U.S. Environmental Protection Agency Draft, 12/ 9 30 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

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 chemi cals 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 appr oach for addressing polybrominated diphenyl ethers (PB DEs )

. 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 Polybrominated 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 elsewher e: 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 a ssociated with those mi xtures continue to
be found in humans and the environment. Some re ports indicate that levels are continuing to increase. Imported articles treated with c-pentaB DE and c-octaBDE could be a source of human and environmental exposure to these PBDE cong eners. 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, co ntributing further to the potential risk from expos ure to these congeners.

The Agency undertook this review to evaluate whether action EPA is needed concerned that some of the component congeners are pers istent, 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 intends These 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-pe ntaBDE or c-octaBDE has been added

. This designation w ould 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 notif ication would p rovide EPA with the opport unity 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. S upport ); (2) support and encourage a the voluntary phase

- out of the manufacture and import of c-decaBDE

. a) EPA has entered into discussions with th e principal manufacturers and importer of c

decaBDE regarding a commitment to initiate reductions of manufacture, import and sales of decaBDE starting in 2010

. Ordinary production, impo rt and sales ofU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

2 decaBDE wo uld 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

Dec ember 31, 2013

. b) EPA intends to encoura ge other importers of decaBDE to join this effo rt

. c) The commit ment 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

co ntaining decaBDE would also not be affected by the commit ment

.

3. I nitiate ; (3) initiate rulemaking to simultaneously propos e a SNUR and a test rule for cdecaBDE in late 2010

. a) The (the SNUR would designate manufacture (i ncluding import) of c-decaBDE or
articles to which c-decaBDE has b een 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 sec tion 4 of TSCA would re quire 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 impor t) of c

- decaBDE or
articles to which c

- decaBDE has been added h as not ceased, it intends to l promulgate the
test rule

.

P romulgate a rule ); (4) initiate rulemaking under Section 5(b)(4) of TS CA to add the commercial PBDE mixtures and/or the congeners they contai n 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 alternat ives analysis for c-decaBDE (intended to begin in spring 2010).

1. D evelop an alternatives analysis for c

- decaBDE

. The alternatives analysis , which is
intended to begin in spring 2010, w ould 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 th e existing chemicals program under the Toxic Substances Control Act (TSCA) 1 , the Agency identified an ini tial list of widely recognized chemicals, including polybrominated diphenyl et hers (PBDEs), for action plan development

1 15 U.S.C. §2601 et seq.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

3 based on their presence in human blood; pe rsistent, bioaccumulative, humans and toxic (PBT) 2
characteristics; the environment; their persistence, and toxicity; their use in consumer products;
their production volume; and or other similar factors. This Acti on Plan is based on EPA’s initial review of readily available use, exposure, and hazard information 3 on PBDEs. EPA considered
which of the various authorities provided under TSCA and other stat utes might be appropriate to address potential concerns w ith PBDEs in developing the Action Plan. The Action Plan is
intended to describe the courses of action the Agency plans to pursu e in the near term to address
its concerns. The Action Plan doe s not constitute a final Agency determination or other final Agency action. Regulatory proceedings indicate d by the Action Plan will include appropriate opportunities for public and stakeholder i nput, including through notice and comment rulemaking processes.

III. Scope of Review

This action plan addresses uses of the th ree commercial PBDE mixtures as flame
retardants and concerns for human and envir onmental exposure resulting from their use.

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

Figure 1. Brominated diphenyl molecule

O Br x Br y

x + y = 4 - 10

Each individual PBDE variant, distinguished from others by both the number of bromine atoms and the placement of those atoms, is referre d to as a congener. For example, there are 42 tetrabromodiphenyl ether congeners, each with four bromine atoms in different configurations. 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 numbe r of congeners are commonly found in the commercial PBDE products and in measuremen ts 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 interna tional 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 Europ ean Union; and others. Action plans will reference sp ecific
sources used.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

4 (Table 1). Scientific studies, particularly those meas uring presence of PBDEs in tissues and the environment, often repot their findings by BDE number.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

5 T able 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 c ongener/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).U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

6 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.

