U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

1 Phthalates Action Plan

I. Overview

This plan explains the U.S. Environmental Protection Agency (EPA)’s Agency’s (EPA’s) current management plan for 8 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), d iisononyl phthalate (DINP), and diisodecyl pht halate (DIDP). In developing this plan, EPA considered phthalates’ the toxicity

, of phthalates, their prevalence in the environment

, and their widespread use and human
exposure.

Phthalates are produced in high volume

. They are used primarily as a plasticizer in polyvinylchloride (PVC) products, appear , over 470 million pounds per year (EPA 2006). Manufacturers use them in numerous industrial and consumer products, many of which pose primarily as plasticizers in poly(vinyl chloride) (PVC) products. Many phthalates can potentially lead to high exposure, both individually and in combination together with other phthalates

, and

are . They can often substitute s for each other in products . They are also used in medical applications and their presence has have been detected in food. Phthalates A number of phthalates appear in biomonitoring surveys of human tissues , evidencing widespread human exposure

. Phthalate exposures (CDC 2009)

. Although exposure to phthalates can produce a variety of effects in laboratory animals ; however, their , for certain phthalates the adverse health effects on the development of the male reproductive system are the most sensitive hea lth outcomes

. serious. Several studies have shown associations be tween phthalate exposur es and human health (although no causal link has been established). Recent scientific attention is focusing on whether evaluating the cumulative effect s of several mixtures of phthalates may multiply the reproductive effects in the an exposed organism exposed

. . EPA is concerned about phthala tes because of their toxicity

, and the evidence of pervasive human and environmental exposure to these chemicals

. them. Thus, the Agency EPA intends to initiate action to a ddress the manufacturing, proces sing, distribution in commerce, and/or use of these eight phthalates. The Agency EPA intends to take action as part of a coordinated approach with the Consumer Produc t 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 ini tial list of widely recognized chemicals, including phthalates

, (e.g., see Section VIII of this document), for action plan development based on one or more of the following factors their presence in human blood humans ; persistent, bioaccumulative, and toxic (PBT) 2 characteristics; use in consumer products; production volume ; and other similar factors.

. This Action Plan is based on EPA’s

1 15 U.S.C. §2601 et seq. 2 Information on PBT chemicals can be found on the EPA website at http://www.epa.gov/pbt/

.U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

2 initial review of readily available use, exposure, and hazard information 3 on eight phthalate esters. EPA considered which of the various aut horities provided under TSCA and other statutes might be appropriate to addr ess potential concerns with BPA 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 Ac tion Plan does not constitute a final Agency determination or other final Agency action. Regu latory proceedings indi cated 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) ha ve 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 eight individual phthalate esters as appropriate subjects for a comprehensive developing an assessment and management strategy. EPA believes this group is broad en ough to provide for a meaningful, extensive approach to phthalates management, while r emaining manageable in scope. This group of 8 eight phthalates includes all the phthalates identified by CPSIA and those being evaluated by CPSC and by EPA for the Integrated Risk Information System (IRIS ) database

. Complete overlap with the work being conducted by CPSC ), based on advice from the Natio nal Academy of Sciences (NAS, 2008). Four phthalates are common to CPSIA and by EPA for the IRIS will allow for maximum coordination with those efforts

. assessment. This phthalates category subject to this Action Plan consists of includes the following 8 eight chemical substances, identif ied by 10 separate Chemical Abstracts Service Registry Numbers (CASRNs):

No CASRN CA Index Name Acronym Common Name 1 84-74-2 1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester DBP Dibutyl phthalate 2 84-69-5 1,2-Benzenedicarboxylic acid, 1,2-bis-(2- methylpropyl) ester DIBP Diisobutyl phthalate

3 Information sources used by EPA includes hazard and risk assessments developed by governmental agencies of the U.S., Canada, European Union, and Australia

. These agencies include; the Australian Government, Department of Health and Ageing, the European Chemicals Bureau (ECU), the Chronic Hazard Advisory Panel (CHAP) appointed by the U.S. Consumer Product Safety Commission (CPSC), EPA’s Integrated Risk Information System (IRIS), and the U.S. National Toxics Program National Reproductive and Developmental Health Effects Panel

. In addition, robust summaries of studies for the phthalate category submitted by the sponsors to the EPA under the Chemical Right to Know High Production Volume (HPV) Challenge Program were also considered ( http://www.epa.gov/chemrtk/pubs/summaries/benzene/c13467tc.htm )

. Other governmental and non

- government sources were used as appropriate.U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

3 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 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 each of the commercial products of DINP and DIDP contain is a mixture of two chemicals mixtures in each commercial product.

