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Page 1 of 83 EO12866_PBDE SNUR-Test_NPRM_2010-12-08.doc 1

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BILLING CODE 6560–50–P 3

4

ENVIRONMENTAL PRO TECTION AGENCY 5

6

40 CFR Parts 721 and 799 7

8 EPA–HQ–OPPT–2009-0357; FRL– XXXX

– X ] 9

10

RIN 2070–AJ08 11

12 Certain Polybrominated Diphenylethers; Signif icant New Use Rule (S NUR) and Test Rule 13

14

AGENCY: Environmental Protection Agency (EPA). 15

ACTION: Proposed rule. 16

SUMMARY: The Agency is proposing to amend the Toxic Substances Control Act (TSCA) 17 section 5(a) Significant New Use Rule (SNUR), at 40 CFR 721.10000, that requires any person 18 who intends to manufacture or import te trabromodiphenyl ether (CASRN 40088–47–9; 19 Benzene, 1,1 ′ -oxybis-, tetrabromo deriv.) (tetraBD E), pentabromodiphenyl ether (CASRN 20 32534-81-9; Benzene, 1,1’-oxybis-, pentabromo deriv.) (pentaBDE), he xabromodiphenyl ether 21 (CASRN 36483–60–0; Benzene, 1,1 ′ -oxybis-, hexabromo deriv.) (hexaBDE), 22 heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1 ′ -oxybis-, heptabromo deriv.) 23 (heptaBDE), octabromodiphenyl ether (CASRN 32536-52-0; Benzene, 1,1’-oxybis-, octabromo 24 deriv.) (octaBDE), or nonabr omodiphenyl ether (CASRN 63936–56–1; Benzene, pentabromo 25 (tetrabromophenoxy)-) (nonaBDE), or any combinat ion of these substances resulting from a 26 chemical reaction, for any use on or after Janua ry 1, 2005, to notify EPA at least 90 days in 27 advance. EPA is proposing to amend the S NUR by: (1) designating processing of the six 28 polybrominated diphenyl ethers (P BDE)s, or any combination of these substances resulting from 29 a chemical reaction, for any use as a signifi cant new use, (2) designating manufacturing, 30 importing, and processing of a seventh PBDE , decabromodiphenyl ether (CASRN 1163-19-5; 31 Benzene, 1,1’-oxybis[2,3,4,5,6-pentabromo-)(decaB DE) for any use after December 31, 2012, 32 except military and transportation uses, and for any use including military and transportation 33 uses after December 31, 2013 as a significant new us e, and (3) making inapplicable the article 34 exemption at 721.45(f) for this action. Any pe rson who intends to import or process any 35 chemical substance subject to the proposed SNUR, as part of an article would be subject to 36 significant new use reporting. The purpose of amendi ng the existing SNUR is to ensure that the 37 Agency has an opportunity to review and, if necessa ry, take action to restrict or prohibit a new 38 use, such as resumption of discontinued uses of PBDEs before they resume. EPA expects all 39 manufacture and processing of PBDEs, except as impurities, to be discontinued by the dates 40 specified above. EPA is also proposing a test rule under section 4(a) of TS CA that would require 41 any person who manufactures or processes co mmercial pentaBDE (c-pentaBDE), commercial 42 octaBDE (c-octaBDE), or commercial decaBDE (c -decaBDE), including in articles, for any use 43 after December 31, 2012, except for military and transportation us es of c-decaBDE, or after 44 December 31, 2013 for any use including military and transportation uses of c-decaBDE to 45*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 2 of 83 conduct testing to obtain data on he alth effects, environmental eff ects, and chemical fate. The 46 proposed test rule specifies that testing of c-pentaBDE, c-octaBDE, and c-decaBDE be 47 conducted on a representative commercial product of each. The required testing would provide 48 EPA with data necessary to determine the eff ects of manufacture, di stribution in commerce, 49 processing, use, and disposal of c-pentaBDE, c-octaBDE, and c-decaBDE or any combination of 50

such activities on health or the environment. EP A is proposing to designat e all discontinued uses 51 of PBDEs as significant new uses. The test rule would only be promulgate d if there are persons 52 manufacturing, importing, or pro cessing c-pentaBDE, c-octaBDE, or c-decaBDE for any use, 53 except as impurities, after th e dates specified above. 54

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DATES: Comments must be recei ved on or before [ insert date 60 days after date of publication 56

in the Federal Register ]. 57

ADDRESSES: Submit your comments, identified by doc ket identification (ID) number EPA– 58 HQ–OPPT–2009-0357, by one of the following methods: 59

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line 60 instructions for submitting comments. 61

• Mail : Document Control Office (7407M), Offi ce of Pollution Prevention and Toxics 62 (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 63

20460–0001. 64

• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 65 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ– 66 OPPT–2009-0357. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding 67 legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only 68 accepted during the DCO’s normal hours of operati on, and special arrangements should be made 69

for deliveries of boxed information. 70

Instructions : Direct your comments to docke t ID number EPA–HQ–OPPT–2009-0357. 71 EPA's policy is that all comments received will be included in the docket without change and 72 may be made available on-line at http://www.regulations.gov , including any personal 73 information provided, unless the comment include s information claimed to be Confidential 74 Business Information (CBI) or other information whos e disclosure is restrict ed by statute. Do not 75 submit information that you consider to be CBI or otherwise protec ted through regulations.gov 76 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 77 will not know your identity or contact inform ation unless you provide it in the body of your 78 comment. If you send an e-mail comment directly to EPA without going through 79 regulations.gov, your e-mail address will be automati cally captured and included as part of the 80 comment that is placed in the docket and made available on the Internet. If you submit an 81 electronic comment, EPA recomme nds that you include your name and other contact information 82 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 83 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 84 be able to consider your comment . Electronic files should avoid the use of special characters, 85 any form of encryption, and be fr ee of any defects or viruses. 86

Docket : All documents in the docket are list ed in the docket index available at 87*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 3 of 83 http://www.regulations.gov . Although listed in the index, so me information is not publicly 88 available, e.g., CBI or other information whose disc losure is restricted by statute. Certain other 89 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 90

available docket materials ar e available elect ronically at http://www.regulations.gov , or, if only 91 available in hard copy, at the OPPT Docket. Th e OPPT Docket is located in the EPA Docket 92 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 93 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 94 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 95 Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 96 Docket visitors are required to show photographic identificati on, pass through a metal detector, 97 and sign the EPA visitor log. All visitor bags are processe d through an X-ray machine and 98 subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 99 the building and retu rned upon departure. 100

FOR FURTHER INFORMATION CONTACT: For technical information regarding the 101

SNUR contact : John Bowser, Chemical Control Divi sion, Office of Pollution Prevention and 102 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 103 20460–0001; telephone number: 202- 564-8082; e-mail addresses: bowser.john@epa.gov

. 104

For technical information regar ding the test rule contact : Catherine Roman, Chemical Control 105 Division, Office of Pollution Prevention and T oxics, Environmental Protection Agency, 1200 106 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-8708; e107

mail addresses: roman.catherine@epa.gov

. 108

For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 109 Rochester, NY 14620; telephone numb er: (202) 554–1404; e-mail address: TSCA110 Hotline@epa.gov

. 111

SUPPLEMENTARY INFORMATION: 112

I. General Information 113

A. Does this Action Apply to Me? 114

You may be affected by this action if you manufacture or process tetraBDE, pentaBDE, 115 hexaBDE, heptaBDE, octaBDE, nonaBDE, or d ecaBDE, or intend to, including as part of a 116

mixture or article. TSCA define s manufacture to include import. Unless otherwise noted in this 117 preamble, use of the term “manufacture” include s import. Manufacturers and processors in 118

certain industries to whom this action may apply include, but are not limited to: 119

• Manufacturers and processors of subject chem ical substances and mixtures with North 120 American Industry Classification System (NAICS) codes 325 and 324110,, e.g., chemical 121 manufacturing and petroleum refineries. 122

• textile manufacturers and processo rs (NAICS codes 313, 314, and 315), 123

• furniture manufacturers (NAICS code 337), 124*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 4 of 83 • manufacturers and processors of pol yurethane foam (NAICS code 326150), 125

• manufacturers of high impact pol ystyrene (HIPS) and acrylonitr ile-butadiene-styrene (ABS) 126 plastics (NAICS codes 325, 326140, and 3261), and 127

• manufacturers of electronics eq uipment (NAICS codes 334 and 335). 128

This listing is not intended to be exhaustiv e, but rather provides a guide for readers 129 regarding entities likely to be aff ected by this action. Other types of entities not listed in this unit 130

could also be affected. The North American Industrial Classification System (NAICS) codes 131 have been provided to assist you and others in determining whet her this action might apply to 132 certain entities. If you have any que stions regarding the applicability of this action to a particular 133 entity, consult the tech nical person listed under FOR FURTHER INFORMATION 134

CONTACT

. 135

This action may also affect certain entitie s through pre-existing import certification and 136 export notification rules under TSCA. Persons who import any chemical substance identified in 137 a final SNUR are subject to the TSCA secti on 13 import requirements, codified at 19 CFR 138 12.118 through 12.127; see also 19 CFR 127.28. Those pers ons must certify that the shipment of 139 the chemical substance complies with all appli cable rules and orders under TSCA, including any 140 SNUR requirements. The EPA policy in support of import certification a ppears at 40 CFR part 141 707, subpart B. In addition, any persons who expor t or intend to export a chemical substance 142 that is the subject of the propos ed SNUR on or after [insert da te 30 days after the date of 143 publication in the Federal Register] are subject to the export notificati on provisions of TSCA 144 section 12(b) (15 U.S.C. 2611(b)), (see 40 CF R 721.20), and must comply with the export 145 notification requirements in 40 CFR part 707, subpart D. Persons who export or intend to export 146

a chemical substance or mixture identified in the proposed test rule will be subject to the export 147 notification provisions of TSCA section 12(b) if the test rule is finalized. However, persons who 148 export or intend to export articles containing chemi cal substances or mixtures subject to a final 149 test rule would not be require d to submit notic e of export. 150

151 B. What Should I Consider as I Prepare My Comments for EPA? 152

1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e153 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 154 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD155 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 156

information that is claimed as CBI. In additi on to one complete version of the comment that 157 includes information claimed as CBI, a copy of the comment that does not contain the 158 information claimed as CBI must be submitted for inclusion in the public docket. Information so 159 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 160

2. Tips for preparing your comments . When submitting comments, remember to: 161

i. Identify the document by docket ID number and other identifying information (subject 162 heading, Federal Register date and page number). 163

ii. Follow directions. The Agency may ask you to respond to specific questions or 164*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 5 of 83 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 165

iii. Explain why you agree or disagree; suggest alternatives and substitute language for 166 your requested changes. 167

iv. Describe any assumptions and provide a ny technical information and/or data that you 168

used. 169

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 170 sufficient detail to allow for it to be reproduced. 171

vi. Provide specific examples to illustra te your concerns and suggest alternatives. 172

vii. Explain your views as cl early as possible, avoiding the use of profanity or personal 173

threats. 174

viii. Make sure to submit your comments by the comment period deadline identified. 175

II. Background 176

A. What Action is the Agency Taking? 177

The Agency is proposing to amend the S NUR at 40 CFR section 721.10000 (Ref. 1) that 178 requires any person who intends to manufacture or import te traBDE, pentaBDE, hexaBDE, 179 heptaBDE, octaBDE, or nonaBDE, or any combinati on of these chemical substances that results 180 from a chemical reaction, for any use on or afte r January 1, 2005, to notify EPA at least 90 days 181 in advance. EPA is proposing to amend the S NUR by: (1) designating processing of any of the 182 six PBDEs after December 31, 2012 for any us e a significant new use, (2) designating 183 manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl ether 184 (decaBDE) (CAS No. 1163-19-5) for any use exce pt military and transportation uses after 185 December 31, 2012, and manufacture and processing of decaBDE for any us e including military 186 and transportation after December 31, 2013, as signi ficant new uses, and (3) making inapplicable 187 the article exemption at 721.45(f). A person that imports or processes any of the chemical 188 substances identified in the proposed SNUR as pa rt of an article would not be exempt from the 189 significant new use notification requirements. No person would be able to begin manufacturing, 190 importing, or processing any of the chemical subs tances identified in th e proposed SNUR for a 191 significant new use without first submitting a sign ificant new use notification (SNUN) to EPA. 192

193 In this notice EPA is also proposing to issu e a test rule under sect ion 4(a) of the TSCA 194 that would require any person who manufactures, imports, or processes c-pentaBDE or c195 octaBDE including in articles for any use after December 31, 2012; or manu factures, imports, or 196 processes c-decaBDE for any use except military and transportation uses including in articles 197 after December 31, 2012; or manufactures, impor ts, or processes c-decaBDE for any use, 198 including military and transpor tation uses, including in article s, after December 31, 2013 to 199 conduct testing of such commercial PBDE mi xtures to obtain data on health effects, 200 environmental effects, and chemical fate in acco rdance with the test rule. Hereafter, Dec 31, 201 2012 and December 31, 2013, will be referred to as the relevant effective dates; see 799.xxxx(k). 202 The proposed test rule specifies that testing of c-pentaBDE, c-octaBDE, and c-decaBDE be 203*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 6 of 83 conducted on representative forms of the rele vant commercial mixt ures. The commercial 204 mixture, c-pentaBDE, typically contains tetraB DE, pentaBDE and hexaBDE as the predominant 205 components; the commercial mixture, c-octaBD E, typically contains hexaBDE, heptaBDE, 206 octaBDE and nonaBDE as the predominant com ponents; and the commercial mixture, c207 decaBDE, typically contains decaBDE in the highest percent composition. 208

209 If EPA finds that the proposed significant new uses have not ceased by the specified 210 dates, EPA will promulgate a final test rule to require persons who manufacture or process c211 pentaBDE, c-octaBDE, or c-decaBDE to conduct te sting to obtain data on health effects, 212 environmental effects, and chemical fate of t hose mixtures. The required testing would provide 213 EPA with data necessary to determine the e ffects on health and th e environment if the 214 manufacture and processing of t hose mixtures and the associated use, distribution in commerce 215 and disposal are not discontinued. 216

217 EPA is seeking public comment on both the pr oposed SNUR and test rule. Comments 218 may address any aspect of the actions being proposed today. Unit XI of this notice contains a list 219 of specific issues for which the Agency is seeking comment. The actions EPA is proposing 220 today are generally described in the PB DE Action Plan released December 30, 2009 221 ( www.epa.gov/oppt/existingchemica ls/pubs/actionpl ans/pbde.html ). 222

223

224 B. Why is the Agency Taking this Action? 225

226

227

228

EPA is concerned about the effects PB DEs may have on human health and the 229

environment. As discussed in Unit III and the PB DE Action Plan (Ref. 66), there is evidence that 230 PBDEs may be toxic to both hum ans and wildlife. PBDEs have been found in human tissue, 231 wildlife and the environment. However, there is insufficient data to fully evaluate the 232 significance of observed exposures. 233

234

EPA is also concerned that the PBDEs incl uded in these proposed actions are highly 235 persistent in the environment. Some lowe r brominated PBDEs are both toxic and highly 236 bioaccumulative. Other, more highly brominated forms such as decaBDE may debrominate to 237

the more toxic and bioaccumulative lower brom inated forms. However, the overall impact of 238

debromination of decaBDE as a source of th e lower brominated PBDE congeners in the 239 environment has not been fully characterized. DecaBDE has been found at high levels in 240 predators such as peregrine falcons. The envi ronmental significance of such accumulations of 241 decaBDE has not been fully characterized. The exact mechanisms or pathways by which the 242 PBDEs move into and through th e environment and allow humans and wildlife to become 243 exposed are not fully understood. The data pr oduced by some of the tests included in the 244 proposed test rule would be necessary to determ ine the effects on the envi ronment if manufacture 245 and processing of c-pentaBDE, c-octaBDE, and c- decaBDE and their associated use, distribution 246 in commerce and disposal are not discontinued. 247

248 In December 2009, EPA received voluntary commitments from the principal 249 manufacturers and importer of c-decaBDE to pha se out manufacture and import for all uses by 250*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 7 of 83 December 31, 2013. The phase out of decaBDE will be accomplished in two steps. No later 251 than December 31, 2012, the manufacturers a nd the importer of c-decaBDE would cease 252 manufacture and import for all uses, including in articles, with the exception of military and 253 transportation uses. No later than Decembe r 31, 2013, they would cease manufacture and import 254 for all uses including military and transportation uses, including in articles. The principal 255 manufacturers and importer of c-decaBDE stated that the additional time required for phasing 256 out military and transportation uses was due to the stringent engineering requirements and risks 257 associated with these applications as well as the multiple levels of testing and certification 258 required for such product changes. EPA believe s these activities will cease by the specified 259 dates and is proposing to use its authority under sec tion 5 of TSCA to designate them as 260 significant new uses. Once an activity has been dete rmined, by rule, to be a significant new use, 261 persons may not manufacture or process the chem ical substance for that activity without first 262 submitting a significant new use notice (SNUN) to EPA. The Agency would then have an 263 opportunity to review and if necessary take ac tion to restrict or prohibit the new use. 264

265 C. Why is EPA Proposing both a SNUR and a Test Rule? 266

EPA has found no evidence of manufacture or processing of c-pentaBDE or c-octaBDE 267 except as impurities. The principal manufacturers and importer of c-decaBDE have informed the 268 Agency that they intend to phase out manufact ure and import of the chemical no later than 269 December 31, 2013. EPA believes that other manuf acturers and importers of decaBDE will also 270 cease their activities by that date. EPA is propos ing to amend the SNUR to ensure that after 271 these activities have been discontinued, no one re sumes them without notifying EPA in advance, 272 thereby providing EPA with an opportunity to review the new uses before they commence. 273 Before promulgating the amende d SNUR, EPA will verify through comments on this action, or 274 by other means, that the proposed significant new uses have ceased. EPA seeks comment on 275 whether anyone intends to import or process articles containing pe ntaBDE, octaBDE, or 276 decaBDE except as impurities for any of the proposed significant new uses. 277

278

In the event that the activiti es proposed as significant new uses of pentaBDE, octaBDE, 279 or decaBDE do not cease by the projected dates, EPA is proposing a test rule to obtain 280

information to assess the effects on humans a nd the environment of the continued manufacture 281 and processing of c-pentaBDE, c-octaBDE, and c- decaBDE and the associated use, distribution 282 in commerce and disposal. 283

284 D. Why does the proposed test rule include three commercial PBDE mixtures while the SNUR 285 includes seven PBDE congeners? 286

287 The test rule is designed to provide the Agency with data relevant to commercial PBDE 288 products actually in use or intended for use. There are three commer cial PBDE products: c289 pentaBDE, c-octaBDE, and c-decaBDE. The test rule proposes that testing be conducted on a 290 representative form of each commercial mixtur e to better understand th eir potential effects on 291

health and the environment. Some of the data ob tained by the test rule would address unmet data 292 needs identified by EPA thr ough the Voluntary Children’s Ch emical Evaluation Program 293 (VCCEP). All three of the commercial PBDE products are mixtures , but have different 294 predominant components. Other PBDE congeners may be present in the mixtures in lesser 295

amounts. 296*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 8 of 83 297 The SNUR is designed to provide the Agen cy with advance notice of manufacture or 298 processing of any one or any combination of th e seven PBDEs for a significant new use. Since 299 the composition of any future commercial PBDE products may vary in terms of congener 300 composition, the Agency determined that it would be more effective to in clude all seven of the 301 individual PBDE congeners in the SNUR. Thus, all congeners in any future commercial PBDE 302 product would be subject to the SNUR reporting requirements. 303

304 E. Will EPA Promulgate both the SNUR and the Test Rule? 305

306 EPA expects that the manufacture and pro cessing of the c-PBDEs identified in this 307 proposed action, except as impurities, including th ese c-PBDEs when contained in articles, will 308 have been discontinued by the dates indicated in the proposed amendments to the SNUR. EPA 309 intends to promulgate amendments to the SNUR designating manufacture and processing for any 310 use, including discontinued uses , as a significant new use. 311

312 If EPA were to learn through comments on the proposed amendments to the SNUR or 313 test rule, or through other means, that a person w ho would be subject to the test rule intended to 314 continue, resume, or commence manufacture or processing of c-pentaBDE, c-octaBDE, or c315 decaBDE after the relevant dates specified in the proposed test rule in 799.xxxx(k), EPA would 316 promulgate the test rule. However, if EPA were to learn that the only persons that would be 317 subject to the test rule would be persons that process c-pentaBDE, c-octa BDE, or c-decaBDE as 318 impurities contained in articles, EPA would not re quire testing because EPA has not determined 319 whether this activity alone may present an unrea sonable risk of injury to health or the 320

environment. 321

322 EPA could promulgate bot h the test rule the SNUR for the corresponding PDBE 323 congeners, i.e., pentaBDE, octaBDE, and decaBDE . If a person indicates his intention to 324 continue to engage in an activ ity proposed as a significant new use for pentaBDE, octaBDE, or 325 decaBDE, EPA intends to promulgate the propos ed amendments to the SNUR designating all 326 other uses of that PBDE as significant new us es, but would exclude the ongoing use from the 327 SNUR. In that situation, EPA would also promulga te the test rule. Persons that manufacture or 328 process that PBDE for the ongoing us e after the dates specified in th e test rule would be subject 329

to the test rule. 330

331 F. What is the Agency's Authority for Taking this Action? 332

333

1 . Significant New Use Rules (SNURs). Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) 334

authorizes EPA to determine that a use of a chem ical substance is a "significant new use." EPA 335 must make this determination by ru le after considering all relevant factors, includ ing those listed 336 in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a 337 significant new use, TSCA section 5(a)(1)(B) re quires persons to submit a significant new use 338 notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical 339 substance for that use (15 U.S.C. 2604(a)(1)(B)). 340

341

2. Test Rule. TSCA section 4(a)(1)(A) (15 U.S.C. 2603(a)(1)(A)) direct s EPA to require 342 by rule that manufacturers and/ or processors of chemical s ubstances and mixtures conduct 343*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 9 of 83 testing, if the EPA Admi nistrator finds that: 344

(A)(i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or 345 mixture, or that any combination of such activities, may pr esent an unreasonable risk of injury to health or the 346
environment, 347

(ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in 348 commerce, processing, use, or disposal of such substan ce or mixture or of any combination of such activities on 349 health or the environment can reasonably be determined or predicted, and 350

(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data [.] 351

352
Once the EPA Administrator has made a finding under TSCA section 4(a)(1)(A), EPA 353 may require any type of health or environmental effects testing necessary to address unanswered 354 questions about the effects of the chemical substa nce or mixture that are relevant to whether the 355 manufacture, distribution in commer ce, processing, use, or disposal of the chemical substance or 356 mixture, or any combination of such activities, pr esents an unreasonable risk of injury to health 357 or the environment. EPA need not limit the scope of testing required to the factual basis for the 358 TSCA section 4(a)(1)(A)(i) findings. This approach is explained in more detail in EPA’s TSCA 359 section 4(a)(1)(B) Final Statemen t of Policy (B Policy) (Ref. 2 ). 360

In this proposed test rule, EPA would use its TSCA section 4(a) authority to obtain data 361 necessary to determine whether the manufacture, processing, distribution in commerce, use, or 362 disposal of any or all of the three commercial PBDE mixtures, i. e., c-pentaBDE, c-octaBDE, and 363 c-decaBDE, present an unreasonable risk of injury to health or the environment. 364

365 EPA is also proposing to use its authority und er TSCA section 12(a)(2 ) to require testing 366 of mixtures named in this proposed test rule which would otherwise be exempted from TSCA 367 under 12(a)(1). TSCA 12(a)(1) exempts from TS CA the manufacture, proc essing, or distribution 368 in commerce of a mixture for export from the Unite d States in certain situ ations. Such testing 369 would be for the purpose of determining whether or not the mixture presents an unreasonable 370 risk of injury to health within the United Stat es or to the environment of the United States 371

372 G. Applicability of General Provisions. 373

374

1. SNUR. General provisions for SNURs appear under 40 CFR part 721, subpart A. 375 These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to 376 reporting requirements, and applicability of the rule to uses occurring before the effective date of 377 the final rule. However, part 721.45(f) would not apply to this proposed SNUR. A person who 378 imports or processes a chemical substance that would be covered by this action as part of an 379 article would not be exempt from submitting a significant new use notice. A person who 380 manufactures or processes a PBDE only as an impurity would be exempt from the SNUR under 381 part 721.45(d). 382

383 Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 384 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA 385 regulatory procedures as submitters of Prema nufacture Notices (PMNs) under TSCA section 386 5(a)(1)(A). In particular, these requirements include the information submissions requirements 387 of TSCA section 5(b) and 5(d)(1 ), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 388*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 10 of 83 (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 389 may take regulatory action under TSCA section 5( e), 5(f), 6 or 7 to control the activities on 390

which it has received the SNUN . If EPA does not take action, EPA is required under TSCA 391 section 5(g) to explain in the Federal Register its reasons for not taking action. 392

393 Persons who export or intend to export a ch emical substance identified in a proposed or 394 final SNUR are subject to the e xport notification provisi ons of TSCA section 12(b). The article 395 exemption at 40 CFR part 707.60(b) would apply to this rule. Pe rsons who export or intend to 396 export articles containing chemical substances subject to this propos ed rule would not be 397 required to submit notice of export. The regulations that interpret TSCA s ection 12(b) appear at 398 40 CFR part 707, subpart D. Also, see Unit VII. 399

400 Persons who import a chemical substance iden tified in a final SNUR are subject to the 401 TSCA section 13 import requirements, codifi ed at 19 CFR 12.118 through 12.127; see also 19 402 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies 403 with all applicable rules and orders under TS CA, including any SNUR requirements. The EPA 404 policy in support of import cert ification appears at 40 CFR part 707, subpart B. Also, see Unit 405

VIII. 406

407

2. Test Rule . General provisions for test rules ap pear under 40 CFR part 790 (subparts A, 408 B, C, and E), part 791, part 792, and part 799 (su bpart A). These provisions describe persons 409 subject to the rule, procedures for developing test rules, implementation, enforcement, and 410 modification of test rules, exemption from te sting, data reimbursement, and good laboratory 411 practice standards. Section 791.48( b) would not apply to this pr oposed test rule for the purpose 412 of defining production volume to determine fa ir reimbursement shares. Production volume 413 would be defined as including amounts of the test chemical imported in bulk form, in mixtures, 414 in articles, and the to tal domestic production of the chemi cal including that produced as a 415 byproduct or as an impurity. See 799.xxxx(f) of th e proposed rule. Also, persons described in 416 part 790.2 as subject to a test rule include, among others, importers and processors of a chemical 417 substance or mixture as part of an article. Submission of a SNUN would not affect a person’s 418 obligations under a test rule. 419

420 Persons who export or intend to export a ch emical substance or mixture identified in a 421 final test rule are subject to the export notifica tion provisions of TSCA s ection 12(b). However, 422 persons who export or intend to export articles containing chem ical substances or mixtures 423 subject to a final test rule would not be required to submit notice of export. The regulations that 424 interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Also, see Unit VII. 425

426

III. Overview of PBDEs 427

428

A. Chemistry of PBDEs

. 429

430 The polybrominated diphenyl ethers (PBDEs) ar e a family of chemicals with a common 431 structure of a brominated diphenyl ether molecu le which may have anywhere from one to ten 432 bromine atoms attached. (Figure 1). 433

434 Figure 1. Brominated diphenyl molecule 435*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 11 of 83 436

O Br x Br y

x + y = 4 - 10 437 438 Each individual PBDE variant, distinguished from others by both the number of bromine 439 atoms and the placement of those atoms, is referre d to as a congener. For example, there are 42 440 tetrabromodiphenyl ether congeners, each with four bromine atoms in different configurations. 441 Specific congeners, also known as isomers, in which both the number and location of bromine 442 atoms is specified are given numbers, e.g., BDE-47. In theory, there could be as many as 209 443 PBDE congeners, but a much smaller numbe r of congeners are commonly found in the 444 commercial PBDE products and in measuremen ts of PBDEs in humans and the environment 445 (Table 1). Scientific studies, particularly thos e measuring presence of PBDEs in tissues and the 446 environment, often report th eir findings by BDE number. 447

448 PBDE congeners can be groupe d as homologs i.e., according to the number of bromine 449 atoms present in the molecule. TSCA inventory listings and regulations for PBDEs are based on 450 these homolog groups. (Table 1). The PBDE homol ogs used in flame retardants have between 451 four and ten bromine atoms. EPA regulations of PBDEs generally appl y to congeners grouped 452 according to homolog groups rather than speci fic congener/isomers designated by BDE number. 453

454 There are three types of commercial PBDE (c-PBDE) products, c-pentaBDE, c-octaBDE, 455 and c-decaBDE; each commercial product is a mi xture of PBDE congeners (see Table 2). 456

457 Table 1. PBDE Homolog 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

458 Table 2. 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

459*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 12 of 83 B. Actions taken to understand and limit risk from use of PBDEs. 460

