U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

Polybrominated Diphenyl Ethers (PBDEs)

I. Overview

As part of the U.S. Environmental Protect ion Agency’s (EPA) efforts to enhance the existing chemicals program under the Toxic Substances Control Act (TSCA), the Agency

identified an initial list of chemicals for acti on plan development based on their presence in human blood, PBT characteristics, use in cons umer products, production volume, and other similar factors. This action plan outlines EP A’s approach for addressing polybrominated diphenyl ethers (PBDEs). These chemicals are pr oduced and sold as complex mixtures, and EPA is concerned that some of the component congene rs are persistent, bioacc umulative and toxic.

PBDEs have been widely used as flame retardants in a number of applications. Three commercial PBDE mixtures have been produced a nd used in the United States and elsewhere: commercial pentabromodiphenyl ether (c-pentaBD E), commercial octabr omodiphenyl ether (coctaBDE), and commercial decabromodiphenyl ether (c-decaBDE). Although manufacture and import of c-pentaBDE and c-octaBDE were pha sed out in 2004, PBDE congeners associated

with those mixtures continue to be found in humans and the environment. Some reports indicate that levels are continuing to increase. Imported articles treated with c-pentaBDE and c-octaBDE

could be a source of human and environmental exposure to these PBDE congeners. c-DecaBDE

is still manufactured and used in the US. Data suggest that de bromination, physical or metabolic removal of bromine atoms, may convert decaBDE to more toxic PBDE congeners, contributing further to the potential risk fr om exposure to these congeners.

The Agency undertook this review to evaluate whether action is needed to limit exposure and release of PBDE congeners of concern due to manufacture (including import) of commercial

PBDEs and/or articles to wh ich they have been added.

The Agency intends to:

1. Initiate rulemaking to propose a TSCA signifi cant new use rule (SNUR). The significant

new use would be manufacture or import of articles to wh ich c-pentaBDE or c-octaBDE has been added. This designation would requ ire anyone who intends to manufacture or import articles to which these chemical substanc es have been added to notify EPA at least 90 days in advance. The required notificati on would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. A notice of proposed rulemaking is intended to publ ish in late 2010.

2. Support and encourage a voluntary phase out of manufacture and import of c-decaBDE. a) EPA has entered into discussions with th e principal manufacturers and importer of cdecaBDE regarding a commitment to initiate reductions of manufacture, import and sales of decaBDE starting in 2010. Ordina ry production, import and sales of

decaBDE would cease no later than D ecember 31, 2012. Certain uses such as transportation uses or military applications may require an additional year to phase out. In any case the companies would ceas e sales for these uses no later than December 31, 2013.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

2 b) EPA intends to encourage other importer s of decaBDE to join this effort. c) The commitment under discussion would not affect articles made with c-decaBDE produced or imported prior to the end of th e phase out period. Recycling of materials containing decaBDE would also not be affected by the commitment.

3. Initiate rulemaking to simultaneously propose a SNUR and a test rule for c-decaBDE in

late 2010. a) The SNUR would designate manufacture (inc luding import) of c-decaBDE or articles to which c-decaBDE has been added as a significant new use. Essential uses and any other uses which have not been voluntarily phased out would not be included in the SNUR. The SNUR would be promulgated af ter the voluntary phase out is complete; b) The test rule under section 4 of TSCA would require development of information necessary to determine the effects that manufacturing, use or other activities involving c-decaBDE have on human health or the environment; If the Agency determines that any manuf acture (including import) of c-decaBDE or

articles to which c-decaBDE has been added has not ceased, it intends tol promulgate the

test rule.

4. Promulgate a rule under Section 5(b)(4) of TSCA to add the commercial PBDE mixtures and/or the congeners they cont ain to the list of chemicals which present or may present

an unreasonable risk to health or the envi ronment. A notice of proposed rulemaking is intended to publish in autumn, 2010.

5. Develop an alternatives analysis for c-d ecaBDE. The alternatives analysis, which is intended to begin in spring 2010, would eval uate the efficacy, availability, cost and

hazard levels of alternatives for a subset of critical uses of c-decaBDE. The alternatives analysis is intended to aid users of c-decaB DE in selecting suitable alternatives and avoiding unintended consequences.

As part of its efforts to address PBDEs, EPA intends to evaluate the potential for disproportionate impact on children and other vulnerable populations.

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 polybrominated diphenyl et hers (PBDEs), for action plan development based on their presence in human blood; pers istent, bioaccumulative, and toxic (PBT) 2
characteristics; use in consumer products; produc tion 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 PBDEs. EPA considered which of the various authorities provided under TSCA

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 customarily employed include Inventory Update Reporting (IUR) submissions; Toxic Release Inventory (TRI) reporting; data submitted to the HPV Challenge Program; existing hazard and risk assessments performed by domestic and international authorities includi ng but not limited to U.S. Federal government agencies,U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

3 and other statutes might be appr opriate to address potential con cerns with PBDEs in developing

the Action Plan. The Action Plan is intended to de scribe the courses of action the Agency plans to pursue in the near term to address its con cerns. The Action Plan does not constitute a final Agency determination or other final Agency action. Regulatory procee dings indicated by the Action Plan will include appropriate opportunitie s for public and stakeholder input, including through notice and comment rulemaking processes.

III. Scope of Review

This action plan addresses uses of the th ree commercial PBDE mixtures as flame

retardants and concerns for human and envir onmental exposure resulting from their use.

The PBDEs are a family of chemicals with a common structure of a brominated diphenyl ether molecule which may have anywhere from one to ten bromine atoms attached. (Figure 1).

