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Polybrominated Diphenyl Ethers (PBDEs)

I. Overview

As part of the U.S. Environmental Protection 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 action plan development based on their presence in 

human blood, PBT characteristics, use in consumer products, production volume, and other 

similar factors. This action plan outlines EPA’s approach for addressing polybrominated 

diphenyl ethers (PBDEs). These chemicals are produced and sold as complex mixtures, and EPA 

is concerned that some of the component congeners are persistent, bioaccumulative and toxic. 

PBDEs have been widely used as flame retardants in a number of applications. Three 

commercial PBDE mixtures have been produced and used in the United States and elsewhere: 

commercial pentabromodiphenyl ether (c-pentaBDE), commercial octabromodiphenyl ether (coctaBDE), and commercial decabromodiphenyl ether (c-decaBDE). Although manufacture and 

import of c-pentaBDE and c-octaBDE were phased 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 debromination, physical or metabolic 

removal of bromine atoms, may convert decaBDE to more toxic PBDE congeners, contributing 

further to the potential risk from 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 which they have been added. 

The Agency intends to: 

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

new use would be manufacture or import of articles to which c-pentaBDE or c-octaBDE 

has been added. This designation would require anyone who intends to manufacture or 

import articles to which these chemical substances have been added to notify EPA at least 

90 days in advance. The required notification 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 publish 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 the principal manufacturers and importer of cdecaBDE regarding a commitment to initiate reductions of manufacture, import and 

sales of decaBDE starting in 2010. Ordinary production, import and sales of 

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. 
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b) EPA intends to encourage other importers 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 the 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 (including 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 after 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 manufacture (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 contain to the list of chemicals which present or may present 

an unreasonable risk to health or the environment. A notice of proposed rulemaking is 

intended to publish in autumn, 2010. 

5. Develop an alternatives analysis for c-decaBDE. The alternatives analysis, which is 

intended to begin in spring 2010, would evaluate 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-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. 

II. Introduction 

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

Substances Control Act (TSCA)1

, the Agency identified an initial list of widely recognized 

chemicals, including polybrominated diphenyl ethers (PBDEs), for action plan development 

based on their presence in human blood; persistent, bioaccumulative, and toxic (PBT)2

characteristics; use in consumer products; production volume; and other similar factors. This 

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

information3

 on 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 including but not limited to U.S. Federal government agencies, 
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and other statutes might be appropriate to address potential concerns with PBDEs in developing 

the Action Plan. The Action Plan is intended to describe the courses of action the Agency plans 

to pursue in the near term to address its concerns. The Action Plan does not constitute a final 

Agency determination or other final Agency action. Regulatory proceedings indicated by the 

Action Plan will include appropriate opportunities for public and stakeholder input, including 

through notice and comment rulemaking processes.

 

III. Scope of Review

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

retardants and concerns for human and environmental 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 referred 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 PBDE 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. 
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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 samples. BDE-47 tends to be found more frequently 
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than other congeners in measurements from humans, 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 carpets and upholstery, used in household and business 

furnishings, cars, buses, trucks and airplanes, as well as uses in plastics and foams which are 

components in electrical appliances and equipment. 

 Domestic manufacture of c-pentaBDE and c-octaBDE stopped in 2004 when the Great 

Lakes Chemical Corporation (now Chemtura Corporation) voluntary phased out their 

production. The EPA subsequently promulgated a SNUR (74 FR 34015, June 13, 2006) which 

requires that anyone who intends to manufacture or import a chemical 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 which 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 (Hale et al. 2003). In 2005, EPA’s design for the 

environment (DfE) program completed an alternatives analysis for pentaBDE in furniture foam 

which provided data to inform substitution to safer alternatives 

(http://www.epa.gov/dfe/pubs/projects/flameret/index.htm). This work complemented the 

voluntary phase-out and the SNUR. 

c-OctaBDE was used in acrylonitrile-butadiene-styrene (ABS) plastic which was used as 

casing for certain electric and electronic devices that are used in both offices and homes. cOctaBDE had a smaller market than c-pentaBDE and was more easily replaced 

 c-DecaBDE, on the other hand, is still manufactured 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 million 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 retardant 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 major use of decaBDE. EPA has not evaluated the 

potential human health or environmental effects of all potential c-decaBDE substitutes. 
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V. Hazard Identification Summary 

Human Health Effects 

 In its 2006 PBDE Project Plan, EPA summarized animal studies of various commercial 

mixtures and individual congeners which suggested potential concerns about liver toxicity, 

thyroid toxicity, developmental toxicity, and developmental neurotoxicity. These findings and 

the presence of PBDEs in house dust and breast milk raise particular concerns about potential 

risks to children (EPA, 2006). 