461 EPA has been concerned about the reported health and environmental effects of PBDEs 462 and potential exposure to PBDEs for some time, and has taken several actions to fully understand 463

their effects and to reduce e xposure to them. Of particular note are the VCCEP, which was 464 announced in 2000 (Ref. 65), and the 2006 PBDE SNUR (Ref. 1). 465

466 C-PentaBDE, c-octaBDE, and c-decaBDE were among the chemicals evaluated in 467 VCCEP. That Program was designe d to collect health effects information on chemicals to which 468 children had a high likelihood of being exposed and to characterize the risk to children from that 469 exposure. Sponsors in VCCEP provided health effects and exposure information on a voluntary 470 basis. Through VCCEP the Agency identified data needs for all three c-PBDEs that were 471 beyond what was provided by the sponsors in the in itial chemical assessmen ts. The sponsors of 472 c-pentaBDE and c-octaBDE, however, declined to conduct testing to address the identified data 473 needs because of plans to discontinue manuf acture of these chemicals in 2004. Later the 474 sponsors of c-decaBDE also declined to conduct testing to provide the data needs identified 475 through VCCEP and subsequently decided to phas e out their activities wi th c-decaBDE. As a 476 result, the sponsoring companies did not meet the additional data needs identif ied through 477 VCCEP for any of the three c-PB DEs. Tests addressing those data needs are among the tests 478 proposed for c-pentaBDE, c-octaBDE, and c-decaBDE in this action. 479

480 C-pentaBDE and c-octaBDE had been widely used as additive flame retardants in a 481 number of applications until their sole U.S. ma nufacturer, the Great Lakes Chemical Corporation 482 (now Chemtura Corporation) voluntary phased out their production in 2004. C-PentaBDE was 483 used primarily in flexible polyurethane foams. C-OctaBDE was used in acrylonitrile-butadiene484 styrene (ABS) plastic which was used in applicat ions such as casing for certain electric and 485

electronic devices used in both offices and hom es. . When manufacture of c-pentaBDE and c486 octaBDE was discontinued, EPA promulgate d a SNUR (74 FR 34015, June 13, 2006) which 487 requires that any person who inte nds to manufacture or import a chemical substance containing 488 any of the congeners present in c-pentaBDE or c-octaBDE (namely tetraBDE, pentaBDE, 489 hexaBDE, heptaBDE, octaBDE, and nonaBDE), or any combination of these substances 490 resulting from a chemical reaction, to notify EPA at least 90 days in advance of manufacture or 491 import for any use on or after January 1, 2005. The SNUR does not address processing of 492 PBDEs, nor does it apply to import of articles wh ich contain any of the congeners present in c493 pentaBDE or c-octaBDE. 494

495 C-DecaBDE is still manufactured and widely used in the United States as an additive 496 flame retardant. The three majo r product categories in which c-de caBDE is used are: textiles, 497 electronic equipment, and building and construction materials. Its primary use is in high impact 498 polystyrene (HIPS) based products . However as a result of the voluntary phase-out announced 499 on December 17, 2009, EPA expects all uses of c-decaBDE except for military and 500 transportation uses to be discontinued in the United States by December 31, 2012, and all 501 remaining uses including military and transportati on uses to be discontinued by the end of 2013. 502

Other actions EPA has taken with PBDEs include (1) supporting he inclusion in 503 voluntary consensus standards of criteria restricting PBDE use as a product component (e.g., in 504 carpets, electronics, and furniture or use in manufacturing processes, and (2) working with and 505*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 13 of 83 through programs (i.e., Furniture Flame Retard ancy Partnership and the Green Suppliers 506 Network) to identify environmen tally safer approaches to meeti ng fire standards and to improve 507

awareness of concerns related to PBDEs. 508

C. Human Health Effects. 509

510 In 2008, EPA published peer-reviewed toxicolo gical reviews of tetraBDE (BDE-47), 511 pentaBDE (BDE-99), hexaBDE (BDE-153), and decaBDE (BDE-209) (Refs. 3-6), to support 512 summary information on EPA's Integrated Ri sk Information System (IRIS) database 513 (www.epa.gov/iris/ ). Developmental neurotoxicity was iden tified as the critical effect for each 514

of the four chemicals. EPA also concluded th at the database for decaBDE (BDE-209) provides 515 “suggestive evidence of carcinoge nic potential” (Ref. 6). 516

517 Through EPA’s Voluntary Children’s Chemi cal Evaluation Program(VCCEP), industry518 sponsored screening level risk assessments fo r c-pentaBDE, c-octaBDE and c-decaBDE were 519 developed to evaluate the poten tial risks to children and pr ospective parents from PBDE 520 exposures (Ref. 7). Adverse neurobehavioral effects following exposure to PBDEs during the 521 postnatal period are believed to be the most se nsitive health endpoint. Repeated-dose toxicity 522 studies for c-pentaBDE showed changes in live r enzyme activity, increased liver weight and 523 histologic changes in liver. Changes in thyroid hormone T 4 levels and thyroid hyperplasia were 524

noted in oral adult rat studies. In limited prenatal developmental studies, decreases in T 4 levels 525 were reported for dams and offspring. The repeat ed-dose toxicity studies for c-octaBDE showed 526 changes in liver enzyme activity and increased live r weights. In prenatal developmental studies, 527 decreased maternal and pup bodyw eight and decreases in T 4 levels were reported for rat dams 528 and their offspring. Evidence of developmen tal and reproductive effects was noted but 529

additional studies are needed to better characterize potential risks to children (Ref. 48)

. EPA 530 through VCCEP identified two-generation reproductiv e toxicity studies with a satellite group for 531 body burden determinations as a data need fo r both c-pentaBDE and c-octaBDE (Ref. 48)

. Also 532 through VCCEP, EPA identified anaerobic debrom ination in aquatic sediments, anaerobic 533 debromination in sludge digesters, and photolysis in the indoor environmen t as data needs for c534

decaBDE to better understand the chemical fate a nd thereby the potential exposure to decaBDE 535 and lower brominated congeners (Ref. 49)

. 536

537

D. Environmental Hazard. 538

539 Laboratory studies have shown that c-pentaBDE is capable of producing adverse effects 540 in a variety of organisms includi ng birds, mammals, fish, and invert ebrates (Refs. 8-19). In some 541 cases, these effects were observed at exposure levels similar to levels found in the environment 542

543

E

. Environmental Releases and Fate

. 544

545 The exact mechanisms or pathways by wh ich the PBDEs move into and through the 546 environment and allow humans to become expos ed are not fully understo od, but are likely to 547 include releases from manufacturing of the chem icals, processing c-PBDEs into products like 548 plastics or textiles, aging and wear of products like sofas and electronics, and releases at the end 549 of product life (disposal or recycling). In gene ral, levels of PBDE congeners in humans and the 550 environment are higher in North America than in other regions of the world, which may be 551*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 14 of 83 attributed to the greater use of c-PBDEs in North America (R ef. 20). The concentration and 552 distribution of congeners detected in the environment appear to depend on the proximity to a 553 source of the congener and the media tested. (Ref. 74) 554

555 PBDE congeners with four to ten bromine atoms are highly persistent, based on a large 556 body of environmental monitoring data in both the United States and abroad (Refs 21-23). 557
Available data also indicate th at the tetra-, penta-, hexa- a nd heptaBDE congeners are highly 558 bioaccumulative (Ref. 24). After reviewing the available information, EPA has concluded that 559 decaBDE is a likely contributor to the form ation of bioaccumulative and/or potentially 560 bioaccumulative transformation products, such as lo wer brominated PBDEs, in organisms and in 561 the environment see, e.g., (Refs 25-28), but the overa ll impact of this process as a source of the 562 more toxic, lower brominated PBDE congeners has not been fully characterized. DecaBDE 563 undergoes photolytic and possibly microbial debr omination under certain conditions (Refs. 22 564 and 28). Photolysis is expected to be a si gnificant transformation process for decaBDE 565 whenever the substance is significantly exposed to light. For example, it has been found that 566 decaBDE undergoes photolytic debromination in house dust (Ref. 29). DecaBDE would also be 567 exposed to light when waste sludg e containing PBDEs is used as a soil amendment, albeit only 568 on the soil surface (Ref. 30). Studies have show n that photodegradation of decaBDE may result 569 in PBDEs from tri- to nona-, although most photolysis studies were done under conditions that 570 do not allow direct extrapolation to environm ental conditions. Metabolism of decaBDE in 571 organisms results predominantly in nona-, octa- and heptaBDE formation (as reviewed in Ref. 572 22). Stapleton (Ref. 28) summarized the eff ects of decaBDE debromination, noting that the 573 formation potential for the pentaBDE and lower c ongeners was low, but that the formation of the 574 hepta, octa and nonaBDE congeners was environmentally relevant. 575

576 The atmosphere and marine currents can tr ansport PBDEs over relatively long distances 577 (> 1,000 km). Evidence for this comes from the pr esence of PBDEs in the tissues of deep ocean578 dwelling whales and other marine mamma ls far from anthropogenic sources (Ref. 23), as well as 579 from modeling (Ref. 30). The body burdens of PB DE congeners in a wide variety of biota, 580 indigenous to geographical areas ranging from the equator to th e poles also substantiate the 581 PBDE propensity for long-range transport (LRT), and constitute evid ence of environmental 582 persistence ( Ref. 24 ). 583

584

F. Human Exposure

. 585

586 The use of c-PBDEs as flame retardants in consumer products is believed to be a source 587 of exposure. Dermal exposure may occur th rough direct contact with c-PBDE-containing 588 products such as computer housings and textiles (Ref. 31). The lower brominated tetra- and 589 penta- congeners have also been detected in the vapor phase of air samples while the higher 590 brominated congeners are found in associated pa rticulate matter, including house dust (Refs. 32 591 and 33). Lorber (Ref.33) and EPA (Ref. 31) reported that a signifi cant source of human 592 exposures to PBDEs appears to be their use in commercial products that are part of the indoor 593 environment (computer circuitry, foam cushions, fabrics in curtains, et c). They found that 594 food/water ingestion and inhala tion explained less than 20% of the body burden, based upon the 595 estimate of total exposure derived using a pharmac okinetic model. They stat ed that the remainder 596 of the estimated exposure likely came from house dust through the pathways of ingestion and 597 dermal contact, or some other, unknown source. Ot her literature indicates that inhalation may be 598*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 15 of 83 a significant potential route of exposure for the general populati on (Ref. 31). In addition, PBDE 599 exposure can occur by ingestion of foods that are contaminated (Ref. 35). PBDEs have been 600 detected in human tissue, blood (usua lly serum), and breast milk (Ref. 36)

. Exposures to PBDEs 601 in some occupational settings, such as in com puter recycling, can be hi gher than those of the 602 general population (Ref. 37). PBDE use as fl ame retardants in many household products, and 603 subsequent exposure to indoor house dust containing PBDEs, coupled with the elevated 604 ingestion potential due to increased intakes of food, water, and air pe r pound of body weight, as 605 well as childhood-specific exposure pathways such as breast milk consumption and increased 606 contact with the floor, make chil dren especially vulnerable. 607

608 Recent human biomonitoring data on PBDEs are available in CDC’s “Fourth National 609 Report on Human Exposure to Environmental Chem ical” (http://www.cdc.gov/ exposurereport/). 610 The PBDE data have also been published in th e peer-reviewed literature (Ref. 38). The data 611 were obtained from samples from participants in the 2003-2004 National Health and Nutrition 612 Examination Survey (Ref. 39). Ten PBDE congene rs (containing from three to seven bromines) 613 were included in the analysis: BDE- 17, BDE-28, BDE-47, BDE-66, BDE-85, BDE-99, BDE614 100, BDE-153, BDE-154 and BDE-183; decaBDE was not included. Participants were aged 12 615 years and older. BDE-47 was detected in serum from almost all of the participants and it was 616 highest in 12-19 years old, and t hose over 59 years old. Furthermore, serum levels were highest 617 in 12-19 year olds for other lower brominated congeners. In addition, these congeners were 618 significantly correlated with each other--concentr ation of individual congeners and total PBDE 619 content in blood serum steadily in creased annually over a five year period, suggesting a similar 620 pathway of exposure via diet, or via direct inhalation or dermal contact (Ref. 38). 621

622

G. Environmental Exposure

. 623

624 The food chain is likely a larg e contributor to environmenta l exposures. In general, 625 PBDE concentrations are highest in sedi ment samples collected downstream from 626 industrial/urban areas, outfalls from sewage treatment plants, a nd urban locations without heavy 627

industries. The lowest PBDE concentrations are generally found in sediments collected in 628 remote and agricultural areas. DecaBDE (BDE-209) appears to dominate congener profiles of 629 aquatic sediments. Researchers have determin ed concentrations of PBDEs in waterways, 630 sediments, and biota from various locations such as the Great Lakes, the San Francisco Bay, and 631 near unnamed polyurethane foam manufacturing facility for which PBDE contamination was 632 known or suspected. (Ref. 31) 633

634

Some studies show evidence that concentra tions of PBDEs in biota have doubled every 3 635 to 6 years, the doubling time depending on species, lif e stage, and location. PBDE levels in trout 636

from the Great Lakes rose from non-detectab le in 1975, to approxima tely 50 nanograms/gram 637 (ng/g) in 1990, and to approxi mately 200 ng/gm in 2000 (Ref. 40)

. PBDE concentrations in 638 marine biota in North America are the highest in the world, and are increasing (Ref. 23). After 639 reviewing the available informa tion, EPA has concluded that the extent of accumulation of 640 congeners in biota is directly re lated to dietary levels of PBDEs. Observed differences in PBDE 641 congener profiles in marine mammals from Californi a, Alaska, and the Gulf of Mexico indicate 642 that diet is a significan t source of PBDE exposure in marine wildlife (Ref.23)

. 643

644 DecaBDE has been found at high levels in pr edators such as peregrine falcons (Ref. 41)

. 645*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 16 of 83 Biomonitoring studies of wild mink from the Great Lakes region revealed th at margins of safety 646 for mink are small, and that PBDE concentratio ns in mink from Hamilton Harbor exceeded the 647

no observed adverse effect concentrations (Ref. 15 ). 648

649 Biomagnification is the process in which the concentration of a chemical in an organism 650 achieves a level that exceeds that in the organism ’s diet, due to dietary absorption (Ref. 42). 651 Biomagnification occurs as predators up the f ood chain ingest the accumulated PBDEs in the 652 bodies of their prey (Refs. 23, 43- 45). Environment Canada conclude d that the greatest potential 653

risks from PBDEs in the Canadian environment are the secondary poisoni ng of wildlife from the 654 consumption of prey containing elevated con centrations of PBDEs, and effects on benthic 655 organisms that may result from elevated con centrations of certain PBDEs in sediments ( Ref. 24 ). 656 Biomagnification of PBDEs has been observed in fi sh; PBDE levels in sediment were directly 657

related to increases and decreases in the PBDE levels measured in fish ( Ref. 46 ). Environment 658

Canada concluded that decaBDE is available fo r uptake in organisms, and may accumulate to 659 high and potentially problematic leve ls in certain species such as birds of prey or mammalian 660 predators (Ref. 22). 661

662 Although not conclusive, some data suggests that PBDEs may debrom inate in the bodies 663 of wild birds. Park, et al., (Ref. 40) found th at younger peregrine falcons had higher levels of 664 BDE-209 and other highly brominated congeners, wh ereas older birds had higher levels of the 665 less brominated (hexa) BDE-153, which could not be explained by the BDE-153 levels in diet. 666 Further, in eggs that were collected yearly fr om the same bird, PBDE congener concentrations 667 changed yearly, with levels of BDE-209 decreasing, and levels of BDE 153 increasing in the two 668 last years relative to the former four years (but no such obvious changes in polychlorinated 669 biphenyl (PCB) levels). The chemical measurem ents and comparison in this study are valuable 670 because a similar laboratory study would take ma ny years in similar long-lived avian species 671 (peregrines live 7-15 years or longer), and enviro nmental variables that affect PBDE uptake and 672 biomagnifications, including exposur e to other chemicals, might be difficult to simulate. Similar 673

evidence of debromination of decaBDE has been observed in carp (Refs. 28 and 47) and British 674 starlings (Ref. 47). 675

676 IV. Proposed Findings 677

A. SNUR. 678

Section 5(a)(2) of TSCA states that EPA' s determination that a use of a chemical 679 substance is a significant new us e must be made after consider ation of all relevant factors 680 including: 681

682 • The projected volume of manufacturing and processing of a ch emical substance. 683

684 • The extent to which a use changes the t ype or form of exposure of human beings 685

or the environment to a chemical substance. 686

687

• The extent to which a use increases th e magnitude and duration of exposure of 688 human beings or the environment to a chemical substance. 689

690*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 17 of 83 • The reasonably anticipated manner a nd methods of manufacturing, processing, 691 distribution, in commerce, and disposal of a chemical substance. 692

693

To determine what would constitute a si gnificant new use of PBDEs, EPA also 694 considered other relevant factors including inform ation about the toxicity of PBDEs as well as 695 exposures and environmental presence resulting from past use. 696

697 As discussed in Unit III, there is eviden ce that PBDEs may be toxic to humans and 698 wildlife. However, there is insufficient data to fully evaluate the significance of observed 699 exposures. EPA is also concerne d that the PBDEs included in thes e proposed amendments to the 700 SNUR are highly persistent in the environment. Some lower brominated PBDEs are highly 701 bioaccumulative, and others may debrominate to the lower brominated forms. In general, levels 702 of PBDEs in humans and the environment are highe r in North America than in other regions of 703 the world, which may be attributed to the grea ter use of PBDE in No rth America. Some 704 monitoring data show a steady incr ease from non-detectable levels when PBDEs first came into 705

use to current levels. The exact mechanisms or pathways by which the PBDEs move into and 706 through the environment and allow humans and wildlife to become exposed are not fully 707 understood, but are likely to include releases from manufacturing of the chemicals, processing 708 PBDEs into products like plastic s or textiles, aging and wear of products like sofas and 709 electronics, and releases at the end of product life (dis posal or recycling). 710

711 Once the manufacture and processing of PB DEs have been discontinued, EPA expects 712 their presence in humans and the environment to d ecline over time as has been observed in the 713 past when production and use of othe r persistent chemicals has ceased. 714

715

EPA is concerned that if manufacture and processing of PBDEs were to resume, the 716 anticipated decline in levels in humans and th e environment will be disrupted as PBDEs are 717 introduced into the environment at levels greate r than would otherwise oc cur. The result would 718 be that the magnitude and durat ion of exposure of humans and the environment in the future 719 would likely increase. 720

721

B. Test Rule. 722

Based on the data cited in Unit III.C. through III.G. of this preamble, EPA has made the 723 following preliminary determinations. First, c-pentaBDE, c-octaBDE, and c-decaBDE may 724 present a hazard to human health. C-pentaBDE, c-octaBDE and c-decaBDE were all reviewed 725 under EPA’s VCCEP program. Members of the p eer consultation panel for c-pentaBDE and c726

octaBDE noted that there are indi cations of thyroid toxicity in some rodent studies, and thyroid 727 toxicity can have adverse eff ects on reproductive success and fetal development (Ref. 48). For 728 c-decaBDE, VCCEP identified anaerobic debrom ination in aquatic sediments, anaerobic 729 debromination in sludge digesters, and photolysis in the indoor environment as a potential source 730 of human and environmental exposure to lower br ominated congeners (Ref. 49). Debromination 731 of decaBDE to form lower brominated, more toxi c congeners is potentially relevant to effects on 732

both human health and the environment. EPA’s IRIS database indicates that neurobehavioral 733 effects are critical endpoints of concern for components of c-pentaBDE and c-decaBDE. EPA 734 has also concluded that there is suggestiv e evidence of carcinogeni c potential for decaBDE 735 (BDE-209), which is the main component of c-decaBDE. 736*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 18 of 83 Second, c-pentaBDE and c-decaBDE may pres ent a hazard to the environment. 737 Laboratory studies have shown th at c-pentaBDE is capable of producing adverse effects in a 738 variety of organisms including birds, mammals, fi sh, and invertebrates. In some cases these 739 effects were observed at exposure levels similar to levels found in the environment. C-decaBDE 740 may contribute to these levels by debrominating to lower, more toxic brominated congeners in 741

the environment. 742

Third, pentaBDE, octaBDE, and decaBDE congeners, which are among the predominant 743 components of c-pentaBDE, c-octaBDE, and c- decaBDE respectively, are ubiquitous in soil, 744 sediments and living organisms (Ref. 50). Pent aBDE, octaBDE, and decaBDE congeners have 745 been found in human tissue, blood and breast milk (Ref. 51). These chemicals persist in the 746 environment and accumulate in organisms that inge st or inhale them. For example, high levels 747 of decaBDE have been found in high trophic leve l animals, e.g., predatory animals such as the 748 peregrine falcon. However, the predominant conge ners present in living organisms tend to be 749 the lower brominated, more toxic forms, which in clude pentaBDE (Refs. 52 and 53). Infants and 750 children, as well as people who ar e occupationally exposed, may be exposed at higher levels than 751 the general public. 752

Based on the evidence of human and envir onmental exposure to pentaBDE, octaBDE, 753 and decaBDE congeners, which derive from c- pentaBDE, c-octaBDE, and c-decaBDE, coupled 754

with the evidence of human and/or environmen tal hazard of c-pentaBDE, c-octaBDE, and c755 decaBDE, EPA preliminarily finds under TSCA section 4(a)(1)(A)(i) that the manufacture, 756 processing, distribution in comm erce, use, and disposal of c-pentaBDE, c-octaBDE, and c757 decaBDE, or any combination of such activities, may present an unreasonable risk of injury to 758

human health and the environment. 759

760 Through the testing of c-pentaBDE and c- octaBDE in VCCEP, EPA identified two761 generation reproductive toxicity studies with a satel lite group for body burden determinations as 762 a data need for c-pentaBDE and c-octaBDE (Ref. 48)

. For c-decaBDE, VCCEP identified 763 anaerobic debromination in aquatic sediments, anaerobic debromination in sludge digesters, and 764 photolysis in the indoor environment as data needs (Ref. 49). Therefore, EPA also preliminarily 765 finds under TSCA section 4(a)(1)(A)(i i) that there are insufficient data upon which the effects of 766 such manufacture, processing, di stribution in commerce, use, a nd disposal of c-pentaBDE, c767 octaBDE, and c-decaBDE, or any combination of such activities, on health or the environment 768 can reasonably be determined or predicted. Under TSCA section 4(a)(1)(A)(iii), EPA 769 preliminarily finds that testing of c-pentaBDE, c-octaBDE, and c-decaBDE with respect to these 770

and other toxic effects is nece ssary to develop such data. 771

772

EPA has determined in accordance with secti on 4(a)(2) of TSCA that the effects of the 773 mixtures, c-pentaBDE, c-octaBDE, and c-decaB DE, may be reasonably and more efficiently 774 determined by testing the commercial products th emselves rather than the individual chemical 775 substances which comprise these mixtures. EPA be lieves that testing of the individual chemical 776 substances that are present in the commercial mi xtures at different per centages would be a less 777 efficient mechanism to determine the effects of the commercial mixtures than testing of 778 representative forms of commercial products as they are manufactured. 779

780*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 19 of 83 V. Proposed A mendments to the SNUR 781

A. Summary of proposed amendments to the SNUR. 782

This proposed rule would amend the signi ficant new use rule at 40 CFR part 721.10000. 783 Under the existing SNUR, any person who inte nds to manufacture certain PBDEs must notify 784 EPA at least 90 days before commencing the manuf acture of any one or more of those chemical 785 substances after January 1, 2005 for any use. Th e following chemicals substances are subject to 786 reporting under the existing SNUR : tetraBDE, pentaBDE, hexaBD E, heptaBDE, octaBDE, and 787 nonaBDE, or any combination of these substa nces resulting from a chemical reaction. 788

789 Among other activities, the use of a PBDE in the manufacture of an article is considered 790 processing of the PBDE. In the existing SNUR, the Agency did not designate processing of the 791 subject PBDEs as a significant new use because it believed that such activities were ongoing. 792 The Agency now believes that processing of thes e chemical substances has been discontinued 793 and therefore is proposing to am end the SNUR to include proce ssing as a significant new use. 794 EPA believes that resumption of the practice of processing PBDEs would increase exposure to 795

PBDEs and releases of PBDEs to the environment. 796

797 On December 19, 2009 the principle U.S. manufacturers and importers of decaBDE 798 committed to end production, and importation of d ecaBDE in the United States for all uses 799 except military uses and transportation uses by December 31, 2012, and for all uses including 800 military and transportation uses by the end of 2013. The Agency also expects all other 801

manufacturers to discontinue manufacture and use of decaBDE by the end of 2013. Therefore, 802 the Agency is proposing to amend the SNUR by a dding decaBDE to the list of chemicals subject 803 to reporting and by designating manufacture a nd processing of decaBDE for any use except 804 military and transportation use af ter December 31, 2012 a significant new use. The Agency is 805 proposing to designate manufacture and processing of decaBDE for any use, including military 806 and transportation uses, after December 31, 2013, a significant new use. Military use means use 807 by the armed forces of the United States, or prepar ation of an article for use by the armed forces 808 of the United States. Transportation use means prep aration of an article fo r use as an integral 809 component of a moving vehicle such as a car, truck, train, ship, or aircraft. 810

811 EPA’s immediate objective in proposing thes e amendments to the PBDE SNUR is to 812 enable the Agency to review and, if necessar y, limit or prohibit resumption of any activities 813

which could result in increasi ng the amount of PBDEs in commerce in the United States. 814

815 Under the general SNUR exemption provi sions at 40 CFR 721.45, a person that imports 816 or processes a substance covered by a SNUR identif ied in subpart E of pa rt 721 is not generally 817 subject to the notifica tion requirements of § 721.25 for that s ubstance, if the person imports or 818 processes the substance as part of an article. However, EP A is concerned that if PBDEs 819 contained in articles are exempt, they could be imported without a not ification and thereby 820

increase the amount of PBDEs in commerce in the United States without a review by EPA. 821 Therefore, the Agency is proposing that the arti cle exemption at § 721.45(f) not apply to this 822

action. 823

824

825*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 20 of 83 B. Alternatives to the Significant New Use Rule. 826

Before proposing these amendments to the PBDE SNUR, EPA considered the following 827 alternative regulatory actions: 828

829 1. Promulgate a TSCA s ection 8(a) reporting rule

. Under a TSCA section 8(a) rule, 830 EPA could, among other things, generally require persons to report information to the Agency 831 when they intend to manufacture or process a lis ted chemical for a specific use or any use. 832 However, for polybrominated diphenyl ethers the use of TSCA section 8(a) rather than SNUR 833 authority would have several limitations. First, if EPA was to require reporting under TSCA 834 section 8(a) instead of TSCA s ection 5(a), EPA would not have the opportunity to review human 835 and environmental hazards and exposures associat ed with the proposed significant new uses and, 836 if necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to 837 prohibit or limit the activity before it begins. In view of the le vel of health and environmental 838 concerns about the chemicals subj ect to this proposed rule, if they were used for the proposed 839 significant new uses, EPA believes that a TSCA s ection 8(a) rule for th is substance would not 840 meet EPA's regulatory objectives. 841

842 2. Regulate under TSCA section 6. EPA may regulate under TSCA section 6 if "the 843

Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, 844 distribution in commerce, use or di sposal of a chemical substance or mixture “ . . presents or will 845 present an unreasonable risk of injury to health or the environment." (TSCA section 6(a)). 846

Given that the chemicals named in this proposed rule are no longer being manufactured or 847 processed for the proposed significant new uses , or the activities are scheduled to be 848 discontinued, EPA concluded th at risk management action un der TSCA section 6 is not 849 necessary at this time. These proposed amendm ents to the SNUR would allow the Agency to 850 address the potential risks associated with the proposed significant new use. If the manufacture 851 and processing of pentaBDE or octaBDE, in cluding in articles, resumes after December 12, 852 2012, or if the manufacture and processing of de caBDE, including in articles, does not cease as 853 anticipated, EPA is proposing to require that pers ons engaging in those ac tivities conduct testing 854 in accordance with the proposed test rule whic h accompanies these proposed amendments to the 855 SNUR. The Agency may pursue additiona l regulatory action as appropriate. 856

857 C. Applicability of the Significant New Use Rule to Uses Occurring before the Effective Date of 858

the Final Rule 859

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided 860 that the intent of section 5(a)(1)(B) of TSCA is best served by designa ting a use as a significant 861 new use as of the date of publication of the proposed rule rather than as of the effective date of 862 the final rule. If uses begun af ter publication of the proposed rule were considered ongoing rather 863 than new, it would be difficult for EPA to esta blish SNUR notice requirements, because a person 864 could defeat the SNUR by initiating the proposed significant new use before the rule became 865 final, and then argue that the use was ongoing as of the effective date of the final rule. EPA has 866 decided that a similar interpretati on is appropriate for a SNUR that is premised in part on all uses 867 ceasing between proposal and promulgation of a fi nal rule. Thus, persons who begin commercial 868 manufacture or processing of the chemical subs tance(s), or articles c ontaining those chemical 869 substances that would be regulat ed through this proposed rule, if finalized, would have to cease 870*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 21 of 83 any such activity before the effective date of the rule if and when finalized. This applies to all 871 entities that do not currently engage in these activities; it does not apply to entities that are 872 currently engaged in these activities -- i.e., the entities EPA expects to terminate such activities 873 by the proposed significant new use dates of the SNUR. To resume their activities, these 874 persons would have to comply with all applicab le SNUR notice requirements and wait until the 875 notice review period, including all extensions, expires. EPA ha s promulgated provisions to 876 allow persons to comply with this SNUR before th e effective date. If a person were to meet the 877 conditions of advance compliance under section 721.45(h), that person would be considered to 878 have met the requirements of the final SNUR for those activities. 879