Figure 1. Brominated diphenyl molecule

O Br x Br y

x + y = 4 - 10

Each individual PBDE variant, distinguished from others by both the number of bromine atoms and the placement of those atoms, is referre d to as a congener. For example, there are 42 tetrabromodiphenyl ether congeners, each with four bromine atoms in different configurations. In theory, there could be as many as 209 PB DE congeners, but a much smaller number of congeners are commonly found in the commercial PBDE products and in measurements of PBDEs in humans and the environment (Table 1).

the Organization for Economic Cooperation and Development, the Stockholm Convention on Persistent Organic Pollutants, Health and Environment Canada, the European Union; and others. Action plans will reference specific

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

4 Table 1. Selected PBDE Congeners

Congener Number of

Bromine Atoms Chemical Name

BDE-28

BDE-47

BDE-85

BDE-99

BDE-100

BDE-153

BDE-154

BDE-183

BDE-197

BDE-206

BDE-209 3

4

5

5

5

6

6

7

8

9

10 2,4,4’-tribromodiphenyl ether 2,2’,4,4’-tetrabromodiphenyl ether 2,2’,3,4,4’-pentabromodiphenyl ether 2,2’,4,4’,5-pentabromodiphenyl ether 2,2’,4,4’,6-pentabromodiphenyl ether 2,2’,4,4’,5,5’-hexabromodiphenyl ether 2,2’,4,4’,5,6’-hexabromodiphenyl ether 2,2’,3,4,4’,5’,6-heptabromodiphenyl ether 2,2’,3,3’,4,4’,6,6’-octabromodiphenyl ether 2,2’,3,3’,4,4’,5,5’,6-nonabromodiphenyl ether 2,2’,3,3’,4,4’,5,5’,6,6’-decabromodiphenyl ether

PBDE congeners can be grouped according to the number of bromine atoms present in the molecule. TSCA inventory listings and regulations for PBDEs are based on these groups. Table 2. The congeners used in flame retardants have between four and ten bromine atoms. .

Table 2. PBDE Congener Groups

Common Name CAS Index Name CASRN Number

Br atoms TetraBDE Benzene, 1,1'-oxybis-, tetrabromo derivative 40088-47-9 4 PentaBDE Benzene, 1,1'-oxybis-, pentabromo derivative 32534-81-9 5 HexaBDE Benzene, 1,1'-oxybis-, hexabromo derivative 36483-60-0 6 HeptaBDE Benzene, 1,1'-oxybis-, heptabromo derivative 68928-80-3 7 OctaBDE Benzene, 1,1'-oxybis-, octabromo derivative 32536-52-0 8 NonaBDE Benzene, 1,1’-oxybis-, nonabromo derivative 63936-56-1 9 DecaBDE. Benzene, 1,1'-oxybis-, 2,3,4,5,6-pentabromo- 1163-19-5 10

There are three types of commercial PBDE products, c-pentaBDE, c-octaBDE, and cdecaBDE, each contains a mixture of PBDE congeners (see Table 3).

Table 3. Congeners in Commercial PBDE Mixtures Commercial Mixture Major components Minor components c-pentaBDE tetraBDEs pentaBDE hexaBDE

c-octaBDE heptaBDE

octaBDE hexaBDE

nonaBDE

decaBDE

c-decaBDE decaBDE nonaBDE

A small number of the PBDE congeners are found most frequently, and in the greatest concentrations, in human and environmental samp les. BDE-47 tends to be found more frequentlyU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

5 than other congeners in measurements from hu mans, fish and other biota, followed by BDEs 99, 100, 153 and 154. In measurements of environmental media, like some samples of house dust, sediments, and indoor air, BDE-209 (decaBDE) seems to be dominant.

IV. Uses and Substitutes Summary

PBDEs are added to materials to reduce the risk of fires and to increase escape time when a fire occurs. They were widely used on carpe ts and upholstery, used in household and business furnishings, cars, buses, trucks and airplanes, as well as uses in plas tics and foams which are components in electrical appliances and equipment.

Domestic manufacture of c-pentaBDE a nd c-octaBDE stopped in 2004 when the Great Lakes Chemical Corporation (now Chemtura Corporation) voluntary phased out their production. The EPA subsequently promulgate d a SNUR (74 FR 34015, June 13, 2006) which requires that anyone who intends to manufacture or import a ch emical substance or mixture containing any of the congeners present in c- pentaBDE or c-octaBDE notify EPA at least 90 days in advance. The notice would provide EPA with an opportunity to evaluate the intended new use and if necessary take action to limit or prohibit it. The SNUR did not address importation of articles to wh ich c-pentaBDE or c-octaBDE has been added.