In 2008, EPA published peer reviewed Toxicological Reviews of four PBDE congeners: 

tetraBDE (BDE-47), pentaBDE (BDE-99), hexaBDE (BDE-153), and decaBDE (BDE-209), to 

support summary information on EPA's Integrated Risk Information System (IRIS) database. 

Neurobehavioral effects was identified 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 guidelines 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 assessments for pentaBDE, octaBDE and decaBDE were 

developed to evaluate the potential risks to children and prospective 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, EPA requested that the 

sponsors provide 2-generation reproductive toxicity studies for both 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, particularly with respect to the 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 sponsors and decaBDE was subsequently terminated 

from the VCCEP program. 

Environmental Effects 

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

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

environmental effects of PBDEs was limited, with the most detailed reviews found in European 

Union risk assessments of certain congeners. Since then, Environment Canada in its 2006 

ecological assessment of PBDEs concluded that the greatest potential risks from PBDEs in the 

Canadian environment are the secondary poisoning of wildlife from the consumption of prey 

containing elevated concentrations of PBDEs and effects on benthic organisms that may result 

from elevated concentrations of certain PBDEs in sediments (Environment Canada, 2006). In a 

more recent report, Environment Canada has also concluded that decaBDE is available for 

 

4

 Information on VCCEP is available at http://www.epa.gov/oppt/vccep. 
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uptake in organisms and may accumulate to high and potentially problematic levels in certain 

species such as birds of prey or mammalian predators (Environment Canada, 2009a). 

Laboratory studies have shown that congeners associated with c-pentaBDE and coctaBDE are capable of producing adverse effects 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 kestrels and chickens exhibited 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 conducted in San Francisco Bay and the Great Lakes 

(McKernan et al. 2009). Adverse effects included histopathological changes in immune organs, 

altered reproductive behavior and decreased embryo survival and decreased hatching rates. 

Zhang et al. (2009) reported that c-pentaBDE produced adverse reproductive and developmental 

effects in ranch mink. Zhang et al. (2009) also reported that biomonitoring of wild mink from the 

Great Lakes region revealed that margins of safety for mink are small. Mink from the Hamilton 

Harbor exceeded the no observed effect concentrations. Timme-Laragy et al. (2006).reported 

that c-pentaBDE produced developmental and behavioral effects of fish embryos including spine 

curvature and hatching delay 

 Breakdown of PBDEs involves debromination, where highly brominated PBDEs can 

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

metabolic debromination of decaBDE to a variety 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. Volatilization 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 substantial 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 vapor pressures. The tetraBDE and pentaBDE 

congeners are distributed between vapor and particle phases but predominantly in the vapor 

phase; the hexa- and octaBDEs are mostly attached to atmospheric particles; and decaBDE is 

exclusively adsorbed to particles. 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 significance of this process is uncertain. DecaBDE undergoes 

photolytic and possibly microbial debromination under certain conditions (Environment Canada 

2009a; Stapleton 2006). Photolysis is expected to be the dominant transformation process for 
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decaBDE where the substance is significantly exposed to light. For example, it has been found 

that decaBDE undergoes photolytic debromination 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 bromine 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). More recently it has been concluded that 

decaBDE likely contributes to the formation of bioaccumulative and/or potentially 

bioaccumulative transformation products such as lower brominated PBDEs in organisms and in 

the environment. Studies have shown that that 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 transport PBDEs over relatively long distances 

(> 1,000 km). Evidence for this comes from the presence of PBDEs in the tissues of deep oceandwelling whales and other marine mammals far from anthropogenic sources (Shaw and Kannan 

2009), as well as from modeling (Wania and Dugani, 2003). The body burdens of PBDE 

congeners in a wide variety of biota indigenous to geographical areas ranging from the equator to 

the poles also substantiate their propensity for long-range transport (LRT), and constitute 

evidence of environmental persistence (Environment Canada 2006). 