880 D. Test Data and Other Information 881

EPA recognizes that TSCA section 5 generally does not require the development of any 882 particular test data before submission of a SNUN , however EPA is also pr oposing a test rule for 883 pentaBDE, octaBDE, and decaBDE under TSCA section 4(a). If a chemical is subject to a test 884 rule, persons submitting a significant new use notice are required to comply with data 885 submission requirements under TSCA 5(b)(1). In th e absence of a test rule or a section 5(b)(4) 886 rule (see section 5(b)(2)) covering the chemical s ubstance, persons are required to submit test 887 data in their possession or control and to desc ribe any other data know n to or reasonably 888 ascertainable by them (see section 720.50). As a general matter, EPA recommends that SNUN 889 submitters include data that would permit a reasoned evaluation of risks posed by the chemical 890 substance during its manufacture, processing, or us e. EPA encourages persons to consult with 891 the Agency before submitting a SNUN. As part of this optional pre- notice consultation, EPA 892 would discuss specific data it believes may be useful in evaluating a significant new use. 893 SNUNs submitted for significant new uses without any test data may increase the likelihood that 894 EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this 895

chemical. 896

897

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that 898 provide detailed information on: 899

900 1. Human exposure and environmental releas es that may result from the significant new 901

uses of the chemical substance. 902

2. Potential benefits of the chemical substance. 903 3. Information on risks posed by the chemical substances resulting from the significant new 904 use compared to risks posed by pot ential substitutes. 905

906

E. SNUN Submissions. 907

EPA recommends that submitters consult with the Agency prior to submitting a SNUN to 908 discuss what data may be useful in evaluati ng a significant new use. Discussions with the 909 Agency prior to submission can afford ample time to conduct any tests that might be helpful in 910 evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a 911 SNUN must comply with the same notice re quirements and EPA regulatory procedures as 912 persons submitting a PMN, including submission of test data on health and environmental effects 913

as described in 40 CFR 720.50. 914

915*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 22 of 83 SNUNs must be mailed to the Environm ental Protection Agency, OPPT Document 916 Control Office (7407M), 1200 Pennsylvania Av enue, NW., Washington, D.C. 20460-0001. 917

Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This 918

form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania 919 Avenue, NW., Washington, D.C. 20460-0001 (see 40 CFR 721.25 and 720.40). Forms and 920 information are also available electronically at 921 http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm

. 922

VI. Proposed Test Rule 923

A. What Testing is Being Proposed in this Action? 924

EPA is proposing specific testing an d reporting requirements for c-pentaBDE, c925 octaBDE, and c-decaBDE. These requirements ar e presented in Table 3 of this unit. 926

Table 3: Proposed Testing and Reporting Requirement s for PentaBDE, OctaBDE, and DecaBDE 927

Proposed Test Proposed Test

Guideline Test Proposed for: Deadline for submitting final report (Number of

months

after the

relevant

effective

date in 799.xxxx(k))cpenta

BDE cocta

BDE cdeca

BDE

Toxicity to freshwater

invertebrates of sedimentassociated contaminants ASTM E 1706-05e1

and ASTM E 1391-

03 1 X X X 12

Laboratory soil toxicity and

bioaccumulation tests with

the lumbricid earthworm Eisenia fetida and the enchytraeid potworm

E nchytraeus albidu ASTM E 1676-04

and ASTM E 1391-

03 2 X X X 12

Toxicity to polychaetous

annilids of sedimentassociated contaminants ASTM E 1611-00

and ASTM E 1391-

03 1 X X X 12

Laboratory soil toxicity to

nematode Caenorhabditis elegans ASTM E 2172-01

and ASTM E 1391-

03 2 X X X 12*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 23 of 83 Toxicity to estuarine and

marine invertebrates of

sediment-associated

contaminants ASTM E 1367-03,

ASTM E 1676-04 3

and ASTM E 1391-

03 1 X X X 12

Prenatal developmental toxicity in rabbits 40 CFR 799.9370 X X X 12

Two-generation reproductive toxicity with satellite group for body

burden determinations 40 CFR 799.9380 X X X 29

Immunotoxicity 40 CFR 799.9780 X X X 12

Neurotoxicity screening battery, acute and

subchronic 40 CFR 799.9620 X X X 21

Developmental neurotoxicity 40 CFR 799.9630 X X X 4 21

Chronic toxicity/Carcinogenicity 40 CFR 799.9430 X X 60

Anaerobic aquatic

metabolism 799.XXXX(i)(2) (modified 835.4400) X 60

Biodegradation in Anaerobic Digester Sludge 799.XXXX(i)(3) (modified 835.3280) X 24

Photolytic degradation in

the indoor environment 799.XXXX(i)(4) X 24

1. ASTM E 1391-03 provides guidance on the collection, storage, characterization, and manipulation of sediments 928 when toxicity to various organisms of sediment-associated contaminants is tested. 929

2. ASTM E 1391-03 provides general guidance. 930

3. ASTM E 1676-04 provides guidance for collecting laboratory soil. 931

4. A developmental neurotoxicity study of decaBDE (R ef. 54) conducted according to OECD Guideline 426 and 932 sponsored by the Bromine Science and Environmental Forum (BSEF) was submitted to EPA. If EPA considers the 933 study to be adequately conducted and the study requirements of OECD 426 comparable to the study requirements 934
of 40 CFR 799.9630, EPA will most lik ely accept the study and not finalize th e proposed requir ement to conduct 935 developmental neurotoxicity testing of c-decaBDE. 936

The proposed testing requirements are listed in § 799.XXXX(h) and (i) of the proposed 937 regulatory text and include the specification of test methods covering health effects testing, 938 ecotoxicity testing, and chemical fate testing. EPA's TSCA 799 test guidelines (40 CFR part 939*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 24 of 83 799, subpart H) and Office of Chemical Safety and Pollution Prevention (OCSPP) 835 series 940 guidelines have been harmonized with the OECD test guidelines. However, EPA is specifying 941 that the TSCA 799 test guidelines and OCSPP 835 guidelines, as well as American Society for 942 Testing and Materials International (ASTM Internati onal) standards, be used rather than OECD 943 test guidelines because the language in the TSCA 799 test guidelines, the OCSPP 835 series 944 guidelines, and the ASTM Intern ational standards makes clear which steps are mandatory and 945 which steps are only recommended. Accordingly, in order to comp ly with the testing required 946 by a final rule, EPA is proposing that testing must be conducted in accordance with the specified 947 TSCA 799, OCSPP series 835, and ASTM Internationa l test guidelines. In addition, EPA is 948 proposing a guideline developed by the Agency to test for photolytic degradation. 949

Most of the proposed testing re quirements for a particular endpoi nt are specified in one test 950

standard. In the case of certain endpoints, however, additional guidance is provided in a second 951 guideline and possibly a third guideline (e.g., ASTM E 1391-03 provides guidance in the 952 collection, storage, characteriza tion, and manipulation of sediment s when toxicity to various 953 organisms of sediment-associated contaminants is tested). The following testing endpoints and 954 test standards are proposed to be required for one or more of the test substances in this rule. 955

1. Ecotoxicity: 956

a. Toxicity to freshwater inve rtebrates of sediment-associated contaminants conducted 957 in accordance with ASTM E 1706-05e1 (Ref. 55) and following the guidance of ASTM E 1391- 958 03 (Ref. 56)

. EPA proposes this guideline as appropriate to evaluate the toxi city to freshwater 959

invertebrates of the test substance when associated with whole sediments. 960

b. Laboratory soil toxicity and bioaccumulati on tests with the lumbricid earthworm 961 Eisenia fetida and the enchytraeid potworm E nchytraeus albidu conducted in accordance with 962 ASTM E 1676-04 (Ref. 57) and following the ge neral guidance of ASTM E 1391-03 (Ref. 56). 963 EPA proposes this guideline as appropriate to evaluate the adverse e ffects and bioaccumulation 964 in earthworms and potworms of the test substance when associated with soils. 965

c. Toxicity to polychaetous anni lids of sediment-associated contaminants conducted in 966 accordance with ASTM E 1611-00 (Ref. 58) and following the guidance of ASTM E 1391-03 967 (Ref. 56). EPA proposes this guideline as appropri ate to evaluate the t oxicity to polychaetous 968

annelids of the test substance when associated with sediment. 969

d. Laboratory soil toxicity to nematode Caenorhabditis elegans conducted in 970 accordance with ASTM E 2172-01 (Ref. 59) and following the general guidance of ASTM E 971 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the adverse effects on 972

nematodes of the test substance when associated with soils. 973

e. Toxicity to estuarine and marine inverteb rates of sediment-associated contaminants 974 conducted in accordance with ASTM E 1367-03 (Ref. 60) and following the guidance of ASTM 975 E 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evalua te the toxicity to 976 estuarine or marine organisms of the test subs tance when associated with whole sediments. 977

2. Mammalian toxicity: 978*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 25 of 83 a. Prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 979 799.9370. EPA proposes this guideline as appropriat e to provide general information concerning 980 the effects of exposure to the test substance on the pregnant test anim al and on the developing 981 organism. 982

b. Two-generation reproductive toxicity with a satellite group for body burden 983

determinations conducted in accordance with 40 CFR 799.9380. EPA proposes this guideline as 984 appropriate to provide general information co ncerning the effects of exposure to the test 985 substance on the integrity and pe rformance of the male and fema le reproductive systems, and on 986 the growth and development of the offspring. 987

c. Immunotoxicity conducted in accordance with 40 CFR 799.9780. EPA proposes this 988 guideline as appropriate to provide informati on on suppression of the immune system which 989 might occur as a result of repeated exposure to a test chemical. 990

d. Neurotoxicity screening batte ry, acute and subchronic, conducted in accordance with 991 40 CFR 799.9620. EPA proposes this guideline as appropriate to provide information on gross 992 functional deficits, level of ac tivity, and histopathologi cal changes in the cen tral and peripheral 993 nervous systems of the test animals as a resu lt of acute and subchronic exposure to a test 994

chemical. 995

e. Developmental neurotoxicity conducted in accordance with 40 CFR 799.9630. EPA 996 proposes this guideline as appropriate to develop data on the potential functional and 997 morphological hazards to the nervous system whic h may arise in the offspring from exposure of 998 the mother during pregnancy and lactation. 999

f. Chronic toxicity/Carcinogenicity con ducted in accordance with 40 CFR 799.9430. 1000 EPA proposes this guideline as appropriate to id entify the majority of chronic and carcinogenic 1001 effects and determine dose-response relationshi ps in a mammalian species following prolonged 1002 and repeated exposure to a test substance. 1003

3. Chemical Fate: 1004

a. Anaerobic aquatic metabolism conducted in accordance with OCSPP 835.4400 as 1005 modified for c-decaBDE in section 799.XXXX(i)(2). EPA proposes this guideline as appropriate 1006

to assess transformation of decaBDE in anaerobic aquatic sediment systems. 1007

b. Biodegradation in anaerobic digester sl udge conducted in accordance with OCSPP 1008

835.3280 as modified for c-decaBDE in section 79 9.XXXX (i)(3). EPA propos es this guideline 1009 as appropriate to assess biotransform ation in anaerobic digester sludge. 1010

c. Photolytic degradation of c-decaBDE conducted in accordance with an EPA1011 developed method in section 799.X XXX(i)(4). EPA proposes this guideline as appropriate to 1012 assess whether PBDEs can migrate out of plastic s/fabrics by volatilizatio n; and if photolytic 1013 degradation can take place on the surfaces of plastics and fabrics. 1014

B. When Would any Testing Proposed by this Rule Begin? 1015

The testing requirements contained in this proposed rule are not effective until and unless 1016*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 26 of 83 the Agency issues a final rule. If any manufactur er or processor of c-pentaBDE or c-octaBDE is 1017 subject to the test rule after December 31, 2012, th e test sponsor may plan the initiation of any 1018 required testing as appropriate to submit the requi red final report by the de adline indicated as the 1019 number of months, shown in § 799.XXX(j) of the proposed regulat ory text, after December 31, 1020 2012. If any manufacturer or processor of c-deca BDE is subject to the test rule after Dec 31, 1021 2012, the test sponsor need not begin testing until it is known whether ther e are manufacturers or 1022 processors of c-decaBDE for military and transportation uses that will be subject to the test rule 1023 after December 31, 2013. The test sponsor will then know whethe r there are additional persons 1024 subject to the rule after Decem ber 31, 2013, from the letters of intent to test or exemption 1025 applications which would have to be filed by the deadline of January 30, 2014 (30days after the 1026 relevant effective date of December 31, 2013). After December 31, 2013, a ll the test sponsor(s) 1027 for decaBDE may plan the testing as appropriate to submit the required final reports by the 1028

deadlines indicated as the num ber of months, shown in § 799.XXXX(j) of the final regulatory 1029 text, after December 31, 2013. 1030

C. How Would the Studies Proposed under this Test Rule be Conducted? 1031

Persons required to comply with the fi nal rule would have to conduct the necessary 1032 testing in accordance with the testing and repor ting requirements establis hed in the regulatory 1033 text of the final rule, with 40 CFR Part 790—Procedures Governing Testing Consent 1034 Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; 1035 paragraph (a)(2) and paragraph (b) of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85), and 1036 with 40 CFR Part 792—Good Laboratory Practice Standards. 1037

D. What Forms of Test Mixtures Would be Tested Under this Rule? 1038

The test rule proposes that th e test mixtures be the repres entative forms of pentaBDE1039 containing commercial mixtures, octaBDE-containing commercial mixtures, and decaBDE1040 containing commercial mixt ures. To fully describe the three test mixtures, the percentage of 1041 each of the seven congeners present in each of th e three test mixtures must be identified by the 1042 test sponsor(s). 1043

1044 Each of the three proposed test mixtures is described by its predominant components. C1045 pentaBDE) is a mixture predominantly comprise d of pentaBDE, tetraBDE, and hexaBDE. C1046 octaBDE is a mixture predominantly compri sed of octaBDE, hexaBDE, heptaBDE, and 1047

nonaBDE. C-decaBDE is a mixture with decaBDE being present in the highest percentage. 1048 EPA believes that the proposed testing of c-pe ntaBDE, c-octaBDE, and c-decaBDE will provide 1049 EPA with data necessary to determine the e ffects of commercial PBDE products on human 1050

health and the environment. EPA is seeki ng comment on whether testing of c-pentaBDE, c1051

octaBDE and c-decaBDE should be conducted with the pure congener or each congener in each 1052 mixture instead of the commercial products. EPA is also seeking comment on whether its 1053 descriptions of the commercial mixtures to be tested accurately predict what commercial forms 1054 of pentaBDE, octaBDE, and decaBDE might be produced. Finally, EPA solicits comment on 1055

whether more than one commercial form each of c-pentaBDE, c-octaBDE, and c-decaBDE 1056

should be tested. 1057

1058 E. Would I Be Required to Test Under this Rule? 1059*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 27 of 83 Under TSCA section 4(a)(1)(A)(ii), EPA ha s made preliminary findings that there are 1060 insufficient data and experience to reasonably de termine or predict health and environmental 1061 effects resulting from the manufacture, proce ssing, use, and distribution in commerce of the 1062 mixtures listed in this proposed rule. As a re sult, under TSCA section 4(b)(3)(B), manufacturers 1063 and processors of mixtures listed in this propo sed rule, and those who intend to manufacture or 1064 process them, would be subject to the rule withregard to those listed mixtures which they 1065 manufacture or process. 1066

1. Would I be subject to this rule? You would be subject to this rule and may be required 1067 to test if you manufacture (which is defined by stat ute to include import) or process, or intend to 1068 manufacture or process, one or more mixtures listed in this pr oposed test rule during the time 1069 period discussed in Unit VI.E.2. Yo u would also be subject to th is rule if you manufacture or 1070 process the subject mixtures for export from the Un ited States. For this rule, importers of articles 1071 which include c-pentaBDE, c-octaBDE, or c-de caBDE would be considered manufacturers and 1072 subject to this rule. If you do not know or ca nnot reasonably ascertain that you manufacture or 1073 process a listed test rule mixture (based on all information in your possession or control, as well 1074

as all information that a reas onable person similarly situated might be expected to possess, 1075 control, or know, or could obt ain without unreasonable burden), you would not be subject to the 1076

rule for that listed mixtures. 1077

2. When would my manufacture or processing (o r my intent to do so) cause me to be 1078 subject to this rule? You would be subject to this rule if you manufacture or process, or intend to 1079 manufacture or process, a mixture listed in the rule at any time from the relevant effective date in 1080 799.xxxx(k) of the final test rule to the end of the test data reimbursement period. The term 1081 “reimbursement period” is defi ned at 40 CFR 791.3(h) and may vary in length for each mixture 1082 to be tested under a final TSCA section 4(a) test rule, depending on what testing is required and 1083 when testing is completed. See Unit VI.E.4. 1084

3. Would I be required to test if I were subject to the rule? It depends on the nature of 1085 your activities. All persons who would be subjec t to this TSCA section 4(a) test rule, which, 1086 unless otherwise noted in the regulatory text, in corporates EPA’s generic procedures applicable 1087 to TSCA section 4(a) test rule s (contained within 40 CFR part 790), would fall into one of two 1088 groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who would have to 1089 initially comply with the final rule) would either: 1090

• Submit to EPA letters of intent to conduc t testing, conduct this testing, and submit the 1091 test data to EPA, or 1092

• Apply to and obtain from EPA exemptions from testing. 1093

Persons in Tier 2 (those who would not have to initially comply with the final rule) would 1094 not need to take any action unless they are no tified by EPA that they are required to do so 1095 (because, for example, no person in Tier 1 had subm itted a letter of intent to conduct testing), as 1096 described in Unit VI.E.3.d. Note that both person s in Tier 1 who obtain exemptions and persons 1097 in Tier 2 would nonetheless be subject to pr oviding reimbursement to persons who actually 1098 conduct the testing, as described in Unit VI.E.4. 1099

a. Who would be in Tier 1 and Tier 2? All persons who would be subject to the final rule 1100*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 28 of 83 are considered to be in Tier 1 un less they fall within Tier 2. Tabl e 4 of this unit describes who is 1101

in Tier 1 and Tier 2. 1102

Table 4.--Persons Subject to the Ru le: Persons in Tier 1 and Tier 2 Tier 1 (Persons initially required to comply) Tier 2 (Persons not initi ally required to comply)

Persons who manufacture (as defined at TSCA section 3(7)), or intend to manufacture, a test rule

mixture and who are not listed under Tier 2. Importers of articles containing PBDEs are

manufacturers. A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a test rule mixture solely as one or more of the following: --As a byproduct (as defined at 40 CFR791.3(c)); --As an impurity (as defined at 40 CFR 790.3); --As a naturally occurring chemical substance (as defined at 40 CFR 710.4(b); --As a non-isolated intermediate (as defined at 40 CFR 704.3); --As a component of a Class 2 substance (as

described at 40 CF R 720.45(a)(1)(i)); --In amounts of less than 500 kg (1,100 lbs.) annually (as described at 40 CFR 790.42(a)(4)); or --In small quantities solely for research and development (R and D) (as described at 40 CFR 790.42(a)(5)).

B. Persons who process (as defined at TSCA section 3(10)) or intend to process a test rule mixture including in articles (see 40 CFR 790.42(a)(2)).

1103

Under 40 CFR 790.2, EPA may establish procedures applying to specif ic test rules that 1104 differ from the generic procedures governing TSCA section 4(a) test ru les in 40 CFR part 790. 1105 For purposes of this proposed rule, EPA is propos ing to establish certain requirements that differ 1106 from those under 40 CFR part 790. 1107

In this proposed test rule, EPA has conf igured the tiers in 40 CFR 790.42 as in certain 1108 previous test rules. In add ition to processors, manufacturers of less than 500 kg (1,100 lbs.) per 1109 year (‘‘small-volume manufacturer s’’), and manufacturers of small quantities for research and 1110 development (‘‘R&D manufacturers’’), EPA ha s added the following persons to Tier 2: 1111 Manufacturers of byproducts, manufacturers of impur ities, manufacturers of naturally occurring 1112 chemical substances, manufacturers of non-isol ated intermediates, and manufacturers of 1113 components of Class 2 chemical substances. The Agency took administrative burden and 1114 complexity into account in determining who was to be in Tier 1 in this proposed rule. EPA 1115 believes that those persons in Tier 1 who woul d conduct testing under this proposed rule, when 1116 finalized, would generally be large chemical manufacturers who, in the experience of the 1117 Agency, have traditionally conducted testing or pa rticipated in testing consortia under previous 1118 TSCA section 4(a) test rules. 1119*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 29 of 83 The Agency also believes that manufact urers of byproducts, impurities, naturally 1120 occurring chemical substances, manufacturers of non-isolated intermediate s, and manufacturers 1121 of components of Class 2 chemical substances hist orically have not themselves participated in 1122 testing or contributed to reim bursement of those persons who have conducted testing. EPA 1123 understands that these manufacturers may include persons for whom the marginal transaction 1124 costs involved in negotiating and administering testing arrangements are deemed likely to raise 1125 the expense and burden of testing to a level that is disproportional to the additional benefits of 1126 including these persons in Tier 1. Therefore, EPA is not proposi ng to burden these persons with 1127 Tier 1 requirements (e.g., submitting requests for exemptions). Nevertheless, these persons, 1128 along with all other persons in Tier 2, would be subject to reimbursement obligations to persons 1129 who actually conduct the testing, as described in Unit VI.E.4. 1130

TSCA section 4(b)(3)(B) requi res all manufacturers and/or pro cessors of a mixture to test 1131

that mixture if EPA has made fi ndings under TSCA sections 4(a)(1 )(A)(ii) or 4(a )(1)(B)(ii) for 1132 that mixture, and issued a TSCA section 4(a) test rule requiring testing. However, practicality 1133 must be a factor in determining who is subject to a particular te st rule. Thus, persons who do not 1134 know or cannot reasonably ascertai n that they are manufacturing or processing a mixture subject 1135 to this proposed rule, e.g., manufacturers or pro cessors of a mixture as a trace contaminant who 1136

are not aware of or cannot reasonab ly ascertain these activities, woul d not be subject to the rule. 1137 See Unit VI.E.1.and §799.XXXX(b)(2) of the proposed regulatory text. 1138

EPA believes it is possible that there will be no persons in Tiers 1 and 2A that will be 1139 subject to the test rule. If EPA learns that th e only persons that would be subject to the rule 1140 would be persons that process c-pentaBDE, c-oc taBDE, or c-decaBDE as impurities contained in 1141 articles, EPA will not require testing because EPA has not determined whether this activity alone 1142 may present an unreasonable risk of injury to health or the environment. EPA is seeking 1143 comment on whether the Agency should address persons who manufacture or process PBDEs as 1144 impurities whether or not they are contained in articles, and whether such persons should be 1145 required to conduct testing. 1146

1147

b. Subdivision of Tier 2 entities . The Agency is proposing to prioritize which persons in 1148 Tier 2 would be required to perf orm testing, if needed. Specif ically, the Agency is proposing 1149

that Tier 2 entities be subdivided into: 1150

i. Tier 2A–manufacturers, i.e., those who manufacture, or intend to manufacture, a test 1151 rule chemical substance including in articles solely as one or more of the following: A 1152 byproduct, an impurity, a naturally occurring chemi cal substance, a non-isol ated intermediate, a 1153 component of a Class 2 chemical substance, in amounts less than 1,100 lbs. annually, or in small 1154 quantities solely for research and development. 1155

ii. Tier 2B–processors, i.e., those who process, or intend to process, a test rule mixture in 1156 any form including in articles. The terms ‘‘p rocess’’ and ‘‘processor’’ are defined by TSCA 1157 sections 3(10) and 3(11), respectively. 1158

If the Agency needs testing from persons in Tier 2, EPA would seek testing from persons 1159 in Tier 2A before proceeding to Ti er 2B. It is appropria te to require manufact urers in Tier 2A to 1160

submit letters of intent to test or exemption applications be fore processors are called upon 1161 because the Agency believes that testing costs are traditionally passed along by manufacturers to 1162*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 30 of 83 processors, enabling them to share in the costs of testing (Ref. 61). In addition, ‘‘[t]here are 1163 [typically] so many processors [of a given test rule chemical] that it would be difficult to include 1164

them all in the technical decisions about the te sts and in the financial decisions about how to 1165 allocate the costs’’ (Ref. 62, 48 FR 31786, July 11, 1983). 1166

c. When would it be appropriate for a person w ho would be required to comply with the 1167 rule to apply for an exemption rather than to submit a letter of inte nt to conduct testing? You 1168 may apply for an exemption if you believe that the required testing will be performed by another 1169 person (or a consortium of persons formed unde r TSCA section 4(b)(3)(A)). You can find 1170 procedures relating to exempti ons in 40 CFR 790.80 through 790.99, and § 799.XXXX(c)(2), 1171 (c)(5), (c)(7), and (c)(11) of th e proposed regulatory text. In th is proposed rule, EPA would not 1172 require the submission of equivale nce data (i.e., data demonstrati ng that your chemical substance 1173 or mixture is equivalent to the chemical subs tance or mixture actual ly being tested) as a 1174 condition for approval of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 1175 would not apply to this proposed rule. 1176

d. What would happen if I subm itted an exemption application? EPA believes that 1177 requiring the collection of duplicat ive data is unnecessarily burden some. As a result, if EPA has 1178

received a letter of intent to te st from another source or has rece ived (or expects to receive) the 1179 test data that would be required under this ru le, the Agency would conditionally approve your 1180 exemption application under 40 CFR 790.87. 1181

The Agency would terminate conditional ex emptions if a problem occurs with the 1182 initiation, conduct, or completion of the required testing, or with the submission of the required 1183 data to EPA. EPA may then require you to subm it a notice of intent to test or an exemption 1184 application. See 40 CFR 790.93 and § 799.XXXX(c)(8) of the proposed regulatory text. In 1185 addition, the Agency would terminate a conditional ex emption if no letter of intent to test has 1186 been received by persons required to comply with the rule. See, e.g., § 799.XXXX(c)(6) of the 1187 proposed regulatory text. Note that the provisions at 40 CFR 790.48( b) have been incorporated 1188 into the regulatory text of this proposed rule; thus, persons subject to this rule are not required to 1189 comply with 40 CFR 790.48 itself (see § 799.XXXX(c)(4) through (c)(7) and § 799.XXXX(d)(3) 1190 of the proposed regulatory text). Persons who obtain exemptions or receive automatic 1191 conditional exemptions would none theless be subject to provid ing reimbursement to persons 1192 who do actually conduct the testing, as described in Unit VI.E.4. 1193

e. What would my obligations be if I were in Tier 2? If you are in Tier 2, you would be 1194 subject to the rule and you would be responsible for providing reimbursement to persons in Tier 1195 1, as described in Unit VI.E.4. There is no differe nce whether you are in Tier 2A or Tier 2B as 1196 regards reimbursement. EPA is not aware of any ci rcumstances in which test rule Tier 1 entities 1197 have sought reimbursement from Tier 2 entiti es either through private agreements or by 1198 soliciting the involvement of the Agency under the reimbursement regula tions at 40 CFR part 1199

791. 1200

Concerning testing, if you ar e in Tier 2, you are considered to have an automatic 1201 conditional exemption. You would not need to subm it a letter of inte nt to test or an exemption 1202 application unless you are notified by EPA that you are required to do so. As previously noted, 1203

Tier 2A manufacturers would be notified to test before Tier 2B processors (Unit VI.E.3.ii.). 1204*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 31 of 83 If a problem occurs with th e initiation, conduct, or completion of the re quired testing, or 1205 with the submission of the required data to EP A, the Agency may require you to submit a notice 1206

of intent to test or submit an exem ption application. See 40 CFR 790.93 and § 1207 799.XXXX(c)(10) of the pr oposed regulatory text. 1208

In addition, you would need to submit a not ice of intent to test or an exemption 1209 application if: 1210

• No manufacturer in Tier 1 has notified EP A of its intent to conduct testing, and 1211

