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Polybrominated Diphenyl Ethers (PBDEs)

Action Plan

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. 

PBDEsPolybrominated diphenyl ethers (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 (cpentaBDE), commercial octabromodiphenyl ether (c-octaBDE), and commercial 

decabromodiphenyl ether (c-decaBDE). Although manufacture and import of c-pentaBDE and coctaBDE 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.United States. 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 EPA is neededconcerned 

that some of the component congeners are persistent, bioaccumulative and toxic and intends to

initiate a number of actions to limit the 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. 

1. The Agency intendsThese actions are to: (1) Initiate rulemaking to propose a TSCA 

significant new use rule (SNUR). The significant new use would be) for the 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 (a

notice of proposed rulemaking is intended to publish in late 2010.

2. Support); (2) support and encourage athe voluntary phase-out of the 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 
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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 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; (3) initiate rulemaking to simultaneously propose a SNUR and a test rule for cdecaBDE in late 2010.

a) The (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 and 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. 

Promulgate a 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 (a notice of proposed rulemaking is 

intended to publish in autumn, 2010.);and (5) develop an alternatives analysis for c-decaBDE

(intended to begin in spring 2010). 

1. 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 

 

1

 15 U.S.C. §2601 et seq.
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based on their presence in human blood; persistent, bioaccumulative,humans and toxic (PBT)2

characteristics;the environment; their persistence, and toxicity; their use in consumer products; 

their production volume; andor 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 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. 

Specific congeners, also known as isomers, in which both the number and location of bromine 

atoms is specified are given numbers, e.g., BDE-47. 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 

 

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, 

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). Scientific studies, particularly those measuring presence of PBDEs in tissues and the 

environment, often repot their findings by BDE number.
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Table 1. Selected PBDE Congeners 

 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. 

EPA regulations of PBDEs generally apply to congeners grouped according to number of 

bromine atoms rather than specific congener/isomers designated by BDE number.

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

Table 2. PBDE Congener Groups

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 

 

Table 3. Congeners In Commercial PBDE Mixtures

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 hexaBDE 
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octaBDE 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 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 onin textiles, plastics and polyurethane foam. PBDE treated 

articles were used in the home, in business settings, and in the transportation sector. Articles 

which were often treated with PBDEs include carpets and, upholstery, used in household and 

business furnishings, cars, buses, trucks fabric, cushions, and airplanes, as well as uses in plastics 

and foams which areused as 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 provideprovides 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 dDesign for the 

eEnvironment (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.United 

States and abroad, although legislative action to restrict its use has been undertaken by some US 
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Sstates. Based on IUR data (2006)4 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. 

 

4 Information on Invertory update data is available at http://www.epa.gov/oppt/iur
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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. (EPA, 2006b). 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. 5

database (www.epa.gov/iris/).

Neurobehavioral effects was identified as the critical endpoint of concern for each of the 

four congeners (EPA, 2008a, 2008b, 2008c, and 2008d).-d). 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)6, 

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-b). These data waswere 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. EPA then announced its intention to proceed with a test rule under 

TSCA section 4. Before a test rule could be proposed, however, the main manufacturers or 

importers, Albemarle Corporation, Chemtura Corporation and ICL Industrial Products

volunteered to phase out manufacture, import and sales of decaBDE. However, some relatively 

minor importation may be taking place with other companies.

Environmental Effects 

 

5 Information on IRIS is available at http://www.epa.gov/iris/

6

 Information on VCCEP is available at http://www.epa.gov/oppt/vccep. 
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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 At the time the EPA 

Project Plan was published in 2006, 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 specifically is available for 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 thatconducted biomonitoring of wild 

mink from the Great Lakes region revealedand concluded that margins of safety for mink are 

small. Mink and that 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., 20076) 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. Physical-Chemical Properties and Fate Characterization Summary

PBDEs are expected to be minimally mobile in moving 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 
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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 

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 a soil

amendment (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 fromwith four to ten bromine atoms are highly persistent is 

suggested bybased on several lines of evidence, but especially by a large body of environmental 

monitoring data forin both the USUnited States 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 After 

reviewing the available information, EPA 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 (as reviewed in Environment Canada 2009

a). 

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 
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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 PlanEPAb, 2006). 

Environmental Exposure

 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; Voorspoels 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, 2009). After reviewing the available 

information, EPA has concluded that the extent of accumulation of congeners is 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). 

Human Exposure

 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 offgassingoff gassing 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 have 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.are currently available from the Centers 

for Disease Control (CDS) Fourth National Report on Human Exposure to Environmental 

Chemical (http://www.cdc.gov/exposurereport/). This report was released on December 10, 
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2009, but the PBDE data have been published in the peer-reviewed literature (Sjodin et al., 

2008). Although this is the fourth report from this federal agency, it is the first time that PBDEs 

were included as analytes. The data were obtained from samples from participants in the 2003-

2004 National Health and Nutrition Examination Survey (NHANES). Ten different PBDE 

congeners were analyzed for (containing from three to seven bromines), including BDE-47, 

BDE-85, BDE-99, BDE-100, BDE-153, BDE-154 and BDE-183. 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 Lorber (2008),

reviewed and synthesizinged 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 The report 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, 

notingsuggesting that the primary causesource for PBDEhuman exposures to PBDEs 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 human 

body 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 
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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. Risk Management Considerations

U.S. EPA and State/Local Regulatory Status of PBDEsReviews and Actions

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. 

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. 
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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 theThe principal manufacturers and importer of cdecaBDE regarding a commitmenthave committed to initiate reductions ofphase out the

manufacture, import and sales of c-decaBDE 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 c-decaBDE 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 

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 Regulatory Reviews and Actions

PentaBDE and OctaBDE

The European Union has banned both 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. 
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Canada is also working on regulatory controls to restrict PBDEs in manufactured and imported 

products (Environment Canada, 2009b).

Summaries of country actions include:to ban or severely restrict PBDEs can be found in 

the respective Risk Management Evaluations for each located on the Stockholm Convention 

website at http://chm.pops.int.

DecaBDE

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 c-decaBDE 

(Environment Canada, 2009b).

IX. Risk Management Considerations

 

Risk management considerations –Ongoing Activities and Issues

c-pPentaBDE and c-oOctaBDE

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 breast 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. 
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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 not 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. 

Risk management considerations – c-decaBDE

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 isare 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

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 
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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). 

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: 

On the basis of existing information, the Agency believes that the following actions would be 

warranted: 

2.1.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. 

3.2.Support and encourage athe voluntary phase out of manufacture and import of cdecaBDE. 

a) EPA has entered into discussionsAs a result of negotiations with the principal 

manufacturers and importer of c-EPA, several companies have announced that they 

will undertake a three year phaseout of decaBDE regarding a commitment. They have 

committed 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. 

(http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/deccadbe.html)

b) EPA intends to encourage other importers of decaBDE to join this effport. 

c) The commitment under discussion wouldvoluntary phase out is not affectdesigned to 

address 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. 
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4.3.Initiate rulemaking to simultaneously propose a SNUR and athe previously announced

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. 

5.4.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. 

6. 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. 

5. As part of its inquiry, EPA will explore the potential risks presented by PBDE 

substitutes. The alternatives analysis is intended to aid users of c-decaBDE in selecting 

suitable alternatives and avoiding unintended consequences. 

 As part of the Agency’s efforts to address PBDEsthese chemicals, EPA intends to 

evaluate the potential for disproportionate impact on children and other vulnerable subpopulations. The Agency will also continue to analyze the science as it pertains to making any 

necessary findings for the rulemakings indicated above

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