B

. Physical/Chemical Property Characterization

The chemicals in this category are oi ly liquids at room temperature. They have low to moderate vapor pressures, and neglig ible to moderate water solubility

. The water solubility and vapor pressure decrease an d the octanol

- water partition co efficient (log K ow ) 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 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 NICN AS, 2008; HSDB 2009 ; Beilstein 2009 ; ExxonMobil Biomedical Sciences, Inc

. 2001 )

. Commonly, the structural characteristics of the ester side chains also affect the physic al

- chemical and toxicological properties of these phthalates ; e.g., the phthalates that cause the most potent reproductive effects are ge nerally those with ester side chains containing 4

- 8 carbon atoms

.

IV. Volumes, Uses and Substitutes Summary

A

. Production Volume

According to the 2006 TSCA Inventor y Update Reporting (IUR) database

, (EPA, 2006), reported volume of production (including imports) for the 10 individual phthalates ranged from none up to 500 million pounds. DINP had the highest production volume, followed by DIDP and DEHP, then BBP, DBP, DnOP and DIBP. There was no production volume data reported for DnPP in the 2006 IUR database.

B

. Uses

The major use of phthalates is as plasticizers (Austr alian Government, Existing Chemical Hazard Assessment Reports, 2008 2008a-h ; HSDB, 2009). A majo r application of plasticizers is in PVC (polyvinyl , [poly(vinyl chloride ), )], where they are added to impart flexibility and other desirable properties. Phthalated Phthalate-containing PVC products included a variety of industrial and commercial products, as well as specialized medical and dentalU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

4 applications. The particular phthalate or combinat ion of phthalates used in a particular product’s formulation depends on the properties the phthalate s impart, as well as their cost. BBP is the most widely used stain-re sistant 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 lac quers, use in cosmetics, medical supplies, textiles, propellants, food packagi ng, dental materials, and paper

. (OSHA, 2009). More specifically, it is used as a plastic izer in uses such as nail polis hes, 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. Th e 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 po lyacrylate and polyacetate dispersions

. (ECPI, 2009). The major use of DIDP is in PVC as a plasticizer (95 %)

. %) (EC2003b). DIDP is extensively used in wire and cable applications, and is, the main plasticizer used in this application

. (TURI, 2006). Non-PVC uses of DIDP include poly mer -related uses and nonpolymer uses such as anticorrosion and anti-fouling paints, sealing compounds, and textile inks

. (EC2003b). DINP is a mixture of phthalates and is a commonly used plasticizer

. (TURI, 2006). PVC applications account for 95 % percent of the volume. There are no known commercial uses for pure DnOP. However, DnOP constitutes approximately 20 % percent of the C 6–10 phthalate mixtures used in PVC products

. (NTP, 2003a).

C

. Substitutes

There are various possible alternatives for phthalates in plasticized PVC (Biron, 2009; SCENIHR

, 2007). Four chemicals have been cite d as already being used in various children’s products : Acetyl ; they are acetyl tri- n -butyl citrate (ATBC); Di di (2-ethylhexyl) adipate (DEHA); 1,2- C c yclohexanedicarboxylic acid, diis ononyl ester (DINCH), and Di 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 a lternative for applications such as medical devices (SCENIHR

, 2007). Another chemical, trioctyltr imellitate (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 (dip ropylene glycol dibenzoate) and DEHA (di(2-ethylhexyl) adipate). Other possi ble 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 resource s), and other organic este rs such as isobutyrate trimethylpentanediol, and diethy l 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 plas ticizers may also be potential substitutes for phthalate s (Biron, 2009; SCENIHR 2007). , 2007). As part of its inquiry, EPA will explore the potential risks as well as costs presented by phthalate substitutes.

In response to a European ban on the use of some phthalates in toys and personal care products for children, plasticizers based on isos orbide esters were developed (Roquett, 2009). These plasticizers can cover a br oad range of phthalate applicati ons, such as adhesive, sealants,U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

5 inks, floor coverings, wall paper, and medical disposables. It is worth noting that isosorbide esters could be prepared under solvent-fr ee conditions (Chalecki, 1997), providing an environmentally friendly a pproach to manufacturing.

