U.S. Environmental Protection Agency 12/30/20 09

Polybrominated Diphenyl Ethers (PBDEs)

Action Plan

I. Overview

Polybrominated diphenyl ethers (PBDEs) have been widely used as flame retardants in a number of applications. Three commercial PBDE mi xtures have been produced and used in the

United States and elsewhere: commercial pentabromodiphenyl ether (c-pentaBDE), commercial octabromodiphenyl ether (c-octaBDE), and co mmercial decabromodiphenyl ether (c-decaBDE). Although manufacture and import of c-pentaBDE and c-octaBDE were phased out in 2004, PBDE congeners associated with those mixtures continue to be found in humans and the environment. Some reports indicate that levels are continuing to increase. Imported articles treated with c-pentaBDE and c-octaBDE could be a source of human and environmental exposure to these PBDE congeners. c-DecaBDE is still manufactured and used in the United States. Data suggest that debr omination, physical or metabolic removal of bromine atoms, may

convert decaBDE to more toxic PB DE congeners, contributing furthe r to the potential risk from exposure to these congeners.

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

toxic and intends to initiate a number of acti ons to limit the exposure and release of PBDE congeners and/or articles to which they have been added. These actions are to: (1) Initiate rulemaking to propose a TSCA significant new us e rule (SNUR) for the manufacture or import of articles to which c-pentaBDE or c-octaBDE has been added (a notice of proposed rulemaking is intended to publish in late 2010); (2) support and encourage the volunta ry phase-out of the manufacture and import of c-decaBDE; (3) init iate rulemaking to simultaneously propose a

SNUR and a test rule for c- decaBDE in late 2010 (the SNUR would designate manufacture (including import) of c-decaBDE or articles to which c-decaBDE has been added as a significant

new use and the test rule under section 4 of TSCA would require development of information necessary to determine the effects that manuf acturing, use or other activities involving cdecaBDE have on human health or the environment); (4) initiate rulemaking under Section 5(b)(4) of TSCA to add the commercial PBDE mixt ures and/or the congeners they contain to the list of chemicals which present or may present an unreasonable risk to hea lth or the environment (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).

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

II. Introduction

As part of EPA's efforts to enhance th e existing chemicals program under the Toxic Substances Control Act (TSCA) 1 , the Agency identified an ini tial list of widely recognized chemicals, including polybrominated diphenyl et hers (PBDEs), for action plan development based on their presence in humans and the environm ent; their persistence, and toxicity; their use

1 15 U.S.C. §2601 et seq.U.S. Environmental Protection Agency 12/30/20 09

2 in consumer products; their production volume; or other similar factors. This Action Plan is

based on EPA’s initial review of readily available use, exposure, and hazard information on

PBDEs. EPA considered which of the various authorities provided under TSCA and other statutes might be appropriate to address potentia l 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 Ac tion Plan does not constitute a final Agency determination or other final Agency action. Regu latory proceedings indi cated by the Action Plan will include appropriate opportunities for public and stakeholder input, including through notice and comment rulemaking processes.

III. Scope of Review

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 (Table 1). Scientific studies, particularly thos e measuring presence of PBDEs in tissues and the environment, often repot th eir findings by BDE number.

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 12/30/20 09

3 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

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

Commercial Mixture Major components Minor components c-pentaBDE tetraBDE pentaBDE hexaBDE

c-octaBDE heptaBDE

octaBDE hexaBDE

nonaBDE

decaBDE

c-decaBDE decaBDE nonaBDE

A small number of the PBDE congeners are found most frequently, and in the greatest concentrations, in human and environmental samples. BDE-47 tends to be found more frequently 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 SummaryU.S. Environmental Protection Agency 12/30/20 09

4 PBDEs are added to materials to reduce the risk of fires and to increase escape time when a fire occurs. They were widely used in textiles, plastics and polyurethane 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, upholstery fa bric, cushions, and plastics used as components in electrica l 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 provides 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 (H ale et al., 2003). In 2005, EPA’s Design for the Environment (DfE) program completed an alternativ es analysis for pentaBDE in furniture foam which provided data to inform substitution to safer alternatives ( http://www.epa.gov/dfe/pubs/p rojects/flameret/index.htm ). This work complemented the voluntary phase-out and the SNUR.