.

T able 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 c

decaBDE, each contains a mixture of PBDE congeners (see Tabl e 3).

Table 3

. Congeners in Commercial PBDE Mixture s Commercial Mixture Major components Minor components c-pentaBDE tetraBDE s pentaBDE hexaBDE

c-octaBDE heptaBDE hexaBDEU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

7 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, BD E-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 in textiles, plastics and pol yurethane foam. PBDE treated articles were used in the home, in business sett ings, and in the transpor tation 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 f oams which are used as components in electrical appliances and equipment.

Domestic manufacture of c-pentaBDE a nd c-octaBDE stopped in 2004 when the Great Lakes Chemical Corporation (now Chemtura Corporation) voluntary phased out their production. The EPA subsequently promulgate d a SNUR (74 FR 34015, June 13, 2006) which requires that anyone who intends to manufacture or import a ch emical substance or mixture containing any of the congeners present in c- pentaBDE or c-octaBDE notify EPA at least 90 days in advance. The notice would provide provides EPA with an opportunity to evaluate the
intended new use and

, if necessary

, take action to limit or prohib it it. The SNUR did not address importation of articles to wh ich c-pentaBDE or c-octaBDE has been added.

Most of c-pentaBDE’s consumption took place in the United States. It was used primarily
as an additive flame retardant in flexible polyurethane foams. A 2002 study estimated that 80 percent of c-pentaBDE was used in foam for furniture and mattresses, while the remaining
amount was used in automotiv e applications (Hale et al

. ., 2003). In 2005, EPA’s d D esign for the

e E nvironment (DfE) program completed an alternativ es analysis for pentaBDE in furniture foam which provided data to inform substitution to safer alternatives ( http://www.epa.gov/dfe/pubs/p rojects/flameret/index.htm ). This work complemented the voluntary phase-out and the SNUR.

c-OctaBDE was used in acrylon itrile-butadiene-styrene (ABS ) plastic which was used as casing for certain electric and electronic 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 USU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

8 S s tates. 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 retard ant because relatively small quantities are necessary to achieve a flame retardant effect . The three major product categories in which
decaBDE are used as an additive flame retardant are: textiles, electronic equipment, and building and construction materials. Its primary use is in high impact polystyrene (HIPS) based products. Several potential substitutes exist for each majo r use of decaBDE. EPA has not evaluated the potential human health or environmental eff ects of all potential c-decaBDE substitutes.

4 Information on Invertory update data is available at http://www.epa.gov/oppt/iurU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

9 V. Hazard Identification Summary

Human Health Effects

In its 2006 PBDE Project Plan, EPA summari zed animal studies of various commercial mixtures and individual congene rs which suggested potential c oncerns about liver toxicity, thyroid toxicity, developmental toxi city, and developmental neurotoxicity

. (EPA, 2006b). These findings and the presence of PBDEs in house dust a nd breast milk raise particular concerns about potential risks to children (EPA, 2006).

.
In 2008, EPA published peer reviewed Toxico logical Reviews of four PBDE congeners: tetraBDE (BDE-47), pentaBDE (BDE-99), he xaBDE (BDE-153), and decaBDE (BDE-209), to support summary information on EPA's Integrated Risk Information System (IRIS) database. 5 database (www.epa.gov/iris/).

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

.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

10 In March of 2006, EPA published a PBDE Project Plan which included a review of the
current scientific unders tanding 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 a ssessment of PBDEs concluded that the greatest potential risks from PBDE s 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 elev ated 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 leve ls in certain species such as birds of prey or mammalian predators (Environment Canada, 2009a).

