*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 1 of 91 EO12866_PBDE

- SNUR-Test

_ - NPRM_ 2010

- 12

- 08.doc Revised_2012-02-15.docx 1

2 Revised to address Interagency Co mments received under EO 12866 Review. 3

BILLING CODE 6560–50–P 4

5
ENVIRONMENTAL PRO TECTION AGENCY 6

7
40 CFR Parts 721 and 799 8

9 EPA–HQ–OPPT– 20 0 9

- 0 357 2010-1039 ; FRL– XXXX

– X ] 10

11
RIN 2070–AJ08 12

13 Certain Polybrominated Diphenylethers; Signif icant New Use Rule (S NUR) and Test Rule 14

15
AGENCY: Environmental Protection Agency (EPA). 16

ACTION: Proposed rule. 17

SUMMARY: The Agency is proposing to amend the Toxic Substances Control Act (TSCA) 18 section 5(a) Significant New Use Rule (SNUR), at 40 CFR 721.10000, that requires any person 19
who intends to manufacture or import tetrabromodiphenyl ether (CASRN 40088

– 47

– 9; 20 Benzene, 1,1 ′

- oxybis

- , tetrabrom o deriv.) (tetraBDE), pentabromodiphenyl ether (CAS R N 21
32534

- 81

- 9 ; Benzene, 1,1’

- oxybis

- , pentabromo deriv. ) (pentaBDE) , hexabromodiphenyl ether 22 (CASRN 36483

– 60

– 0; Benzene, 1,1 ′

- oxybis

- , hexabromo deriv.) (hexaBDE), 23 heptabromodiphenyl ether (CASRN 68928

– 8 0

– 3; Benzene, 1,1 ′

- oxybis

- , heptabromo deriv.) 24 (heptaBDE), octabromodiphenyl ether (CAS R N 32536

- 52

- 0 ; Benzene, 1,1’

- oxybis

- , octabromo 25
deriv. ) (octaBDE)

, or nonabromodiphenyl ether (CASRN 63936

– 56

– 1; Benzene, pentabromo 26 (tetrabromophenoxy)

- ) (nonaBDE) , o r any combination for certain polybrominated diphenyl 27 ethers (PBDEs) by: (1) desi gnating processing of six PBDEs, or any combination - of these 28 substances resulting from a chemical reaction, for any use on or after January 1, 2005, to notify 29 EPA at least 90 days in advance. EPA is proposing to amend the SNUR by: ( 1) designating 30

process ing of the six polybrominated diphe nyl ethers ( PBDE ) s , or any combination of these 31 substances resulting from a chemical reaction, for any use as a significant new use, (2) 32 designating manufacturing, impor ting, and processing of a seve nth PBDE, decabromodiphenyl 33 ether ( CAS R N 1163

- 19

- 5 ; Benze ne, 1,1’

- oxybis[2,3,4,5,6

- pentabromo

- ) ( decaBDE) for any use 34 after December 31, 2012, except military a nd transportation uses, and for any use including 35 military and transportation uses which is not ongoing after December 31, 2013

, as a significant 36 new use, and (3) making inapplicable the article exemption at 721.45(f) for SNURs for this 37*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 2 of 91 action. A ny A person who intends to import or process any chemical substance subject to of the 38
seven PBDEs included in the proposed SNUR, as part of an article for a significant new use 39
would be subject to signifi cant new use reporting. The purpose of amending th e existing SNUR 40
is required to notify EPA at least 90 days in advance to ensure that the Ag ency has an opportunity 41 to review and, if necessary, take action to restrict or prohibit a new use

, such as resumption of 42
discontinued uses of PBDEs before they resume. EPA expects all manufactu r e and processing of 43

P BDEs

, except as impurities, to be discontinued by th e dates specified above. it begins. EPA is 44 also proposing a test rule under section 4(a )(1)(A ) of TSCA that would require any person who 45 manufactures or processes commercial pentaBDE ( pentabromodiphenyl ether ( c-pentaBDE), 46
commercial octaBDE octabromodiphenyl ether (c-octaBDE), or commercial decaBDE (c47 decaBDE), including in articles, for any use after December 31, 2012, except for military and 48 transportation uses of c

- decaBDE, or after December 31, 2013 for a ny use including military and 49 transportation uses of c

- decaBD E 2013 to conduct testing to obtain data on their effects on health 50 effects, environmental effects, and chemical fate

. The proposed test rule specifies that testing of 51

c

- pentaBDE

, c

- octaBDE , and c

- decaBDE be conducted on a representative commercial product 52
of each

. The require d testing would provide EPA with data necessary to determine the effects of 53 manufacture, distribution in commerce, processing, use, and disposal of c

- pentaBDE , c

54
octaBDE , and c

- decaBDE or any combination of such activities on health or and the 55
environment. EPA is proposing to designate all discont inued uses of PBDEs as significant new 56
uses. The test rule would only be promulgated if EPA determines that there are persons 57 manufacturing, importing who intend to manufacture, import , or processing process c-pentaBDE, 58 c-octaBDE, or c-decaBDE

, for any use, except as impurities including in articles , after the dates 59 specified above. December 31, 2013. 60

61
DATES: Comments must be received on or before [ insert date 60 days after date of publication 62
in the Federal Register ]. 63