• EPA has published a Federal Register document directing persons in Tier 2 to submit 1212

to EPA letters of intent to conduct tes ting or exemption applications. See § 799.XXXX(c)(4), 1213 (c)(5), (c)(6), and (c)( 7) of the proposed regulatory text . The Agency would conditionally 1214 approve an exemption application under 40 CFR 790.87, if EPA has received a letter of intent to 1215 test or has received (or expects to receive) the test data required under this rule. 1216

f. What would happen if no one submitted a letter of intent to conduct testing? EPA 1217 anticipates that, if there were manufacturers or processors of t hose chemical substances subject 1218 to the final rule, it would receiv e letters of intent to conduct tes ting for all of the tests specified 1219 for each mixture from one of those persons. Howeve r, in the event it does not receive a letter of 1220 intent for one or more of the tests required by th e final rule for any of the mixtures in the final 1221 rule within 30 days af ter the publication of a Federal Register document notifying Tier 2 1222 processors of the obligation to submit a letter of intent to conduct testing or to apply for an 1223 exemption from testing, EPA would notify all manuf acturers and processors of the mixture of 1224 this fact by certified letter or by publishing a Federal Register document specifying the test(s) 1225

for which no letter of intent has been submitted. This letter or Federal Register document 1226 would additionally notify all manuf acturers and processors that all exemption applications 1227 concerning the test(s) have been denied, and woul d give them an opportun ity to take corrective 1228

action. If no one has notified EPA of its intent to conduct the required testing of the mixture 1229 within 30 days after rece ipt of the certified lett er or publication of the Federal Register 1230 document, all manufacturers and processors subject to the final rule with respect to that mixture 1231 who are not already in violation of the final rule would be in violation of the final rule. 1232

4. How do the reimbursement procedures work? In the past, persons subject to test rules 1233 have independently worked out among themselves their respective financial contributions to 1234 those persons who have actually co nducted the testing. However, if persons are unable to agree 1235 privately on reimbursement, they may take advant age of EPA’s reimbursement procedures at 40 1236 CFR part 791, promulgated under the authority of TS CA section 4(a). These procedures include: 1237 The opportunity for a hearing with the American Arbitration Association; publication by EPA of 1238

a document in the Federal Register concerning the request for a hearing; and the appointment of 1239 a hearing officer to propose an order for fair and equitable reim bursement. The hearing officer 1240 may base his or her proposed order on th e production volume formula set out at 40 CFR 791.48, 1241 but is not obligated to do so. The hearing o fficer’s proposed order may become the Agency’s 1242 final order, which is reviewable in Federal c ourt (40 CFR 791.60). Under this proposed rule, for 1243 the purpose of determining fair reimbursement sh ares if the hearing o fficer chooses to use a 1244 formula based on production volume, the total production volume will include amounts of a 1245 mixture produced as an impurity and amounts imported in articles. 1246*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 32 of 83 F. What Reporting Requirements ar e Proposed Under this Test Rule? 1247

If you were required to test, you would be requ ired to submit a final report for a specific 1248 test by the deadline indicated in Table 3 in Unit VI.A of this preamble as the number of months 1249

after the relevant effective da te of the final rule; this deadline is also shown in § 799.XXXX(j) of 1250 the proposed regulatory text. 1251

EPA is also proposing that a robust summary of the final report for each specific test be 1252 required to be submitted electronically in addition to and at the same time as the final report. 1253 The term “robust summary” is used to describe th e technical information necessary to adequately 1254 describe an experiment or study and includes th e objectives, methods, results, and conclusions of 1255 the full study report which can be either an e xperiment or in some cases an estimation or 1256 prediction method. Guidance for the compilati on of robust summaries is described in a 1257 document entitled “Draft Guidance on Developing Robust Summaries” (Ref. 63). 1258

G. What Would I Need to Do if I Cannot Comp lete the Testing Required by the Final Rule? 1259

A person who submits a letter of intent to te st under the final rule and who subsequently 1260 anticipates difficulties in completing the testing by the deadline set forth in the final rule may 1261 submit a modification request to the Agency, pursuant to 40 CFR 790.55. EPA will determine 1262

whether modification of the test schedule is a ppropriate, and may first seek public comment on 1263

the modification. 1264

H. Would There be Sufficient Test Facilities and Personnel to Undertake the Testing Proposed 1265

Under this Test Rule? 1266

EPA’s most recent analysis of laboratory capacity (Ref. 64 ) indicates that available test 1267 facilities and personnel would adequately accomm odate the testing proposed in this rule. 1268

I. Might EPA Seek Further Testing of the Chemicals in this Proposed Test Rule? 1269

If EPA determines that it needs additional data regarding any of th e chemical substances 1270 included in this proposed rule, the Agency woul d seek further health and/or environmental 1271 effects testing for these mixtures. Should the Agen cy decide to seek such additional testing via a 1272 test rule, EPA would initiate a separate action for this purpose. 1273

VII. Export Notification 1274

A. SNUR 1275

Any person who exports, or intends to e xport decaBDE will be subject to the export 1276 notification requirements in TSCA section 12(b)(2) and at 40 CFR part 707, subpart D when the 1277 rule is proposed. Any person who exports, or in tends to export, tetraBDE, pentaBDE, hexaBDE, 1278 heptaBDE, octaBDE, and nonaBDE became subject to those requirements with the proposal of 1279 the SNUR in 2004 (Ref. 7). Expor t notification is generally not required for articles under a 1280 SNUR, as provided by 40 CFR 707.60(b), and for th ese proposed amendments to the SNUR, the 1281 article exemption for export notification would apply. 1282

1283

B. Test Rule 1284*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 33 of 83 Any person who exports, or intends to export, one of the mixtures contained in this 1285 proposed test rule would be s ubject to the export no tification requirements in TSCA section 1286 12(b)(1) and at 40 CFR part 707, subpart D, but only after the final rule is promulgated and only 1287

if the mixture is contained in the final rule. Export notification w ould not be required for 1288 articles under the proposed test rule. 1289

VIII. Import Certification 1290

Persons who import a chemical substance iden tified in a final SNUR are subject to the 1291 TSCA section 13 import requirements, codifi ed at 19 CFR 12.118 through 12.127; see also 19 1292 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies 1293 with all applicable rules and orders under TSCA , including any SNUR re quirements. Chemical 1294

substances contained in articles are exempt from import certification. The EPA policy in support 1295 of import certificati on appears at 40 CFR part 707, subpart B. 1296

1297

IX. The Dates that the SNUR, Proposed Am ended SNUR, and Proposed Test Rule 1298 Requirements Apply to the Seven PB DEs and the Three Commercial Mixtures 1299

1300 The SNUR that became effective on August 14, 2006, requires that persons that intend to 1301 manufacture any of six PBDEs (tetraBDE, pe ntaBDE, hexaBDE, heptaBDE, octaBDE, and 1302 nonaBDE) for any use after January 1, 2005, submit a SN UN to EPA at least 90 days in advance. 1303 EPA believes that all import and processing of these six PBDEs fo r any use including as part of 1304 an article have been discontinued. These propos ed amendments to the SNUR would designate 1305 processing for any use after December 31, 2012, a si gnificant new use. The proposed amended 1306 SNUR would also make inappli cable the article exemption at 40 CFR 721.45(f). Therefore, a 1307 person who intends to import or process any of the six PBDEs as part of an article after 1308 December 31, 2012, would not be exempt from submitting a significant new use notice. EPA 1309 will promulgate the amended SNUR after it has verified that the proposed significant new uses 1310

have been discontinued. 1311

1312 Any person who manufactures or processes or intends to manufacture or process c1313 pentaBDE, c-octaBDE, or c-decaBDE after the relevant proposed effective dates would be 1314 subject to the test rule. For a discussion of applicabil ity of the significant new use rule to uses 1315 occurring before the effective date of the final rule see Unit V.C

. 1316

1317 On December 2009, the principal manufactur ers and importer of decaBDE announced 1318 their intent to phase out their activities with decaBDE and committed to do so by December 31, 1319 2012 for all uses, except military and transp ortation, and by December 31, 2013, for all uses 1320 including military and transporta tion, with possibly an additional 6 months to sell remaining 1321 inventory of decaBDE. The Agency does not be lieve that manufacturers would need additional 1322 time to sell remaining inventory or that proce ssors would require any additional time to use 1323 existing stocks, and has not pr oposed any additional time in this action. EPA is seeking 1324

comment on this in Unit XI.A.2. 1325

1326 With this Proposed SNUR-Test Rule, EPA is proposing to amend the 2006 PBDE SNUR 1327 by designating manufacture and processing of decaBDE for any use except military and 1328 transportation uses including in articles after December 31, 2012, and manufacture and 1329*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 34 of 83 processing of decaBDE for all uses including m ilitary and transportation uses, including in 1330 articles after December 31, 2013, significant new uses that would require the submission of a 1331 SNUN to EPA at least 90 days before commenci ng such activity. If any persons engage in such 1332

activities with decaBDE after the relevant significant new use da tes, EPA would promulgate the 1333 test rule and they would be subject to the test rule requirements. 1334

1335 Table 5 presents the date when the requi rements of the existing SNUR applied to 1336

activities with certain PBDEs and the dates when the requirements of the proposed amendments 1337 to the SNUR and test rule, if promulgated, woul d apply to the manufactur e and processing of the 1338 seven PBDEs depending on whether those activ ities are ongoing or have ceased. 1339

1340

1341 Table 5: The Date SNUR, Amended SNUR, or Test Rule Requirements Apply to the 1342

Seven PBDEs and the Three Commercial Mixtures 1343

1344

PBDE On or After Jan 1, 2005 After Dec 31, 2012 After Dec 31, 2013

SNUR applies

to nonongoing: Amended

SNUR wouldapply to nonongoing: Test Rule would apply to ongoing: Amended

SNUR would apply

to nonongoing: Test Rule would apply to ongoing:

tetraBDE
hexaBDE heptaBDE

nonaBDE pentaBDE

octaBDE Manufacture for any use. Processing for any use.

Manufacture

and processing including in

articles for

any use. decaBDE Manufacture

and processing for any use,
except military and transportation

uses, including in

articles. Manufacture

and processing for any use, including military and transportation

uses, including in

articles.

cpentaBDE
and coctaBDE Manufacture

and processing for any use including in*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 35 of 83 articles.

cdecaBDE Manufacture

and processing for any use,
except military and transportation

uses, including in

articles. Manufacture

and processing for any use, including military and transportation

uses, including in

articles.

1345

1346

X. Economic Considerations 1347

1348

A. SNUR 1349

1350 The proposed amendment to the SNUR would require persons intending to engage in 1351 significant new use to submit a Significant Ne w Use Notice (SNUN), incurring an estimated 1352 submission cost of $8,143 per chemical, plus other co sts (Ref. 72). In addition to the firms that 1353 make a SNUN submission, the proposed amendments to the SNUR may also impact firms that 1354 do not make a submission. By avoiding a signifi cant new use, a firm can avoid submission and 1355 testing costs but may incur other compliance costs. The firm may also incur “hidden” costs; for 1356 example, it could forego profitabl e opportunities to use th e chemical in an a pplication that would 1357 be a significant new use or limit production volume to avoid a si gnificant new use. Costs are 1358

estimated at the firm level and reflect the burden of a SNUR on the firms that make a 1359

submission. The hidden costs to the firms that do not make a submission are not quantified. 1360 EPA receives only a handful of SNUNs per year due to SNURs. However, the number of firms 1361 affected by not making submissions to EPA is not known; therefore, costs are not aggregated 1362

across the affected entities. 1363

1364

B. Test Rule 1365

EPA has prepared an economic assessment entitled Economic Impact Analysis for the 1366 Proposed Section 4 Test Rule for c-Pentabrom odiphenyl Ether, c-Octabr omodiphenyl Ether, and 1367 c-Decabromodiphenyl Ether (Ref. 73), a copy of wh ich has been placed in the docket for this 1368 rulemaking. The economic analysis evaluates the costs associated wi th the testing that would be 1369 required by a final test rule. The analysis looks at costs due to te sting all three mixtures and to 1370 each mixture separately. The total costs to industry of compliance, including testing and 1371 administrative costs, for all three mixtures are estimated under the low- and high-cost scenarios 1372 to be $9.68 million and $15.1 million, respectivel y. The testing cost (not including 1373 administrative costs) to comply with the test rule requirements for c-pentaBDE or c-octaBDE 1374 under the low- and high-cost scenarios woul d be $2.8 million and $4.7 million, respectively. 1375 The testing cost (not including admi nistrative costs) to comply with the test rule requirements for 1376 c-decaBDE under the low- and high-cost s cenarios would be $1.8 million and $2.5 million, 1377 respectively. (Ref. 73) These costs would onl y be incurred if ther e were entities that 1378*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 36 of 83 manufacture or process c-pentaB DE, c-octaBDE, or c-decaBDE, in cluding in articles, after the 1379 relevant dates specified in the proposed test rule in §799.xxxx(k) of December 31, 2012 and 1380 December 31, 2013. 1381

1382 Currently, there are no known entities that manufacture or process c-pentaBDE or c1383 octaBDE in the United States except as impurities, so an economic impact analysis could not be 1384

done for these two chemicals. 1385

1386 EPA has identified six ultimate parent companies that manufacture or import c-decaBDE 1387

in the United States. The total annualized co mpliance costs for decaBDE are estimated to be, 1388 under low- and high-cost scenarios, $264,582 and $360,218, respectively. To evaluate the 1389 potential for an adverse economic impact of testing on manufacturer s and importers of c1390 decaBDE, EPA employed an initial screening appr oach that estimated the impact of testing 1391 requirements as a percentage of c-decaBDE’s sa le price. This measure compares annual 1392

revenues from the sale of a mixture to the annuali zed compliance cost for that mixture to assess 1393 the percentage of testing costs that can be accommodated by the revenue stream generated by 1394 that mixture over a number of years. Comp liance costs include costs of testing and 1395 administering the testing, as well as reporting cost s. In addition, they include the estimated cost 1396 of the TSCA section 12(b) expor t notification requirements, wh ich, under the final rule, would 1397 be required for the first export to a particular country of a mixtur e subject to the rule, estimated 1398 to range from $26.86 per notice to $85.70 per no tice (Ref. 72). Thes e export notification 1399 requirements (included in the tota l and annualized cost estimates) that would be triggered by the 1400 final rule are expected to have a negligible impact on exporters. 1401

1402 Annualized compliance costs divide testing e xpenditures into an e quivalent, constant 1403 yearly expenditure over a longer pe riod of time. To calculate th e percent price impact, testing 1404 costs (including laboratory and administrative expenditures) are annualiz ed over 15 years using a 1405 7% discount rate. These annualized testing co sts are then divided by the estimated annual 1406

revenue of the mixture to de rive a cost-to-sales ratio. 1407

1408 For five companies manufacturing or importing c-decaBDE, the cost-to-sales ratios is 3 1409 percent or less. One company was identified as a small business by TSCA’s employment-based 1410

definition and has a cost-to-sales ratio greater than 3 percent. Mixtures for which the price 1411 impact is expected to exceed 1% of the revenue from that chemical have a higher potential for 1412 adverse economic impact. However, EPA also compared the annualized cost of testing c1413 decaBDE to company revenue because, in some cases, companies may choose to use revenue 1414 sources other than the profits fr om the individual mixture to pay for testing. EPA estimates that 1415 the costs of testing will exceed 1% of company revenue for only one of the affected companies, 1416 i.e., the company identified as a small business. 1417

1418 While processors are legally subject to this test rule if they process c-decaBDE after 1419 December 31, 2012, processors of c-decaBDE w ould be required to comply with the 1420 requirements of the rule only if they are directed to do so by EPA as described in 1421 §799.XXXX(c)(6) and (c)(8) of the proposed re gulatory text. EPA would only require 1422 processors to test if no subject person in Tier 1 or Tier 2A has submitted a notice of its intent to 1423 conduct testing, or if under 40 CFR 790.93, a proble m occurs with the initiation, conduct, or 1424 completion of the required testing or the submi ssion of the required data to EPA. Because 1425*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 37 of 83 processors would not need to comp ly with the proposed rule initiall y if there are persons in Tiers 1426 1 or 2A subject to the rule , the economic assessment does not address processors. 1427

1428 The benefits resulting from this proposed test rule are discussed qualitatively in 1429 Economic Impact Analysis for the Proposed Secti on 4 Test rule for c-Pentabromodiphenyl Ether, 1430 c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether (Ref. 73). EPA believes the major 1431 benefits of the test rule will be the developmen t of hazard information on these chemicals and the 1432 use of this information by the public, industry, and government. 1433

1434 XI. Request for Public Comment 1435

A. Solicitation of Comments on the proposed amendments to the SNUR. 1436

1437 (1) EPA welcomes comments on any aspect of the proposed amendments to the SNUR, but is 1438 especially interested in comments regarding the designation of a new use of decaBDE as (1) 1439 manufacture and processing of decaBDE for a ny use except military and transportation uses 1440 including in articles after December 31, 2012, a nd (2) manufacture and processing of decaBDE 1441 for any use including military and transportation uses, including in artic les after December 31, 1442

2013. 1443

1444 (2) EPA is projecting that processors will di scontinue their activities by December 31, 2013. 1445 Should EPA assume that processors will continue their activities beyond that date? For example, 1446 should EPA assume that processors will con tinue their activities for six months after 1447

manufacture of decaBDE ceases? Should EPA de signate processing of decaBDE after June 30, 1448 2014, or some other date, a significant new use? 1449

1450 (3) EPA welcomes comments on the designati on of a significant ne w use of tetraBDE, 1451 pentaBDE, hexaBDE, heptaBDE, octaBDE, a nd nonaBDE as manufacture and processing for 1452 any use including in articles after December 31, 2012. 1453

1454 (4) In this action, EPA is proposi ng to make inapplicab le the article exemption for SNURs at 40 1455 CFR part 721.45(f). A person who intends to pro cess a chemical substan ce identified in this 1456 section as part of an article, other than as an impurity, would not be exempt from submitting a 1457 significant new use notice. EPA welcomes co mment on this proposed course of action. 1458

1459 (5) EPA requests comment on when to finalize the proposed amendments to the SNUR. Should 1460 they be finalized before or afte r the phase-out dates of decaBDE? 1461

1462 (6) EPA requests comment on whether the propos ed significant new uses are still ongoing and 1463 will be ongoing on the relevant dates of December 31, 2012 and December 31, 2013. 1464

1465 B. Solicitation of Comments on the Proposed Test Rule. 1466

(1) EPA is soliciting comment rega rding additional information pertaining to potential exposure 1467 of the general population, consumers, and worker s to c-pentaBDE, c-octaBDE, and c-decaBDE. 1468 Also, the Agency solicits comment regarding ad ditional information pertaining to environmental 1469 releases of any of these three PBDE mixtures. 1470*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 38 of 83 (2) EPA is soliciting comments which identify existing studies that may satisfy the data needs 1471 identified in the proposed test rule . To the extent that data relevant to the testing specified in this 1472 proposed rule are known to exist, EPA strongly enc ourages the submission of this information as 1473 comments to the proposed rule. Such data submitted to EPA must be in the form of full copies of 1474 unpublished studies or full citations of publishe d studies, and accompanied by a robust summary 1475 (Ref. 63). To the extent that st udies proposed in this action are cu rrently available, and the data 1476 are judged sufficient by EPA, testing for the endpoint/mixture combination will not be required 1477

in a final test rule. 1478

(3) EPA is soliciting comment on what test s ubstances should be required for pentaBDE, 1479 octaBDE, and decaBDE. EPA is proposing that the test substances be the representative 1480 commercial forms with the percent congener co mposition identified by the test sponsor(s). 1481 Instead, should the test substances be the 99% pure pentaBDE, octaBDE, and decaBDE with an 1482 isomer composition identified for each? 1483

(4) EPA is soliciting comment on wh ether a purity level of 99% or greater can be attained for 1484 pentaBDE, octaBDE, and decaBDE. 1485

(5) EPA is soliciting comment on whether the de scriptions in section 799.XXXX(a) of the 1486 commercial mixtures to be tested adequately encompass the range of commercial forms of 1487 pentaBDE, octaBDE, and decaBDE that might be produced. 1488

1489 (6) EPA is soliciting comment on whether, for the purpose of the testing proposed in this action, 1490 a single commercial form each of pentaBDE, octa BDE, and decaBDE can be representative of 1491 the possible variations of those commercial mixtur es. If not, should more than one commercial 1492 form each of pentaBDE, octaBDE, and decaBDE be tested? How should those forms be 1493

determined? 1494

1495 (7) EPA is soliciting comment on whether testing should be requi red of tetraBDE, pentaBDE, 1496 hexaBDE, heptaBDE, octaBDE, nonaBDE, and d ecaBDE comparable to that proposed for c1497 pentaBDE, c-octaBDE, and c-decaBDE if they are present in commercial PBDE products. 1498

(8) EPA is also soliciting comment on the propo sed test methods, the proposed requirement for 1499 submission of robust summaries, the proposed deadlines to submit final reports, and the 1500 economic impact analysis detailing the burdens a nd costs that would resu lt from complying with 1501

a final test rule. 1502

(9) The Agency invites comment on the potential use of voluntary consensus standards in the 1503 proposed test rule, and, specifically, invites th e public to identify potentially applicable 1504 consensus standard(s) and to explain why such standard(s) should be used here. 1505

(10) EPA is interested in receiving comments on whether the Agency should consider 1506 establishing an alternate definition for small busin ess to use in the small entity impact analyses 1507 for future TSCA section 4(a) test rules, and what size cutoff may be appropriate. 1508

1509 (11) EPA is soliciting comment on whether, in a future rulema king, persons who manufacture or 1510 process c-PBDEs contained in articles as impurit ies should be required to conduct testing. EPA 1511 also solicits comment on whether persons w ho manufacture or process c-PBDEs as impurities 1512*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 39 of 83 not contained in articles s hould be required to test. 1513

1514

XII. References 1515

As indicated under ADDRESSES , a docket has been established for this rulemaking 1516 under docket ID number EPA–HQ–OPPT–2009–0357. The following is a listing of the 1517 documents that have been placed in the doc ket for this rulemaking. The docket includes 1518 information considered by EPA in developing this proposed rule, including the documents listed 1519 in this unit, which are physica lly located in the docket. In addition, interested parties should 1520 consult documents that are referenced in the documents that EPA has placed in the docket, 1521 regardless of whether these referenced documents are physically located in the docket. For 1522 assistance in locating documents that are referenc ed in documents that EPA has placed in the 1523 docket, but that are not physica lly located in the docket, please consult either technical person 1524

listed under FOR FURTHER INFORMATION CONTACT . The docket is available for 1525 review as specified under ADDRESSES

. 1526

1. EPA. Significant New Use Rule for Certai n Polybrominated Diphenylethers. 40 CFR 1527

721.10000. 1528

2. EPA. TSCA Section 4(a)(1)(B) Fi nal Statement of Policy. Notice. Federal Register 1529 (58 FR 28736 at 28738–28739, May 14, 1993). 1530

3. EPA, 2008a. Toxicological Review of 2,2 ',4,4' -Tetrabromodiphenyl Ether (BDE-47), 1531 EPA/635/R-07/005F, June 2008. 1532

4. EPA, 2008b. Toxicological Review of 2,2',4,4',5-Pentabrom odiphenyl Ether (BDE1533 99), EPA/635/R-07/006F, June 2008. 1534

5. EPA, 2008c. Toxicological Review of 2,2',4,4',5,5’-Hexabromodiphenyl Ether (BDE1535 153), EPA/635/R-07/007F, June 2008. 1536

6. EPA, 2008d. Toxicological Review of Decabromodiphenyl Ether (BDE-209), 1537 EPA/635/R-07/008F, June 2008. 1538

7. EPA. Certain Polybrominated Diphenyl Ethers; Proposed Signifi cant New Use Rule. 1539 69 FR70404, December 6, 2004. 1540

8. Arkoosh MR, Boylen D, Dietrich J, Anulacion BF, Ylitalo G, Bravo CF, Johnson LL, 1541 Loge FJ, Collier TK, Disease susceptibility of salmon exposed to polybrominated diphenyl 1542 ethers (PBDEs). Aquatic Toxicology 98(1): 51-59. (2010) 1543

1544 9. McKernan MA, Rattner BA, et al. Toxicity of Polybrominated Diphenyl Ethers (De1545 71) In Chicken ( Gallus gallus ), Mallard ( Anas platyrhynchos ), and American Kestrel ( Falco 1546 sparverius ) Embryos and Hatchlings. Environmental Toxicology and Chemistry 28(5):1007- 1547

1017. 2009. 1548

10. Fernie KJ, Mayne G, Shutt LJ, Pekarick C, Grasman KA, Letcher RJ, Drouillard KG. 1549

Evidence of immunomodulation in nestling American kestrels ( Falco sparverius ) exposed to 1550*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 40 of 83 environmentally relevant PBDEs. Environmental Pollution. 138:485-493. 2005a. 1551

11. Fernie KJ, Shutt LJ, Mayne G, Hoffman DJ , Letcher RJ, Drouillard KG, Richie IJ. 1552 Exposure to polybrominated diphenyl ethers (PBDEs): Changes in thyroid, vitamin A, 1553 glutathione homeostasis, and oxidative stress in American kestrels ( Falco sparverius ). 1554 Toxicological Sciences. 88:375-383. 2005b. 1555

12. Fernie K, Shutt L, et al. The effects of exposure to polybrominated diphenyl ethers on 1556 reproductive performance and immune func tion in captive American Kestrels. Journal of 1557 Ornithology. 147(5): 92-92. 2006. 1558

13. Fernie KJ, Marteinson S, Shutt JL , Bird DM, Letcher RJ, Ritchie JI. In ovo DE-71 1559 exposure of male American kestrels: Reproductive and behavioral effects. Presented at the 10th 1560 Workshop on Brominated Flame Retardants in the Environment. 2008. 1561

14. Fernie, KJ, Shutt JL, Letcher RJ, Ritchie IJ , and Bird DM. Environmentally Relevant 1562

Concentrations of DE-71 and HBCD Alter Eggshell Thickness and Reproductive Success of 1563

American Kestrels. Environmental Science & Technology. 43(6):2124-2130. 2009. 1564

15. Zhang S, Bursian SJ, Martin PA, Chan HM, Tomy G, Palace VP, Mayne GJ, Martin 1565 JW. Reproductive and developmental toxicity of a pentabrominated diphenyl ether mixture, DE1566 71, to ranch mink (Mustela vison) and hazard assessment for wild mink in the Great Lakes 1567 region. Toxicological Sciences. 110 (1):107-116. 2009. 1568

16. Timme-Laragy AR, Levin DE, Di Giulio RT . Developmental and behavioral effects 1569 of embryonic exposure to the polybrominated di phenylether mixture DE-71 in the killifish 1570 ( Fundulus heteroclitus ). Chemosphere. 62:1097-1104. 2006 1571

17. Lema SC, Schultz IR, Scholz NL, Incardona PJ, Swanson P. Neural defects and 1572 cardiac arrhythmia in fish larvae following embryonic exposure to 2,2’,4,4’-tetrabromodiphenyl 1573 ether (PBDE 47). Aquatic Toxicology. 82: 296-307. 2007. 1574

18. Kuiper RV, Vethaak AD, Cantón RF, An selmo H, Dubbeldam M. Toxicity of 1575 analytically cleaned pentabromodiphenylether af ter prolonged exposure in estuarine European 1576 flounder ( Platichthys flesus ), and partial life-cy cle exposure in fresh water zebrafish ( Danio 1577

rerio ). Chemosphere. 73:195-202. 2008. 1578

19. Nakari and Huhtala 2008. EPA, 2006. Pol ybrominated Diphenyl Ethers (PBDEs) 1579 Project Plan. March, 2006. Available at http ://www.epa.gov/oppt/pbde/pubs/proj-plan32906a.pdf 1580 (accessed Dec. 15, 2009). 1581

20. Vonderheide AP, Mueller KE, et al. Po lybrominated diphenyl ethers: Causes for 1582 concern and knowledge gaps regarding envi ronmental distribution, fate and toxicity . Science of 1583

the Total Environment. 400(1-3): 425-436. 2008. 1584

21. Environment Canada. Ecological State of the Science Report on Decabromodiphenyl 1585 Ether (decaBDE) Bioaccumulation and Transformation. 2010. Available from: 1586 http://www.ec.gc.ca/lcpe-cepa/documents /substances/decabde/e ss_report_decabde-eng.pdf 1587*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 41 of 83 22. Shaw SD, Kannan K. Polybrominated diphenyl ethers in marine ecosystems of the 1588

American continents: foresi ght from current knowledge. Reviews on Environmental Health. 1589

24 : 157-229. 2009. 1590

23. Environment Canada. Ecological Screen ing Assessment Report on Polybrominated 1591 Diphenyl Ethers (PBDEs). 2006. Available from: 1592 http://www.ec.gc.ca/CEPARegistry/documen ts/subs_list/PBDE_SAR/PBDEs_SAR_EC_June_2 1593 006_%28en%29.pdf

. 1594

24. Thuresson K, Bergman A, Jakobsson K. Occupational Exposur e to Commercial 1595 Decabromodiphenyl Ether in Workers Manufactu ring or Handling Flame-Retarded Rubber. 1596 Environmental Science & Technology. 39:1980-1986. 2005. 1597

25. Tokarz JA, Ahn MY, Leng J, Filley TR , Nies L. Reductive Debromination of 1598 Polybrominated Diphenyl Ethers in Anaerobi c Sediment and a Biomimetic System. 1599 Environmental Science & Technology. 42:1157-1164. 2008. 1600