c-OctaBDE was used in acrylon itrile-butadiene-styrene (ABS ) plastic which was used as casing for certain electric and electronic devices used in both offices a nd homes. c-OctaBDE had a smaller market than c-pentaBDE and was more easily replaced.

c-DecaBDE, on the other hand, is still manufactur ed and widely used in the United States and abroad, although legislative actio n to restrict its use has been undertaken by some US states. Based on IUR data2 between 50 – 100 million pounds were manufactured or imported in the

United States in 2005. That is of the same orde r 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.

2 Information on Invertory update data is available at http://www.epa.gov/oppt/iurU.S. Environmental Protection Agency 12/30/20 09

5 V. Hazard Identification Summary

Human Health Effects

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

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

Neurobehavioral effects was identified as th e critical endpoint of concern for each of the four congeners (EPA, 2008a-d). The protocols fo r the studies were unique and did not conform to health effects test guidelines for neurotoxicit y. For decaBDE, EPA also proposed that the data support a finding of "suggestive eviden ce of carcinogenic potential" (EPA, 2008d).

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

, industry-sponsored screening level risk assessm ents for pentaBDE, octaBDE and decaBDE were developed to evaluate the poten tial risks to children and pr ospective parents from potential PBDE exposures. In August, 2005, EPA released its Data Needs Decision documents on PBDEs. Noting the evidence suggesting developmental and reproductive effects, EP A requested that the sponsors provide 2-generation repr oductive toxicity studies for bot h pentaBDE and octaBDE, to characterize risks to children (EPA, 2005a-b). These data were not made available through VCCEP, as the companies ceased their sponsor ship 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 th e significance of its lower BDE breakdown products,

as this could relate to its ri sk characterization (EPA, 2005c). Th e decaBDE data needs were not met by the VCCEP sponsors and decaBDE was s ubsequently terminated from the VCCEP program. EPA then announced its intention to pro ceed 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. Howe ver, some relatively minor importation may be taking place with other companies.

Environmental Effects

At the time the EPA Project Plan was published in 2006, information on environmental effects of PBDEs was limited, with the most de tailed reviews found in European Union risk

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

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

.U.S. Environmental Protection Agency 12/30/20 09

6 assessments of certain congeners. Since then, En vironment Canada concluded that the greatest potential risks from PBDEs in the Canadian en vironment are the secondary poisoning of wildlife from the consumption of prey containing elev ated concentrations of PBDEs and effects on benthic organisms that may result from elevated concentrations of certa in PBDEs in sediments (Environment Canada, 2006). In a more recent re port, Environment Canada has also concluded that decaBDE specifically is available for uptak e in organisms and may accumulate to high and potentially problematic levels in certain specie s 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 histopathologica l 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 conducted biomonitoring of wild mink from the Great Lakes region and concluded that margins of safety for mink are small and that mink from

the Hamilton Harbor exceeded the no observed effect concentrations. Timme-Laragy et al. (2006) reported that c-pentaBDE produced developm ental and behavioral effects of fish embryos including spine curvat ure 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 tr out; Kierkegaard et al., 1999; Stapleton et al., 2004; Stapleton et al., 2006); birds (Van den Steen et al

., 2007), cows (Kierkegaard et al., 2006) and rats (Huwe and Smith, 2007). There is incr easing concern that th is process can be a significant source of exposure to lower brominated congeners.