] 64

ADDRESSES: Submit your comments, identified by doc ket identification (ID) number EPA– 65 HQ–OPPT– 20 0 9

- 0 357 2010-1039 , by one of the following methods: 66

• • Federal eRulemaking Portal : : http://www.regulations.gov . Follow the on-line 67 instructions for submitting comments. 68

• • Mail : Document Control Office (7407M), Office of Pollution Prevention and 69 Toxics (OPPT), Environmental Protection Ag ency, 1200 Pennsylvania Ave., NW., Washington, 70
DC 20460–0001. 71

• • Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 72 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ– 73
OPPT– 20 0 9

- 0 357 2010-1039 . The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, 74 excluding legal holidays. The te lephone number for the DCO is (202) 564–8930. Such deliveries 75 are only accepted during the DCO’s normal hours of operation, and special arrangements should 76
be made for deliveries of boxed information. 77

Instructions : Direct your comments to doc ket ID number EPA–HQ–OPPT– 20 0 9

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

Page 3 of 91 0 357 2010-1039 . EPA's policy is that all comments re ceived will be included in the docket 79 without change and may be made available on-line at http://www.regulations.gov , including any 80 personal information provided, unless the comme nt includes information claimed to be 81 Confidential Business Information (CBI) or other information whose disclosure is restricted by 82 statute. Do not submit information that you cons ider to be CBI or ot herwise protected through 83 regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which 84 means EPA will not know your identity or contac t information unless you provide it in the body 85 of your comment. If you send an e-mail co mment directly to EP A without going through 86 regulations.gov, your e-mail address will be automati cally captured and included as part of the 87 comment that is placed in the docket and made available on the Internet. If you submit an 88 electronic comment, EPA recomme nds that you include your name and other contact information 89 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 90 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 91 be able to consider your comment . Electronic files should avoid the use of special characters, 92 any form of encryption, and be free of any defects or viruses. 93

Docket : All documents in the docket are list ed in the docket index available at 94 http://www.regulations.gov

. . Although listed in the index, so me information is not publicly 95 available, e.g., CBI or other information whose disc losure is restricted by statute. Certain other 96 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 97
available docket materials ar e available elect ronically at http://www.regulations.gov

, , or, if only 98 available in hard copy, at the OPPT Docket. Th e OPPT Docket is located in the EPA Docket 99 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 100 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 101 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 102 Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 103 Docket visitors are required to show photographic identificati on, pass through a metal detector, 104 and sign the EPA visitor log. All visitor bags are processe d through an X-ray machine and 105 subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 106 the building and retu rned upon departure. 107

FOR FURTHER INFORMATION CONTACT: For technical information regarding the 108
SNUR contact : John Bowser, Chemical Control Divi sion, Office of Pollution Prevention and 109 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 110 20460–0001; telephone number: 202- 564-8082; e-mail addresses: 111 bowser.john@epa.gov bowser.john@epa.gov

. 112

For technical information regar ding the test rule contact : Catherine Roman, Chemical Control 113 Division, Office of Pollution Prevention and T oxics, Environmental Protection Agency, 1200 114 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-8708; e115
mail addresses: roman.catherine@epa.gov

. 116

For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 117 Rochester, NY 14620; telephone numb er: (202) 554–1404; e-mail address: TSCA118 Hotline@epa.gov

. . 119

SUPPLEMENTARY INFORMATION: 120*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 4 of 91 I. General Information 121

A. Does this Action Apply to Me? 122

You may be affected by this action if you manufacture or process tetraBDE, pentaBDE, 123 hexaBDE, heptaBDE, octaBDE, nonaBDE, or d ecaBDE, or intend to, including as part of a 124
mixture or article. TSCA define s manufacture to include import. Unless otherwise noted in this 125 preamble, use of the term “manufacture” include s import. Manufacturers and processors in 126
certain industries to whom this action may apply include, but are not limited to: 127

• Manufacturers and processors of subject chem ical substances and mixtures with North 128 American Industry Classification System (NAICS) codes 325 and 324110,, e.g., chemical 129 manufacturing and petroleum refineries. 130

• textile manufacturers and processo rs (NAICS codes 313, 314, and 315), 131

• furniture manufacturers (NAICS code 337), 132

• manufacturers and processors of pol yurethane foam (NAICS code 326150), 133

• manufacturers of high impact pol ystyrene (HIPS) and acrylonitr ile-butadiene-styrene (ABS) 134 plastics (NAICS codes 325, 326140, and 3261), and 135

• manufacturers of electronics eq uipment (NAICS codes 334 and 335). 136

This listing is not intended to be exha ustive, but rather provides a guide for 137 readers regarding entities likely to be affected by th is action. Other types of entities not listed in 138
this unit could also be affected. The North Am erican Industrial Classification System (NAICS) 139 codes have been provided to assi st you and others in determining whether this ac tion might apply 140 to certain entities. If you have any questions regarding the app licability of this action to a 141 particular entity, consult the technical person listed under FOR FURTHER INFORMATION 142
CONTACT

. . 143

This action may also affect certain entitie s through pre-existing import certification and 144 export notification rules under TSCA. See Units VII and VIII for a discussion of how this action 145 may affect import certification and e xport notification re quirements. 146