V. Hazard Identification Summary

A

. Human Hazard Health Effects

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 of some phthalates in animal studies are the phthalate syndrome effects, which consist of changes in the fetal development of the reproductive system (NAS

, 2008

, ; NTP-CERHR , 2003a-e, 2006; EC, 2003a-b, 2003- 2006(al l), European Union 2003

- 2008 (all)

, 4, 2008a-b; Australian Government 2008 (all) )

. , 2008a-h). The phthalates that are the most pot ent at causing the phtha late syndrome effects are generally those with linear ester side chains having 4-6 carbons. Phthalates with shor ter or longer chain lengths typically exhibit less se vere or no effects; however, branching of the ester side chain is also important. It appears that the age of the animal at the time of 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 adu lt animals. The fetus is the most sensitive life stage

. (NAS 2008).

Several human studies have reported associa tions 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 incl ude shortened anogenital 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 general population to phthalates ( NHANES 2005 CDC, 2009 ). Biomonitoring data from amniotic fl uid and urine have demonstrated that humans are exposed to phthalates in utero , as babies 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 effect s of mixtures of several active phthalates on testosterone production, fetal mortality, and male and female reproductive development later in life showed all mixtures were cumulative for all endpoints

. (Rider et al., 2008, 2009; Howdeshell, et al., 2007, 2008a, 2008b; Gray et al., 2006; Hotchkiss et al., 2004). In conclusion, taken together, the reproductive effects observed in animal studies and in humans, the human biomonitoring data, and the data on cumulative effects of mixtures support EPA’s concern for potential human health hazard following exposure to phthalates.

A major cumulative hazard assessment of phthalates is currently being 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 theU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

6 CPSC/CHAP activity is 2012 4 . EPA is conducting its own cu mulative hazard assessment of 6 six of the phthalates in this Action Pl an as part of the updating of th e IRIS database. In a separate effort EPA is screening certain phthalates to assess their endocrine disrupting properties.

B

. Environmental Hazard Effects

Of the 8 phthlates, BBP, DEHP, and DBP elicit the mo st 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 wh ich 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.

All Some phthalates studied have been show n to affect reproduction and impair development in all studied animal groups. Most plasticizers 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 plasticizers phthalates in laboratory experiments coincide are consistent with measured environmental concentrations , and thus there is a very real potential for effects of these chemicals on some wildlife populations. (Oehlmann, et al., 2008).

VI. Fate 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 mode rate 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  10 -5 to 1.38  10 -8 mm Hg at 20 o C; the water solubility range from 10 mg/L to 3.81  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, 2008a-h; HSDB, 2009; Crossfir e 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 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

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 purp oses, the staff estimates that the report will be completed in 2012U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

7 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 re lease from products c ontaining phthalates. Only two (DBP and DEHP) of the 8 phthalates are listed on EPA’s Toxics Release Inventory (TRI ) data are available only for two phthalates (DBP and DEHP)

. ).list of toxic chemicals. The available release data for these two phthalates indicate that releas es of phthalates can be expected to all primary environmental media. 2007 TRI data ( US EPA

, 2009) for DBP and DEHP show total onsite and off-site releases of more th an 336,000 pounds from 134 sites and 1,229,000 pounds from 251 sites, respectively; however, under TRI, some volume of releases ar e 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 )

. ) (Babich, 2004; Clausen 2004; EC, 2003 a-b; 2003-04; 2008 ab; CPSC, 2001; 2002). The p redominant most studied population and route of exposure that has been studied for this class of chemicals has been dire ct 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 Un ion Scientific Committ ee on Medicinal Products and Medical Devices

. (FDA, 2002a; Health Canada, 2002; EC 2002). The overarching conclusion is that premature in fants are the population most hi ghly exposed to phthalates via these uses. In 2002, the FDA recommended the use of alternatives to DEHP-containing medical devices if specified for a specific list of procedures that were to be performed on high-risk individuals. Depending on the proce dure, these individuals include infants, boys male neonates

, pregnant or nursing women who are carrying male fetuses , and , for some procedures, healthy adults. peripubertal males (FDA, 2002b).