26. La Guardia MJ, Hale RC, Harvey E. Evidence of Debromination of 1601 Decabromodiphenyl Ether (BDE-209) in Biota from a Wastewater Receiving Stream. 1602 Environmental Science & Technology. 41(19):6663-6670. 2007. 1603

27. Stapleton HM. Brominated flame retardan ts: assessing the decaBDE debromination in 1604

the environment. Health and Environmenta l Alliance (formerly the EPHA Environmental 1605 Network (EEN)). May 2006. 1606

28. Stapleton HM, Dodder NG. Photodegrada tion of decabromodiphenyl ether in house 1607 dust by natural sunlight. Environmental Toxicology and Chemistry. 27:306-312. 2008 1608

29. Wania F, Dugani CB. Assessing the long-rang e transport potential of polybrominated 1609 diphenyl ethers: a comparison of four multimedia models. Environmental Toxicology and 1610 Chemistry. 22:1252–1261. 2003. 1611

30. ATSDR. Agency for Toxic Substances a nd Disease Registry. Toxicological Profile 1612 for Polybrominated Diphenyl Ethers and Polybrominated Biphenyls. 2004. 1613 www.atsdr.cdc.gov/toxprofiles/tp68.html

. 1614

31. EPA. An exposure assessment of polybrom inated diphenyl ethe rs. National Center 1615 for Environmental Assessment, Washington, DC; EPA/600/R-08/086F. 2010. Available from the 1616

National Technical Information Servi ce, Springfield, VA, and online at 1617 http://www.epa.gov/ncea. 1618

1619 32. Allen JG, McClean MD, Stapleton HM, We bster TF. Critical factors in assessing 1620 exposure to PBDEs via house dust. Environment International. 34(8):1085-1091. November 1621

2008. 1622

33. Lorber M. Exposure of Americans to polybrominated diphenyl ethers. Journal of 1623 Exposure Science and Environmental Epidemiology. 18:2-19. 2008. 1624

34. Jones-Otazo HA, Clarke J, Diamond ML , Archbold J, Ferguson G, Harner T, 1625*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 42 of 83 Richardson SM, Jakeryan J, and Wilford BY. Is House Dust the Missing Exposure Pathway for 1626 PBDEs? An Analysis of the Urban Fate and Human Exposure to PBDEs. Environmental Science 1627 & Technology. 39: 5121-5130. 2005 1628

35. Hites RA. Polybrominated Diphenyl Ethe rs in the Environment and in People: A 1629 Meta-Analysis of Concentrations. Environmental Science & Technology. 38: 945. 2004 1630

36. Cal/EPA PBDE Workgroup. Polybrominated Diphenyl Ethers: Recommendations to 1631 Reduce Exposure in California. California E nvironmental Protection Agency, Sacramento, 1632 California. February 2006. Available at: http://oeha.ca.gov/pdf/ PBDEWrkgrpRptFeb06.pdf. 1633

37. Sjodin A, Wong LY, Jones RS, Park A, Zha ng Y, Hodge C, Dipiet ro E, McClure C, 1634 Turner W, Needham LL and Patterson DG. Seru m concentrations of polybrominated diphenyl 1635 ethers (PBDEs) and polybrominated biphenyl (P BB) in the United States population: 2003-2004. 1636 Environmental Science & Technology. 42:1377-1384. 2008. 1637

38. NHANES. Centers for Disease Control and Prevention, Atlanta (GA). December 1638

2009. Available at: http://www.cdc.gov/exposurereport/faq.html 1639

39. Environment Canada. Flame Retardan ts: A threat to the environment? Science & the 1640

Environment Bulletin. 30:5. May/June 2002. Available at: http://dsp1641 psd.pwgsc.gc.ca/Collection/En1-28-1-2002-03E.pdf 1642

40. Park JS, Holden A, et al. Time-Trends and Congener Profiles of PBDEs and PCBs in 1643 California Peregrine Falcons (Falco peregrinus). Environmental Science & Technology. 1644 43(23):8744-8751. 2009. 1645

41. Gobas FAPC and Morrison HA. Bioconcentra tion and biomagnification in the aquatic 1646

environment. In Handbook of Property Estimation Methods for Chemicals. Environmental and 1647

Health Sciences. pp. 189-231. RS Boethling and DMackay, Eds,

. Lewis/CRC, Boca Raton, FL 1648

USA. 2000. 1649

42. Chen D, Mai B, Song J, Sun Q, Luo Y, Luo X, Zeng EY, Hale RC. Polybrominated 1650 diphenyl ethers in birds of prey from Northern China. Environmental Science & Technology. 1651

41:1828-1833. 2007. 1652

43. Voorspoels S, Covaci A, Lepom P, Jaspers VLB, Neels H, Schepens P. 1653 Biomagnification of PBDEs in thre e small terrestrial food chains. Environmental Science & 1654 Technology. 41:411–-416. 2007. 1655

44. Stapleton HM, Baker JE. Compari ng polybrominated diphenyl ether and 1656 polychlorinated biphenyl bioaccumulation in a f ood web in Grand Traverse Bay, Lake Michigan. 1657 Archives of Environmental Contamination and Toxicology. 45 : 227–234. 2003. 1658

45. Gandhi et.al. Development of a Multich emical Food Web Model: Application to 1659 PBDEs in Lake Ellasjøe n, Bear Island, Norway. Environmental Science & Technology. 1660 40(15):4714–4721. 2006. 1661

46. Stapleton HM, Alaee M, Letcher RJ, Baker JE. Debromination of the flame retardant 1662*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 43 of 83 decabromodiphenyl ether by juvenile carp ( Cyprinus carpio ). Environmental Science & 1663 Technology. 38:112-119. 2004. 1664

47. Van den Steen E, Covaci A, Jaspers VLB, Dauwe T, Voorspoels S, Eens M, 1665 Pinxten R. Accumulation, tissue- specific distribution and biot ransformation of BDE 209 in 1666 European starlings ( Sturnus vulgaris ). Environmental Pollution. 148:648-653. 2007. 1667

48. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 1668 Document for Pentabromodiphenyl Ether and Oc tabromodiphenyl Ether. Prepared by Risk 1669 Assessment Division, OPPT. June 2005. 1670

49. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 1671 Document for Decabromodiphenyl Ether. Prepar ed by Risk Assessment Division, OPPT. June 1672

2005. 1673

50. Darnerud PO. Toxic effects of brominated flame retardants in man and in wildlife. 1674

Environment International. 29:841-853. 2003. 1675

51. Harley KG, et al. PBDE Concentrati ons in Women’s Seru m and Fecundability. 1676 Environmental Health Perspectives. 118(5): 699-704. May 2010. 1677

52. Costa LG, et al. Polybrominated diphenyl ether (PBDE) flame retardants: 1678 environmental contamination, human body burden and potential adverse health effects. Acta 1679

Biomed. 79:172-183. 2008. 1680

53. Herbstman JB, et al. Prenatal Ex posure to PBDEs and Neurodevelopment. 1681 Environmental Health Perspectives. 118(5):712-719. May 2010. 1682

54. Bromine Science and Environmental Fo rum. An Oral (gavage) Developmental 1683 Neurotoxicity Test of Decabromodiphenyl Oxide in Rats. Submitted to EPA on May 19, 2010. 1684

55. ASTM. Standard test method for measur ing the toxicity of sediment-associated 1685

contaminants with freshwater invertebrates. ASTM E 1706-05e1. 1686

56. ASTM. Standard guide for collection, stor age, characterization, and manipulation of 1687 sediments for toxicological tes ting and for selection of sample rs used to collect benthic 1688

invertebrates. ASTM E 1391-03. 1689

57. ASTM. Standard guide for conducting laboratory soil toxicity or bioaccumulation 1690

tests with the Lumbricid Earthworm Eisenia Fe tida and the Enchytraeid Potworm Enchytraeus 1691

albidus. ASTM E 1676-04. 1692

58. ASTM. Standard guide for conducting se diment toxicity tests with Polychaetous 1693

Annelids. ASTM E 1611-00. 1694

59. ASTM. Standard guide for conducting laboratory soil toxici ty tests with the 1695 Nematode Caenorhabditis elegans. ASTM E 2172-01. 1696

60. ASTM. Standard test method for measur ing the toxicity of sediment-associated 1697*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 44 of 83 contaminants with estuarine and marine invertebrates. ASTM E 1367-03. 1698

61. EPA. Toxic Substances; Test Rule Deve lopment and Exemption Procedures; Interim 1699

Final Rule. Federal Register (50 FR 20652, May 17, 1985). 1700

62. EPA. Toxic Substances Control Act; Data Reimbursement; Final Rule. Federal 1701 Register (48 FR 31786, July 11, 1983). 1702

63. EPA. OPPT. Draft Guidance on Developing Robust Summaries. October 22, 1999. 1703 Available on-line at http://www.epa .gov/chemrtk/pubs/general/robsumgd.htm. 1704

64. EPA. Analysis of Laboratory Ca pacity to Support U.S. EPA Chemical Testing 1705 Program Initiatives. Economic and Policy Analysis Branch. Washington, DC. August 2004. 1706

65. EPA. VCCEP Web s ite home page. (www.epa.gov/oppt/vccep). 1707

66. EPA, 2009. Polybrominated Diphe nyl Ethers (PBDEs) Action Plan. Available at: 1708 http://www.epa.gov/oppt/existingc hemicals/pubs/pbdes_ap_2009_1230_final.pdf 1709

67. Chemtura. Letter from Robert Campbell to Jim Willis, Director, CCD, OPPT, 1710 USEPA. January 6, 2006. 1711

68. Albermarle Corporation. Letter fro m David W. Clary, Albemarle Corp. to Lisa P. 1712 Jackson, USE EPA. EPA-Industry DecaB DE Phase-Out Initiative. Dec 15, 2009. 1713

69. Chemtura Corporation. Letter from Craig A. Rogerson, Chemtura Corp. to Lisa P. 1714 Jackson, US EPA. DecaBDE Phase-Out Initiative. Dec 17, 2009. 1715

70. ICL Industrial Products. Letter from Nissim Adar to Lisa P. Jackson, US EPA. 1716 Voluntary Phase-Out of DecaBDE. Dec 15, 2009. 1717

71. Arnold & Porter LLP. Letter from Lawrence Culleen to Ward Penberthy, CCD, 1718 EPA. June 25, 2010. 1719

72. EPA. Economic Analysis of the Proposed Significant New Use Rule for 1720 Polybrominated Diphenyl Ethers. Prepared by Timothy Lehman and Abt Associates Inc. 1721 September 30, 2010. 1722

73. EPA. Economic Impact Analysis for the Proposed Section 4 Test Rule for c1723 Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether. 1724 Prepared by Timothy Lehman and Abt Associates Inc. September 30, 2010. 1725

74. Kimbrough KL, Johnson WE, Lauenstein GG, Christensen JD, and Apeti DA. An 1726 Assessment of Polybrominated Diphenyl Ethers (P BDEs) in Sediments and Bivalves of the U.S. 1727

Coastal Zone. NOAA Technical Memorandum NOS NCCOS 94. 2009. 1728

1729 XIII. Statutory and Executive Order Reviews 1730

A. Executive Order 12866 1731*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 45 of 83 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 1732 October 4, 1993), this action has be en designated a “significant re gulatory action” by the Office 1733 of Management and Budget (OMB). Accordingl y, EPA submitted this action to OMB for review 1734 and any changes made in response to OMB r ecommendations have been documented in the 1735

docket for this action. 1736

1737 In addition, EPA has prepared two economic anal yses of the potentia l impacts associated 1738 with this action. A copy of th ese economic analyses, entitled Economic Impact Analysis for the 1739 Proposed Section 4 Test Rule for c-Pentabrom odiphenyl Ether, c-Octabromodiphenyl Ether, and 1740 c-Decabromodiphenyl Ether (Ref. 73) and Economic Analysis of the Proposed Significant New 1741 Use Rule for Polybrominated Diphenyl Ethers (Ref. 72), are available in the docket for this 1742 proposed rule and are summarized in Unit X. of this preamble. 1743

1744 B. Paperwork Reduction Act 1745

This proposed rule does not impose any pa perwork collection requirements that would 1746 require additional review and/or approval by OMB under the Paperwork Reduction Act (PRA), 1747

44 U.S.C. 3501 et. seq. The information collection requireme nts related to the proposed SNUR 1748 (i.e., the submission of a SNUN) have been approved by OMB pursuant to the PRA under OMB 1749 control number 2070-0038 (EPA ICR No. 1188). The information collection requirements 1750 related to the proposed test ru le have been approved by OMB pursuant to the PRA under OMB 1751 control number 2070-0033 (EPA ICR No. 1139). A lthough the test rule information collection 1752 activities are approved, the additional burden associat ed with this test rule is not yet covered by 1753 the approved ICR until the final rule is effective. In the context of developing a new test rule, 1754 the Agency must determine whether the total annual burden covered by the approved ICR needs 1755

to be amended to accommodate the burden associated with the new test rule. If so, the Agency 1756

must submit an Information Correction Worksh eet (ICW) to OMB and obtain OMB approval of 1757 an increase in the total approved an nual burden in the OMB inventory. 1758

1759

The information collection ac tivities related to export notification under TSCA section 1760 12(b)(1) are already approved under OMB control number 2070–0030 (EPA ICR No. 0795). 1761 This rulemaking does not propose any new or cha nges to the export notif ication requirements, 1762 and is not expected to result in any substantive changes in the burden estimates for EPA ICR No. 1763 0795 that would require additional re view and/or approval by OMB. 1764

1765 Under the PRA, an agency may not conduct or sponsor, and a person is not required to 1766 respond to, a collection of info rmation that is subject to approval under the PRA, unless it 1767 displays a currently valid OMB control number. The OMB control numbers for the EPA 1768 regulations codified in chapter 40 of the CFR, af ter appearing in the preamble of the final rule, 1769 are listed in 40 CFR part 9, displa yed either by publication in the Federal Register or by other 1770 appropriate means, such as on the related collect ion instrument or form, if applicable. The 1771 display of OMB control numbers in certain EPA regulations is c onsolidated in 40 CFR part 9. 1772

1773 To submit a SNUN, EPA estimates that the industry burden ho urs per chemical to be 92 1774 hours. (Ref. 72). The standard chemical testi ng program involves the submission of letters of 1775 intent to test (or exemption applications), study plans, semi-annual progress reports, test results, 1776 and administrative costs. For this proposed ru le, EPA estimates the total industry burden hours 1777*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 46 of 83 for all three mixtures to be 37,074 hours (56,717 hours) for the low (high) cost scenario. 1778 Average industry burden hours per mixture ar e estimated to be 12,358 hours (18,906 hours) in 1779 the low (high) cost s cenario. (Ref. 72). 1780

1781

The estimated burden of the information colle ction activities related to export notification 1782 is estimated to average 1 burden hour for each mixture/country combination for an initial 1783 notification and 0.5 hours for each subsequent noti fication (Ref. 72). In estimating the total 1784 burden hours approved for the information collecti on activities related to export notification, the 1785 Agency has included sufficient burden hours to accommodate any export no tifications that may 1786 be required by the Agency’s issuance of final test ru les. As such, EPA does not expect to need to 1787 request an increase in the total burden hours approved by OMB for export notifications. 1788

1789 As defined by PRA and 5 CFR 1320.3(b), ‘‘burden’’ means the total time, effort, or 1790 financial resources expended by persons to genera te, maintain, retain, or disclose or provide 1791 information to or for a Federal agency. This includes the time needed to : Review instructions; 1792 develop, acquire, install, and utilize technology and systems fo r the purposes of collecting, 1793 validating, and verifying information, processi ng and maintaining information, and disclosing 1794 and providing information; adjust the existing wa ys to comply with any previously applicable 1795 instructions and requirements; train personnel to be able to respond to a collection of 1796 information; search data sources; complete a nd review the collection of information; and 1797

transmit or otherwise disclose the information. 1798

1799 Comments are requested on the Agency’s need for this information, the accuracy of the 1800 provided burden estimates, and any suggest ed methods for minimizing respondent burden, 1801 including through the use of automa ted collection techniques. Send comments to EPA as part of 1802 your overall comments on this proposed act ion in the manner specified under ADDRESSES . In 1803 developing the final rule, the Agency will ad dress any comments received regarding the 1804 information collection requirement s contained in this proposal. 1805

1806 C. Regulatory Flexibility Act 1807

Pursuant to section 605(b) of the Regulat ory Flexibility Act (RFA), 5 U.S.C. 601 et seq.

, 1808 after considering the potential economic impacts of this proposed rule on small entities, the 1809 Agency hereby certifies that this proposed rule does not have a signifi cant adverse economic 1810 impact on a substantial number of small enti ties. The factual basis for the Agency’s 1811 determination is presented in the small entity imp act analysis prepared as part of the economic 1812 analyses for this proposed rule (Refs. 72 and 73), which are su mmarized in Unit X. of this 1813 document, and copies of which are available in the docket for this rulemaking. The following is 1814 a brief summary of the factual basis for this certification. 1815

1816 Under the RFA, small entities include small businesses, small organizations, and small 1817 governmental jurisdictions. For purposes of asse ssing the impacts of this proposed rule on small 1818 entities, small entity is defined in accordance w ith the RFA as: 1) A small business as defined 1819 by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201; 2) A small 1820 governmental jurisdiction that is a government of a city, county, town, school district, or special 1821 district with a population of le ss than 50,000; and 3) A small orga nization that is any not-for1822 profit enterprise which is indepe ndently owned and operated and is not dominant in its field. 1823*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 47 of 83 1824 Based on the industry profile that EPA prepared as part of the economic analysis for this 1825 rulemaking (Ref. 73), EPA has determined that this proposed rule is not expected to impact any 1826 small not-for-profit organizations or small governmental jurisdic tions. As such, the Agency’s 1827 analysis presents only the estimated potential impacts on small business. 1828

1829

Two factors are examined in EPA’s small en tity impact analysis (Ref. 73) in order to 1830 characterize the potential small en tity impacts of this proposed rule on small business: 1) The 1831 size of the adverse economic impact (measured as the ratio of the cost-to-sales or cost-to1832 revenue), and 2) The total number of small entities that experience the adverse economic 1833 impact. 1834

1835 Section 601(3) of the RFA establishes as th e default definition of “small business” the 1836

definition used in section 3 of the Small Bu siness Act, 15 U.S.C. 632, under which the Small 1837 Business Administration (SBA) establishes small business size standards (13 CFR 121.201). For 1838 this rulemaking, EPA has analyzed the potential small business impacts using the size standards 1839

established under this default definition. The SB A size standards, which are primarily intended 1840 to determine whether a business entity is el igible for government pr ograms and preferences 1841 reserved for small businesses (13 CFR 121.101), “seek to ensure that a concern that meets a 1842 specific size standard is not dominant in it s field of operation.” (13 CFR 121.102(b)). See 1843 section 632(a)(1) of the Small Business Act. In analyzing potential impacts, the RFA recognizes 1844 that it may be appropriate at times to use an al ternate definition of sma ll business. As such, 1845 section 601(3) of the RFA provides that an agency may establish a different definition of small 1846

business after consultation with the SBA Office of Advocacy and after notice and an opportunity 1847 for public comment. Even though the Agency has used the default SBA definition of small 1848 business to conduct its analysis of potential small busin ess impacts for this proposed rule, EPA 1849

does not believe that the SBA si ze standards are generally the be st size standards to use in 1850 assessing potential small entity impacts with regard to TSCA secti on 4(a) test rules. 1851

1852 The SBA size standard is generally based on the number of employe es an entity in a 1853 particular industrial sector may have. For exam ple, in the chemical manufacturing industrial 1854 sector (i.e., NAICS 325 and NAICS 324110), approximately 98% of the firms would be 1855

classified as small businesses under the default SBA definition. The SBA size standard for 75% 1856 of this industry sector is 500 empl oyees, and the size standard for 23% of this industry sector is 1857 either 750, 1,000, or 1,500 employees. When assessi ng the potential impacts of test rules on 1858 chemical manufacturers, EPA believe s that a standard based on to tal annual sales may provide a 1859 more appropriate means to judge the ability of a chemical manufacturing firm to support 1860 chemical testing without si gnificant costs or burdens. 1861

1862 EPA is currently determining what level of annual sales woul d provide the most 1863 appropriate size cutoff with regard to various segments of the chemical industry usually 1864 impacted by TSCA section 4(a) test rules, but has not yet reached a determination. As stated 1865 above, therefore, the factual basis for the RFA de termination for this proposed rule is based on 1866 an analysis using the default SBA size standard s. Although EPA is not currently proposing to 1867

establish an alternate definition for use in the analysis conducted for this proposed rule, the 1868 analysis for this proposed rule also presents the results of calculations using a standard based on 1869 total annual sales (40 CFR 704.3). EPA is intere sted in receiving comments on whether the 1870*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 48 of 83 Agency should consider establishing an alternate definition for small business to use in the small 1871 entity impact analyses for future TSCA section 4(a) test rules, and what size cutoff may be 1872 appropriate. 1873

1874 The SBA has developed 6 digit NAICS code-specific size standards based on 1875 employment thresholds. These size standards range from 500 to 1,500 employees for the various 1876 6 digit NAICS codes that are potentially impacted (Ref. 73). For a conservative estimate of the 1877

number of small businesses affect ed by this rule, the Agency c hose an employment threshold of 1878 less than 1,500 employees for a ll businesses regardless of the NAIC-specific threshold to 1879

determine small business status. 1880

1881 For manufacturers and importers of decaBDE covered by this proposed rule, six parent 1882 companies (ultimate corporate entity, or UCE) we re identified and sales and employment data 1883 were obtained for companies where data were pub licly available. Parent company sales data 1884 were used to identify companies that qualified as a “small business” for purposes of the RFA 1885 analysis. Based on the TSCA employment stan dard (1,500 employees or less), one company 1886 was identified as small. This company had cost -to-sales ratios of greater than 3% under both the 1887 low- and high-cost scenarios. Gi ven these results, the Agency has determined that there is not a 1888 significant economic impact on a substantial number of small entities as a re sult of this proposed 1889 rule, if finalized. 1890

1891 The estimated cost of the TSCA section 12(b) (1) export notification, wh ich, as a result of 1892 the final rule, would be required fo r the first export to a particular country of a mixture subject to 1893 the rule, is estimated to be $85.70 for the first time that an exporter must comply with TSCA 1894 section 12(b)(1) export notification requirements, and $26.86 for each subsequent export 1895 notification submitted by that exporter (Ref. 72). EPA has concluded that the costs of TSCA 1896 section 12(b)(1) export no tification would have a negligible impact on exporters of the mixtures 1897 in the final rule, regardless of the size of the exporter. 1898

1899 Any comments regarding the impacts that th is action may impose on small entities, or 1900 regarding whether the Agency should consider establishing an alternate definition of small 1901 business to be used for analytical purposes fo r future test rules and what size cutoff may be 1902 appropriate, should be submitted to the Agency in the manner specified under ADDRESSES

. 1903

1904 D. Unfunded Mandates Reform Act 1905

This action does not contain any Federal manda tes for State, local, or tribal governments 1906 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 1907 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory ac tion will not result in 1908 annual expenditures of $100 million or more for St ate, local, and tribal governments, in the 1909 aggregate, or for the private sector. For the privat e sector, it is estimated that the total aggregate 1910 costs of this proposed rule would be $15.1 million. The total annualized costs of this proposed 1911 rule to the private sector are estimated to be $5.34 and 5.75 million using a 3% and 7% discount 1912 rate over 3 years (high cost scen ario). In addition, since EPA does not have any information to 1913 indicate that any State, local , or tribal government manufactur es or processes the mixtures 1914 covered by this action such that this rule would apply directly to State, local, or tribal 1915 governments, EPA has determined that this propo sed rule would not significantly or uniquely 1916*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 49 of 83 affect small governments. Accordingly, this propos ed rule is not subject to the requirements of 1917 sections 202, 203, 204, and 205 of UMRA. 1918

1919

E. Executive Order 13132 1920

Under Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), 1921 EPA has determined that this proposed rule doe s not have “federalism implications” because it 1922 will not have substantial direct effects on the States, on the relationship between the national 1923 government and the States, or on the distribution of power and responsibilities among the various 1924 levels of government, as specified in the Ex ecutive Order. The proposed test rule would 1925 establish testing and recordkeeping requireme nts that apply to ma nufacturers (including 1926 importers) and processors of cer tain mixtures. The proposed am endments to the SNUR would 1927 establish notification and submission requireme nts that apply to manufacturers (including 1928 importers) before certain chemicals may be ma nufactured or imported. Because EPA has no 1929 information to indicate that any State or lo cal government manufactures or processes the 1930 chemical substances and mixtures covered by th is action, the proposed SNUR-Test Rule does not 1931 apply directly to States and lo calities and will not affect State and local governments. Thus, 1932 Executive Order 13132 does not apply to this proposed rule. 1933

F. Executive Order 13175 1934

Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 1935

Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule 1936 does not have tribal implications because it will not have any affect on tribal governments, on the 1937 relationship between the Federal Government and the Indian tribes, or on the distribution of 1938 power and responsibilities between the Federal Government and Indian tribes, as specified in the 1939 Executive Order. As indicated previously, EPA has no information to indicate that any tribal 1940 government manufactures or processes the chemic al substances or mixtures covered by this 1941 action. Thus, Executive Order 13175 does not apply to this proposed rule. 1942

G. Executive Order 13045 1943

EPA interprets Executive Order 13045, entitled Protection of Children from 1944

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 1945 those regulatory actions that con cern health or safety risks, such that the analysis required under 1946

section 5-501 of Executive Order 13045 has the potential to influe nce the regulation. This action 1947 is not subject to Executive Order 13045 because it does not establish an environmental standard 1948 intended to mitigate health or safety risks. Nevertheless, the information obtained by this 1949 proposed rule could inform the Agency’s decisi on-making process regarding mixtures to which 1950 children may be disproportionately exposed. The proposed test rule woul d establish testing and 1951 recordkeeping requirements that apply to manufac turers (including importe rs) and processors of 1952 certain mixtures, and would resu lt in the development of data about those mixture substances 1953 that can subsequently be used to assist the Agency and others in determining whether the 1954 mixtures in the proposed test rule present potentia l risks, allowing the Agency and others to take 1955 appropriate action to investigate and mitigate th ose risks. Similarly, the proposed amendments 1956

to the SNUR would allow EPA to review availabl e information to identify and take action to 1957 address potential risk because it would requir e manufacturers to submit notification and hazard 1958

information in the form of a SNUN to EPA befo re a chemical may be manufactured or imported. 1959*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 50 of 83 H. Executive Order 13211 1960

This action is not a “significant energy action” as defined in Executive Order 13211, 1961

entitled Actions Concerning Regulations that Signific antly Affect Energy Supply, Distribution, or 1962

Use (66 FR 28355, May 22, 2001), because it is not likel y to have a significant adverse effect on 1963 the supply, distribution, or use of en ergy as described in the Order. 1964

I. National Technology Tr ansfer and Advancement Act 1965

Section 12(d) of the Nati onal Technology Transfer and Advancement Act (NTTAA), 15 1966 U.S.C. 272 note, directs EPA to use voluntary co nsensus standards in its regulatory activities 1967

unless to do so would be inconsis tent with applicable law or ot herwise impractical. Voluntary 1968

consensus standards are technical standards (e.g., materials specifi cations, test methods, 1969 sampling procedures, and business practices) that are developed or adopted by voluntary 1970

consensus standards bodies. The NTTAA dir ects EPA to provide Congress, through OMB, 1971 explanations when the Agency decides not to use available and applic able voluntary consensus 1972

standards. 1973

The proposed test rule involves technical st andards because it proposes to require the use 1974 of particular test methods. If the Agency makes findings under TSCA section 4(a), EPA is 1975 required by TSCA section 4(b) to in clude specific standards or test methods that are to be used 1976 for the development of the data required in the test rules issued under TSCA section 4. For 1977 some of the testing that would be required by the final rule, EPA is proposing the use of 1978 voluntary consensus standards issu ed by ASTM International and ISO which evaluate the same 1979 type of toxicity as the TSCA 799 test guideline s and OECD test guidelines, where applicable. 1980 Copies of the ASTM International standards re ferenced in the proposed regulatory text at § 1981 799.XXXX (h)(2)(i) through (v) have been placed in the docket for this proposed rule where they 1982 are available for reading, but not copying. Y ou may obtain copies of the ASTM International 1983 standards from the American Society for Testin g and Materials Internat ional, 100 Bar Harbor 1984 Dr., West Conshohocken, PA 19428–2959. In the final rule, EPA intends to seek approval from 1985

the Director of the Federal Register for the incorporation by reference of the ASTM 1986

International and ISO standards used in the fina l rule in accordance with 5 U.S.C. 552(a) and 1 1987 CFR part 51. 1988

EPA is not aware of any potentially app licable voluntary consensus standards which 1989 evaluate prenatal developmenta l toxicity, two-generation reproduc tive toxicity, developmental 1990 neurotoxicity, immunotoxicity, or chronic toxicity/carcinogenicity, or screen for neurotoxicity 1991 which could be considered in lieu of the TSCA 799 test guidelines, 40 CFR 799.9370, 799.9380, 1992 799.9630, 799.9780, 799.9430, and 799.9620, respectively, upon which the test standards in the 1993 proposed rule are based. 1994