Most of c-pentaBDE’s consumption took place in the United States. It was used primarily

as an additive flame retardant in flexible polyurethane foams. A 2002 study estimated that 80 percent of c-pentaBDE was used in foam for furniture and mattresses, while the remaining amount was used in automotive applications (H ale et al. 2003). In 2005, EPA’s design for the environment (DfE) program completed an alternativ es analysis for pentaBDE in furniture foam which provided data to inform substitution to safer alternatives ( http://www.epa.gov/dfe/pubs/p rojects/flameret/index.htm ). This work complemented the voluntary phase-out and the SNUR.

c-OctaBDE was used in acrylon itrile-butadiene-styrene (ABS ) plastic which was used as casing for certain electric and electronic devi ces that are used in both offices and homes. cOctaBDE had a smaller market than c-pe ntaBDE and was more easily replaced

c-DecaBDE, on the other hand, is still manufact ured and widely used in the U.S. and abroad, although legislative action to restrict its use has been undertaken by some US States. Based on IUR data (2006) between 50 – 100 m illion pounds were manufactured or imported in

the United States in 2005. That is of the same order of magnitude as the amount reported in

2002.

c-DecaBDE is an economical flame retard ant because relatively small quantities are necessary to achieve a flame retardant effect . The three major product categories in which

decaBDE are used as an additive flame retardant are: textiles, electronic equipment, and building and construction materials. Its primary use is in high impact polystyrene (HIPS) based products. Several potential substitutes exist for each majo r use of decaBDE. EPA has not evaluated the potential human health or environmental eff ects of all potential c-decaBDE substitutes.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

6 V. Hazard Identification Summary

Human Health Effects

In its 2006 PBDE Project Plan, EPA summari zed animal studies of various commercial mixtures and individual congene rs which suggested potential c oncerns about liver toxicity, thyroid toxicity, developmental toxicity, and developmental neurotoxicity. These findings and the presence of PBDEs in house dust and breast milk raise partic ular concerns about potential risks to children (EPA, 2006).

In 2008, EPA published peer reviewed Toxicolo gical Reviews of four PBDE congeners: tetraBDE (BDE-47), pentaBDE (BDE-99), he xaBDE (BDE-153), and decaBDE (BDE-209), to support summary information on EPA's Integrated Risk Information System (IRIS) database.

Neurobehavioral effects was identi fied as the critical endpoint of concern for each of the four congeners (EPA, 2008a, 2008b, 2008c, and 2008d). The protocols for the studies were unique and did not conform to health effects testg guid elines for neurotoxicity. For decaBDE, EPA also proposed that the data supports a finding of "suggestive evidence of carcinogenic potential" (EPA, 2008d).

Through EPA’s Voluntary Children’s Chemical Evaluation Program (VCCEP) 4

, industry-sponsored screening level risk assessm ents for pentaBDE, octaBDE and decaBDE were developed to evaluate the poten tial risks to children and pr ospective parents from potential PBDE exposures. In August, 2005, EPA released its Data Needs Decision documents on PBDEs. Noting the evidence suggesting developmental and reproductive effects, EP A requested that the sponsors provide 2-generation repr oductive toxicity studies for bot h pentaBDE and octaBDE, to characterize risks to children (EPA, 2005a, EPA, 2005b). This data was not made available through VCCEP, as the companies ceased their sponsorship of pentaBDE and octaBDE under VCCEP. For decaBDE, EPA indicated a need to further understand fate and transport of decaBDE in the environment, pa rticularly with respect to th e significance of its lower BDE breakdown products, as this could relate to its risk characterization (EPA, 2005c). The decaBDE data needs were not met by the VCCEP sponsor s and decaBDE was subsequently terminated from the VCCEP program.

Environmental Effects

In March of 2006, EPA published a PBDE Proj ect Plan which included a review of the

current scientific understandi ng of PBDEs (EPA, 2006). At that time, information on

environmental effects of PBDEs was limited, with the most detail ed reviews found in European Union risk assessments of certain congeners. Since then, Environment Canada in its 2006 ecological assessment of PBDEs concluded that th e greatest potential risks from PBDEs in the Canadian environment are the secondary poisoni ng of wildlife from the consumption of prey containing elevated concentrations of PBDEs an d effects on benthic organisms that may result

from elevated concentrations of certain PBDE s in sediments (Environment Canada, 2006). In a more recent report, Environment Canada has al so concluded that decaBDE is available for

4 Information on VCCEP is available at http://www.epa.gov/oppt/vccep

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

7 uptake in organisms and may accumulate to high and potentially problematic levels in certain species such as birds of prey or mamma lian predators (Environment Canada, 2009a).

Laboratory studies have show n that congeners associated with c-pentaBDE and coctaBDE are capable of producing adverse effect s in a variety of organisms including birds, mammals, and fish. In some cases these effects were observed at exposures levels similar to

levels found in the environment. American kestre ls and chickens exhib ited adverse effects in laboratory studies when exposed to levels of c-pentaBDE and c- octaBDE similar to those which have been observed in monitoring studies condu cted in San Francisco Bay and the Great Lakes (McKernan et al. 2009). Adverse effects in cluded histopathological chan ges in immune organs, altered reproductive behavior and decreased embryo survival and decreased hatching rates. Zhang et al. (2009) reported that c-pe ntaBDE produced adverse reproductive and developmental effects in ranch mink. Zhang et al. (2009) also reported that biom onitoring of wild mink from the Great Lakes region revealed that margins of sa fety for mink are small. Mink from the Hamilton

Harbor exceeded the no observed e ffect concentrations. Timme-Laragy et al. (2006).reported that c-pentaBDE produced developmental and beha vioral effects of fish embryos including spine curvature and hatching delay

Breakdown of PBDEs involves debromina tion, where highly brominated PBDEs can

breakdown to form lesser brominated PBDEs. Although its overall significance is unclear,

metabolic debromination of decaBDE to a va riety of PBDE breakdown products has been observed in fish (carp, fathead minnows, rainbow trout), and in microsomal fractions derived from fish (Kierkegaard et al . 1999; Stapleton et al. (2004a); Stapleton et al. 2006); and in birds (Van den Steen et al. 2007), cows (Kierkegaard et al. 2007) and rats (Huwe and Smith 2007). There is increasing concern that this process can be a significant source of exposure to lower brominated congeners.