VI. Physical-Chemical Properties a nd Fate Characterization Summary

PBDEs are expected to be minimally mobile in moving from soil to ai r or water, except as borne on particulate matter. Volatilization from moist soil surfaces is e xpected to be low to moderate depending on the number of bromine atom s. 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 the 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).U.S. Environmental Protection Agency 12/30/20 09

7 Based on available evidence, PBDEs can be debrominated under environmental conditions; however, the overall si gnificance of this process is uncertain. DecaBDE undergoes photolytic and possibly microbial debrominati on under certain conditions (Environment Canada, 2009a; Stapleton, 2006). Photolysis is expected to be the domin ant transformation process for decaBDE where the substance is significantly expos ed to light. For example, it has been found that decaBDE undergoes photolytic debrominatio n in house dust (Stapleton and Dodder, 2008). DecaBDE would also be exposed to light when wa ste sludge containing PBDEs is used as a soil amendment (Hale et al., 2001). However, the hy drophobicity of PBDEs implies that in the aquatic environment they will tend to partition to benthic sediments, where light exposure is insignificant.

That PBDE congeners with four to ten bromine atoms are highly persistent based on several lines of evidence, but especially by a large body of environmenta l monitoring data in both the United States and abroad (Environment Canada, 2009a; Shaw and Kannan, 2009; Vonderheide et al., 2008). Available data also indicate that tetra-, pe nta-, and hexa-BDE are highly bioaccumulative (Environment Canada, 2006) . After reviewing the available information, EPA has concluded that decaBDE likely contribu tes to the formation of bioaccumulative and/or potentially bioaccumulative transformation pr oducts such as lower brominated PBDEs in organisms and in the environment. Studies have shown that that phot odegradation of decaBDE may result in PBDEs from tri- to nona- and bi odegradation 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 persis tence (Environment Canada, 2006).

VII. Exposure Characterization Summary

In recent years, scientists have measur ed PBDEs in human adipose tissue, serum and breast milk, fish, birds, marine mammals, sediments, sludge, hous e dust, indoor and outdoor air, and supermarket foods. The mechanisms or pa thways by which the PBDEs move into and through the environment and humans are not known, but are likely to include releases from manufacturing of the chemicals, manufacturing of products like pl astics or textiles, aging and wear of products like sofas and electronics, and releases at the end of product life (disposal, recycling). In general, levels of PBDEs in humans and the en vironment are higher in North America than in other regions of the world, a finding that is often attributed to the greater use of pentaBDE in North America (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 ofU.S. Environmental Protection Agency 12/30/20 09

8 PBDEs from their prey (Chen et al., 2007; V oorspoels et al., 2007; Shaw and Kannan, 2009; Stapleton and Baker, 2003). In some studies evid ence has been provided that the concentrations of PBDE in biota have doubled every 3 to 6 years, the doubling time depending on species, life stage, and location. PBDE concentr ations in marine biota in Nort h America are the highest in the world and are increasing (Shaw and Kannan, 2009). After reviewing the available information,

EPA has concluded that the extent of accumulati on of congeners is dire ctly 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). Inhalati on exposures could also occu r from off gassing of PBDEs from furniture and electrical applia nces into indoor air, but lit tle information is known about the potential exposure through this route (ATS DR, 2004). Dermal exposure may occur through contact with PBDE-containing products such as po lymers and textiles. A large number of human samples have been analyzed, and the PBDE conc entrations 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 com puter recycling, can be hi gher than those of the general population (Cal/E PA PBDE Workgroup, 2008).

Recent human biomonitoring data 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, 2009, but the PBDE data have been published in the peer-re viewed literature (Sjodi n et al., 2008). Although this is the fourth report from this federal agen cy, it is the first time that PBDEs were included as analytes. The data were obtained from samp les from participants in the 2003-2004 National Health and Nutrition Examination Survey ( NHANES). Ten different PBDE congeners were analyzed for (containing from three to seve n bromines), including BDE-47, BDE-85, BDE-99, BDE-100, BDE-153, BDE-154 and BDE-183. Participan ts 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 highes t in 12-19 year olds a nd those 60 years old and above. Furthermore, serum levels were highest in 12-19 year olds for other lower brominatedU.S. Environmental Protection Agency 12/30/20 09

9 congeners. In addition, these congeners were sign ificantly correlated with each other, suggesting a similar pathway of exposure (Sjodin et al., 2008).