This action may also affect certain entities through pre

- existing import certification and 147 export notification rule s under TSCA. Persons who import any chemi cal substance identified in 148 a final SNUR are subject to the TSCA section 13 import requirements

, codified at 19 CFR 149 12.118 through 12.127 ; see also 19 CFR 127.28. Those persons must certify that the shipment of 150 the chemical substance complies with all app licable rules and orders under TSCA, including any 151 SNUR requirements. The EPA policy in support of import certification a ppears at 40 CFR part 152 707, subpart B. In addition, any persons who expor t or intend to export a chemical substance 153 that is the subjec t of th e proposed SNUR on or after [insert date 30 days after the date of 154 publication in the Federal Register] are subject to the export notificati on provisions of TSCA 155 section 12(b) (15 U.S.C. 2611(b)), (see 40 CF R 721.20), and must comply with the export 156 notification requirements in 40 CFR part 707, subpart D. Persons who export or intend to export 157*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 5 of 91 a chemical substance or mixture identified in the proposed test rule will be subject to the export 158 notification provisions of TSCA section 12(b) if the test r ule is finalized . However, persons who 159 export or intend to export articles containing chemical substances or mixtures subject to a final 160
test rule would not be required to submit notice of export. 161
162
B. What Should I Consider as I Prepare My Comments for EPA? 163

1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e164 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 165 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD166 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 167
information that is claimed as CBI. In additi on to one complete version of the comment that 168 includes information claimed as CBI, a copy of the comment that does not contain the 169 information claimed as CBI must be submitted for inclusion in the public docket. Information so 170 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 171

2. Tips for preparing your comments . When submitting comments, remember to: 172

i. Identify the document by docket ID number and other identifying information (subject 173 heading, Federal Register date and page number). 174

ii. Follow directions. The Agency may ask you to respond to specific questions or 175 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 176

iii. Explain why you agree or disagree; suggest alternatives and substitute language for 177 your requested changes. 178

iv. Describe any assumptions and provide a ny technical information and/or data that you 179
used. 180

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 181 sufficient detail to allow for it to be reproduced. 182

vi. Provide specific examples to illustra te your concerns and suggest alternatives. 183

vii. Explain your views as cl early as possible, avoiding the use of profanity or personal 184
threats. 185

viii. Make sure to submit your comments by the comment period deadline identified. 186

C. Can I Request an Opportunity to Pr esent Oral Comments to the Agency? 187

You may submit a request for an opportunity to present oral comments on this proposed 188 test rule. This request must be made in writing. If such a request is received on or before [ insert 189
date 90 days after date of publication in the Federal Register ], EPA will hold a public meeting 190 on this proposed test rule in Washington, DC. This written request must be submitted to the 191 mailing or hand delivery addresses provided under ADDRESSES . If such a request is received, 192 EPA will announce the scheduling of the public meeting in a subsequent document in the 193 Federal Register . If a public meeting is announced, and if you are inte rested in attending or 194*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 6 of 91 presenting oral and/or written comments at the public meeting, you should follow the 195 instructions provided in the subsequent Federal Register document announcing the public 196 meeting. 197

II. Background 198

A. What Action is the Agency Taking? 199

The Agency is proposing to amend the S NUR at 40 CFR section 721.10000 (Ref. 1) that 200 requires any person who intends to manufacture or import te traBDE, pentaBDE, hexaBDE, 201 heptaBDE, octaBDE, or nonaBDE, or any combinati on of these chemical substances that results 202 from a chemical reaction, for any use on or afte r January 1, 2005, to notify EPA at least 90 days 203 in advance. EPA is proposing to amend the S NUR by: (1) designating processing of any of the 204 six PBDEs after December 31, 201 2 2013 for any use which is not ongoing as a significant new 205 use, (2) designating manufacturing, importi ng, and processing of a seventh PBDE, 206 decabromodiphenyl ether (decaBDE) (CAS No. 1163-19-5) for any use except military and 207 transportation uses after December 31, 2012, and manufact ure and process ing of decaBDE for 208

any use including military and transportation which is not ongoing after December 31, 2013, as a 209 significant new uses use , and (3) making inapplicable for this SNUR, the article exemption for 210
SNURs at 40 CFR 721.45(f). A person that imports or proc esses any of the chemical substances 211 identified in the proposed SNUR for a significant new use as part of an article would not be 212 exempt from subject to the significant new use notification requirements. No person would be 213 able to begin manufacturing, importing, or processing , including as contained in an article, any 214
of the chemical substances id entified in the proposed SNUR fo r a significant new use without 215 first submitting a significant ne w use notification (SNUN) to EPA. Ongoing uses would be 216
excluded from the SNUR. 217
218 EPA will not designate ongoing uses as signi ficant new uses. Persons who manufacture, 219 import, or process any of the chemicals include d in the proposed SNUR, including as contained 220 in an article, for an ongoing use, would be free to continue without submitting a SNUN. Note, 221 however, that uses not already ongoing as of [ insert date of publication in the Federal Register ] 222 would not be considered ongoing uses if they later arise, even if they ar e in existence upon the 223
issuance of a final rule. Furtherm ore, uses that are ongoing as of [ insert date of publication in 224
the Federal Register ] would not be considered ongoing uses if they have ceased by the date of 225 issuance of a final rule. (See Unit V.C for furthe r discussion of what constitutes an ongoing use.) 226
227 Persons who intend to begin (or resume) commercial manufact ure or processing of the 228 chemical substance(s), including in articles, for a significant ne w use, would have to comply 229 with all applicable SNUN requirements. Unde r TSCA section 5(b)(1)( A), any person who is 230 required to submit a SNUN for a chemical substance and who is also required to submit test data 231 under a final test rule, must submit the test data at the time that the SNUN is submitted. 232
233 In this notice EPA is also proposing to issue a test rule under section 4(a )(1)(A ) of the 234 TSCA that would require any person who ma nufactures, imports, or processes c-pentaBDE or , c235
octaBDE including in articles for any use after December 31, 2012 ; or manufactures, imports, or 236