EPA is also not aware of any potentially app licable voluntary consensus standards which 1995 evaluate anaerobic aquatic metabolism, biode gradation in anaerobic digester sludge, or 1996 photolytic degradation in the indoor environment. As a result, EPA is proposing the use of three 1997 guidelines which are published in full in the proposed regulatory text at § 799.XXXX (h)(3) (ii) 1998 through (iv). 1999

The Agency invites comment on the potential use of voluntary consen sus standards in the 2000*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 51 of 83 proposed test rule, and, specifically, invites th e public to identify potentially applicable 2001 consensus standard(s) and to explain why such standard(s) should be used here. 2002

J. Executive Order 12898 2003

This proposed rule does not have an a dverse impact on the envi ronmental and health 2004 conditions in low-income and minority communiti es that require specia l consideration by the 2005 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 2006 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 2007 The Agency believes that the information collect ed under this proposed rule, if finalized, will 2008 assist EPA and others in determining the potential hazards and risks associat ed with the mixtures 2009 covered by this proposed rule. Although not dire ctly impacting environmental justice-related 2010 concerns, this information will enable the Agen cy to better protect human health and the 2011 environment, including in low-income and minority communities. 2012

K. Executive Order 12630 2013

EPA has complied with Executive Order 12630, entitled G overnment Actions and 2014 Interference with Constitutionally Pr otected Property Rights (Takings) (53 FR 8859, March 15, 2015 1988), by examining the takings implications of this proposed rule in accordance with the 2016 “Attorney General’s Supplemental Guidelines for the Evaluation of Risk and Avoidance of 2017 Unanticipated Takings” issued under the Executive Order. 2018

L. Executive Order 12988 2019

In issuing this proposed rule, EPA has take n the necessary steps to eliminate drafting 2020 errors and ambiguity, minimize potential litigat ion, and provide a clear legal standard for 2021 affected conduct, as required by sec tion 3 of Executive Order 12988, entitled Civil Justice 2022 Reform (61 FR 4729, February 7, 1996). 2023

List of Subjects in 40 CFR Part 721 2024

Environmental protection, Chemicals, Hazardous substances, Premanufacture 2025 notification, Reporting and r ecordkeeping requirements. 2026

List of Subjects in 40 CFR Part 799. 2027

2028 Environmental protection, Chemicals, Hazardous substances, Laboratories, Reporting 2029 and recordkeeping requirements. 2030

Dated: __________________ 2031

2032

_____________________________ 2033 Assistant Administrator, Office of Ch emical Safety and Pollution Prevention. 2034*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 52 of 83 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 2035

2036 PART 721---[AMENDED] 2037

1. The authority citation for part 721 continues to read as follows: 2038

Authority: [ 15 U.S.C. 2604, 2607, and 2625(c). ]

. 2039

2040 2. By amending 721.10000 to read as follows : 2041

§ 721. 10000 Certain Polybrominated Diphenylethers

. 2042

2043 (a) Definitions . The definitions in § 721.3 apply to th is section. In a ddition, the following 2044 definitions apply: 2045 (1) Military use means use by the armed forces of the United States. 2046 (2) Transportation use means preparation of an article for use as an integral component 2047 of a moving vehicle such as a car, truck, train, ship, or aircraft. 2048 (b) Chemical substances subject to significant new use reporting

. 2049 (1) The chemical substances identified as tetrabromodiphenyl ether (CAS No. 40088–47– 2050 9; Benzene, 1,1 ′ -oxybis-, tetrabromo deriv.), pentab romodiphenyl ether (CAS No. 32534–81–9; 2051 Benzene, 1,1 ′ -oxybis-, pentabromo deriv.), hexabr omodiphenyl ether (CAS No. 36483–60–0; 2052 Benzene, 1,1 ′ -oxybis-, hexabromo deriv.), heptabro modiphenyl ether (CAS No. 68928–80–3; 2053 Benzene, 1,1 ′ -oxybis-, heptabromo deriv.), octabr omodiphenyl ether (CAS No. 32536–52–0; 2054 Benzene, 1,1 ′ -oxybis-, octabromo deriv.), and nona bromodiphenyl ether (CAS No. 63936–56–1; 2055 Benzene, pentabromo(tetrabromophenoxy)-), or any combination of these substances resulting 2056

from a chemical reaction are s ubject to reporting under this sec tion for the significant new uses 2057 described in paragraph (c )(2) of this section. 2058 (2) Decabromodiphenyl ether (CAS No. 1163-19-5; Benzene, 1,1'-oxybis[2,3,4,5,6- 2059 pentabromo-) 2060 (c) Significant new uses

. 2061 (1) The significant new uses for chemicals iden tified in paragraph (b )(1) of this section 2062

are: 2063 (i) Manufacture or import for any use on or after January 1, 2005, and 2064 (ii) Processing for any use after December 31, 2012. 2065 (2) The significant new uses for the chemical identified in paragraph (b )(2) of this section 2066

are: 2067 (i) Manufacture, import or processing for a ny use except military and transportation uses 2068 after December 31, 2012, and 2069 (ii) Manufacture, import or processing for any use including military or transportation 2070 uses after December 31, 2013. 2071 (d) Specific requirements. The provisions of subpart A of th is part apply to this section 2072 except as modified by this paragraph. 2073 (1) Revocation of certain notification exemptions . The provisions of § 721.45(f) do not 2074 apply to this section. A person who imports or pr ocesses a chemical substa nce identified in this 2075 section as part of an article is not exempt from submitting a significant new use notice. 2076

(2) [Reserved] 2077*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 53 of 83 2078

PART 799---[AMENDED] 2079

3. The authority citation for part 799 continues to read as follows: 2080

Authority: 15 U.S.C. 2603, 2611, 2625 2081

2082 4. By adding § 799.XXXX to subpart D to read as follows: 2083

§ 799.XXXX Certain polybrominated diphenylethers. 2084 (a) What mixtures will be tested under this section? The chemical mixtures that must be 2085

tested under this section are three representative commercial forms of pentabromodiphenyl ether, 2086 octabromodiphenyl ether, and decabro modiphenyl ether, as follows: 2087 (1) commercial pentabromodiphenyl ether (c-p entaBDE), whose predominant components are 2088 tetrabromodiphenyl ether (CASRN 40088–47–9; Benzene, 1,1 ′ -oxybis-, tetrabromo deriv.), 2089 pentabromodiphenyl ether (CASRN 32534-81-9; Ben zene, 1,1’-oxybis-, pentabromo deriv.), and 2090 hexabromodiphenyl ether (C ASRN 36483–60–0; Benzene, 1,1 ′ -oxybis-, hexabromo deriv.), 2091

2092 (2) commercial octabromodiphe nyl ether (c-octaBDE), whose predominant components are 2093 heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1 ′ -oxybis-, heptabromo deriv.), 2094 octabromodiphenyl ether (CAS N o. 32536-52-0; Benzene, 1,1’- oxybis-, octabromo deriv.), and 2095 nonabromodiphenyl ether (CAS RN 63936–56–1; Benzene, pentabromo (tetrabromophenoxy)-), 2096

and 2097

2098 (3) commercial decabromodiphenyl ether (c-dec aBDE), whose component with the highest 2099 percent composition is decabromodiphenyl ether (CASRN 1163-19-5; Benzene, 1,1’- 2100 oxybis[2,3,4,5,6-pentabromo-), aka BDE-209. 2101

2102 The test sponsor(s) must identify the percentage of each of the seven PBDE congeners present in 2103 each of the representative commercial mixtures that will be tested. 2104

2105 (b) Am I subject to this section? (1) If you manufacture (inc luding import) or process c2106 pentaBDE or c-octaBDE for any use including inarticles at any time after December 31, 2012; 2107 or manufacture or process c-decaBDE for any use except for military and transportation uses 2108 including in articles at any time after Decembe r 31, 2012; or manufactur e (including import) or 2109 process c-decaBDE for any use including military or transportation uses in cluding in articles at 2110 any time after December 31, 2013, until the end of the test data reimbursement period as defined 2111 in 40 CFR 791.3(h), you are subject to this section with respect to that mixture. You are also 2112 subject to this rule if you ma nufacture (including import) or pro cess c-pentaBDE, c-octaBDE, or 2113 c-decaBDE for export from the United States. For this rule, importers of articles containing c2114 pentaBDE, c-octaBDE, or c-decaBDE are considered manufacturers and are subject to this rule. 2115

(2) If you do not know or cannot reasonably as certain that you manuf acture or process a 2116 mixture listed in paragraph (a) of this secti on during the time period described in paragraph 2117 (b)(1) of this section (b ased on all information in your possession or control, as well as all 2118 information that a reasonable person similarly situ ated might be expected to possess, control, or 2119 know, or could obtain without unreasonable burden) , you are not subject to this section with 2120*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 54 of 83 respect to that mixture. 2121

(c) If I am subject to this secti on, when must I comply with it? (1) (i) Persons subject to 2122 this section are divided into two groups, as set fort h in Table 1 of this paragraph: Tier 1 (persons 2123 initially required to comply) and Tier 2 (pers ons not initially required to comply). If you are 2124 subject to this section, y ou must determine if you fall within Ti er 1 or Tier 2, based on Table 1 of 2125 this paragraph. 2126

Table 1.--Persons Subject to the Ru le: Persons in Tier 1 and Tier 2 2127

Tier 1 (Persons initially required to comply ) Tier 2 (Persons not initially required to comply) Persons who manufacture (as defined at TSCA section 3(7)), or intend to manufacture, a test rule

mixture and who are not listed under Tier 2. Importers of articles containing PBDEs are

considered manufacturers. A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to

manufacture a test rule mixture solely as one or more of the following: --As a byproduct (as defined at 40 CFR791.3(c)); --As an impurity (as defined at 40 CFR 790.3); --As a naturally occurring chemical substance (as defined at 40 CFR 710.4(b)); --As a non-isolated intermediate (as defined at 40 CFR 704.3); --As a component of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i)); --In amounts of less than 500 kg (1,100 lbs.) annually (as described at 40 CFR 790.42(a)(4)); or --In small quantities solely for research and development (R and D) (as described at 40 CFR 790.42(a)(5)).

B. Persons who process (as defined at TSCA section 3(10)) or intend to process a test rule mixture, including in articles (see 40 CFR 790.42(a)(2)).

2128

(ii) Table 1 of paragraph (c)(1)(i) of this se ction expands the list of persons in Tier 2, that 2129 is those persons specified in § 790.42(a)(2), (a)(4) and (a)(5) of th is chapter, who, while legally 2130 subject to this section, must comply with the requirements of this section only if directed to do so 2131 by EPA under the circumstances set forth in paragraphs (c)(4), (c)( 5), (c)(6), (c)(7), and (c)(10) 2132

of this section. 2133

(2) If you are in Tier 1 with respect to a mi xture listed in paragra ph (a) of this section, 2134*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 55 of 83 you must, for each test required under this section for that mixture, either submit to EPA a letter 2135 of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 2136 exemption application must be received by EPA no later than 30 days after the relevant effective 2137 date in paragraph (k ) of this section. 2138

(3) If you are in Tier 2 with respect to a mi xture listed in paragra ph (a) of this section, 2139 you are considered to have an automatic condi tional exemption and you will be required to 2140 comply with this section with regard to that mixture only if directed to do so by EPA under 2141 paragraphs (c)(5), (c)(7), or (c)(10) of this section. 2142

(4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests 2143 required by this section on any mixture listed in pa ragraph (a) of this sec tion within 30 days after 2144 the relevant effective date in paragra ph (k) of this section, EPA will publish a Federal Register 2145 document that would specify the test(s) and the mi xture (s) for which no letter of intent has been 2146 submitted and notify manufacturers in Tier 2A of their obligation to submit a letter of intent to 2147 test or to apply for an exemption from testing. 2148

(5) If you are in Tier 2A (as specified in Ta ble 1 in paragraph (c) of this section) with 2149 respect to a chemical substance listed in paragraph (a) of this section, and if you manufacture, or 2150 intend to manufacture, this chemi cal substance after the relevant effective date in paragraph (k) 2151 of this section, or within 30 days after publication of the Federal Register document described 2152 in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance 2153 in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of 2154 intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 2155 exemption application must be received by EPA no later than 30 days af ter publication of the 2156 Federal Register document described in paragr aph (c)(4) of this section. 2157

(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one 2158 or more of the tests required by this section on a ny chemical substance listed in paragraph (a) of 2159 this section within 30 days after the publication of the Federal Register document described in 2160 paragraph (c)(4) of this s ection, EPA will publish another Federal Register document that 2161 would specify the test(s) and the chemical substa nce(s) for which no letter of intent has been 2162 submitted, and notify processors in Tier 2B of their obligation to submit a letter of intent to test 2163 or to apply for an exemption from testing. 2164

(7) If you are in Tier 2B (as specified in Ta ble 1 in paragraph (c) of this section) with 2165 respect to a mixture listed in pa ragraph (a) of this section, an d if you process, or intend to 2166 process, this mixture after the relevant effective da te in paragraph (k) of this section, or within 30 2167 days after publication of the Federal Register document described in paragraph (c)(6) of this 2168 section, you must, for each test spec ified for that mixture in the Federal Register document 2169 described in paragraph (c)(6) of th is section, either submit to EPA a letter of intent to test or 2170 apply to EPA for an exemption from testing. The letter of intent to test or the exemption 2171 application must be received by EPA no la ter than 30 days after publication of the Federal 2172 Register document described in para graph (c)(6) of this section. 2173

(8) If no manufacturer or pro cessor has notified EPA of its in tent to conduct one or more 2174 of the tests required by this section for any of the mixtures listed in paragr aph (a) of this section 2175 within 30 days after the publication of the Federal Register document described in paragraph 2176*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 56 of 83 (c)(6) of this section, EPA will notify all manufacture rs and processors of those mixtures of this 2177 fact by certified lette r or by publishing a Federal Register document specifying the test(s) for 2178

which no letter of intent has been submitted. This letter or Federal Register document will 2179 additionally notify all manufacturers and processors that all exemption applications concerning 2180 the test(s) have been denied, and will give the ma nufacturers and processors of the mixture (s) an 2181 opportunity to take corrective action. 2182

(9) If no manufacturer or pro cessor has notified EPA of its in tent to conduct one or more 2183 of the tests required by this section for any of the mixtures listed in paragr aph (a) of this section 2184 within 30 days after rece ipt of the certified lett er or publication of the Federal Register 2185 document described in paragraph (c)(8) of this section, all manufacturers and processors subject 2186 to this section with respect to that mixture who ar e not already in violation of this section will be 2187

in violation of this section. 2188

(10) If a problem occurs with the initiati on, conduct, or completion of the required testing 2189 or the submission of the required data with respec t to a mixture listed in paragraph (a) of this 2190 section, under the procedures in §§ 790.93 and 790.97 of this chapter, EPA may initiate 2191 termination proceedings for all testing exemptions with respect to that mixture and may notify 2192 persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption 2193 applications within a specified period of time. 2194

(11) If you are required to comply with th is section, but your manu facture or processing 2195 of, or intent to manufacture or process, a mixtur e listed in paragraph (a) of this section begins 2196 after the applicable compliance date referred to in paragraphs (c)(2), (c)( 5), or (c)(7) of this 2197 section, you must either submit a le tter of intent to test or appl y to EPA for an exemption. The 2198 letter of intent to test or the exemption applic ation must be received by EPA no later than the day 2199 you begin manufacture or processing. 2200

(d) What must I do to comply with this section? (1) To comply with this section you 2201

must either submit to EPA a letter of intent to test, or apply to and obtain from EPA an 2202 exemption from testing. 2203

(2) For each test with respect to which you submit to EPA a letter of intent to test, you 2204 must conduct the testing specified in paragraphs (h) and (i) of th is section and submit the test 2205

data to EPA. 2206

(3) You must also comply with the procedur es governing test rule requirements in part 2207 790 of this chapter, as modified by this section, including the submission of letters of intent to 2208 test or exemption applications, the submission of study plans prior to testing, the conduct of 2209 testing, and the submission of data; Part 792—G ood Laboratory Practice Standards of this 2210 chapter; and this section. The following provi sions of 40 CFR part 790 do not apply to this 2211 section: Paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; paragraph (a)(2) and paragraph (b) 2212 of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85. 2213

2214 (e) If I do not comply with this section, when will I be considered in violation of it? You 2215

will be considered in violation of this section as of 1 day after the date by which you are required 2216 to comply with this section. 2217*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 57 of 83 (f) How are EPA’s data reimbursement procedures affected for purposes of this section? 2218 If persons subject to this sect ion are unable to agree on the amount or method of reimbursement 2219 for test data development for one or more mixt ures included in this section, any person may 2220 request a hearing as described in 40 CFR part 791. In the determination of fair reimbursement 2221 shares under this section, if the hearing officer chooses to use a formula based on production 2222 volume, the total production volume amount will include amounts of a mixture manufactured 2223 and processed as impurities and amounts imported in articles. 2224

(g) Who must comply with the export notification requirements? Any person who 2225 exports, or intends to export, a mi xture listed in paragraph (a) of this section is subject to part 2226 707, subpart D, of this chapter except when the mixture is in articles. 2227

(h) How must I conduct my testi ng of c-pentaBDE and c-octaBDE? The tests that are 2228 required for c-pentaBDE and c-octaBDE and the test methods that must be followed are listed in 2229 subparagraphs (1) through (11) of paragraph (h) of this secti on. All tests must be conducted in 2230 accordance with the requirements described in 40 CFR Part 792—Good Laboratory Practice 2231

Standards. 2232

(1) toxicity to freshwater invertebrates of sediment-associated contaminants conducted in 2233 accordance with ASTM E 1706-05e1 and following the guidance of ASTM E 1391-03, 2234

(2) Laboratory soil toxicity and bioaccumul ation tests with the lumbricid earthworm 2235 Eisenia fetida and the enchytraeid potworm E nchytraeus albidu conducted in accordance with 2236 ASTM E 1676-04 and following general guidance in ASTM E 1391-03, 2237

(3) toxicity to polychaetous annilids of sediment-associated contaminants conducted in 2238 accordance with ASTM E 1611-00 and following the guidance of ASTM E 1391-03, 2239

(4) laboratory soil toxicity to nematode Caenorhabditis elegans conducted in accordance 2240 with ASTM E 2172-01 and following guidance fo r collecting laboratory soil in ASTM E 1676- 2241 04, and following general guidance in ASTM E 1391-03, 2242

(5) toxicity to estuarine and marine invert ebrates of sediment-associated contaminants 2243 conducted in accordance with ASTM E 1367-03 and following the guidance of ASTM E 1391- 2244 03, 2245

(6) prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 2246 799.9370, 2247

(7) two-generation reproductive toxicity with a satellite group for body burden 2248 determinations conducted in accordance with 40 CFR 799.9380, 2249

(8) immunotoxicity conducted in accordance with 40 CFR 799.9780, 2250

(9) neurotoxicity screening battery, acute a nd subchronic, conducted in accordance with 2251 40 CFR 799.9620, 2252

(10) developmental neurotoxicity co nducted in accordance with 40 CFR 799.9630, 2253*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 58 of 83 (11) chronic toxicity/carcinogenicity conducted in accordance with 40 CFR 799.9430. 2254

(i) How must I conduct my testing of c-decaBDE? The tests that are required for c2255 decaBDE and the test methods that must be followed are listed in subparagraphs (1) through (4) 2256 of paragraph (i) of this section. The use of the term “test substance” in the guidelines listed in 2257 subparagraphs (2) through (4) of paragraph (i) of this secti on, should be unde rstood to mean c2258 decaBDE or test mixture where appropriate. All tests must be conducted in accordance with the 2259 requirements described in 40 CFR Part 792—Good Laboratory Practice Standards. 2260

(1) The tests and test methods listed in para graphs (h)(1) through (h)(1 0) of this section. 2261

(2) anaerobic aquatic metabolism conducted in accordance with th e following guideline: 2262

(i) Title . Decabromodiphenyl ether: Anaerobic Aquatic Metabolism 2263

(ii) Source . U.S. Environmental Protection Agen cy, Series 835 – Fate, Transport and 2264 Transformation Test Guidelines, OCSPP Guideline 835.4400—Anaerobic Aquatic Metabolism. 2265

(iii) Introduction. Chemicals can enter shallow or deep surface waters by a wide variety 2266 of routes including direct application, run-o ff, groundwater seepage drainage, waste disposal, 2267 industrial or agricu ltural effluent and atmospheric depos ition. This study plan describes a 2268 proposed laboratory test method to assess transf ormation of the test substance in anaerobic 2269 aquatic sediment systems. 2270

2271 (iv) Objectives

. The objectives of the study are to 1) measure the rate of transformation 2272 of the test substance, decabromodiphenyl et her; 2) identify and qua ntify all detectable 2273 degradation products; 3) identify and quantify the transformation pa thways and rate of formation 2274 and degradation of intermediate products in th e water, vapor and sediment phases; and 4) 2275

measure the distribution of the te st substance and degradation pr oducts and intermediates within 2276

each phase in the test system. 14 C-labeled decabromodiphenyl ether sh all be used to help ensure 2277

mass balance over time. 2278

2279 (v) Experimental design. The test shall be conducted using six sediments and their 2280

associated waters at two concentrations ( one trace; the other significantly higher), using 14 C2281

labeled test substance. Sediment s shall be selected to include a variety of sediment types and 2282 shall include sediments known to contain po lybrominated diphenyl ethers (PBDEs) and 2283 polychlorinated biphenyls (PCBs). 2284

Untreated live and killed controls and test substance-dosed biotic and abiotic systems 2285 shall be prepared for each sediment type. Ba sed on published studies on the biodegradation of 2286 decabromodiphenyl ether in sediments, the half -life of decabromodiphenyl ether may be long. 2287 Tokarz (2008) reported sediment ha lf-lives ranging from 6-50 years with an average of 14 years. 2288 Therefore, it is expected that untreated control, test substance-dosed li ve, and killed control 2289 systems will be incubated at approximately 20° C for at least 36 months. However, the actual 2290 study duration shall be dependent on the analytical results for initi al sampling periods. The total 2291 duration and interval for later samples may be changed depending on the observed rate of 2292 degradation. 2293 Duplicate test vessels for each treatment (i.e. treated a nd control) option, each test 2294*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 59 of 83 substance concentration and each sediment shall be s acrificed at appropriate time intervals. Test 2295 substance-dosed systems shall be used for quant ification of parent material and degradation 2296 products. Untreated controls shall be used to de termine background levels of the parent material 2297 and other PBDEs over time. Sampling shall be performed at time zero and seven times 2298 thereafter. Additional sample vessels may be pr epared for additional analyses, if necessary. 2299 These vessels shall be sampled at the request of the sponsor in consultation with EPA. 2300

Additional untreated chambers shal l be prepared for use as matrix fortification samples, water2301 sediment characterizations and viability controls, as necessary. 2302

2303 (vi) Materials and methods . (A) The test system and study conditions are selected to 2304 comply with the Fate, Transport and Transformation Test Guidelines, OCSPP 835.4400 (at 2305 paragraph (i)(2)(xii)(B) of this section) with appropriate modifi cations, if any, for decaBDE. 2306

2307 (B) Test substance . Information on the characterizati on of test, control or reference 2308 substances is required by Good Laboratory Pr actice (GLP) Standards and Principles. Ring2309

labeled, 14 C-labeled test substance sha ll be used. The Sponsor is responsible for providing the 2310

test substance and verification th at it has been characterized acco rding to GLP requirements prior 2311 to its use in the study. If verifi cation of GLP test substance char acterization is not provided, it 2312 shall be noted in the compliance statement of the final report. The Sponsor is responsible for all 2313 information related to the test substance including the following descriptions of the radiolabeled 2314 form of the test substance: name, lot numb er, specific activity, radiochemical purity, sample 2315 form, solubility in water, and storage conditions. For the nonlabeled form of the test substance, 2316 the Sponsor is responsible for th e following descriptions: name, lot number, purity, sample form, 2317 solubility in water, and storage conditions. Th e Sponsor must agree to accept any unused test 2318

substance and/or test substance containe rs remaining at th e end of the study. 2319

2320 (C) Test substance preparation and administration . A dispersal powder of test substance 2321 shall be prepared using an inert carrier (e.g. sili ca gel, quartz sand). Radi olabeled test substance 2322 shall be placed in a round bottom flask and di ssolved with an appropr iate solvent (i.e., 2323 tetrahydrofuran). The inert carrie r shall be added to the flask and the solvent shall be evaporated 2324 using a rotary evaporator until the carrier is dry. This method of creating a dispersal powder is 2325 an appropriate route of administration for poorly water-soluble materials. Prior to the test, 2326 characteristics of sorption of the test substance on various carriers shall be evaluated. 2327

2328 (D) Sediments and associated waters . Sediments and associated water shall be obtained 2329 from at least six different sites known or susp ected to be contaminated with polybrominated 2330 diphenyl ethers including, but not limited to decab romodiphenyl ether, and PCBs. Selection and 2331 approval of the collection sites shall be the responsibility of the study Sponsor and must be 2332 approved by EPA. 2333

Sediments shall be collected and handled usi ng strict anaerobic procedures (for example 2334 see Loveley and Phillips (1986) at paragraph (i)(2)(xii)(A ) of this section). They shall be 2335 immediately sealed under nitrogen and transporte d and stored to mainta in anaerobic conditions. 2336

All collection containers shall be stored in a nitrogen atmosphere until and during use. In 2337 addition, the containers shall be purged with nitr ogen in the field after collection. The anaerobic 2338

sediment and associated waters shall be taken from the same lo cation. The reduction potential or 2339 Redox potential (Eh) of the sediment shall be me asured prior to collection and should be less 2340 than –150 mV. The dissolved oxygen concentration of the overlying wate r shall be measured 2341*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 60 of 83 and should be less than 0.5 mg/L. The sediments and water shall be tran sported to the lab under 2342

anaerobic conditions. The sediment s and associated waters may be stored at room temperature 2343 in sealed containers for up to 7 days. If longer storage is necessary, the sediments and associated 2344 waters may be stored in sealed c ontainers in a refrigerator for up to 4 weeks. Prior to use, the 2345 sediment shall be settled, then separated from the water by decanting. The settled sediment shall 2346 be wet-sieved using a 2 mm sieve. All handling of anaerobic sediment after collection and prior 2347 to testing shall be performed unde r a constant flow of nitrogen. 2348 At a minimum, the following properties of the sediment shall be determined: 2349 • Particle size (i.e., percentage of sand, silt and clay) 2350 • Organic carbon content 2351

• Microbial biomass 2352 • Nitrate, sulfate and iron species 2353

• Percent water 2354 • Microbial biomass (fumigation extraction method) 2355 • pH 2356

• Concentration of humic material 2357 • Concentrations of electron acceptors including me thane, nitrate, nitrite, sulfate, sulfide, 2358 and iron species. 2359 Similar characterization of the aqueous phase shall be performed prio r to the start of the 2360 test. Prior to the test, resazurin shall be added to the water at a nominal concentration of 1 mg/L. 2361 The water shall be sparged with nitrogen until a light pink color is obtained and the dissolved 2362 oxygen concentration is less than 0.1 mg/L. Re dox conditions in the test vessels shall be 2363 monitored by measuring dissolved hydrogen gas and Eh at each sampling. The test vessels shall 2364 be stored under nitrogen or other inert atmosphere throughout the test. 2365

2366 (E) Test apparatus and conditions . The test vessels shall be 1-L glass bottles sealed with 2367 butyl rubber septa and screw caps. Prior to begi nning the study, the integr ity of the test vessels 2368 and caps and their ability to maintain anaer obic conditions and pr event leakage of H 2 and other 2369 gas species for long periods shall be verified. The test vessels shall be identified by project 2370 number, test substance ID, test concentration, and a unique identifie r. The test vessels shall be 2371 incubated under an atmosphere of nitrogen at approximately 20°C in a anaerobic glove box. Test 2372 temperatures shall be recorded each working day using a min/max thermometer. The need for 2373 venting of the test systems shall be evaluated pr ior to the start of the study. The procedure for 2374 venting and frequency shall be a dded to the study protocol, if necessary, prior to beginning the 2375 study. 2376

2377 (F) Preparation of the test chambers and acclimation. Test chambers shall be prepared 2378 in an anaerobic glove box or under a constant fl ow of nitrogen. Appropriate amounts of sediment 2379

and water shall be added to each test chamber so the resulting water:sediment volume ratio is 2380 between approximately 1:3 and 1:4. The dept h of the sediment layer shall depend upon the 2381 characteristics of the specific sediment. As a practical example, 200 g dry weight equivalent of 2382 sediment and 250 mL of associated water typically result in a sediment layer of 6.5 cm and a 2383 water layer of 2.5 cm. Amounts of sediment and wa ter to be added may be determined prior to 2384 the preparation of the test chambers. The sedi ment/water samples shall be acclimated under the 2385

same conditions as in the test for at least 7 days prior to the start of the test. 2386