Exposure routes of concern will depend on th e product and its use patterns. For example, inhalation exposure for adults and children could be an issue of concern in vehicle interiors, particularly in summer due to elevated temperatur es in vehicles given the vapor pressure range of these chemicals. Exposure to phthalates can occur from releases th at result from the manufacturing, processing or industr ial use of phthalates as well as contamination of air, water, food, and dust from the use or disposal of products containing phtha lates. The publishedU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

8 literature indicates that the exposure sour ces listed from highest to lowest are : food, cosmetics, consumer products (other than toys), and toys

. While there (NTP-CERHR, 2003 a-e, 2006; HSDB, 2009). There are limited data on the migration of phthalate from plasticized PVC into environmental media. However, due the total volume of pl asticized PVC produced , it is possible that PVC or other polymer/poly meric-like materials containing phthalates may be long-term and dispersive sources of human and envi ronmental 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 babies infants , during puberty, a nd in adult life, and that people are exposed to several phthala tes at once. For example, NHANES detected a DEHP urinary metabolite in 78% of the 2541 samples tested with wom a e n 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 (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

. (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. Data Animal data on the cumulative effect of mixtures of several phthalates indicates 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 biom onitoring surveys, such as NHANES, evidencing that provide evidence of widespread human exposure

. Phthalates are also found in the environment and wildlife species. EPA is concerned with phtha lates based on toxicity, particularly to the development of the male reproductive system, prev alence in the environment, widespread use and human exposure and recent work focusing on th e potential cumulative effect of mixtures of phthalates.

Potential Impacts on ChildrenU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

9 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 life stage for male reproductive effects, a nd pubertal animals show effects at lower doses than those showi ng effects in adult animals. Child ren are exposed to phthalates through a number of consumer products (e.g., toys, infant feeding products), as well as environmental sources (e.g., air, water, food )

. ) as well as consumer products (e.g., toys).. Children’s estimated exposures are often greater than those in adults which may be due to increased intakes of food, water, and air on a bodyweight basis, as well children’s unique exposure pathways such as mouthing of object s and ingestion of non-food items. The 1999-2000 and 2001-2002 NHANES biomonitoring data in the Third National Report on Human Exposure to Environmental Chemicals demonstrate that children have the highest exposures to phthalates of all groups monitored, and othe r 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 additional that the cumulative h ealth risks of phthalates should be assessed to determine what actions are warranted to insure protection of ch ildren’s health from this group of chemicals.

A

. Existing Risk Management Activities

1

. Foreign Governments

.

A number of nati ons have taken steps to manage risk associated with phthalates or further assess those risks. Fo r example, i n 2005 , the European Commission banned DEHP, DBP and BBP in all toys an d childcare articles. DINP, DIDP and Dn OP 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 t hose already in effect in the EU and U S, 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, DI NP, DBP, BBP, DnOP, DEP and bi s(2

- methyl ethyl) phthalate as Priority Existing Chemicals and initiated h ealth risk assessments for these phthalates , which were concluded in 2008.

2

. State Governments

.
Several states, such as California and Washington, have proposed or enacted legislation regarding phthalates, including prohibiting the sale of children's products containing phthalates, investigating the risks involved in the use of phthalates, and requiring manufacturers to use the least toxic alternative

. Some of these state provisions have been superseded by the federal bans in CPSIA.

3

. Federal Government Outside EPA

. The federal government both regulates and con tinues to study phthala tes. Federal entities involved in phthalate manage ment and research include:U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

10 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 th ese banned phthalates, DINP, DIDP, and DnOP may be reinstituted by CPSC if scientific research conducted pending review by CPSC pursuant to the Act warrants

. the Chronic Hazard Advisory Panel. The CPSIA tasks the CPSC with appointing a Chronic Hazard Advisory Panel and examining the cumulative health risks of phthalates health effects and exposure 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 phthalate s in food contact substances (such as plastic wrap), cosme tics, pharmaceuticals and medical devices. FDA announced in June 2008 that it is conducting a co mprehensive inventory of regulated products that contain phthalate s and is reviewing available use and toxico logy information associated with phthalate exposure from food contact use FDA regulated products to better characterize any potential risk from these uses.

4

.

Environmental Protection Agency ( EPA

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

 Office of Water DEHP concentration is limited in drinking water DEHP is regulated under the Safe Drinking Water Act. The hi ghest 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.

 O ffice of E nvironmental I nformation DBP and DEHP are listed as reportable to the Toxic Release Inventory (TRI) chemicals under section 313 of the Emergency Planning and Community Right-to-know Act (EPCRA).

 Office BBP, DBP and DEHP are included in the first group of 67 chemicals to be screened as part of Prevention, Pesticides and Toxic Substances

 O ffice of Science Coordination and Policy and the Office of Pesticide Programs. OPP is conducting an the Endocrine Disruptor Sc reening Program (EDSP ) under a Congressional mandate in the Food Quality Protection Act

. Test orders are being issuedU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

11 for the first group of 67 chem icals (74 FR 54422), including three phtha lates 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 section 8(e) Inventory Update Reporting (IUR) requirements, including production a nd use information for sites having production volumes of at least 25,000lbs/yr. All 8 eight Phthalates (10 CASRNs) subject
to included in this Action Plan are listed on the TSCA Chemical Substance Inventory.