processes , or c-decaBDE for any use except military and transportation uses including in articles 237 after December 31, 2012 ; or m anufactures, imports, or processes c

- decaBDE for for any use , 238*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 7 of 91 including military and transportation uses, including in articles, after December 31, 2013 to 239 conduct testing of such commercial PBDE mi xtures to obtain data on health effects, 240 environmental effects, and chemical fa te in accordance with the test rule. Hereafter, Dec 31, 241
2012 and The effective date of the test rule will be after December 31, 2013 , will be referred to as 242
the relevant effective dates ; see 799.xxxx(k). The proposed test ru le specifies that testing of c243 pentaBDE, c-octaBDE, and c-decaBDE be conducte d on representative forms of the relevant 244 commercial mixtures. The commercial mixture, c-pentaBDE, typically contains tetraBDE, 245 pentaBDE and hexaBDE as the predominant com ponents; the commercial mixture, c-octaBDE, 246 typically contains hexaBDE, heptaBDE, octaBDE and nonaBDE as the predominant 247 components; and the commercial mixture, c-decaBDE, typically contains decaBDE in the 248 highest percent composition. 249
250
If EPA finds that the proposed significant new uses have not cease d by the specified 251
dat es manufacture, import or processing of c-pe ntaBDE, c-octaBDE or c-decaBDE for any 252 purpose, including as contained in an article othe r than as an impurity, will occur after December 253 31, 2013 , EPA will promulgate a final test rule to require persons who manufacture or process c

254 pentaBDE, c

- octaBDE

, or c

- decaBDE those mixtures to conduct testing to obtain data on health 255 effects, environmental effects, and chemical fate of those mixtures. The test rule would apply to 256 all uses, new or ongoing. The existence or ab sence of a SNUR does not affect a person’s 257 obligations under a test rule. The required testing would provide EPA with data necessary to 258
determine the effects on health and the environm ent if the manufacture an d processing of those 259
mixtures and the their associated use, distributi on in commerce and disposal are not discontinued. 260
261 EPA is seeking public comment on both the pr oposed SNUR and test rule. Comments 262 may address any aspect of the actions action being proposed today. Unit XI of this notice 263 contains a list of specific issues for which the Agency is seeking comment. The actions EPA is 264 proposing today are generally described in th e PBDE Action Plan released December 30, 2009 265 ( www.epa.gov/oppt/existingchemica ls/pubs/actionpl ans/pbde.html ). 266
267
268
B. Why is the Agency Taking this Action? 269
270
271
272
EPA is concerned about the effects PB DEs may have on human health and the 273
environment. As discussed in Unit III and the PB DE Action Plan (Ref. 66), there is evidence that 274 PBDEs may be toxic to both hum ans and wildlife. PBDEs have been found in human tissue, 275
wildlife and the environment

. (Refs. 15, 23, 31, and 41). However, a panel of experts in the 276 VCCEP reported to EPA that there is were insufficient data to fully evaluate the significance of 277 observed exposures. exposure to pentaBDE, octaBDE, and decaBDE (Refs. 48 and 49). 278
279
EPA is also concerned that the PBDEs incl uded in these proposed actions are highly 280 persistent in the environment. Some lowe r brominated PBDEs are both toxic and highly 281 bioaccumulative. Other, more highly brominated forms such as decaBDE may debrominate to 282
the more toxic and bioaccumulative lower brom inated forms. However, the overall impact of 283
debromination of decaBDE as a source of th e lower brominated PBDE congeners in the 284 environment has not been fully characterized. DecaBDE has been found at high levels in 285*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 8 of 91 predators such as peregrine falcons. The enviro nmental significance of such accumulations of 286 decaBDE has not been fully characterized. The exact mechanisms or pathways by which the 287
PBDEs , including those cont ained in articles, move into and through the environment and allow 288 humans and wildlife to become exposed are not fully understood. The data produced by some of 289 the tests included in the proposed test rule would be necessary to determine the effects on the 290 environment if manufacture and processing of c-pentaBDE, c-octaBDE, and c-decaBDE and 291 their associated use, distribution in co mmerce and disposal are not discontinued. 292
293 In December 2009, EPA received voluntary commitments from the principal 294 manufacturers and importer of c-decaBDE to pha se out manufacture and import for all uses by 295 December 31, 2013