Laboratory studies have show n that congeners associated with c-pentaBDE and coctaBDE are capable of producing adverse effect s in a variety of organisms including birds, mammals, and fish. In some cases these effects were observed at exposures levels similar to
levels found in the environment. American kestre ls and chickens exhib ited adverse effects in laboratory studies when exposed to levels of c-pentaBDE and c- octaBDE similar to those which have been observed in monitoring studies condu cted in San Francisco Bay and the Great Lakes (McKernan et al

. ., 2009). Adverse effects included histopa thological changes in immune organs, altered reproductive behavior and decreased embryo survival and decreased hatching rates. Zhang et al. (2009) reported th at c-pentaBDE produced adverse reproductive and developmental effects in ranch mink. Zhang et al. (2009) also reported that conducted biomonitoring of wild mink from the Great Lakes region revealed and 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 in cluding spine curvature and hatching delay

.

Breakdown of PBDEs involves debromina tion, where highly brominated PBDEs can
breakdown to form lesser brominated PBDEs. Although its overall significance is unclear,
metabolic debromination of decaBDE to a va riety of PBDE breakdown products has been observed in fish (carp, fathead minnows, rainbow trout ), and in microsomal fractions d erived
from fis h ( ; Kierkegaard et al

. ., 1999; Stapleton et al.

, ( 2004 a ) ; Stapleton et al

. ., 2006); and in birds (Van den Steen et al

. ., 2007), cows (Kierkegaard et al.

, 200 7 6 ) and rats (Huwe and Smith

, 2007). There is increasing concern th at this process can be a signi ficant 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 bromin e 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 th at a substantial proporti on is likely to be bound to particles in water. PBDEs are expected to exis t in both the vapor and pa rticulate phases in theU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

11 ambient atmosphere based upon measured and es timated vapor pressures. The tetraBDE and pentaBDE congeners are distribut ed between vapor and particle phases but predominantly in the vapor phase; the hexa- and octaBDEs are mostly a ttached to atmospheric particles; and decaBDE is exclusively adsorbed to particles. Part iculate phase compounds are removed from the atmosphere by wet and dry deposition (HSDB

, 2009).

Based on available evidence, PBDEs can be debrominated under environmental conditions; however, the overall si gnificance of this process is uncertain. DecaBDE undergoes photolytic and possibly microbial debrominati on under certain conditions (Environment Canada

, 2009a; Stapleton

, 2006). Photolysis is expected to be the dominant transformation process for decaBDE where the substance is significantly expos ed to light. For example, it has been found that decaBDE undergoes photolytic debromina tion 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 from with four to ten bromine atoms are highly persistent is suggested by based on several lines of evidence, but espe cially by a large body of environmental monitoring data for in both the US United States and abroad (Environment Canada

, 2009a; Shaw
and Kannan

, 2009; Vonderheide et al

. ., 2008). Available data also indicate s 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 decaB DE likely contributes to the formation of bioaccumulative and/or po tentially bioacc umulative transformation products such as lower brominated PBDEs in organisms a nd 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 tran sport PBDEs over relatively long distances (> 1,000 km). Evidence for this comes from the pres ence of PBDEs in the tissues of deep oceandwelling whales and other marine mammals fa r from anthropogenic sources (Shaw and Kannan

, 2009), as well as from modeling (Wania a nd Dugani, 2003). The body burdens of PBDE congeners in a wide variety of biota indigenous to geographical ar eas ranging from the equator to the poles also substantiate their propensity fo r long-range transport (L RT), and constitute evidence of environmental pe rsistence (Environment Canada

, 2006).

VII. Exposure Characterization Summary

In recent years, scientists have measured PBDEs in human adipose tissue s , serum and breast milk, fish, birds, marine mammals, sediments, sludge, hous e dust, indoor and outdoor air, and supermarket foods. The mechanisms or pa thways by which the PBDEs move into and through the environment and humans are not known, but are likely to include releases from manufacturing of the chemicals, manufacturing of products like pl astics or textiles, aging and wear of products like sofas and electronics, and releases at the end of product life (disposal, recycling). In general, levels of PBDEs in humans and the en vironment are higher in NorthU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

12 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 EPAb , 2006).