VI. Fate Characterization Summary

PBDEs are expected to be minimally mobile from the soil to air or water, except as borne on particulate matter. Volatilizati on from moist soil surfaces is expected to be low to moderate depending on the number of bromine atoms. If PBDEs are released to water, the individual constituents of these complex mixtures would be expected to adsorb to sediment and suspended particulate matter, and it is thought that a subs tantial proportion is likely to be bound to particles in water. PBDEs are expected to exist in both the vapor and particulate phases in the ambient atmosphere based upon measured and estimated va por pressures. The tetraBDE and pentaBDE congeners are distributed between vapor and particle phases bu t predominantly in the vapor phase; the hexa- and octaBDEs are mostly attach ed to atmospheric particles; and decaBDE is exclusively adsorbed to particle s. Particulate phase compounds are removed from the atmosphere by wet and dry deposition (HSDB 2009).

Based on available evidence, PBDEs can be debrominated under environmental conditions; however, the overall si gnificance of this process is uncertain. DecaBDE undergoes photolytic and possibly microbial debrominati on under certain conditions (Environment Canada 2009a; Stapleton 2006). Photolysis is expected to be the domin ant transformation process forU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

8 decaBDE where the substance is significantly expos ed to light. For example, it has been found that decaBDE undergoes photolytic debrominatio n in house dust (Stapleton and Dodder 2008). DecaBDE would also be exposed to light when waste sludge containing PBDEs is used as soil (Hale et al. 2001). However, the hydrophobicity of PBDEs implies that in the aquatic environment they will tend to partition to benthic sediments, where light exposure is insignificant.

That PBDE congeners from four to ten br omine atoms are highly persistent is suggested by several lines of evidence, but especially by a large body of environmental monitoring data for both the US and abroad (Environment Canada 2009a; Shaw and Kannan 2009; Vonderheide et
al. 2008). Available data also indicates that tetra-, penta-, and hexa-BDE are highly bioaccumulative (Environment Canada 2006). Mo re recently it has been concluded that decaBDE likely contributes to the forma tion of bioaccumulative and/or potentially bioaccumulative transformation products such as lower brominated PBDEs in organisms and in

the environment. Studies have shown that th at photodegradation of decaBDE may result in PBDEs from tri- to nona- and biodegradation of decaBDE may result in nona-, octa- and heptaBDEs (Environment Canada 2009).

The atmosphere and marine currents can tran sport PBDEs over relatively long distances (> 1,000 km). Evidence for this comes from the pres ence of PBDEs in the tissues of deep oceandwelling whales and other marine mammals fa r from anthropogenic sources (Shaw and Kannan 2009), as well as from modeling (Wania a nd Dugani, 2003). The body burdens of PBDE congeners in a wide variety of biota indigenous to geographical ar eas ranging from the equator to the poles also substantiate their propensity fo r long-range transport (L RT), and constitute evidence of environmental persis tence (Environment Canada 2006).

VII. Exposure Characterization Summary

In recent years, scientists have measur ed PBDEs in human adipose tissues, serum and breast milk, fish, birds, marine mammals, sediments, sludge, hous e dust, indoor and outdoor air, and supermarket foods. The mechanisms or pa thways by which the PBDEs move into and through the environment and humans are not known, but are likely to include releases from manufacturing of the chemicals, manufacturing of products like pl astics or textiles, aging and wear of products like sofas and electronics, and releases at the end of product life (disposal, recycling). In general, levels of PBDEs in humans and the en vironment are higher in North America than in other regions of the world, a finding that is often attributed to the greater use of pentaBDE in North America (EPA Project Plan, 2006).

The food chain is likely the largest contributor to environmental exposures with PBDE depositing in soil and water where fish a nd benthic organisms are initially exposed. Biomagnification occurs as predators up the food chain ingest the accumulated concentrations of PBDEs from their prey (Chen et al. 2007; Vorspoels et al . 2007; Shaw and Kannan 2009; Stapleton and Baker 2003). In some studies eviden ce has been provided that the concentrations of PBDE in biota have doubled every 3 to 6 years, the doubling time depending on species, life stage, and location. PBDE concentr ations in marine biota in Nort h America are the highest in the world and are increasing (Shaw and Kannan 2009). The extent of accumulation of congeners isU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

9 directly related to PBDE levels in diet. Observed differences in PBDE congener profiles in marine mammals from California, Alaska, and th e Gulf of Mexico indicate that diet is a significant source of PBDE exposure in marine wildlife (Shaw and Kannan 2009).

The concentration and distribution of congene rs detected in the environment appears to depend on the proximity to a source of the conge ner in question and the media tested. Studies have been performed measuring waterways, sedi ments, and biota for PBDE concentrations in various known hot spots, such as the Great Lakes, the San Francisco Bay, and near a polyurethane foam manufactur ing facility (ATSDR, 2004).

The general population is exposed to PBDE s through the use of consumer products. Body

burden data indicate that the general population appears to be exposed to primarily lower brominated BDEs (e.g., tetra and penta). PBDEs have been detected in human tissue, blood (usually serum), and milk. The primary source of human exposure to PBDEs, especially the lower brominated congeners, may be from dietar y intake, particularly high fat content foods (ATSDR, 2004). The lower brominated tetra- and penta- congeners ha ve also been detected in air samples and indicate that inhala tion may also be a potential r oute of exposure for the general population (ATSDR, 2004). Inhalati on exposures could also occu r from offgassing of PBDEs from furniture and electrical applia nces into indoor air, but lit tle information is known about the potential exposure through this route (ATS DR, 2004). Dermal exposure may occur through contact with PBDE-containing products such as po lymers and textiles. A large number of human samples been analyzed, and the PBDE concentrat ions have increased by a factor of ~100 during the last 30 years (Hites as ci ted in 2007 BFR Conference abstracts). Exposures to PBDEs in some occupational settings, such as in computer recycling, can be higher than those of the general population (Cal/E PA PBDE Workgroup, 2008).