. (Refs. 68 – 70). The phase out of c- decaBDE will be accomplished in two 296 steps. No later than December 31, 2012, th e manufacturers and the importer of c-decaBDE 297
would cease manufacture and import for all uses, including in articles, with the exception of 298 military and transportation uses. No la ter than December 31, 2013, they would cease 299 manufacture and import for all uses including military and transportation uses, including in 300 articles. The principal manufact urers and importer of c-decaBDE stated that the additional time 301 required for phasing out military and transportatio n uses was due to the stringent engineering 302 requirements and risks associated with these appli cations as well as the multiple levels of testing 303 and certification required for such product changes. EPA believes these activities manufacture 304 and processing for most uses of decaBDE will cease have ceased by the specified dates December 305 31, 2013 and is proposing to use its authority under section 5 of TSCA to designate 306
them discontinued uses as significant new uses. Once an activ ity has been determined, by rule, to 307 be a significant new use, persons may not manufact ure or process the chemical substance for that 308 activity without first submitting a significant new use notice (SNUN) to EPA. The Agency 309 would then have an opportunity to review and if necessary take act ion to restrict or prohibit the 310

new use. 311
312
C. 313
C. How would the proposed SNUR and Test Rule affect PBDEs contained in articles? 314
315 The proposed SNUR includes a proposal to e liminate the article ex emption for SNURs at 316 40 CFR 721.45(f), for the covered PBDEs. S ee 40 CFR 721.10000(c)(1) of the proposed rule. 317 In general, persons who import or process chemical substances contained in articles are exempt 318 from significant new use notification requirements. However, as discus sed in Unit III and the 319 PBDE Action Plan (Ref. 66), there is growing evidence that people and the environment are 320 exposed to PBDEs contained in articles, and that those PBDEs may have adverse effects on 321 human health and the environment. The Agency is concerned that commencement of new uses 322 of PBDEs or resumption of discontinued uses, including in articles, may lead to increased 323 exposure of humans and the environment to thes e chemicals. Making the article exemption for 324 SNURs inapplicable for this pr oposed SNUR would ensure that the Agency has an opportunity 325 to review and, if necessary, take action to restrict or prohibit significant new uses of PBDEs in 326 articles before they resume. Thus, anyone who intends to manufacture or process a PBDE for a 327 significant new use, including persons who intend to import or process articles containing a 328 PBDE for a significant new use, would have to submit a SNUN at l east 90 days before 329 commencing such activity. Any ongoing uses iden tified at the point of finalization, including 330 import or processing of articles containing PBDEs, would not be designated as significant new 331
uses. These activities would be allowed to continue wit hout the submission of a SNUN. 332*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 9 of 91 Eliminating article importers’ and article proce ssors’ exemption from the requirement to submit 333 a SNUN, as described in this proposed rule, w ould have no effect on article importers’ general 334 exemption from import certification requirements, or on the articles exem ption described at 40 335 CFR 707.60(b), respecting export notifications. 336
337 The proposed test rule applies to certai n commercial PBDE mi xtures, including those 338 contained in articles. See 799.xxxx(b)(1) of the proposed test rule. Importers of articles 339 containing c- pentaBDE, c-octa BDE, or c-decaBDE are consid ered manufacturers of these 340 mixtures and would be subject to the proposed te st rule, along with persons who domestically 341
manufacture these chemicals in bul k or as part of a mixture. Persons who process c-pentaBDE, 342 c-octaBDE, or c-decaBDE, including persons wh o process articles containing these mixtures, 343 would also be subject to the pr oposed test rule. (These tes ting requirements apply even in 344
circumstances where the manufactur e [including import] or proces sing is for purposes of export 345 from the United States.) Persons who do not know or cannot reasonably ascertain that they 346 manufacture or process a listed test rule mixtur e (based on all information in their possession or 347 control, as well as all information that a reasona ble person similarly situated might be expected 348 to possess, control, or know, or could obtain without unreasonable burden), would not be subject 349 to the rule for the listed mixtures. The proposed test rule would not requi re testing of articles 350
themselves

. The testing would be required of a repres entative commercial form of the c-PBDE 351
contained in the article. S ee 799.xxxx(a)(1) of the proposed test rule. Eliminating article 352 importers’ and article processors’ exemption fr om the requirement to conduct testing of c353 PBDEs, as described in this proposed rule, w ould have no effect on ar ticle importers’ general 354 exemption from import certification requirements, or on the articles exem ption described at 40 355 CFR 707.60(b), respecting export notifications. 356

This proposed rulemaking would not affect the article exemption at 40 CFR 707.60(b) for 357 notices of export under section 12 (b). Thus, persons who export PBDEs contained in articles 358 would remain exempt from the requirement to s ubmit a notice of export re specting such PBDEs. 359
See Unit VII. 360
361 Furthermore, this proposed rulemaking woul d not alter the applic ation of the import 362 certification regulations at 19 CFR 12.118 through 12.127. PBDEs contained in articles would 363
therefore continue to be exem pt from import certification re quirements under section 13(b). 364 PBDEs imported in bulk or as part of a mixt ure would continue to be subject to import 365 certification requirements under se ction 13(b), consistent with 19 CFR 12.120(b). See Unit VIII. 366
367
D. Why is EPA Proposing both a SNUR and a Test Rule? 368