Environmental Exposure

The food chain is likely the largest contributor to environmental exposures with PBDE depositing in soil and water where fish a nd benthic organisms are initially exposed. Biomagnification occurs as predators up the food chain ingest the accumulated concentrations of PBDEs from their prey (Chen et al

. ., 2007; Vo o rspoels et al

. ., 2007; Shaw and Kannan

, 2009; Stapleton and Baker

, 2003). In some studies evidence has b een provided that the concentrations of PBDE in biota have doubled every 3 to 6 years, the doubling time depending on species, life stage, and location. PBDE concentr ations in marine biota in Nort h America are the highest in the world and are increasing (Shaw and Kannan 2009)

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

Human Exposure

The general population is exposed to PBDE s through the use of consumer products. Body burden data indicate that the general popula tion appears to be expo sed to primarily lower brominated BDEs (e.g., tetra and penta). PBDEs have been detected in human tissue, blood (usually serum), and milk. The primary source of human exposure to PBDEs, especially the lower brominated congeners, may be from dietar y intake, particularly high fat content foods (ATSDR, 2004). The lower brominated tetra- and penta- congeners ha ve also been detected in air samples and indicate that inhala tion may also be a potential r oute of exposure for the general population (ATSDR, 2004). Inhalation e xposures could also occur from offgassing off 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 su ch as polymers and textiles. A large number of human samples have been analyzed, and the PBDE concen trations have increased by a factor of ~100 during the last 30 years (Hites as cite d 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/). Th is report was released on December 10,U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

13 2009, but the PBDE data have been published in the pe er-reviewed literatu re (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 obt ained from samples from participants in the 2003-
2004 National Health and Nutrition Examinati on 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 synthesiz ing ed 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 proce ss used to gather exposure information, model body burden, and comp are it to representati ve PBDE profiles in blood and milk. The analysis focused on i ndoor measurements of dust/soil and air, noting suggesting that the primary ca use source for PBDE human exposures to PBDEs appears to be their use in commercial products that are pa rt of the indoor environm ent (computer circuitry, foam cushions, fabrics in curtains, etc). Alt hough the article recommended more research to verify the findings and better quantify identified uncertainties, it concl uded that exposures to PBDEs through food and water ingestion and in halation explained less than 20% of the 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 PB DE congeners in male rats dosed to mimic PBDE exposure from food or household dust. This study found differences in PBDE congener distribution in the body. While the lower brominated congeners tended to di stribute equally into lipids, plasma was the best matrix for detecti on of the higher brominated congeners (especially BDE-209), indicating that blood may be the most reliable matrix for overall PBDE biomonitoring (Huwe et al., 2008).

ATSDR (2004) states that a child’s exposure may differ from that of adults because children drink more fluids, eat more food, breat he more air per kilogram of body weight and have a larger skin surface area in proportion to body volume. Their diets and behavior patterns
are also different. Infants who consume breas t milk may have higher exposure to lower
brominated BDEs than children who drink fo rmula (ATSDR, 2004). PBDEs have been found in breast milk in the U.S. and in Europe. The medi an concentration of tota l PBDEs was found to be 34.0 ng/g lipid, with the BDE 47 being the predominant congener present. Other populations identified with potentially high exposures ar e subsistence fishermen who consume PBDEcontaminated fish and Native Americans who resi de in Arctic regions and consume whale andU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

14 seal blubber (ATSDR, 2004). Thes e populations are potentially e xposed to lower brominated PBDEs (ATSDR, 2004).

Fisher et al. (20 06) 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

sam ples 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 exposur es 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 th at 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 PBDEs Reviews and Actions

PentaBDE and OctaBDE

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

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

International regulations include the following :

 The European Union ban ned the c

- p entaBDE and c

- octaBDE. The ban prohibits goods containing OctaBDE and PentaBDE from being placed on the market in the
EU. TetraBDE, pentaB DE, 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 Anne x A. The listing for these PBDEs includes a speci fic exemption for articles containing these subs tances, and also permits recycling of such articles. TetraBDE, pentaBDE a nd hexaBDE are components of c

- pentaBDE; hexaBDE and heptaBDE are components of c

- octaBDE. Thus c

- pentaBDE and c

- octaBDE are effectivel y designated for elimination under the SC. Canada's regulations effective in June 2008 prohibit manufacture of the tetra

- through decaBDEs which resulted in prohibiting manufactu re of the three commercial mixtures also.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

15 Canada is also working on regulator y controls to restrict PBDE s in manufactured and imported products (Environment Canada, 2009b).