2387 (G) Characterization of wa ter-sediment systems . The pH, total organic carbon 2388*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 61 of 83 concentration, dissolved oxygen concentration, redox potential of the water and sediment 2389 (including microbial biomass), and other paramete rs characteristics of th e water-sediment media 2390

in the test vessels shall be measured at each sa mpling period noted in Table 1 of this paragraph. 2391 The sediment and water shall be kept anaerobi c with a redox potential lower than –100 mV. 2392

2393

Table 1: Measurements at Various Stages of the Test Procedure 2394

2395

Parameter Stage of Test Procedure

Field Sampling PostHandling Start of

Acclimation Start of

Test During Test End of Test

Water

Origin/source X

Temperature X

pH X X X X X

TOC X X X

O 2 concentration X X X X X

Redox potential X X X X

Sediment

Origin/Source X

Depth of layer X

pH X X X X X

Particle size X

TOC X X X X

Microbial biomass X X X

Redox potential X X X X X

2396 (H) Application of the test substance. Chambers containing th e sediment/water systems 2397

shall be fortified at the start of the test with th e test substance by applying the test material to the 2398 water layer. Methods for mixing the test material with sediment shall be evaluated prior to the 2399

start of the test. Methods to be evaluated sha ll include but are not lim ited to mixing by hand and 2400 the use of roller and tumbling mixers. 2401

2402 (I) Preparation of abiotic systems. Test substance-dosed abio tic controls shall be heat2403 sterilized (autoclaved three times at 120 °C fo r 60 minutes on three consecutive days). A 2404 preliminary evaluation of the effects of heat ster ilization on the test subs tance shall be conducted 2405 prior to the start of the study. If this method is found to be un satisfactory, irradiation shall be 2406 used to sterilize the test systems. 2407

2408 (J) Sample collection. Proposed sampling intervals are day 0 and months 3, 6, 12, 18, 24, 2409 30, and 36. If analysis of initial sampling results suggests more rapid degradation, the sampling 2410 interval may be modified after consultation with EPA using procedures sp ecified in the ECA. 2411 The actual sampling intervals shall be documented inthe study records and in the final report. 2412 Duplicate test vessels for each treatment (i.e. treated and control) option, each test substance 2413

concentration and each sediment shall be sacr ificed at appropriate time intervals. 2414

2415*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 62 of 83 (K) Headspace analysis. The headspace of the treated systems shall be analyzed for 2416

radiolabeled mineraliza tion products including 14 CO2- hydrocarbons and 14 CO2 and 14 CH4 using 2417 purge and trap methods. At each sampling time prio r to extraction of the test system, the septum 2418 shall be pierced using a needle connected to an appropriate trap and the vessel headspace shall be 2419 purged and trapped using a hydrocarbon trap follow ed by a mineralization trapping apparatus. 2420 The headspace within eachof test chamber shall be continuo usly purged with a flow of nitrogen 2421 for a minimum of 1 hour and pa ssed through a gas collection system consisting of a hydrocarbon 2422 trap and two sets of CO2 traps and a combustion apparatus. The displaced gases shall initially 2423 pass through a sorption tube containing appropr iate solid phase to trap any hydrocarbon 2424 degradation products present, then one em pty bottle followed by two more bottles, each 2425 containing approximately 100 mL of 1.5N KOH (CO2 trapping solution), followed by another 2426 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 2427 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 2428

furnace to combust methane to CO2. Because Br may poison the surface of the cupric oxide, a 2429 preliminary experiment shall be run to test this, and the protocol adjusted if necessary. The gas 2430 exiting the combustion column shall be pa ssed through an empty bottle followed by two 2431 additional CO2 traps. 2432

2433 (L) Sample processing and analysis for total radioactivity. After purging, the overlying 2434

water shall be removed with minimal disturba nce to the sediment and assayed for total 2435 radioactivity by liquid scintillati on counting (LSC). Sediment samples shall be analyzed using 2436 combustion followed by LSC counting to determine to total amount of radioactivity associated 2437 with the sediment. Water and sediment samples shall be extracted following aggressive methods 2438 designed to extract the maximum am ount of parent and degradation products from the sediment. 2439 These shall be evaluated and verified and approv ed by EPA prior to the st art of the study. These 2440 methods shall be able to detect and quantify pa rent and degradates at least as well as those 2441 reported in the literature for PBDE analysis. The extraction method shall be robust, for example 2442 sequential extraction by solvent washing, soxhlet ex traction and supercritical fluid extraction, but 2443 shall not substantially change th e test substance or degradation products, or the structure of the 2444

matrix itself. Solvent extracts and extracted soli ds shall be analyzed to determine total residual 2445 radioactivity. Untreated controls shall be extracted in the same manner as the test substance 2446 treated systems. 2447

2448 (M) Characterization of extra cted radioactivity. Water and sediment extracts from the 2449 treated and untreated systems sha ll be analyzed for radiolabeled test substance and degradation 2450 products using high performance liquid chromat ography (HPLC) and gas chromatography (GC) 2451 with mass spectrometry (MS) and radiochemical dete ction. Methods of analysis shall be verified 2452 prior to the start of the study a nd shall be at least as sensitiv e and accurate as reported in the 2453 literature for analysis of PBDEs and products. 2454

2455 (N) Quantification of test subs tance and degradation products. Water and sediment 2456

extracts from the untreated cont rols and treated systems shall be analyzed for quantification of 2457 BDE-209 (decaBDE) and trace level lower brominat ed diphenyl ethers including but not limited 2458 to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE-201 (octaBDE), as well as, brominated 2459 dibenzofurans. This analysis shall be c onducted using gas chromat ography/electron capture 2460 negative chemical ionization mass spectrometry (G C/ECNI-MS). Expected limits of detection 2461 (LOD) and quantitation (LOQ) fo r reasonably anticipated products shall be determined and 2462*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 63 of 83 reported to EPA prior to starting the test. All debromination produc ts shall be measured in each 2463 sample, including background and time zero samples, and both biotic systems and abiotic 2464 (inhibited) controls. 2465

2466 (O) Viability controls. The assessment of the metabolic activity of untreated 2467 sediment/water systems shall be conducted w ithin one week of each sampling interval. 2468 Duplicate incubation vessels for each sediment, wh ich have been incubate d in parallel under the 2469 same conditions, shall be dosed at approxima tely 100 mg/kg sediment dry weight with a 2470

combination of radiolabeled and nonlabeled substa nce suitable (i.e. glucose, benzoic acid) for 2471 viability determination. The methods and procedur es used shall be documented in study protocol 2472 prior to beginning the study. 2473

2474 (P) Treatment of results. Total mass balance of radioactiv ity shall be calculated at each 2475 sampling interval. Results shall be reported as total and percenta ge of added radioactivity. The 2476 behavior of the test substance and major and minor metabolites in the whole system as well as 2477 water, gas and sediment compartments shall be ev aluated. Regression analys is of the percentage 2478 of test substance and major metabolites as a function of time shall be performed and the time for 2479 50% degradation (DT50) and the time for 90% de gradation (DT90) of the test substance and 2480 major metabolites shall be calculated, when po ssible. The ratio of BDE-209 (decaBDE) to all 2481 detected degradation products shall be determine d. All analytical results and all raw data shall 2482 be submitted to EPA, including the mass of each analyte at each time. 2483

2484 (vii) Records to be maintained. Records to be submitted to EPA shall include, but are not 2485 limited to, the following: 2486

2487 (A) The original signed protocol and any amendments. 2488

2489 (B) Identification and charac terization of the test substa nce as provided by Sponsor. 2490

2491 ( C) Experiment initiation and termination dates. 2492

2493 (D) Stock solution concen tration calculations a nd solution preparation. 2494

2495 (E) Inoculum source and pretreatment data. 2496

2497 (F) Results of LSC and HPLC and/or ot her analysis (e.g. GC or GC/ECNI-MS). 2498

2499 (G) Temperature data reco rded during test period. 2500

2501 (H) Copy of final report. 2502

2503 (viii) Final report. A final report of the results of the study shall be prepared and 2504 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 2505

2506 (A) Name and address of facility performing the study. 2507

2508 (B) Dates on which the study was initiated and completed. 2509*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 64 of 83 2510 (C) Objectives and procedures stated in th e approved protocol, including any changes in 2511 the original protocol. 2512

2513 (D) Identification and charac terization of the test substa nce as provided by Sponsor. 2514

2515 (E) A summary and analysis of the data a nd a statement of the conclusions drawn from 2516 the analysis. 2517

2518 (F) A description of the transformations and calculations performed on the data. 2519

2520 (G) A description of the methods used and reference to any standard method employed. 2521

2522 (H) A description of the test system. 2523

2524 (I) A description of the preparation of the te st solutions, the testing concentrations, and 2525

the duration of the test. 2526

2527 (J) A description of sampling and analytical methods, including leve l of detection, level 2528 of quantification, and references. 2529

2530 (K) A description of the te st results including measured values for individual PBDE 2531 congeners and PBDF homolog group. 2532

2533 (L) A description of all circumstances that may affect the quality or integrity of the data. 2534

2535 (M) The name of the study director, the names of other scientists or professionals, and the 2536 names of all supervisory pe rsonnel involved in the study. 2537

2538 (N) The signed and dated reports of each of the individual scientists or other 2539 professionals involved in the study, if applicable. 2540

2541 (O) The location where the raw data a nd final report are to be stored. 2542

2543 (P) A statement prepared by the Quality Assu rance Unit listing the types of inspections, 2544 the dates that the study inspections were made and the findings reported to the Study Director 2545 and Management. 2546

2547 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks and 2548

data sheets etc. 2549

2550 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 2551 final report after it has been accepted, such change s shall be made in the form of an amendment 2552 issued by the Study Director. The amendment shall clearly identify the part of the study that is 2553 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 2554 Study Director and Laboratory QA officer. 2555

2556*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 65 of 83 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 2557 written amendments signed by the Study Director and approved by the Sponsor’s Representative 2558 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 2559 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 2560 form of written deviations signed by the Study Dire ctor and filed with the raw data. All changes 2561 to the protocol shall be indicated in the final re port. Changes to the teststandard require prior 2562 approval from EPA using procedures in 40 CFR 790.55. 2563

2564 (xi) Good laboratory practices. This study shall be conducted in accordance with Good 2565 Laboratory Practice Standards for EPA and shall be consistent w ith OECD Principles of Good 2566 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 2567 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 2568 Operating Procedures, and the specified prot ocol. A statement of compliance with Good 2569 Laboratory Practices shall be prepared for all portions of the study c onducted by the testing 2570 facility. The Sponsor is re sponsible for compliance with Good Laboratory Practices for 2571 procedures that may be performed by other laborat ories (e.g., residue analyses). Raw data for all 2572 work performed at the testing facility and a c opy of the final report sh all be filed by project 2573

number in archives located on the fa cility’s site or at an alternativ e location to be specified in the 2574 final report. 2575

2576 (xii) Literature cited. 2577

2578 (A) Lovley DR, Phillips EJP. Organic matte r mineralization with reduction of ferric iron 2579

in anaerobic sediments. Applied Environmental Microbiology 51 :683–689. 1986. 2580

2581 (B) U.S. Environmental Protection Agency. Series 835-Fate, Transport and 2582

Transformation Test Guidelines. OCSPP Nu mber 835.4400: Anaerobic Aquatic Metabolism. 2583

EPA 712-C-08-019. June 2008. 2584

2585 (C) Tokarz JA, III, Ahn MY , Leng J, Filley TR, Nies L. Reductive debromination of 2586 polybrominated diphenyl ethers in anaerobi c-sediment and a biomimetic system. Environmental 2587 Science & Technology 42:1157-1164. 2008. 2588

(3) Biodegradation in anaerobic digester sl udge conducted in accordance with the 2589 following guideline : 2590

(i) Title . Decabromodiphenyl ether: Biodegrad ation in Anaerobic Digester Sludge 2591

2592 (ii) Source. U.S. Environmental Protection Agency Series 835 - Fate, Transport and 2593 Transformation Test Guidelines, OCSPP guideli ne 835.3280—Simulation test to assess primary 2594 and ultimate biodegradability of chemicals di scharged to wastewat er: Mineralization and 2595 transformation in digester sludge. 2596

2597 (iii) Introduction. Anaerobic digesters are commonly used in municipal wastewater 2598 treatment plants to stabilize various plant sludge s. The digestion proce ss reduces the amount of 2599 solids present in the sludge, destroys pathoge nic bacteria and viru ses, and removes the 2600 biodegradable portion of the sludg e. A test for biodegradation during anaerobic sludge digestion 2601*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 66 of 83 is particularly relevant for sorbing substances, which partition to primary and secondary sludge. 2602 This test is useful for determining the concentra tion of a substance present in the sludge leaving a 2603 treatment plant as well as demonstrating the pote ntial for anaerobic biodegr adation. The test is 2604 characterized by reducing conditi ons, a high level of anaerobic bi omass, and a level of test 2605 substance based on expected wastewater concentr ations and partitioning behavior. The test is 2606 designed to assess the extent to which a substance can be degraded during anaerobic digestion. 2607 This protocol describes the methods employed in determining the biodegradability of the test 2608

substance in anaerobic digester sludge. 2609

2610 (iv) Objectives . The objective of the study is to assess the potential for mineralization 2611 and transformation of decabromodiphenyl ether in anaerobic digester sludge, and the quantity 2612 and identity of degradants (if present). 2613

2614 (v) Experimental design. The test shall be conducted us ing digester sludge from six 2615

different sources. Untreated control and test su bstance-dosed systems shall be prepared for each 2616 sludge source. Additionally, an abiotic control sh all be prepared. The test substance treatment 2617 systems shall be dosed at two concentrations with 14 C-labeled test or a combination of 2618

radiolabeled and nonlabeled forms of the test subs tance. A very low concentration is used to 2619 establish environmentally releva nt transformation kinetics; wher eas a higher concentration is 2620 required to quantify product formation. The test systems shall be inc ubated at approximately 2621 35°C for approximately 10 months; e.g. approxi mately 300 days. Studies using anaerobic 2622 digester sludge normally involve incubating sludge for 60 days, wh ich is about twice the normal 2623 residence time of sludge in anaerobic digesters. The extended length of this study is based on a 2624 half-life of the test substance in sludge w ithout added primers of 1400 days as reported by 2625 Gerecke et al. at paragraphs (i)(3)(xii)(A ) and (B) of this se ction, and the general 2626

recommendation that test duration be at le ast 20% of the antici pated half-life. 2627 Based on the length of the study, bench-sc ale anaerobic reactor systems with semi2628 continuous feeding shall be used. A system c onsists of a 5-L glass reactor containing an 2629 anaerobic digester sludge mixture incubated at 35° C and gas collection bladder. On a weekly 2630 basis, supernatant shall be removed from the reactor and replaced with an anoxic mixture of 2631 settled activated sludge solids (s econdary sludge) and fresh anaerob ic digester sludge solids. 2632 Test substance-dosed systems shall be used for quantification of parent material and 2633 degradation products. Untreated controls shall be used to determine b ackground levels of the 2634 parent material and other polybrom inated diphenyl ethers. Samp ling shall be performed at time 2635

zero and seven times thereafter. 2636

2637 (vi) Materials and methods . The test system and study conditions are selected to comply 2638 with the Fate, Transport and Transformati on Test Guidelines, OCSPP 835.3280 at paragraph 2639 (i)(3)(xii)(C) of this section. 2640

(A) Test Substance. Information on the characterization of test, control or reference 2641 substances is required by Good Laboratory Pr actice (GLP) Standards and Principles. The 2642 Sponsor is responsible for providing verification that the test substance has been characterized 2643 according to GLP requirements prior to its use in the study. If verification of GLP test substance 2644 characterization is not provided, it shall be noted in the compliance statement of the final report. 2645 The Sponsor is responsible for all information related to the test substance. Following are 2646 descriptions of the radiolabeled form of the test substance: na me, lot number, specific activity, 2647*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 67 of 83 radiochemical purity, radiolabel position, identities and perc entages of all brominated 2648 diphenylethers, sample form, solubility in water, and storage c onditions. Following are 2649 descriptions of the nonlabeled form of the test substance: name, lot number, purity, identities and 2650 percentages of all brominated di phenyl ethers, sample form, sol ubility in water, and storage 2651 conditions. The Sponsor must agree to accept any unused test substance and/or test substance 2652 containers remaining at the end of the study. 2653

(B) Test substance preparation and administration. A dispersal powder of test substance 2654 shall be prepared using an inert carrier (e .g. silica gel, quartz sand). A combination of 2655

radiolabeled and nonlabeled test substance sha ll be placed in a round bottom flask and dissolved 2656 with an appropriate solvent (i.e. tetrahydrofuran). The inert carrier shall be added to the flask 2657 and the solvent shall be evaporated using a rota ry evaporator until the sediment is dry. This 2658 method of creating a dispersal powder is an approp riate route of administ ration for poorly water2659 soluble materials. Prior to the test, the adsorpti on characteristics of the test substance on various 2660

carriers shall be evaluated. 2661

(C) Test inoculum. Anaerobic digester sludge shall be ob tained from at least six different 2662

sites. Selection of the collec tion sites shall be the responsibil ity of the study Sponsor, with 2663 review and final approval by the EPA. All collec tion containers shall be purged with nitrogen 2664 and immediately sealed prior to us e. In addition, purging the contai ners with nitrogen in the field 2665 after collection shall be perfor med if possible. Sludge shall be screened using a 2 mm mesh 2666 screen to remove debris and may be held for up to 7 days prior to the start of the test. The total 2667 solids level of the digester sludge shall be measured and should be in the range of 4-6% (40,000- 2668 60,000 mg/L). On the day the test is to start, th e inoculum shall be diluted with mineral salts 2669

solution to an initial solids le vel of approximately 25,000 mg/L. If the solids concentration is too 2670 low, the solids can be allowed to settle, the supernatant decanted, and the sludge resuspended in 2671

mineral salts solution. A final so lids level and pH shall then be determined. All handling of 2672 anaerobic sludge after collection an d prior to testing sh all be performed under a constant flow of 2673 nitrogen or in an anaerobic glove box. 2674

(D) Mineral salts solution. A mineral salts solution shall be prepared using high quality 2675

water as described below. All chemicals used in the preparation of the solution shall be reagent 2676 grade or better, if available. The solution sha ll be autoclaved for 30 min and allowed to cool 2677 overnight in an anaerobic chamber or under an an aerobic atmosphere. The solution shall contain 2678 the following constituents per liter of high quality water: 2679

• Anhydrous potassium dihydrogen phosphate (KH 2 PO 4 ) 0.27 g 2680

• Disodium hydrogen phosphate dodecahydrate (Na 2 HPO 4 •12H 2 O) 1.12 g 2681

• Ammonium chloride (NH 4 Cl) 0.53 g 2682

• Calcium chloride dihydrate (CaCl 2 •2H 2 O) 0.075 g 2683

• Magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.10 g 2684

• Iron (II) chloride tetrahydrate (FeC1 2 •4H 2 O) 0.02 g 2685*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 68 of 83 • Resazurin (oxygen indicator) 0.001 g 2686

• Sodium sulphide nonahydrate (Na 2 S•9H 2 O) 0.10 g 2687

(E) Digester sludge feed. The source guideline for this study, OCSPP 835.3280, has no 2688 provision for feeding. However, due to the length of the study, peri odic feeding is needed. The 2689 anaerobic digester sludg e shall be fed an anoxic mixture of settled activated sludge solids 2690 (secondary sludge) and fresh anaerobic digester sludge solids. Activated sludge shall be 2691 collected from a sewage treatment plant receiving waste from predominantly domestic sources. 2692 The sludge shall be sieved using a 2 mm mesh sc reen to remove debris, then dewatered using 2693 filtration. A feed solution shall be prepared at a sludge solids concentration of approximately 50 2694 g/L using mineral salts solution. The feed so lution shall be stored under nitrogen and 2695 refrigerated. In addition, freshly prepared solutio ns should be stored for at least 1 week prior to 2696

use. 2697

(F) Test apparatus and conditions. The test reactors shall be 5-L glass bottles and shall 2698 be identified by project number, te st substance ID, test concentrat ion, and unique identifier. The 2699

reactors shall be sealed with black rubber stoppers with stopcock ports and connections used for 2700 the addition of feed sludge, sample removal and gas collection bag. The test reactors shall be 2701

incubated at 35 ± 3 °C and in the dark. Reactor contents shall be mixed for at least 10 min every 2702 day using a magnetic stirrer and test temperatur es shall be measured each working day using a 2703

min/max thermometer. 2704

(G) Preparation of the test reactors. Working under a constant fl ow of nitrogen, 1.5 L of 2705 anaerobic digester sludge (4 -6% solids), mineral salts solution to achieve an initial solids level of 2706 approximately 25,000 mg/L, and test substance dispersal powder shall be combined in the 2707 reactor. The headspace in the reactor shall be purged with nitrogen, then the reactor sealed and 2708

transferred to the incubator. 2709

(H) Reactor maintenance, The contents of the reactors (anaerobic sludge and mineral 2710

salts solution at a solids level of approx. 25,000 mg/L) shall be fed on a weekly basis. Prior to 2711 mixing, approximately 75 mL of supernatant shall be removed from the reactor and replaced 2712 with an equal volume of digester sludge feed solution. The solids added in this way are expected 2713 to be approximately equivalent to 10% of the total digester so lids reasonably expected to be 2714 present. The amount of digest er sludge feed solution added may be adjusted based on the 2715 observed level of gas production. The activity of the supernatant removed shall be measured 2716 using liquid scintillation counting (LSC). 2717

(I) Abiotic control. An abiotic control shall be included. Biological activity is inhibited 2718 in the abiotic control, which is used for es timating mineralization by difference, establishing 2719 extraction efficiency and recovery of the test substance, and quantifying other loss processes 2720 such as hydrolysis, oxidation, volatilization or sorp tion to test apparatus. The preparation of the 2721 abiotic system is typically performed using a comb ination of chemical and heat sterilization. A 2722 proven approach is to add mercuric chloride (1 g/l) to the sludge, which is then autoclaved for at 2723 least 90 min. Typically the volum e of medium is less than or e qual to half the volume of the 2724 container being autoclaved (e.g. 500 ml sludge in a 1-liter container). Af ter cooling, the pH of 2725 the abiotic system should be measured and adju sted to match that of the biologically active 2726 system. Alternative approaches to deac tivate the system can also be used. 2727*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 69 of 83 (J) Sample collection schedule. Proposed sampling times are day 0 and months 1, 2, 4, 6, 2728 8, 9, and 10, but the actual sampling times shall be documented in the study records and in the 2729 final report. The timing of the sampling may be altered at the discreti on of the Study Director, 2730 and more frequent sampling may be conducted. Ba sed on the analytical method that is selected, 2731 the minimum change in the initial concentration of the test substance that can be detected shall 2732 be estimated, then applied to help determine the sampling schedule and assess the need for 2733 additional samples. As an example, if the mini mum reliably detectable change is 5% relative to 2734 the starting concentration, and if this has already occurred at th e first suggested sampling time (1 2735 month), then measurements should be made mont hly up to 10 months. The solids concentration 2736 of sludge shall be measured at each sampling interval. 2737

(K) Evolved gas and headspace analysis. The evolved gas and headspace of the treated 2738 systems shall be analyzed for radiolabeled mineralization products ( 14 CO 2 and 14 CH 4 ). At 2739 intervals throughout the study, evolve d gases shall be analyzed by pa ssing the contents of the gas 2740 collection bags through the mineralization appa ratus described below. Reactor headspace 2741 analysis shall be performed at the end of the st udy. The headspace gases w ithin the reactor shall 2742 be continuously purged with a flow of nitr ogen for a minimum of 2 hours and passed through a 2743 gas collection system consisting of two sets of CO 2 traps and a combustion apparatus. The 2744 displaced gases shall initiall y pass through one empty bottle followed by two bottles each 2745 containing approximately 100 mL of 1.5N KOH (CO 2 trapping solution) followed by another 2746 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 2747 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 2748

furnace to combust methane to CO 2 . The gas exiting the combus tion column shall be passed 2749 through an empty bottle followed by two additional CO 2 traps. 2750

(L) Sample processing and analysis for total radioactivity. Treated digester sludge 2751 samples shall be analyzed using a combin ation of LCS and combustion followed by LSC 2752 counting to determine the total amount of radioactivity associ ated with the sludge. At each 2753 sampling interval, replicate (minimum 3) one mL aliquots of well mixed digester sludge shall be 2754 placed into microcentrifuge tubes and centr ifuged at 10,000 x g for 15 min. The activity 2755 associated with the supernatant shall be meas ured by LSC. Solids shall be analyzed using 2756 combustion followed by LSC to determine to total amount of radioactivity associated with the 2757 sludge solids. 2758

Digester sludge shall be ex tracted following methods evalua ted and verified prior to the 2759 start of the study. These methods shall be able to detect and qua ntify parent and degradates at 2760 least as well as those reported in the literature for PBDE analysis. The extraction method shall 2761 be robust, for example sequential extracti on by solvent washing, s oxhlet extraction and 2762 supercritical fluid extraction, but shall not substantially change th e test substance or degradation 2763 products, or the structure of the matrix itself. Solvent extracts and ex tracted solids shall be 2764 analyzed to determine total radioactivity. Untr eated controls shall be extracted in the same 2765 manner as the test substance-treated systems, but will not be analyzed for radioactivity. 2766

(M) Characterization of extra cted radioactivity. Digester sludge extracts from the treated 2767 systems shall be analyzed for radiolabeled te st substance and degrad ation products using high 2768 performance liquid chromatography with radiochemi cal detection. Methods of analysis shall be 2769 verified prior to the start of the study. 2770*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 70 of 83 2771 (N) Quantification of test subs tance and degradation products. Digester sludge extracts 2772 from the untreated control, abiotic control and treated systems shall be analyzed for 2773 quantification of BDE-209 (decaBDE) and trace level lower brominated diphenyl ethers 2774 including but not limited to BDE-202 (o ctaBDE), BDE-197 (octaBDE), and BDE2775 201(octaBDE), as well as brominated dibenzofurans. 2776 Methods for analysis shall be evaluated and verified prior to the start of the study and 2777 shall reference available best practi ce techniques for the type of an alyte. This analysis shall be 2778 conducted using gas chromatography/electron capture negative chemical ionization mass 2779 spectrometry (GC/ECNI-MS). Expected limits of detection (LOD) and quantitation (LOQ) for 2780 reasonably anticipated products sh all be determined and reported to EPA prior to starting the 2781

test. 2782 All debromination products shall be measured in each sample, including background and 2783 time zero samples, and both biotic syst ems and abiotic (inhibited) controls. 2784

2785 (O) Treatment of results. Total mass balance of radioactivit y shall be calculated at each 2786 sampling interval. Results shall be reported as a percentage of added radioactivity. Regression 2787 analysis of the percentage of te st substance and major metabolites as a function of time shall be 2788 performed and the time for 50% degradation (DT 50 ) and the time for 90% degradation (DT 90) of 2789 the test substance and major metabolites shall be calculated, when appropr iate. The ratio of 2790 BDE-197 (octaBDE) to BDE-201 (octaBDE) sh all be determined, if present. 2791

(vii) Records to be maintained. Records to be maintained shall include, but are not 2792 limited to, the following: 2793

(A) The original signed protocol and any amendments. 2794

(B) Identification and charac terization of the test substa nce as provided by Sponsor. 2795

(C) Experiment initiation and termination dates. 2796

(D) Stock solution concen tration calculations a nd solution preparation. 2797

(E) Inoculum source and pretreatment data. 2798

(F) Results of LSC and/or ot her (e.g. GC/ECNI-MS) analyses. 2799

(G) Temperature data reco rded during test period. 2800

(H) Copy of final report. 2801

(viii) Final report. A final report of the results of the study shall be prepared by the 2802 testing facility. The report sha ll include, but is not limited to the following, when applicable: 2803

(A) Name and address of facility performing the study. 2804

(B) Dates on which the study was initiated and completed. 2805

(C) Objectives and procedures stated in th e approved protocol, including any changes in 2806*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 71 of 83 the original protocol. 2807

(D) Identification and charac terization of the test substa nce as provided by Sponsor. 2808

(E) A summary and analysis of the data a nd a statement of the conclusions drawn from 2809 the analysis. 2810

(F) A description of the transformations and calculations performed on the data. 2811

(G) A description of the methods used and reference to any standard method employed. 2812

(H) A description of the test system. 2813

(I) A description of the preparation of the te st solutions, the testing concentrations, and 2814

the duration of the test. 2815

2816 (J) A description of sampling and analytical methods, including leve l of detection, level 2817 of quantification, and references. 2818

2819 (K) A description of the te st results including measured values for individual PBDE 2820 congeners and polybrominated di oxin/furan (PBDF) homolog group. 2821

2822 (L) A description of all circumstances that may affect the quality or integrity of the data. 2823

(M) The name of the study director, the names of other scientists or professionals, and the 2824 names of all supervisory pe rsonnel involved in the study. 2825

2826 (N) The signed and dated reports of each of the individual scientists or other 2827 professionals involved in the study, if applicable. 2828