VII. Exposure Characterization Summary

 

 In recent years, scientists have measured PBDEs in human adipose tissues, serum and 

breast milk, fish, birds, marine mammals, sediments, sludge, house dust, indoor and outdoor air, 

and supermarket foods. The mechanisms or pathways 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 plastics 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 environment 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 and 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 evidence 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 concentrations in marine biota in North America are the highest in the 

world and are increasing (Shaw and Kannan 2009). The extent of accumulation of congeners is 
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directly related to PBDE levels in diet. Observed differences in PBDE congener profiles in 

marine mammals from California, Alaska, and the 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 congeners detected in the environment appears to 

depend on the proximity to a source of the congener in question and the media tested. Studies 

have been performed measuring waterways, sediments, and biota for PBDE concentrations in 

various known hot spots, such as the Great Lakes, the San Francisco Bay, and near a 

polyurethane foam manufacturing facility (ATSDR, 2004). 

 The general population is exposed to PBDEs 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 dietary intake, particularly high fat content foods 

(ATSDR, 2004). The lower brominated tetra- and penta- congeners have also been detected in air 

samples and indicate that inhalation may also be a potential route of exposure for the general 

population (ATSDR, 2004). Inhalation exposures could also occur from offgassing of PBDEs 

from furniture and electrical appliances into indoor air, but little information is known about the 

potential exposure through this route (ATSDR, 2004). Dermal exposure may occur through 

contact with PBDE-containing products such as polymers and textiles. A large number of human 

samples been analyzed, and the PBDE concentrations have increased by a factor of ~100 during 

the last 30 years (Hites as cited 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/EPA PBDE Workgroup, 2008). 

 Recent human biomonitoring data is currently available from the National Health and 

Nutrition Examination Survey (NHANES) 2003-2004. Participants 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 highest in 12-19 year olds and those 60 

years old and above. Furthermore, serum levels were 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 exposure (Sjodin, et al, 2008). 

 In the 2006 PBDE Project Plan, EPA committed to reviewing and synthesizing the 

available information on exposure pathways for PBDEs, including identifying the relative 

importance of different exposure pathways and how PBDEs get into various exposure media. In 

November, 2008, EPA issued an external review draft of its PBDE exposure assessment which is 

still undergoing public and peer review. In the meantime, an article based on portions of that 

assessment explained the process used to gather 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 the primary cause for PBDE exposures appears to 

be their use in commercial products that are part of the indoor environment (computer circuitry, 

foam cushions, fabrics in curtains, etc). Although the article recommended more research to 

verify the findings and better quantify identified uncertainties, it concluded that exposures to 

PBDEs through food and water ingestion and inhalation explained less than 20% of the body 
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burden, while 80 to 90% of total exposures in the indoor environment 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 PBDE 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 distribute equally into 

lipids, plasma was the best matrix for detection 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, breathe 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 breast milk may have higher exposure to lower 

brominated BDEs than children who drink formula (ATSDR, 2004). PBDEs have been found in 

breast milk in the U.S. and in Europe. The median concentration of total 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 are subsistence fishermen who consume PBDEcontaminated fish and Native Americans who reside in Arctic regions and consume whale and 

seal blubber (ATSDR, 2004). These populations are potentially exposed to lower brominated 

PBDEs (ATSDR, 2004). 

Fisher et al. (2006) conducted a study on a family of 4, including the parents and 2 

children ages 5 years old and 18 months old. Results 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. Fischer 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. Fisher et al. also noted that 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 produced or imported in the United States. The 

sole domestic producer, Great Lakes Chemical (now Chemtura), voluntarily 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 days in advance. The required notification would 

provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or 

limit the activity before it occurs. However, the SNUR did not address the import of articles 

containing penta- or octa-BDEs. 
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Several states including California, Hawaii, Illinois, Maine, Maryland, Michigan, 

Minnesota, New York, Rhode Island, Oregon and Washington have banned c-pentaBDE and coctaBDE. 

 International regulations include the following: 

 The European Union banned the c-pentaBDE 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 exemption 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 products (Environment Canada, 2009b). 

DecaBDE 

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

been taken to restrict its use. DecaBDE was included in OPPT’s Voluntary Children’s Chemical 

Evaluation program (VCCEP) which identified a number of environmental fate testing needs. 

The c-decaBDE manufacturers did not adequately address these testing needs within VCCEP. 