Recent human biomonitoring data is currently available from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. Pa rticipants were aged 12 years and older

and decaBDE was not included. BDE-47 was detected in serum from almost all of the participants and at the highest concentrations and it was high est in 12-19 year olds and those 60 years old and above. Furthermore, serum levels we re highest in 12-19 year olds for other lower brominated congeners. In addition, these congeners were significantly correlated with each other, suggesting a similar pathway of e xposure (Sjodin, et al, 2008).

In the 2006 PBDE Project Plan, EPA comm itted to reviewing and synthesizing the available information on exposure pathways for PBDEs, including id entifying the relative importance of different exposure pathways and how PBDEs get into various exposure media. In November, 2008, EPA issued an external review draf t of its PBDE exposure assessment which is still undergoing public and peer review. In the m eantime, an article based on portions of that assessment explained the process used to gath er exposure information, model body burden, and compare it to representative PBDE profiles in blood and milk. The analysis focused on indoor measurements of dust/soil and air, noting that th e primary cause for PBDE exposures appears to be their use in commercial products that are pa rt of the indoor environm ent (computer circuitry, foam cushions, fabrics in curtains, etc). Alt hough the article recommended more research to verify the findings and better quantify identified uncertainties, it concl uded that exposures to PBDEs through food and water ingestion and in halation explained less than 20% of the bodyU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

10 burden, while 80 to 90% of total exposures in the indoor environm ent were through contact with house dust (Lorber, 2008).

To further examine exposure pathway issues, EPA and the USDA have collaborated on a study which examined the tissue distribution of PB DE congeners in male rats dosed to mimic PBDE exposure from food or household dust. This study found differences in PBDE congener distribution in the body. While the lower brominated congeners tended to di stribute equally into lipids, plasma was the best matrix for detecti on of the higher brominated congeners (especially BDE-209), indicating that blood may be the most reliable matrix for overall PBDE biomonitoring (Huwe et al., 2008).

ATSDR (2004) states that a child’s exposure may differ from that of adults because children drink more fluids, eat more food, breat he more air per kilogram of body weight and have a larger skin surface area in proportion to body volume. Their diets and behavior patterns

are also different. Infants who consume breas t milk may have higher exposure to lower

brominated BDEs than children who drink fo rmula (ATSDR, 2004). PBDEs have been found in breast milk in the U.S. and in Europe. The medi an concentration of tota l PBDEs was found to be 34.0 ng/g lipid, with the BDE 47 being the predominant congener present. Other populations identified with potentially high exposures ar e subsistence fishermen who consume PBDEcontaminated fish and Native Americans who resi de in Arctic regions and consume whale and seal blubber (ATSDR, 2004). Thes e populations are potentially e xposed to lower brominated PBDEs (ATSDR, 2004).

Fisher et al. (2006) conducte d a study on a family of 4, including the parents and 2 children ages 5 years old and 18 months old. Resu lts of the study showed that the youngest child had the highest concentration of total PBDEs. The concentrations of total PBDE in serum samples ranged from 239-249, 418-488, 106-147, and 64-67 ng/g lipid weight for the child, toddler, mother, and father, respectively. This study also found that house dust is a more significant source of PBDE exposures in children than in adults. Fi scher et al. (2006) noted that in a study conducted by Thomsen et al. (2002),* it was found that PBDE levels in infants and children were 2- to 3-fold higher than in adults. Fi sher et al. also noted th at Thomsen et al. is the only study that had measured body burdens of the very young.

VIII. Regulatory Status of PBDEs

PentaBDE and OctaBDE

c-PentaBDE and c-octaBDE are no longer produc ed or imported in the United States. The sole domestic producer, Great Lakes Chemical (n ow Chemtura), voluntari ly terminated their production in 2004. In 2006, EPA issued a SNUR (74 FR 34015, June 13, 2006) that requires anyone who intends to manufacture or import any of the PBDE congeners found in c-pentaBDE and c-octaBDE to notify the Agency at least 90 da ys in advance. The requ ired notification would provide EPA with the opportunity to evaluate th e intended use and, if ne cessary, to prohibit or limit the activity before it occurs. However, the SNUR did not address the import of articles containing penta- or octa-BDEs.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

11 Several states including Ca lifornia, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, New York, Rhode Isla nd, Oregon and Washington have banned c-pentaBDE and coctaBDE.

International regulations include the following:

 The European Union banned the c-pentaB DE and c-octaBDE. The ban prohibits goods containing OctaBDE and PentaBDE from being placed on the market in the

EU.

 TetraBDE, pentaBDE, hexaBDE, and heptaBDE have been listed in Annex A of the Stockholm Convention (SC). Parties to the SC are required to prohibit or take measures to eliminate production and use of chemicals listed in Annex A. The listing for these PBDEs includes a specific exem ption for articles containing these substances, and also permits recycling of such articles. TetraBDE, pentaBDE and hexaBDE are components of c-pentaBDE; hexaBDE and heptaBDE are components of c-octaBDE. Thus c-pentaBDE and c- octaBDE are effectively designated for

elimination under the SC.