DecaBDE

In the United States, decaBDE remains avai lable for all uses and no federal action has
been taken to restrict its use. DecaBDE was in cluded in OPPT’s Voluntary Children’s Chemical Evaluation program (VCCEP) which identified a nu mber of environmental fate testing needs.
The c-decaBDE manufacturers did not adequately address these testing needs within VCCEP. Consequently, EPA announced its intention to pr oceed with a test rule under TSCA section 4. The companies then offered to test under an enforceable consent agreement

.

EP A has entered into discussions with the The principal manufactur ers and importer of cdecaBDE regarding a commitment have committed to initiate reductions of phase out the manufacture, import and sales of c-decaBDE starting in 2010. Ordinary production, import and
sales of c-decaBDE would cease no later th an 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 thes e uses no later than December 31, 2013. EPA intends to encourage other importers of c-decaB DE 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 de caBDE would also not be affected by the commitment.

Washington State banned the use of decaB DE in mattresses as of January 2008, and starting in January 2011, decaBDE will be prohibited from use in televisions, computers and upholstered furniture. Maine also banned decaBDE in mattresses and upholstered furniture as of January 2008 and will extend that ban to televi sions and other plastic encased electronics by January 2010. Washington State and Maine conduc ted studies which concluded that adequate substitutes for decaBDE exist. Other states, su ch as Maryland and Oregon, have introduced similar legislation to ban the sale of products containing this flame retardant (Buckley, 2009).

International Regulatory Reviews and Actions

PentaBDE and OctaBDE

The European Union has banned both c-pent aBDE 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 ha ve 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 Anne x A. The listing for these PBDEs includes a specific exemption for articles containing these s ubstances, 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 manufactu re of the three commercial mixtures also.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

16 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 restri ct PBDEs can be found in the respective Risk Management Evaluations for each located on th e 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 (Joine d Cases C-14/06 and C-295/06). The ban applies to manufactured and imported electronics and el ectrical 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 aime d at monitoring and minimizing release of c-decaBDE (Environment Canada, 2009b).

I X . Risk Management Considerations

Risk management considerations

– Ongoing Activities and Issues

c-

p P entaBDE and c- o O ctaBDE

PBDE congeners found in c-pentaBDE and c- octaBDE are widely di stributed in soil, sediments and living organisms, including humans. PBDEs have been found in human tissue,
blood and breast milk. The predominant congeners presen t 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 th e environment and living organisms, including humans

, are increasing. There are reports that these chemicals biomagnify as evidenced by high levels report ed in some predators such as falcons, dolphins and seals. The presence of PBDEs in remote environments, such as the arctic, indicates that they may be subject to long range transport. The environmental fate a nd transport, as well as the routes of exposure for humans and other organisms

, are not fully understood.

Exposure to PBDEs raises concerns for adve rse effects to both hu mans and wildlife.
EPA’s IRIS database identifies neurobehavioral eff ects as the critical endp oint of concern for the principal congeners present in c-pentaBDE and c-octaBDE. Laboratory studies have shown that congeners associated with c-pe ntaBDE and c-octaBDE are capabl e of producing adverse effects in a variety of organisms includ ing birds, mammals, and fish. In some cases these effects were observed at exposures levels similar to levels found in the environment.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

17 c-PentaBDE and c-octaBDE were withdrawn fr om the U.S. market in 2004. Each of the congeners contained in them is subject to a si gnificant new use rule and may not be produced or imported in to the U.S. without advance notice to the EPA. The SNUR does not address articles
to which these chemicals have been added. Altho ugh 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 particle s in indoor air. Some reports indicate that environmental concentrations are increasing.

