, lower se x and thyroid hormones, and reduced sperm quality observed in adults. Since the pathway fo r sexual differentiation in the fetus is highly conserved in all mammals, the reproductive develo pmental 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 gene ral population to phthalates (NHANES 2005). Biomonitoring data from amniotic fluid an d 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 addi tion, recent studies in animals evaluating the

cumulative effects of mixtures of several phthalates on testoste rone production, fetal mortality, and male and female reproductive development late r 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 phtha lates in this Action Plan as pa rt of the updating of the IRIS database. In a separate effort EPA is screen ing certain phthalates to assess their endocrine disrupting properties.

B. Environmental Hazard

BBP, DEHP, and DBP elicit the most toxicity to terrestrial organism s, fish, and aquatic invertebrates. Ecotoxicity studies with these phthalates showed adve rse 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 a ffect reproduction and impair development in all studied animal groups. Most pl asticizers appear to act by inte rfering with th e functioning ofU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

6 various hormone systems, but some phthalates have wider pathways of effects. Effect concentrations of plasticizers in laboratory ex periments 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 modera te volatility from moist soil surfaces and water. They have low to moderate mobility in soil and water syst ems. They are expected to be readily biodegradable and the rate of abiotic hydr olysis is considered negligible to slow under environmental conditions. Based on available data, the phthalates are ranked low for persistence and low for bioaccumulation although bioconcentra tion factors for DEHP in freshwater shrimp were moderate (HSDB. 2009, NITE, 2002).

VII. Exposure Characterization Summary

A. Releases

Phthalates are released to the environmen t from multiple sources including industrial releases, the disposal of manuf acturing, processing and industrial wastes, municipal solid waste, land application of sewage sludge, and releas e from products containi ng 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 DE HP show total on-site and off-site releases of more than 336,00 0 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 particul ar media generally ranks in the following order (from highest to lowest re lease volume): land, air, water. Some facilities report relatively high releases and may create potentially high local ized environmental concentrations of phthalates. Based on a compar ison 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 mu ltiple sources, (including air, water, food, soil, sediments, and biota) and in multiple environments (including home, work, and when undergoing medical procedures). The predominan t population and route of exposure that has

been studied for this class of chemicals has been direct exposure via inge stion 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 Un ion Scientific Committ ee on Medicinal Products

and Medical Devices. The overarchi ng conclusion is that premat ure infants are the population most highly exposed to phthalates via these uses. In 2002, the FDA recommended the use ofU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

7 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 wome n, and, for some procedures, healthy adults.

Exposure routes of concern will depend on th e product and its use patterns. For example, inhalation exposure for adults and children could be an issue in vehicle inte riors, particularly in summer due to elevated temperatures in vehicl es 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 pr oducts containing phthalates. The pub lished literature indicates that the exposure sources listed fr om highest to lowest are : food, cosmetics, consumer products (other than toys), and toys. Wh ile there are limited data on the migration of phthalate from plasticized PVC, it is possible that PVC or ot her polymer/polymeric-like materials containing phthalates may be long-term and dispersive sour ces of human and environmental exposures to phthalates.

Data from the NHANES indicates widespr ead exposure of the ge neral population to phthalates. Biomonitoring data from amniotic flui d and urine have demonstr ated 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 wi th woman having a higher exposure than men. Children have been reported as having the hi ghest exposures; specifica lly to DEHP, DBP, BBP

and DnOP.

Available information indicat es that workers may be expos ed to phthalates by inhalation and dermal routes, with the dermal route seeming to be more prevalent. The Occupational Safety and Health Administration (OS HA) has established Permissibl e Exposure Limits (PELs) of 5 mg/m 3 time-weighted average (TWA) for both DBP and DEHP (OSHA 2006). According to the IUR data, industrial workers exposed to th ese 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 terr estrial animals have ev ident 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 repr oductive 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. Ph thalates are produced in high volume and they

are used in numerous industri al and consumer products. Phthal ates 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 re productive system, prevalence in the environment,U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

8 widespread use and human exposure and recent wo rk 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 developmen t results in adverse effects on the male reproductive system. The timing of exposure is critical to the severity of eff ects. The fetus is the most sensitive lifestage for male reproductive effects, and pubertal animals show effects at lower doses than those showing effect s in adult animals. Children ar e 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 object s and ingestion of non-food items. The 1999-2000 and 2001-2002 NHANES biomonitoring data demons trate that children have the highest exposures to phthalates of a ll groups monitored, and other biomonitoring data indicate in utero exposures to phthalates. Given th e well-characterized health e ffects of phthalate exposure in conjunction with the demonstrated widespread phthalate exposure in children, EPA believes

additional actions are warranted to insure protection of childre n’s health from this group of

chemicals.

A. Existing Risk Mana gement 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 requireme nts with those already in eff ect 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, DI DP, 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 Washi ngton, 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.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

9 The federal government both regulates and con tinues to study phthala tes. Federal entities involved in phthalate manage ment and research include:

 Consumer Products Safety Commission (CPSC) Among other provisions, the Consumer Product Safety Improvement Ac t 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 reinst ituted by CPSC if scientific research conducted by CPSC pursuant to the Act warrants. CPSIA tasks th e CPSC with appointing a Chronic Hazard Advisory Panel and examining phthala tes 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 comprehe nsive inventory of re gulated products that contain phthalates and review ing available use and toxicol ogy information associated with phthalate exposure from food contact use to better char acterize 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 con centration 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 fi rst 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 reportingU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

10 requirements, including production a nd use information for sites having production volumes of at least 25,000 lbs/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 severa l 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 s ubject to EPA, FDA, and the CPSC. People may be exposed to phthalates from a variety of produc t uses, as well as from industrial releases and environmental exposures; these exposure path ways should be assesse d together to avoid underestimating risk. The assessment of combined exposure is important to determine the potential impacts of these chemicals. Focusing individually on these ph thalates would very likely underestimate their impact since they appe ar 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 an other of similar toxicity. Given this cumulative impact, the management of the risk from comb ined exposure requires a coordinated approach by all three agencies, and, as appr opriate, additional federal agenci es. Therefore, EPA intends to participate in a coordinated approach to address the range of exposures.

In assessing potential restri ctions on certain phthalates, EPA plans to weigh the relative toxicity of other phthalate substitutes. Iden tification 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 th e 8 phthalates to the li st under TSCA section 5(b)(4). Section 5(b)(4) authori zes 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 tw o of the 8 phthalates in this Action Plan are currently on this Emergency Planning and Co mmunity Right-to-Know Act (EPCRA) § 313 list

of toxic chemicals.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

11 EPA intends to lay the groundwork to initia te in 2012 rulemaking under TSCA § 6(a) to regulate the 8 phthalates. In pr eparation for rulemaking, EPA inte nds, in cooperation with CPSC and FDA, to continue its work to more fully assess the use, exposure a nd substitutes for these chemicals. In its further review, EPA plans to consider the future results of the cumulative assessment currently being developed by the C onsumer Product Safety Commission (CPSC), pursuant to the Consumer Product Safety Impr ovement 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 Dr ug 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 re specting 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 befo re manufacturing or pr ocessing DnPP for a significant new use. The most recent Inventory Upda te Reporting data contains no reports of this phthalate being produced or imported into the Unite d 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 Envi ronment and Green Chemistry alternatives assessment by 2012. The information developed coul d 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, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

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