EPA has found no evidence of manufacture or processing of c-pentaBDE or c-octaBDE 369 except as impurities. The principal manufacturers and importer of c-decaBDE have informed the 370 Agency that they intend to phase out manufact ure and import of the chemical no later than 371 December 31, 2013

. (Refs. 68 – 70). EPA believes that other ma nufacturers and importers of 372
decaBDE will also cease their act ivities by that date. EPA is proposing to amend the SNUR to 373
ensure that after these activit ies have been discontinued, no on e resumes them without notifying 374 EPA in advance, thereby providing EPA with an oppor tunity to review the new uses before they 375 commence. Before promulgating the amende d SNUR, EPA will verify through comments on 376 this action, or by other means, that the proposed significant new uses have ceased. EPA seeks 377*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 10 of 91 comment on whether anyone intends to manufacture, import or process any of the PBDEs 378 included in the proposed SNUR, including in articles containing pentaBDE

, octaBDE

, or 379
decaBDE except as impurities

, for any of the proposed significant new uses. 380
381
In the event that the activities propos ed as significant new uses of pentaBD E, octaBDE, 382
or decaBDE do not cease by the projected dates

, EPA is proposing a test rule to obtain 383
information needed to assess the effects on human s and the environment of the continued 384
manufacture and , import or processing of c-pentaBDE, c-octaBDE , and or c-decaBDE and the 385

a ssociated use, distribution in commerce and disposal

. the event these activities do not cease by 386 December 31, 2013. 387
388

D E

. Why does the proposed test rule include th ree commercial PBDE mixtures while the SNUR 389 includes seven PBDE congeners? 390
391 The test rule is designed to provide the Agency with data relevant to commercial PBDE 392 products actually in use or intended for use. There are three commer cial PBDE products: c393 pentaBDE, c-octaBDE, and c-decaBDE. The test rule proposes that testing be conducted on a 394 representative form of each commercial mixtur e to better understand th eir potential effects on 395
health and the environment. Some of the data ob tained by the test rule would address unmet data 396 needs identified by EPA thr ough the Voluntary Children’s Ch emical Evaluation Program 397 (VCCEP). All three of the commercial PBDE products are mixtures , but have different 398 predominant components. Other PBDE congeners may be present in the mixtures in lesser 399

amounts. 400
401 The SNUR is designed to provide the Agen cy with advance notice of manufacture or 402 processing of any one or any combination of th e seven PBDEs for a significant new use. Since 403 the composition of any future commercial PBDE products may vary in terms of congener 404 composition, the Agency determined that it would be more effective to in clude all seven of the 405 individual PBDE congeners in the SNUR. Thus, all congeners in any future commercial PBDE 406 product would be subject to the SNUR reporting requirements. 407
408

E F

. Will EPA Promulgate both the SNUR Test Rule and the Test Rule SNUR ? 409
410
EPA expects that the manufacture and processing of the c

- P BDEs identified in this 411 proposed action

, except as impurit ies , including these c

- PBDEs when contained in articles, will 412 have been discontinued by the dates indicated in the proposed amendments to the SNUR. EPA 413
intends to could promulgate a mendments to the SNUR designating both the test rule and the 414
SNUR. EPA’s focus in this rule making is on the phase-out of the manufacture and processing 415 for any use, including discontinued import of PDBEs for all uses, as a significant new use. 416
417
If EPA were to learn through comments on the proposed amendments to the SNUR or 418
test rule , or through other means, that a person who would be sub ject to the test rule intended to 419
continue , resume, or commence including in articles. EPA’s final action would depend on 420
whether the manufacture or proces sing of c-pentaBDE, c-octaBDE, or c-decaBDE will continue 421
after the relevant dates specified December 31, 2013, as explained in the proposed Unit II.F.1 and 422
Unit II.F.2. The existence or absence of a SNUR does not affect a pers on’s obligations under a 423
test rule in 799.xxxx(k)

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

Page 11 of 91 425
1. Reporting obligations if contin uing existing uses of PBDEs. If EPA were to learn 426 through comments on this proposed action, or thr ough other means, that a person intended to 427 manufacture or process c-pe ntaBDE, c-octaBDE, or c-de caBDE after December 31, 2013, EPA 428 would promulgate the test rule. If a person indicated his intenti on to continue to engage in an 429 activity proposed as a significant new use for a ny of these c-PBDEs, EPA would promulgate the 430 proposed amendments to the SNUR designating a ll other uses of that PBDE as significant new 431 uses. EPA would exclude the ongoing uses from th e final SNUR. Therefore, a person who is 432 manufacturing, importing or processing the c-PBDE s for an ongoing use after the effective date 433
of the test rule would not need to submit a SNUN for that use and would be allowed to continue 434 those activities while complying with the test rule . (See Unit V.C for further discussion of what 435 constitutes an ongoing use.) However, if EPA were to learn th at the only persons that would be 436 subject to the test rule w ould be persons that process (rather than manufacture) c-pentaBDE, c437 octaBDE, or c-decaBDE as impurities contained in articles, EPA would not require testing 438
because EPA has not determined whether this activ ity alone may present an unreasonable risk of 439 injury to health or the environment. For example, persons who grind old plastic pallets 440 containing decaBDE for the purpose of reusing th e ground material in the fabrication of “new” 441 plastic pallets would be considered processors of decaBDE as an impur ity, if the decaBDE is 442 unintentionally present in the recy cled product (see Unit II.C.). If d ecaBDE is still being used as 443 a flame retardant in a recycled product, it w ould have been considered to be processed. 444
445
EPA could promulgate both the test rule the SNUR for the corresponding PDBE 446

congeners , i.e., pentaBDE, octaBDE, and decaBDE

. If a person indicate s his intention to 447 continue to engage in an activity proposed as a significant new use for pentaBDE, octaBDE, or 448
decaBDE