(O) The location where the raw data a nd final report are to be stored. 2829

(P) A statement prepared by the Quality Assu rance Unit listing the types of inspections, 2830 the dates that the study inspections were made and the findings reported to the Study Director 2831 and Management. 2832

2833 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks, 2834

and data sheets etc. 2835

2836 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 2837 final report after it has been accepted, such change s shall be made in the form of an amendment 2838 issued by the Study Director. The amendment shall clearly identify the part of the study that is 2839 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 2840 Study Director and Laboratory QA officer. 2841

(x) Changes to the protocol. Planned changes to the protocol shall be in the form of 2842 written amendments signed by the Study Director and approved by the Sponsor's Representative 2843 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 2844 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 2845*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 72 of 83 form of written deviations signed by the Study Dire ctor and filed with the raw data. All changes 2846 to the protocol shall be indicated in the final re port. Changes to the teststandard require prior 2847 approval from EPA using procedures in 40 CFR 790.55. 2848

(xi) Good laboratory practices. This study shall be conducted in accordance with Good 2849 Laboratory Practice Standards for EPA and shall be consistent w ith OECD Principles of Good 2850 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 2851 the facility's quality assuran ce unit for compliance with Good Laboratory Practices, Standard 2852 Operating Procedures, and the specified prot ocol. A statement of compliance with Good 2853 Laboratory Practices shall be prepared for all portions of the study c onducted by the testing 2854 facility. The Sponsor is re sponsible for compliance with Good Laboratory Practices for 2855 procedures that may be performed by other laborat ories (e.g., residue analyses). Raw data for all 2856 work performed at the testing facility and a c opy of the final report sh all be filed by project 2857

number in archives located on the fa cility's site or at an alternative location to be specified in the 2858 final report. 2859

(xii) Literature cited : 2860

(A) Gerecke AC, Hartmann PC, Heeb NV, K ohler H-PE, Giger W, Schmid P, Zennegg 2861 M, Kohler M. Anaerobic degrada tion of decabromodiphenyl ether. Environmental Science & 2862 Technology 39:1078-1083. 2005 2863

2864 (B) Gerecke AC, Giger W, Hartmann PC, H eeb NV, Kohler H-PE, Schmid P, Zennegg 2865 M, Kohler M. Anaerobic degr adation of brominated flame re tardants in sewage sludge. 2866 Chemosphere 64:311-317. 2006. 2867

2868 (C) U.S. Environmental Protection Ag ency. Series 835-Fate, Transport and 2869

Transformation Test Guidelines. OCSPP Number 835.3280: Simulation test to assess primary 2870 and ultimate biodegradability of chemicals di scharged to wastewat er: Mineralization and 2871 transformation in digester sludge. 2008. 2872

2873 (4) photolytic degradation of decabromodipheny l ether in the indoor environment in 2874

accordance with the following guideline : 2875

(i) Title: Photolytic Degradation Testing of Decabromodiphenyl Ether (CAS No. 1163- 2876 19-5) in the Indoor Environment. 2877

2878 (ii) Source. US EPA, based on a method in an article entitled “Photodegradation of 2879 decabromodiphenyl ether in house dust by natu ral sunlight” by Stapleton and Dodder (2008) 2880 reported in Environmental Toxicology and Chemistry 27:306–312. 2881

2882 (iii) Introduction. Recent studies have found elevat ed levels of polybrominated 2883 diphenylethers (PBDEs) in indoor air and house dust, suggesting the presence of indoor sources. 2884 It has also been observed that photolytic degr adation of BDE-209 (decabromodiphenyl ether) can 2885 take place in house dust when exposed to sunlight, forming debrominated products. It is not well 2886 understood, however, how PBDEs are transferred fr om the sources to indoor media (e.g., house 2887 dust) and whether photolytic degradation can occur under indoor lightin g conditions. Most 2888 Americans spend over 85% of their time indoors. Elderly and young children tend to stay indoors 2889*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 73 of 83 even longer. Therefore, understa nding indoor exposure is a key to exposure assessment and risk 2890 reduction. This guideline describes test methods to characterize poten tial sources of these 2891 emerging contaminants in the indoor environment. 2892

2893 (iv) PBDE off-gassing and photolytic degradation. 2894

2895 (A) Objectives. The objectives of this first part of the investigation are to determine (1 ) if 2896 PBDEs can migrate out of plastics/ fabrics by volatilization; and 2897

2898 (2 ) determine if photolytic degradation can take place on the surfaces of plastics and 2899 fabrics and quantify these processes. 2900

2901 (B) Experimental Design. Accelerated aging tests shall be conducted in an 2902 environmental chamber. PBDE off-gassing will be determined by taking integrated air samples 2903 and potential photolytic degrada tion by taking wipe samples on the surface of test specimens. 2904 The chamber system must meet the following criteria: 2905

2906 (1 ) It has uniform UV-A light irradiation sources; 2907

2908 (2 ) The light intensity is no less th an 5 Watts per square meter (W/m 2 ) incident to the test 2909 specimen; 2910

2911 (3 ) The chamber has a constant air fl ow to allow air sampling; and 2912

2913 (4 ) The moisture content in the ai r flow is no less than 10 g/m 3 (i.e., 50% relative 2914 humidity at 23 °C). 2915

2916 (5) The light source shall be operated according to ASTM G 151-09, Standard Practice 2917 for Exposing Nonmetallic Materials in Accelerat ed Test Devices that Use Laboratory Light 2918

Sources. 2919

2920 (6) Window-filtered sunlight shall be simulated according to ASTM D 4459-06, 2921 Standard Practice for Xenon-Arc Exposure of Plasti cs Intended for Indoor Applications. ASTM 2922 D 4459-06 is intended to simulate the effects pr oduced by exposure to solar irradiation through 2923 glass. A chamber system conforming to D4459-06 can provide spectral irradiance of 2924 approximately 0.3 W/m 2 /nm at 340 nm (i.e., peak emission) when operated in the continuous 2925 light-on mode without water spray. This light s ource satisfies the light intensity requirement of 5 2926

W/m 2 as specified above. 2927

2928 (C) Materials and methods. 2929

2930 (1 ) Test specimens. The test specimens shall include BDE-209-containing high impact 2931 polystyrene (HIPS) coupons and commercial fabric swatches. HIPS coupons shall be prepared 2932 using typical commercial extrusion and injec tion molding conditions fo r the manufacture of 2933

HIPS television cabinet backs. High purity (99% or greater) BDE-209 shall be used in making 2934 the coupons. The high purity will assist in det ection of any lower brominated diphenyl ethers 2935 formed as degradants. The coupons shall be ma nufactured using high impac t polystyrene resin, 2936*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 74 of 83 12 wt% BDE-209, antimony oxide (4% by weight), and the typical additives of television cabinet 2937 backs (UV inhibitors, antioxidants, colorants, etc. ). A total of 36 coupons shall be prepared for 2938 tests listed in Table 1. Each coupon shall have an area of at least 100 cm 2 (one-side). 2939

Fabric swatches shall be obtai ned from a commercial source, depending on availability, or 2940 manufactured using 99+% BDE-209 as the flame reta rdant. A total of 36 swatches shall be 2941 prepared for tests listed in Table 1. Each swatch shall have an area of at least 100 cm 2 (one2942 side). 2943

2944 (2) Test matrix. 2945

2946

A total of six tests listed in Table 1 shall be conducted. 2947

2948

Table 1. Test matrix for PBDE off- gassing and photolytic degradation 2949

2950
Test No. Material UV light Durations (h)
1 HIPS coupons on 300, 600, 900
2 HIPS coupons on 300, 600, 900
3 HIPS coupons off 300, 600, 900
4 Fabric swatches on 300, 600, 900
5 Fabric swatches on 300, 600, 900
6 Fabric swatches off 300, 600, 900

2951

2952 (3 ) Test procedure. 2953

2954 (i ) Prepare 12 identical coupons (or swatches) for an aging test 2955

2956 (ii ) Put aside 3 coupons (or swatches) for taking wipe samples. These wipe samples 2957 represent no-exposure conditions. To take a wipe sample of fabric, use the California roller 2958 method per Ross, et al. (1991) in paragraph (i)(4)(xi)(F). 2959

2960 (iii ) Clean the chamber by wiping the interior surfaces with ethanol-soaked paper towel 2961

2962 (iv ) Take two wipe samples for chamber walls (100 cm 2 area each) 2963

2964 (v ) Place three passive air samplers (PUF di sks) on supporting cradle about half chamber 2965 height and away from inlet air 2966

2967 (vi ) Place the remaining 9 coupons (or swatches ) on chamber floor or rack, depending on 2968 the type of chamber used 2969

2970 (vii ) Close chamber door and, for light-on tests, turn on the UV light, and start the test 2971

2972 (viii ) At 300 elapsed hours, turn off the UV light and then open the chamber door 2973

2974 (ix) Remove three coupons (or swatches) from the chamber for taking wipe samples 2975*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 75 of 83 2976 (x ) Remove one PUF disk for determination of time-integrated air concentrations of 2977 BDE-209, lower PBDE congeners, and pol ybrominated dibenzofurans (PBDFs) 2978

2979 (xi ) Close chamber door and turn on the UV light 2980

2981 (xii ) At 600 elapsed hours, turn off the UV light and then open the chamber door 2982

2983 (xiii ) Remove three coupons (or swatches) from the chamber for taking wipe samples 2984

2985 (xiv) Remove one PUF disk for determination of time-integrated air concentrations of 2986 BDE-209, lower PBDE congeners, and PBDFs 2987

2988 (xv ) Close chamber door and turn on the UV light 2989

2990 (xvi ) At 900 elapsed hours, turn off the UV light and then open the chamber door 2991

2992 (xvii ) Remove the last three coupons (or swat ches) from the chamber for taking wipe 2993 samples 2994

2995 (xviii ) Remove one PUF disk for determination of time-integrated air concentrations of 2996 BDE-209, lower PBDE congeners, and PBDFs 2997

2998 (xix ) Take two wipe samples for chamber walls (100 cm 2 area each) 2999

3000 (4) Sampling and analytical methods. 3001

3002 (i ) Surface sampling for HIPS coupons. ASTM D-6661, Standard Practice for Field 3003 Collection of Organic Compounds from Surfaces Using Wipe Sampling, or an equivalent 3004 method, shall be used for surface sampling on HIPS coupons. The wipe samples shall be 3005 extracted (Stapleton et al. (2008) in paragraph (i)(4)(xi)(F) of this section) and then analyzed for 3006 BDE-209, lower PBDE congeners, and PBDFs. 3007

3008 (ii ) Surface sampling for fabric swatches. A modified ASTM D-6661 method, as 3009 described below, shall be used for surface samp ling on fabric swatches. Modified procedure: 3010

Use 10 × 10 cm 2 heavy filter paper instead of cotton gauze pad; Place the fabric swatch on pre3011 cleaned flat surface; Place the solvent-wetted filter paper on the fabr ic swatch; Place a 10 × 10 3012

cm 2 stainless steel (or aluminum) plate on the paper filter; Add a dditional weights on the plate 3013 such that the total weight is 2 lbs; Wait for 5 minutes; Remove plate and weights; Extract the 3014 paper filter. 3015

3016 (iii ) Air sampling. Time-integrated air samples shall be collected by using passive air 3017 samplers (PUF disks; see Harrad, et al, 2006 (in paragraph(i)(4)(xi)(D) of this section) and 3018 references therein). 3019

3020 (iv ) Analytical method. High sensitivity is a key factor in selecting the analytical method. 3021 A method based on chromatography/mass spectrome try in electron capture negative ionization 3022*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 76 of 83 mode (GC/MS-ECNI) shall be used. The analytes shall include BDEs and PBDFs as listed in 3023 Bezares-Cruz et al. 2004 in paragraph (i)(4)(xi)(B ) of this section; Stapleton and Dodder 2008 in 3024 paragraph (i)(4)(xi)(G) of this section; and Gell er et al. 2006 in paragra ph (i)(4)(xi)(C) of this 3025

section. 3026

3027 (v) Accelerated aging tests for HIPS coupons and fabric swatches with house dust. 3028

3029 (A) Objectives. The objectives of this, second part of the investigation are to determine 3030 (1 ) if PBDEs or PBDF can migrate from plas tics/fabrics to settled house dust by direct 3031 partitioning; and (2) determine if the particle-bound PBDEs are s ubject to photolytic degradation 3032 and quantify these processes. 3033

3034 (B) Experimental design. HIPS coupons and used TV cabinets shall be subjected to 3035 accelerated aging in a test chamber in the presen ce of standard house dust, National Institute of 3036 Standards Technology, Standard Reference Mate rial 2583 (NIST SRM 2583) , free of BDE-209. 3037 This investigation shall be perf ormed as described in (iv) with the exception of the addition of 3038 pre-cleaned house dust to the surface of the HI PS coupons and fabric swatches. Accelerated 3039 aging under simulated sunlight and fluorescen t lighting, exposure durations, and sample 3040

collections shall be identical to those describe d in (iv), with the a ddition of collection and 3041 analysis of the added house dust. This experiment requires that the coup ons are sufficiently large 3042 (500 cm 2 or larger) that there is enough house dust for sampling while the dust layer is not too 3043

thick. 3044 The house dust can be deposited on test spec imens by using a separate dust deposition 3045 chamber or spiked manually on test specimens (A shley et al. 2007 in pa ragraph (i)(4)(xi)(A) of 3046 this section). The test samples and dust shal l then be exposed to accelerated aging for 300, 600, 3047 and 900 hours, the dust collected by vacuum, an d analyzed for content of BDE-209, lower 3048 BDEs, and PBDFs. 3049

3050 (C) Materials and methods. 3051

3052 (1) Test specimens. HIPS coupons and used TV cabinets shall be used in this 3053 investigation. The procedure for prepar ing HIPS coupons described in (iv)(C)(1 ) shall be 3054 followed except that the size of th e coupon shall be at least 500 cm 2 , such that an adequate 3055 amount of house dust can be spiked on the surfa ce without forming a thick layer of dust. The 3056 target dust load is between 0.5 and 1 mg/cm 2 coupon. 3057

Two used TV sets shall be vacuumed and the dust analyzed for PBDEs and PBDFs as 3058 previously described. Samples of the backcover shall be analyzed by Fourier transform infrared 3059 spectroscopy (FT-IR) to identify the plastic and the flame retardant. Ground samples shall be 3060 prepared for determination of PBDE and PBDF content. 3061 The requirements for the test chamber are the sa me as described in (iv)(B) unless indicated 3062

otherwise. 3063

3064 (2 ) Test matrix. A total of five tests listed in Table 2 shall be conducted. 3065

3066 Table 2. Test matrix for PBDE migration from source to house dust and photolytic degradation 3067

3068
Test No. Material UV light Durations (h)*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 77 of 83 1 HIPS coupons Off 300, 600, 900
2 HIPS coupons Off 300, 600, 900
3 HIPS coupons On 300, 600, 900

4 TV cabinet 1a Off 600

5 TV cabinet 1b On 600

6 TV cabinet 2a Off 600

7 TV cabinet 2b On 600

3069 (3 ) Test procedure for HIPS coupons. 3070

3071 (i ) Prepare HIPS coupons 3072

3073 (ii ) Determine PBDE content in test sp ecimens by preparing and analyzing ground 3074 samples 3075

3076 (iii ) Evenly spike approximately 0.25 to 0.5 g NIST standard house dust SRM 2583 on 3077 each of the six HIPS coupons. This can be done e ither manually (Ashley et al. 2007 in paragraph 3078 (i)(4)(xi)(A) of this section) or in a particle deposition chamber. The targeted dust load is 3079 between 0.5 and 1 mg/cm 2 coupon 3080

3081 (iv ) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 3082

towel 3083

3084 (v ) Take two wipe samples from chamber walls (100 cm 2 area each); the PBDE and 3085

PBDF content shall be below the method detection limit 3086

3087 (vi ) Open the chamber door, place six coupons on chamber floor (or rack), and close the 3088

door 3089

3090 (vii ) Set the chamber temperature at 55 °C a nd air change rate between 0.3 to 0.5 air 3091 changes per hour, or the lowest air cha nge flow the chamber system allows 3092

3093 (viii ) Close chamber door and start the test. 3094

3095 (ix ) At 300 elapsed hours, remove 2 coupons for dust sampling, restart chamber 3096

3097 (x ) Repeat the above step at 600 and 900 elapsed hours. 3098

3099 (4 ) Test procedure for used TV cabinets. 3100

3101 (i ) Open the TV set and collect settled dust from the interior surfaces (see Takigami et al. 3102 (2008) in paragra ph (i)(4)(xi)(I)). 3103

3104 (ii ) Determine the PBDE and PBDF content in the settled dust 3105

3106 (iii ) Clean the backcover by soft cloth and air jet; do not clean it with solvents 3107*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 78 of 83 3108 (iv ) Determine PBDE and PBDF content in test specimen by preparing and analyzing 3109 ground samples 3110

3111 (v ) Divide the backcover evenly into two pieces (designated a and b in Table 2), one for 3112 test with light and the other without light 3113

3114 (vi ) For each half, cut flat areas into rectangular panels for te sting; the total area of the 3115 flat panels shall be no less than 1000 cm 2 3116

3117 (vii ) Evenly spike NIST standard house dus t SRM 2583 on the interior side of the 3118 backcover panels for a targeted dust load between 0.5 to 1 mg/cm 2 3119

3120 (viii ) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 3121

towel 3122

3123 (ix ) Take two wipe samples from chamber walls (100 cm 2 area each); the PBDE and 3124

PBDF content shall be below the method detection limit 3125

3126 (x ) Open the chamber door, place the half backcover with NIST house dust on chamber 3127 floor (or rack) 3128

3129 (xi ) Set the chamber temperatur e at 55 °C and air change rate between 0.3 to 0.5 air 3130 changes per hour, or the lowest air cha nge flow the chamber system allows 3131

3132 (xii ) Close chamber door and start test 3133

3134 (xiii ) At 600 elapsed hours, remove the backc over panels from chamber, collect and 3135 extract dust samples 3136

3137 (5 ) Sampling and analytical methods. Dust samples shall be collected by micro3138 vacuuming (Ashley et al. 2007 in paragraph (i)( 4)(xi)(A) of this sec tion or ASTM 7114). 3139 The method described by Staplet on and Dodder (2008) in paragraph (i)(4)(xi)(F) of this section 3140

shall be used to determine the PBDE content in dust samples. Wipe and air sampling methods 3141 are described in (iv)(C)(4 ). 3142

3143 (vi) Records to be maintained . Records to be submitted to EPA shall include, but are not 3144 limited to, the following: 3145

3146 (A) The original signed protocol and any amendments. 3147

3148 (B) Identification and charac terization of the test substa nce as provided by Sponsor. 3149

3150 (C) Experiment initiation and termination dates. 3151

3152 (D) Stock solution concentra tion calculations and solution preparation, if applicable. 3153

3154*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 79 of 83 (E) Results of LSC and HPLC and/or ot her analysis (e.g. GC or GC/ECNI-MS). 3155

3156 (F) Data on temperature, air flow and inlet air moisture content. 3157

3158 (G) Copy of final report. 3159

3160 (vii) Final report. A final report of the results of the study shall be prepared and 3161 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 3162

3163 (A) Name and address of facility performing the study. 3164

3165 (B) Dates on which the study was initiated and completed. 3166

3167 (C) Objectives and procedures stated in th e approved protocol, including any changes in 3168 the original protocol. 3169

3170 (D) Identification and charac terization of the test substa nce as provided by Sponsor. 3171

3172 (E) A summary and analysis of the data a nd a statement of the conclusions drawn from 3173 the analysis. 3174

3175 (F) A description of the transformations and calculations performed on the data. 3176

3177 (G) A description of the methods used and reference to any standard method employed. 3178

3179 (H) A description of the test system a nd test chamber(s), including chamber type, 3180 dimensions and light source; and spectral irra diance inside the chamber if applicable. 3181

3182 (I) A description of the preparation of the te st solutions, the testing concentrations, and 3183

the duration of the test. 3184

3185 (J) A description of sampling and analytical methods, including leve l of detection, level 3186 of quantification, and references. 3187

3188 (K) A description of test specimens and test matrix. 3189

3190 (L) A description of the te st results including measured values for individual PBDE 3191 congeners and PBDF homolog group for each matrix, exposure condition, and exposure 3192

duration. 3193

3194 (M) A description of all circumstances that may affect the quality or in tegrity of the data. 3195

3196 (N) The name of the study director, the names of other scientists or professionals, and the 3197 names of all supervisory pe rsonnel involved in the study. 3198

3199 (O) The signed and dated reports of each of the individual scientists or other 3200 professionals involved in the study, if applicable. 3201*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 80 of 83 3202 (P) The location where the raw data a nd final report are to be stored. 3203

3204 (Q) A statement prepared by the Quality A ssurance Unit listing the types of inspections, 3205 the dates that the study inspections were made and the findings reported to the Study Director 3206 and Management. 3207

3208 (R) A copy of all raw data including but not limited to chromatograms, lab notebooks and 3209

data sheets etc. 3210

3211 (viii) Changes to the final report. If it is necessary to make corrections or additions to the 3212 final report after it has been accepted, such change s shall be made in the form of an amendment 3213 issued by the Study Director. The amendment shall clearly identify the part of the study that is 3214 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 3215 Study Director and Laboratory QA officer. 3216

3217 (ix) Changes to the protocol . Planned changes to the protocol shall be in the form of 3218 written amendments signed by the Study Director and approved by the Sponsor’s Representative 3219 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 3220 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 3221 form of written deviations signed by the Study Dire ctor and filed with the raw data. All changes 3222 to the protocol shall be indicated in the final re port. Changes to the test standard require prior 3223 approval from EPA using procedures in 40 CFR 790.55. 3224

3225 (x) Good laboratory practices . This study shall be conducted in accordance with Good 3226 Laboratory Practice Standards for EPA and shall be consistent w ith OECD Principles of Good 3227 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 3228 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 3229 Operating Procedures, and the specified prot ocol. A statement of compliance with Good 3230 Laboratory Practices shall be prepared for all portions of the study c onducted by the testing 3231 facility. The Sponsor is re sponsible for compliance with Good Laboratory Practices for 3232 procedures that may be performed by other laborat ories (e.g., residue analyses). Raw data for all 3233 work performed at the testing facility and a c opy of the final report sh all be filed by project 3234

number in archives located on the fa cility’s site or at an alternativ e location to be specified in the 3235 final report. 3236

3237 (xi) Literature cited. 3238

3239 (A) Ashley K, Applegate GT, Wise TJ, Fernback JE, Goldcamp MJ. Evaluation of a 3240 standardized micro-vacuum sampling method for collection of surface dust. Journal of 3241 Occupational and Environmental Hygiene 4:215–223. 2007. 3242

3243 (B) Bezares-Cruz J, Jafvert CT, Hua I.. Solar photodecomposition of decabromodiphenyl 3244 ether: products and quantum yield. Environmental Science & Technology 38:4149-4156. 2004 3245

3246 (C) Geller AM, Krüger HU, Palm WU, Zets ch C. Identification of polybrominated 3247 dibenzofurans from photolysis of decabromodi phenyl ether by UV spectroscopy. Abstract from 3248*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 81 of 83 DIOXIN 2006 , Oslo, Norway, August 21-24, 2006. 3249

3250 (D) Harrad S, Hazrati S, Ibarra C. Concentr ations of polychlorinat ed biphenyls in indoor 3251 air and polybrominated diphenyl ethers in i ndoor air and dust in Birmingham, United Kingdom: 3252 implications for human exposure. Environmental Science & Technology 40:4633-4638. 2006. 3253

3254 (E) Ross, J.; Fong, H.; Thongsinthusak,T.: Margetich, S.; Krieger, R. Measuring 3255 potential dermal transfer of su rface pesticide residue generated fr om indoor fogger use: using the 3256 CDFA roller method interim report II. Chemosphere 22:975-984. 1991. 3257

3258 (F) Stapleton HM, Kelly SM, Allen JG, McClean MD, Webster TF. Measurement of 3259 polybrominated diphenyl ethers on hand wipes: estimating exposure from hand-to-mouth 3260

contact. Environmental Science & Technology 42:3329–3334. 2008. 3261

3262 (G) Stapleton HM, Dodder NG. 2008. Photode gradation of decabromodiphenyl ether in 3263 house dust by natural sunlight . Environmental Toxicology and Chemistry 27:306–312. 3264

3265 (H) Strandberg B, Dodder NG, Basu I, Hites RA. 2001. Concentrations and spatial 3266 variations of polybrominated diphenyl ethers and other organohalogen compounds in Great 3267

Lakes air. Environmental Science & Technolnology 35: 1078-(missing page). 3268

3269 (I) Takigami H, Suzuki G, Hirai Y, Sakai S. Transfer of brominated flame retardants 3270 from components into dust inside television cabinets. Chemosphere 73:161–169. 2008. 3271

(j) Reporting requirements . For c-pentaBDE and c-octaBDE, a final report for each 3272 specific test for each subject mixture must be received by EPA by the number of months 3273 designated for that test in this paragraph af ter December 31, 2012, unless an extension is granted 3274 in writing pursuant to 40 CFR 790.55. For c-decaB DE, a final report for each specific test must 3275 be received by EPA by the number of months desi gnated for that test in this paragraph after 3276 December 31, 2013, unless an extension is gr anted in writing pursuant to 40 CFR 790.55. 3277

A robust summary of the final report for each speci fic test shall be submitted electronically in 3278

addition to and at the same time as the final report. The term “robust summary” is used to 3279 describe the technical information necessary to adequately describe an experiment or study and 3280 includes the objectives, methods, results, and conc lusions of the full study report which can be 3281 either an experiment or in some cases an estimation or prediction method. Guidance for the 3282 compilation of robust summaries is described in a document entitled “Draft Guidance on 3283 Developing Robust Summaries” wh ich is available on-line at: 3284 http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm

. 3285

(1) The final report on toxicity to freshw ater invertebrates of sediment-associated 3286 contaminants shall be received by EPA by (12 m onths after the relevant effective date in 3287 paragraph (k) of this section). 3288

(2) The final report on Laboratory soil toxicity and bioaccumulation tests with the 3289

lumbricid earthworm Eisenia fetida and the enchytraeid potworm E nchytraeus albidu shall be 3290 received by EPA by (12 months after the relevant effective date in paragraph (k) of this section). 3291*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 82 of 83 (3) The final report on toxicity to polyc haetous annilids of sediment-associated 3292 contaminants shall be received by EPA by (12 m onths after the relevant effective date in 3293 paragraph (k) of this section). 3294

(4) The final report on toxicity to nematode Caenorhabditis elegans of sediment3295 associated contaminants shall be received by EPA by (12 months after the re levant effective date 3296 in paragraph (k) of this section). 3297

(5) The final report on toxicity to estuar ine and marine invertebrates of sediment3298 associated contaminants shall be received by EPA by (12 months after the re levant effective date 3299 in paragraph (k) of this section). 3300

(6) The final report on prenatal developmenta l toxicity in rabbits shall be received by 3301 EPA by (12 months after the relevant effectiv e date in paragraph (k) of this section.). 3302

(7) The final report on two-generation reproduc tive toxicity with a satellite group for 3303 body burden shall be received by EPA by (29 mont hs after the relevant effective date in 3304 paragraph (k) of this section). 3305

(8) The final report on immunotoxicity shall be received by EPA by (12 months after the 3306 relevant effective date in paragraph (k) of this section). 3307

(9) The final report on the neur otoxicity screening battery, acute and subchronic, shall be 3308 received by EPA by (21 months after the relevant effective date in paragraph (k) of this section). 3309

(10) The final report on developmental ne urotoxicity shall be received by EPA by (21 3310

months after the relevant effective date in paragraph (k) of this section). 3311

(11) The final report for the chronic toxici ty/carcinogenicity test shall be received by 3312 EPA by (60 months after the relevant effectiv e date in paragraph (k) of this section). 3313

(12) The final report fo r anaerobic aquatic metabolism shall be received by EPA by (60 3314

months after the relevant effective date in paragraph (k) of this section). 3315

(13) The final report for biodegradation in anaerobic digester sludge shall be received by 3316 EPA by (24 months after the relevant effective date in paragraph (k) of this section). 3317

(14) The final report for photolytic degrada tion of c-decaBDE in the indoor environment 3318 shall be received by EPA by (24 months after the rele vant effective date in paragraph (k) of this 3319 section). 3320

(k) Effective date . This section is effective after: 3321

(1) December 31, 2012 for manufacturers (inc luding importers) and processors of c3322 pentaBDE and c-octaBDE except as impurities, including c-pentaBDE and c-octaBDE in 3323 articles, for any use, and for manufacturers (i ncluding importers) and processors of c-decaBDE 3324 except as impurities, including c-decaBDE in articles, for any use except military and 3325 transportation uses. 3326*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 83 of 83 (2) December 31, 2013 for manufacturers (i ncluding importers) and processors of c3327 decaBDE except as impurities, including c-decaBDE in articles, for all uses including military 3328 and transportation uses. 3329

[FR Doc. ??–????? Filed ??–??–??; 8:45 am] 3330