 Canada's regulations effective in June 2008 prohibit manufacture of the tetra- through decaBDEs which resulted in prohibiting manufacture of the three commercial mixtures also. Canada is also working on regulatory controls to restrict PBDEs in manufactured and imported produc ts (Environment Canada, 2009b).

DecaBDE

In the United States, decaBDE remains avai lable for all uses and no federal action has

been taken to restrict its use. DecaBDE was in cluded in OPPT’s Voluntary Children’s Chemical Evaluation program (VCCEP) which identified a nu mber of environmental fate testing needs.

The c-decaBDE manufacturers did not adequately address these testing needs within VCCEP. Consequently, EPA announced its intention to pr oceed with a test rule under TSCA section 4. The companies then offered to test under an enforceable consent agreement.

EPA has entered into discussions with th e principal manufacturers and importer of cdecaBDE regarding a commitment to initiate redu ctions of manufacture, import and sales of cdecaBDE starting in 2010. Ordinary production, import and sales of c-decaBDE would cease no later than December 31, 2012. Certain uses such as transportation uses or military applications may require an additional year to phase out. In any case the companies would cease sales for these uses no later than December 31, 2013. EPA intends to encourage other importers of cdecaBDE to join this effort. The commitment under discussion would not affect articles made with decaBDE produced or imported prior to th e end of the phase out period. Recycling of materials containing decaBDE would also not be affected by the commitment.

Washington State banned the use of decaB DE in mattresses as of January 2008, and starting in January 2011, decaBDE will be prohibited from use in televisions, computers and upholstered furniture. Maine also banned decaBDE in mattresses and upholstered furniture as of January 2008 and will extend that ban to televi sions and other plastic encased electronics by January 2010. Washington State and Maine conduc ted studies which concluded that adequateU.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

12 substitutes for decaBDE exist. Other states, su ch as Maryland and Oregon, have introduced similar legislation to ban the sale of products containing this flame retardant (Buckley, 2009).

International actions include:

 As of July 1, 2008, the European Union banned decaBDE from use in electronics and electrical applications (Joined Cases C-14/06 and C- 295/06). The ban applies to manufactured and imported electronics and electrical components in items placed on the market under its Restriction on Hazardous Substances Directive. However, decaBDE is allowed for use in other applications.

 In addition to the regulations cited above, Environment Canada in March 2009 published for public comment a draft Performance Agreement for DecaBDE used at Canadian manufacturing facilities aimed atmonitoring and minimizing release of cdecaBDE (Environment Canada, 2009b).

IX. Risk Management Considerations

Risk management considerations – c-pentaBDE and c-octaBDE

PBDE congeners found in c-pentaBDE and c- octaBDE are widely di stributed in soil, sediments and living organisms, including humans. PBDEs have been found in human tissue, blood and milk. The predominant co ngeners present tend to be the lower brominated forms i.e. tetraBDE and pentaBDE. Infants and children as well as people who are occupationally exposed may be exposed at higher leve ls than the general public.

These chemicals persist in the environment and remain biologically available for a significant period of time. Some reports indicate their levels in both th e environment and living organisms, including humans are increasing. There are reports that these chemicals biomagnify as evidenced by high levels report ed in some predators such as falcons, dolphins and seals. The presence of PBDEs in remote environments, such as the arctic, indicates that they may be subject to long range transport. The environmental fate a nd transport, as well as the routes of exposure for humans and other organisms are not fully understood.

Exposure to PBDEs raises concerns for adve rse effects to both hu mans and wildlife.

EPA’s IRIS database identifies neurobehavioral eff ects as the critical endp oint of concern for the principal congeners present in c-pentaBDE and c-octaBDE. Laboratory studies have shown that congeners associated with c-pe ntaBDE and c-octaBDE are capabl e of producing adverse effects in a variety of organisms includ ing birds, mammals, and fish. In some cases these effects were observed at exposures levels similar to levels found in the environment.

c-PentaBDE and c-octaBDE were withdrawn fr om the U.S. market in 2004. Each of the congeners contained in them is subject to a si gnificant new use rule and may not be produced or imported in to the U.S. without advance notice to the EPA. The SNUR does address articles to which these chemicals have been added. Although it does not appear that treated articles are currently being imported, that activity, if it were to resume, could be a potential source of exposure to PBDEs for humans and the environment.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

13 Risk management considerations – c-decaBDE

DecaBDE is expected to be persistent in the environment. It is widely found in sediments, sewage sludge, and dust particle s in indoor air. Some reports indicate that environmental concentrations are increasing.

There is evidence that decaBDE is entering th e food chain and biomagnifying. It has been found at high levels in predators such as pere grine falcons. There is very little data on the environmental toxicity of decaBDE; however there have been reports that it can be metabolized in organisms to lower brominated forms with known toxic effects.

EPA’s IRIS database identifies neurobehavioral effects as the critical endpoint of concern for decaBDE. EPA also proposed that the data supports a finding of "suggestive evidence of carcinogenic potential"

Human exposure to decaBDE may occur in the home or work environment through the use of products to which it has been added. Exposur e may also occur as a result of exposure to house dust containing decaBDE.

Although decaBDE is still bei ng manufactured, imported and processed in the U.S., the Agency believes that there are suitable alte rnatives for all major uses of the chemical. Furthermore, the Agency believes that persons engaging in these activ ities are likely to voluntarily discontinue them.