Consequently, EPA announced its intention to proceed 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 the principal manufacturers and importer of cdecaBDE regarding a commitment to initiate reductions 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 the 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 decaBDE 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 televisions and other plastic encased electronics by 

January 2010. Washington State and Maine conducted studies which concluded that adequate 
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substitutes for decaBDE exist. Other states, such 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 at monitoring 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 distributed in soil, 

sediments and living organisms, including humans. PBDEs have been found in human tissue, 

blood and milk. The predominant congeners 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 levels 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 the environment and living 

organisms, including humans are increasing. There are reports that these chemicals biomagnify 

as evidenced by high levels reported 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 and transport, as well as the routes of exposure 

for humans and other organisms are not fully understood. 

Exposure to PBDEs raises concerns for adverse effects to both humans and wildlife. 

EPA’s IRIS database identifies neurobehavioral effects as the critical endpoint of concern for the 

principal congeners present in c-pentaBDE and c-octaBDE. Laboratory studies have shown that 

congeners associated with c-pentaBDE and c-octaBDE are capable of producing adverse effects 

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. 

 

c-PentaBDE and c-octaBDE were withdrawn from the U.S. market in 2004. Each of the 

congeners contained in them is subject to a significant 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. 
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Risk management considerations – c-decaBDE 

DecaBDE is expected to be persistent in the environment. It is widely found in sediments, 

sewage sludge, and dust particles in indoor air. Some reports indicate that environmental 

concentrations are increasing. 

There is evidence that decaBDE is entering the food chain and biomagnifying. It has been 

found at high levels in predators such as peregrine 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. Exposure may also occur as a result of exposure to 

house dust containing decaBDE. 

Although decaBDE is still being manufactured, imported and processed in the U.S., the 

Agency believes that there are suitable alternatives for all major uses of the chemical. 

Furthermore, the Agency believes that persons engaging in these activities are likely to 

voluntarily discontinue them. 

Risk Management Considerations - children’s health 

 PBDEs are a concern for children’s health. The most sensitive outcome of PBDE 

exposure is adverse neurobehavioral effects following exposure during the postnatal period. 

PBDEs are used as flame retardants in many household products, and consequently 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 higher intakes of food, water, and air per pound of body 

weight, as well as child-specific exposure pathways such as breast milk consumption and 

increased contact with the floor. International biomonitoring data report that children have the 

highest exposures to PBDEs; biomonitoring data have found PBDEs in cord blood and human 

milk. Some evidence suggests that there is an overlap in the range of PBDE toxicity and the 

range of current exposures. Thus, given the pervasive exposure to PBDEs, the persistence and 

bioaccumulation of PBDEs in the environment, and studies finding deleterious health effects, 

EPA believes risk management actions are warranted to insure adequate protection of children’s 

health. 

X. Next Steps

 In conducting this review of PBDEs, EPA considered a number of potential risk 

management actions, including regulatory actions under TSCA sections 4, 5 and 6; cooperative 

activities with other federal agencies; and voluntary actions through such programs as Design for 

the Environment (DfE). 
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Based on its screening-level review of hazard 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 significant new use rule (SNUR). The significant 

new use would be manufacture or import of articles to which c-pentaBDE or c-octaBDE 

has been added. This designation would require anyone who intends to manufacture or 

import articles to which these chemical substances have been added to notify EPA at least 

90 days in advance. The required notification 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 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 the principal manufacturers and importer of cdecaBDE regarding a commitment to initiate reductions of manufacture, import and 

sales of decaBDE starting in 2010. Ordinary production, import and sales of 

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. 

b) EPA intends to encourage other importers 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 the 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 (including 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 after 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 manufacture (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 contain to the list of chemicals which present or may present 

an unreasonable risk to health or the environment. A notice of proposed rulemaking is 

intended to publish in autumn, 2010. 
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5. Develop an alternatives analysis for c-decaBDE. The alternatives analysis, which is 

intended to begin in spring 2010, will evaluate 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-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

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Diphenyl Ethers and Polybrominated Biphenyls. www.atsdr.cdc.gov/toxprofiles/tp68.html. 

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, California. 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 

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Pentabromodiphenyl Ether, June, 2006. Available at: http://www.epa.gov/oppt/vccep/pubs/finalpenoct.pdf. 

EPA, 2005b. Voluntary Children's Chemical Evaluation Program: Data Needs Decision Document of 

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June,2008. 

EPA, 2008b. Toxicological Review of 2,2',4,4',5-Pentabromodiphenyl Ether (BDE-99), EPA/635/R-07/006F, 

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

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

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

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2008 

 

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