There is evidence that decaBDE is entering th e food chain and biomagnifying. It has been found at high levels in predators such as peregrine falcons. There is are 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 support s a finding of "suggestive evidence of carcinogenic potential " ".

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

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

Risk Management Consi derations

- children’s health

Children’s Health

PBDEs are a concern for children’s healt h. The most sensitive outcome of PBDE exposure is adverse neurobehavi oral effects following exposur e during the postnatal period. PBDEs are used as flame retardants in many household products, and co nsequently PBDEs are present in house dust and environmental media (e .g., air, food). Children’s exposures to PBDEs are greater than those of adults due to highe r intakes of food, water, and air per pound of body weight, as well as child-specific exposure pa thways such as breast milk consumption and
increased contact with the floor. International bi omonitoring data report th at children have the highest exposures to PBDEs; biomonitoring da ta have found PBDEs in cord blood and human milk. Some evidence suggests that there is an ov erlap in the range of PBDE toxicity and theU.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

18 range of current exposures. Thus, given the perv asive exposure to PBDEs, the persistence and bioaccumulation of PBDEs in the environment, a nd studies finding deleteri ous health effects, EPA believes risk management actions are warrante d to insure adequate protection of children’s
health.

X. Next Steps

In conducting this review of PBDEs, EP A considered a number of potential risk management actions, including regulatory actions under TSCA sections 4, 5 and 6; cooperative activities with other federal ag encies; and voluntary actions thr ough such programs as Design for the Environment (DfE).

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

The Agency intends to :

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

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

3. 2. Support and encourage a the voluntary phase out of ma nufacture and import of cdecaBDE. a) EPA has entered into discussions As 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 commit ment . They have
committed to initiate reductions of manuf acture, import and sales of decaBDE starting in 2010. Ordinary production, impor t and sales of decaBDE would cease no later than December 31, 2012. Certain uses su ch 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/existingchemi cals/pubs/actionplans/deccadbe.html) b) EPA intends to encourage other import ers of decaBDE to join this eff p o rt. c) The commitment under discussion would voluntary phase out is not affect designed 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.U.S. Environmental Protection Agency Draft, 12/ 9 15 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

19 4. 3. Initiate rulemaking to simultaneously propose a SNUR and a the previously announced
test rule for c-decaBDE in 2010. a) The SNUR would designate manufacture (inc luding import) of c-decaBDE or articles to which c-decaBDE has been added as a significant new use. Essential uses and any other uses which have not been voluntarily phased out would not be included in the SNUR. The SNUR would be promulgated af ter the voluntary phase out is complete; b) The test rule under section 4 of TSCA would require development of information necessary to determine the effects that manufacturing, use or other activities involving c-decaBDE have on human health or the environment; If the Agency determines that any manuf acture (including import) of c-decaBDE or articles to which c-decaBDE has been added has not ceased, it intends to promulgate the
test rule.

5. 4. Initiate rulemaking under section 5(b)(4) of TSCA to add the commercial PBDE mixtures and/or the congeners they cont ain to the list of chemicals which present or may present
an unreasonable risk to health or the envi ronment. A notice of proposed rulemaking is intended to publish in autumn, 2010.

6. Develop an alternatives analysis for c-d ecaBDE. The alternatives analysis, which is intended to begin in spring 2010, will evaluate the efficacy, availability, cost and hazard
levels of alternatives for a 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 pote ntial risks presented by PBDE substitutes. The alternatives analysis is in tended to aid users of c-decaBDE in selecting
suitable alternatives and avoi ding unintended consequences.

As part of the Agency’s efforts to address PBDEs these chemicals , EPA intends to evaluate the potential for disproporti onate impact on children and other vulnerable subpopulations. The Agency will also continue to analy ze the science as it pertains to making any necessary findings for the rulemakings indicated above

XI. References

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.

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

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