, EPA intends to promulgate the proposed amendments to the SNUR designating all 449
other uses of that PBDE as significant new uses, but would exclud e the ongo ing use from the 450
SNUR. In that situation, EPA would also promulgate the test rule

. P erson s that manufactur e or 451

process that PBDE for the ongoing use after the dates spec ified in the test rule would be subject 452
to the test rule

. 453
454

F 2. Reporting obligations if initiating new uses of PBDEs, including resumption of 455
discontinued uses. Uses not ongoing at the time of the pr oposal would be desi gnated significant 456
new uses in the final SNUR. Us es ongoing at the time of this proposal, but discontinued at the 457 time the SNUR is finalized, would also be desi gnated significant new uses. As required under 458 TSCA section 5(b)(1)(A), if EPA has promulgated a final test rule for a chemical substance, any 459 person who is required to submit a SNUN before beginning the manufacture or processing of 460 that chemical substance is also required to subm it test data under the final test rule for that 461
substance at the time that the SNUN is subm itted. Persons who intend to begin (or resume) 462 commercial manufacture, import, or processing of the chemical substance(s), including in 463 articles, for such uses would have to comply with all applicable SNUN requirements, including 464
submission of data if a test rule is in effect , and wait until EPA’s statutorily-defined time period 465 for its review of the SNUN expires before commencing those activities. 466
467 EPA expects that the manufacture and proces sing of the PBDEs identified in this 468 proposed action, except as impurities, including th ese PBDEs when contained in articles, will 469 have been discontinued for most uses by the date indicated in the proposed amendments to the 470 SNUR. EPA intends to promulgate amendmen ts to the SNUR designating manufacture and 471*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 12 of 91 processing for any use which is not ongoi ng (including uses first arising after [ insert date of 472 publication in the Federal Register ] and uses discontinued since [ insert date of publication in 473
the Federal Register ]) as a significant new use. The proposed SNUR would not apply to any 474 ongoing uses identified at the point of fi nalization (i.e., uses arising before [ insert date of 475 publication in the Federal Register ] and which have not been discontinued as of the date of 476 finalization). All other uses, including discontinue d uses, would be designated as significant new 477 uses. EPA recognizes that certain portions of the proposed significant new use may be still 478 ongoing as of [ insert date of publication in the Federal Register ], and will verify whether they 479 have been discontinued (i.e., whether they are in deed ongoing) before issuing a final SNUR that 480 incorporates them. 481
482
483
484
G

. What is the Agency's Authority fo r Taking this Action? 485
486
1 . Significant New Use Rules (SNURs). Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) 487
authorizes EPA to determine that a use of a chem ical substance is a "significant new use." EPA 488 must make this determination by ru le after considering all relevant factors, includ ing those listed 489 in TSCA section 5(a)(2 )

. ). Once EPA determines that a use of a chemical substance is a 490 significant new use, TSCA section 5(a)(1)(B) re quires persons to submit a significant new use 491 notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical 492 substance for that use (15 U.S.C. 2604(a)(1)(B)). For purposes of section 5 of TSCA, the terms 493 “manufacture” and “process” mean manufacturin g or processing for commercial purposes. 494
495
2. Test Rule. Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states that it is the policy 496 of the United States that ‘‘adequ ate data should be developed w ith respect to the effect of 497
chemical substances and mixtures on health a nd the environment and that the development of 498 such data should be the responsibility of those who manufacture [which is defined by statue to 499 include import] and those who process such chemi cal substances and mixtures[.]’’ To implement 500 this policy, TSCA section 4(a)(1)(A) (15 U.S.C. 2603(a)(1)(A)) directs provides that EPA 501

to shall require by rule that manufacturers and/ or processors or both of chemical substances and 502 mixtures conduct testing, if the EPA Administrator finds that: 503

makes the findings under either or both section 4(a)(1)( ( A )( ) (an “A” finding) and 504 section 4(a)(1)(B) (a “B” finding) in a final rule. 505

506 Under section 4(a)(1)(A), the Administrator must find that: 507 ( i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical 508 substance or mixture, or that any combination of such activities, may present an unreasonable 509 risk of injury to health or the environment, 510 (ii) there are insufficient data and ex perience upon which the effects of such 511 manufacture, distribution in commer ce, processing, use, or disposal of such substance or mixture 512

or of any combination of such ac tivities on health or the en vironment can reasonably be 513 determined or predicted, and 514 (iii) testing of such substance or mixture with respect to such effects is necessary 515 to develop such data [.] 516*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 13 of 91 517
Under Once the EPA Administrator has made a finding under TSCA section 4(a)(1)( A), 518 EPA may require any type of health or envir onmental effects testing necessary to address 519 unanswered questions about the effects of the B), the Administrator must find that: 520 (i) a chemical substance or mixture that are relevant to whether is or will be produced in 521 substantial quantities, and (I) it enters or may r easonably be anticipated to enter the environment 522 in substantial quantities or (II) there is or may be significant or substantial human exposure to 523 such substance or mixture, 524 (ii) there are insufficient data a nd experience upon which the effects of the manufacture, 525 distribution in commerce, proces sing, use, or disposal of the chemical such substance or mixture