Risk Management Considera tions - children’s health

PBDEs are a concern for children’s healt h. The most sensitive outcome of PBDE exposure is adverse neurobehavi oral effects following exposur e during the postnatal period. PBDEs are used as flame retardants in many household products, and co nsequently PBDEs are present in house dust and environmental media (e .g., air, food). Children’s exposures to PBDEs are greater than those of adults due to highe r intakes of food, water, and air per pound of body weight, as well as child-specific exposure pa thways such as breast milk consumption and

increased contact with the floor. International bi omonitoring data report th at children have the highest exposures to PBDEs; biomonitoring da ta have found PBDEs in cord blood and human milk. Some evidence suggests that there is an ov erlap in the range of PBDE toxicity and the range of current exposures. Thus, given the perv asive exposure to PBDEs, the persistence and bioaccumulation of PBDEs in the environment, a nd studies finding deleterious health effects, EPA believes risk management actions are warrante d to insure adequate protection of children’s

health.

X. Next Steps

In conducting this review of PBDEs, EP A considered a number of potential risk management actions, including regulatory actions under TSCA sections 4, 5 and 6; cooperative activities with other federal ag encies; and voluntary actions thr ough such programs as Design for the Environment (DfE).U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

14 Based on its screening-level review of hazar d and exposure information EPA intends to initiate actions to protect the humans and the environment from exposure to PBDE congeners of concern due to manufacture (including import) of commercial PBDEs and/or articles to which they have been added.

The Agency intends to:

1. Initiate rulemaking to propose a TSCA signifi cant new use rule (SNUR). The significant

new use would be manufacture or import of articles to wh ich c-pentaBDE or c-octaBDE has been added. This designation would requ ire anyone who intends to manufacture or import articles to which these chemical substanc es have been added to notify EPA at least 90 days in advance. The required notificati on would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. A notice of proposed rulema king is intended to publish in 2010.

2. Support and encourage a voluntary phase out of manufacture and import of c-decaBDE. a) EPA has entered into discussions with th e principal manufacturers and importer of cdecaBDE regarding a commitment to initiate reductions of manufacture, import and sales of decaBDE starting in 2010. Ordina ry production, import and sales of

decaBDE would cease no later than D ecember 31, 2012. Certain uses such as transportation uses or military applications may require an additional year to phase out. In any case the companies would ceas e sales for these uses no later than December 31, 2013. b) EPA intends to encourage other importer s of decaBDE to join this effprt. c) The commitment under discussion would not affect articles made with c-decaBDE produced or imported prior to the end of th e phase out period. Recycling of materials containing decaBDE would also not be affected by the commitment.

3. Initiate rulemaking to simultaneously propose a SNUR and a test rule for c-decaBDE in

2010. a) The SNUR would designate manufacture (inc luding import) of c-decaBDE or articles to which c-decaBDE has been added as a significant new use. Essential uses and any other uses which have not been voluntarily phased out would not be included in the SNUR. The SNUR would be promulgated af ter the voluntary phase out is complete; b) The test rule under section 4 of TSCA would require development of information necessary to determine the effects that manufacturing, use or other activities involving c-decaBDE have on human health or the environment; If the Agency determines that any manuf acture (including import) of c-decaBDE or articles to which c-decaBDE has been added has not ceased, it intends to promulgate the

test rule.

4. Initiate rulemaking under section 5(b)(4) of TSCA to add the commercial PBDE mixtures and/or the congeners they cont ain to the list of chemicals which present or may present

an unreasonable risk to health or the envi ronment. A notice of proposed rulemaking is intended to publish in autumn, 2010.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

15 5. Develop an alternatives analysis for c-d ecaBDE. The alternatives analysis, which is intended to begin in spring 2010, will evaluate the efficacy, availability, cost and hazard

levels of alternatives for a subs et of critical uses of c-decaBDE. The alternatives analysis is intended to aid users of c-decaBDE in selecting suitable alternatives and avoiding unintended consequences.

As part of its efforts to address PBDEs, EPA intends to evaluate the potential for disproportionate impact on children and other vulnerable populations.

XI. References

ATSDR. 2004. Agency for To xic Substances and Disease Registry. To xicological Profile for Polybrominated Diphenyl Ethers and Polybrominated Biphenyls. www.atsdr.cdc.gov/toxprofiles/tp68.html

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Buckley, Liz. April 6, 2009. “Environment Canada proposes ban on decaBDE in electronics.” Pesticide & Toxic Chemical News, volume 37, number 22, page 1.

Cal/EPA PBDE Workgroup. 2006. Polybrominated Diphenyl Ethers: Recommendations to Reduce Exposure in

California. California Environmental Protection Agency, Sacramento, Calif ornia. February 2006.

Chen D, B Mai, J Song, Q Sun, Y Luo, X Luo, EY Zeng, RC Hale. 2007. Polybrominated diphenyl ethers in birds of prey from Northern China. Environ Sci Technol 41:1828-1833.