Lorber (2008), reviewed and synthesized th e available information on exposure pathways for PBDEs, including the relative importance of different exposure pathways and how PBDEs get into various exposure media. The report expl ained the process used to gather exposure information, model body burden, and compare it to representative PBDE pr ofiles in blood and milk. The analysis focused on indoor measuremen ts of dust/soil and air, suggesting that the primary source for human exposures to PBDEs a ppears 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 res earch to verify the findings and better quantify identified uncertainties, it c oncluded that exposures to PBDE s through food and water ingestion and inhalation explained less than 20% of th e human body burden, while 80 to 90% of total exposures in the indoor envir onment were through contact wi th house dust (Lorber, 2008).

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

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

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

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

VIII. Risk Management Considerations

U.S. EPA and State/Local Regulat ory 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 orU.S. Environmental Protection Agency 12/30/20 09

10 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.

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 principal manufacturers and importer of c-decaBDE have committed to 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 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 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 arti cles made with decaBDE. Recy cling of materials containing decaBDE would also not be affected by the commitment.

Washington State banned the use of decaB DE in mattresses as of January 2008, and starting in January 2011, decaBDE will be prohibited from use in televisions, computers and upholstered furniture. Maine also banned decaBDE in mattresses and upholstered furniture as of January 2008 and will extend that ban to televi sions and other plastic encased electronics by January 2010. Washington State and Maine conduc ted studies which concluded that 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.U.S. Environmental Protection Agency 12/30/20 09

11 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. Canada is also working on regulatory controls to restrict PBDEs in manufactured and imported products (Environment Canada, 2009b).

Summaries of country actions to ban or severely restrict PBDEs can be found in the respective Risk Management Evaluations for each located on the Stockho lm 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).

Ongoing Activities and Issues

c-PentaBDE and c-OctaBDE

PBDE congeners found in c-pentaBDE and c- octaBDE are widely di stributed in soil, sediments and living organisms, including humans. PBDEs have been found in human tissue, blood and breast milk. The predominant congeners present tend to be the lower brominated forms (i.e., tetraBDE and pentaBDE). Infant s 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 12/30/20 09

12 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.

c-DecaBDE

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

There is evidence that decaBDE is entering th e food chain and biomagnifying. It has been found at high levels in predators such as pere grine falcons. There are ve ry 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 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.

Children’s Health

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

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

health.U.S. Environmental Protection Agency 12/30/20 09

13 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.

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

warranted:

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

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

2. Support and encourage the voluntar y phase out of manufacture and import of c-decaBDE. a) As a result of negotiations with EPA, se veral companies have announced that they will undertake a three year pha seout of decaBDE. They have committed to initiate reductions of manufacture, import and sale s 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/existingchemi cals/pubs/actionplan s/deccadbe.html) b) EPA intends to encourage other importer s of decaBDE to join this effort. c) The voluntary phase out is not designed to address articles made with c-decaBDE.. Recycling of materials c ontaining decaBDE would also not be affected by the

commitment.

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

2010. a) The SNUR would designate manufacture (inc luding import) of c-decaBDE or articles to which c-decaBDE has been added as a significant new use. Essential uses and any other uses which have not been voluntarily phased out would not be included in the SNUR. The SNUR would be promulgated af ter the voluntary phase out is complete; b) The test rule under section 4 of TSCA would require development of information necessary to determine the effects that manufacturing, use or other activities involving c-decaBDE have on human health or the environment;U.S. Environmental Protection Agency 12/30/20 09

14 If the Agency determines that any manuf acture (including import) of c-decaBDE or articles to which c-decaBDE has been added has not ceased, it intends to promulgate the

test rule.

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

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

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

levels of alternatives for a s ubset of critical uses of c-de caBDE. As part of its inquiry, EPA will explore the potential risks presente d by PBDE substitutes. The alternatives analysis is intended to aid users of c-decaB DE in selecting suitable alternatives and avoiding unintended consequences.

As part of the Agency’s efforts to address these chemicals, EPA intends to evaluate the potential for disproportionate impact on childr en and other sub-populations. The Agency will also continue to analyze the science as it pe rtains to making any necessary findings for the rulemakings indicated above

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