 TSCA Section 4 Testing In 1989, EPA entered an Enforceable Consent Agreement under TSCA section 4 with six companies to perform certain chemical fate and environmental effects on certain Alkyl Phthalates (54 FR 618).

 High Production Volume Challenge Program In 2001, under the voluntary HPV Challenge Program, the Phthalate Esters Pane l Testing Group of the American Chemical Council submitted a test plan for sponsored a phthalates ester category. It The panel has submitted to EPA robust study summaries or other information for 26 phthalates, including several of those be ing considered in this Ac tion Plan (BBP, DEHP, DINP, DIDP and DnOP)

State Governments

California, Vermont and Washingt on have established standard s 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 co ntains DEHP, DBP, or BBP at greater than 0.1% and of any toy or child-care arti cle, intended for use by children under three years of age that can be mouthed, that contains DINP , DIDP or DnOP at greater th an 0.1%. Vermont prohibits the manufacture, sale, or distributi on in commerce of any toy or child -care article intended for use by a child younger than three years old that cont ains DEHP, DBP, or BBP in concentrations greater than 0.1% and of any toy or child-care article intended for us e by a child under three years of age that can be placed in the mouth and that contains DINP, DIDP, or DnOP in concentrations greater than 0.1% ( CRS, 2008)

. As part of a statute concerning chemicals in children’s products ge nerally, Washington prohibits a manufacturer, wholes aler, or retailer from manufacturing, know ingly selling, offering for sale, or distributing for sale or for use in the state a children’s pr oduct 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 legislati on to prohibit the manufacture, sale, or distribution of certain toys and child care articles containing certain types of phthalates (Hawaii House of Representatives, 2009; CRS, 2008)

Foreign Governments

A number of nations have taken steps to manage risk associated with phthalates or further assess those risks. B

. For example, in 2005, the European Commission banned DEHP, DBP andU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

12 BBP in all toys and childcare articles (Dir ective 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., ensuri ng the same level of protection as children in the U.S. and the EU ( Canada Consumer Product Safety Act). In 20 06, 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 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 pa thways should be assessed together to appropriately characterize exposures and avoid underestimating risk. The assessment of combined exposure is important to determine the potential impacts of these chemicals. Focusing individually on these phthalates would very likely underestimate their impact sin ce they appear to produce similar adverse effects. Also, many phthalates are interc hangeable in their uses as plasticizers for flexible PVC products, so restrictio ns 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 th ree agencies, and, as appropriate , additional federal agencies. Therefore, EPA intends to participate in a coordinated approach work closely with CPSC and FDA to address the range of exposures.

In assessing potential restric tions on certain phthalates, EPA plans to weigh the relative toxicity and feasibility of other phthalate substitutes. Iden tification of safer and affordable nonphthalate substitutes will be an important consider ation in any action that would restrict the use of these chemicals.

IX. Next Steps

EPA intends to initiate On the basis of existing information, the Agency believes that the following regulatory actions would be warranted to manage the risk that may be presented by the 8 eight 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) authori zes the EPA to compile and keep current a list of chemicals it finds present s or may present an unreasonable risk of injury to health or the environment. A EPA intends to publish a notice of proposed rulemaking is intended to publish in autumn, 2010.

EPA intends to initiate rulemaking in late 2010 to add the six phthalates not listed on the Toxics Release Inventory to that list. Only two of the 8 eight phthalates in this Action Plan areU.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

13 currently on this Emergency Planning a nd Community Right-to-Know Act (EPCRA) § section 313 list of toxic chemicals.

EPA intends to lay the groundwork to initiate consider initiating in 2012 rulemaking under TSCA § section 6(a) to regulate the 8 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 currently being that will be developed by the Consum er 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 which may be completed in 2012, as well as th e 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 any future TSCA § section 6 action addressing these chemicals. Depending on the nature of its final determination about the 8 eight phthalates, EPA’s potential control measur es 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) “pre sents or will present an unreas onable 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 respecting 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 manu facturing or processing DnPP for a significant new use. The most recent Inventory Update Reporting data contains no reports of this phthalate being produced or importe d 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 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 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

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