Environment Canada. 2006. Ecological Screening Assessment Report on Polybrominated Diphenyl Ethers (PBDEs). Available from: http://www.ec.gc.ca/CEPARegistry/ documents/subs_list/PBDE_SAR/PBDE s_SAR_EC_June_2006_%28en%29.pd

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Environment Canada. 2009a. State of the Science Report on the Bioaccumulation and Transformation of Decabromodiphenyl Ether (DRAFT). Available from: http://www.ec.gc.ca/ceparegist ry/subs_list/decaBDE/SR_TOC.cfm

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Environment Canada, 2009b. Risk management strategy for Polybrominated Diphenyl Ethers (PBDEs), revised March, 2009. Available from: http://www.ec.gc.ca/Toxics/docs/su bstances/PBDE/rrms/en/intro.cfm

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EPA, 2005a. Voluntary Children's Chemical Evaluation Program: Data Needs Decision Document of Pentabromodiphenyl Ether, June, 2006. Available at: http://www.epa.gov/oppt/vccep/pubs/finalpenoct.pdf

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EPA, 2005b. Voluntary Children's Chemical Evaluation Program: Data Needs Decision Document of Octabromodiphenyl Ether, June, 2006. Available at: http://www.epa.gov/oppt/vccep/pubs/finalpenoct.pdf

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EPA, 2005c. Voluntary Children's Chemical Evaluation Program: Data Needs Decision Document of Decabromodiphenyl Ether, Ju ne, 2006. Available at: http://www.epa.gov/oppt/v ccep/pubs/finaldeca.pdf

EPA, 2006. Polybrominated Diphenyl Ethers (PBDEs) Project Plan. March, 2006.

EPA, 2008a. Toxicological Review of 2,2',4,4',5-Tetrabromodiphenyl Ether (BDE-47), EPA/635/R-07/005F, June,2008.

EPA, 2008b. Toxicological Review of 2,2',4,4',5-Pentabromodiphenyl Ether (BDE-99), EPA/635/R-07/006F, June,2008.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

16 EPA, 2008c. Toxicological Review of 2,2',4,4',5-Hexabromodiphenyl Ether (BDE-153), EPA/635/R-07/007F, June,2008.

EPA, 2008d. Toxicological Review of Decabromodiphenyl Ether (BDE-209), EPA/635/R-07/008F, June,2008.

Fischer D, Hooper K, Athanasiadou M, Athanassiadis I, Bergman A. 2006. Children show highest levels of polybrominated diphenyl ethers (PBDEs) in a California family of four: a case study. Env Health Persp 114:1581-

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Hale RC, M J La Guardia, EP Harvey, MO Gaylor, TM Mainor, WH Duff. 2001. Persistent pollutants in landapplied sludges. Nature 412:140-141.

Hale, R. C.; Alaee, M.; Manchester-Neesvig, J. B.; Staple ton, H. M.; Ikonomou, M. G. Polybrominated diphenyl ether flame retardants in the North American environment. Environ. Int. 2003, 29 (6), 771–779.

Hazardous Substances Data Bank (HSDB). 20 09. United States National Library of Medicine, http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB . Accessed October 2009 for penta-, octa- and decabromodiphenyl ethers.

Penta: http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~YGjnGM:1

Octa: http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~YGjnGM:5

Deca: http://toxnet.nlm.nih.g ov/cgi-bin/sis/search /f?./temp/~YGjnGM:7

Huwe, J.K., Hakk, H., and Birnbaum, L.S. 2008. Tissue distribution of polybrominated diphenyl ethers in male rats and implications for biomonitoring. Environ. Sci. Technol. 42: 7018–7024

Joined Cases C-14/06 and C-295/06: Judgment of the Court (Grand Chamber) of 1 April 2008 — European Parliament (C-14/06), Kingdom of Denmark (C-295/0 6) v Commission of the European Communities (Directive

2002/95/EC — Electrical and electronic equipment — Restriction of us e of certain hazardous substances — Decabromodiphenyl ether (‘DecaBDE ’) — Commission Decision 2005/717/EC — Exemption of DecaBDE from the prohibition on use — Actions for annulment — Commission's implementing powers — Infringement of the enabling provision), Notice No. 2008/C 116/04, Official Journal of the European Union, C116, Vol. 51, May 9,

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McKernan, M. A., B. A. Rattner, et al. (2009). "Toxicity of Polybrominated Diphenyl Ethers (De-71) In Chicken (Gallus Gallus), Mallard (Anas Platyrhynchos), and American Kestrel (Falco Sparverius) Embryos and Hatchlings." Environmental Toxicology and Chemistry 28(5): 1007-1017.

Park, J.-S., A. Holden, et al. (2009 ). "Time-Trends and Congener Profiles of PBDEs and PCBs in California Peregrine Falcons (Falco peregrinus)." Environmental Science & Technology.

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Sjodin, A., Wong, L.Y., Jones, R.S., Park, A., Zhang, Y., Hodge, C., Dipietro, E., McClure, C, Turner, W., Needham, L.L. and Patterson, D.G. 2008. Serum concentrations of poly6brominated diphenyl ethers (PBDEs) and polybrominated biphenyl (PBB) in the United States population: 2003-2004. Environ. Sci. Technol. 42:1377-1384.

Stapleton HM. 2006. Brominated flam e retardants: assessing the decaBDE debromination in the environment. Health and Environmental Alliance (formerly the EPHA Environmental Network (EEN)), May 2006.

Stapleton HM, M Alaee, RJ Letcher, JE Baker. 2004a. Debromination of the flame retardant decabromodiphenyl ether by juvenile carp ( Cyprinus carpio ). Environ Sci Technol 38:112-119.U.S. Environmental Protection Agency Draft, 12/9/200 9 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

17 Stapleton HM, JE Baker. 2003. Comparing polybrominated diphenyl ether and polychlorinated biphenyl bioaccumulation in a food web in Grand Traverse Bay, Lake Michigan. Arch Environ Contam Toxicol 45:227–234.

Stapleton HM, B Brazil, RD Holbrook, CL Mitchelmore, R Benedict, A Konstantinov, D Potter. 2006. In vivo and

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