, 526 or of any combination of such activities on health or the environment can reasonably be 527 determined or predicted, and 528 (iii) testing of such substance or mixture wi th respect to such e ffects is necessary to 529 develop such data. 530
531 Under section 4(a)(2), if the Administrator finds that, in the case of a mixture, the 532 effects which the mixture’s manufacture, distribu tion in commerce, proce ssing, use, or disposal 533 or any combination of such activities , presents may have on health or the environment may not 534 be reasonably and more efficiently determined or predicted by testing the chemical substances 535 which comprise the mixture; the Administrator sh all by rule require that testing be conducted on 536
such mixture. 537

The purpose of the testing would be to deve lop data with respect to the health and 538
environmental effects for which there is an insu fficiency of data and experience, and which are 539 relevant to a determination that the manufacture, distribution in commerce, processing, use, or 540 disposal of the substance or mixture, or that any combination of such activities, does or does not 541 present an unreasonable risk of injury to health or the environment. 542
543 The extent to which such activities may affect health or the environment is dependent in 544 part upon the human and environmental exposure s to the chemical substance or mixture 545 occasioned by those activities. As an example, TSCA section 4(b)(2)(A) specifically addresses 546 testing for persistence of a subs tance. Testing to identify where and in what concentrations a 547 chemical substance or mixture may become pr esent in the environment contributes to an 548 understanding of human and environmental e xposures resulting from those activities. 549
550
Once the Administrator has made the releva nt findings under TSCA section 4(a), EPA 551 may require any health or environmental effects testing for which data are insufficient and which 552 are necessary to develop the data. EPA need not limit the scope of testing required to the factual 553 basis for the TSCA section 4(a)(1)(A)(i) findings. or 4(a)(1)(B)(i) as long as EPA also finds that 554 there are insufficient data and experience upon whic h the effects of the ma nufacture, distribution 555 in commerce, processing, use, or disposal of such substance or mixture or of any combination of 556
such activities on health or the environment can reasonably be determined or predicted, and that 557 testing is necessary to develop such data. This approach is explaine d in more detail in EPA’s 558 TSCA section 4(a)(1)(B) Final St atement of Policy (B Policy) (Ref. 2 ). published in the Federal 559 Register issue of May 14, 1993 (58 FR 28736, 28738–28739). (Ref. 2)

. 560

In this proposed test rule, based on a preliminary “A” finding, EPA would use its TSCA 561*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 14 of 91 authority under section 4(a) authority of TSCA to obtain require the development of data 562

necessary “which are relevant to determine whether a determination that the manufacture, 563 processing, distribution in co mmerce, use, or disposal . . . or any combination of such activities” 564 of any or all of the three commercial c- PBDE mixtures, i.e., c-pentaBDE, c-octaBDE, and c565 decaBDE, does or does not present an unreasonable risk of injury to health or the environment. 566
567 Pursuant to TSCA section 12(a)(2), EPA is also proposing to use its authority 568
under TSCA section 12 4 (a )(2 ) to require testing of mixtures named in this proposed test rule 569 which would otherwise be exempted from TSCA under 12(a)(1). TSCA section 12(a)(1) 570 exempts from TSCA the manufactur e, processing, or distribution in commerce of a mixture for 571 export from the United States in certain situati ons. Such testing would be for the purpose of 572 determining whether or not the mixture presents an unreasonable risk of inju ry to health within 573
the United States or to the environment of the United States

. 574

575
G H

. Applicability of General Provisions. 576
577
1. SNUR. General provisions for SNURs appear under 40 CFR part 721, subpart A. 578 These provisions describe persons subject to the rule, recordkeeping requirements, and 579 exemptions to reporting requirements , and applicability of the rule to uses occurring before the 580
effective date of the final rule

. . 581
582 However, the article exemption for SNURs at 40 CFR part 721.45(f) would not apply to 583 this proposed SNUR. A person who imports or pr ocesses a chemical substance that would be 584 covered by this action as pa rt of an article would not be exempt from submitting a be subject to 585 significant new use notice

. reporting requirements. A person who manufactures or processes a 586 PBDE only as an impurity would be exempt from the SNUR under 40 CFR part 721.45(d). 587
588 Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 589 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA 590 regulatory procedures as submitters of Prema nufacture Notices (PMNs) under TSCA section 591 5(a)(1)(A). In particular, these requirements include the information submissions requirements 592 of TSCA section 5(b) and 5(d)(1 ), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 593 (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 594 may take regulatory action under TSCA section 5( e), 5(f), 6 or 7 to control the activities on 595
which it has received the SNUN . If EPA does not take action, EPA is required under TSCA 596 section 5(g) to explain in the Federal Register its reasons for not taking action. 597
598 Persons who export or intend to export a chemical substan ce identified in a proposed or 599 final SNUR are subject to the export notificat ion provisions of TSCA section 12(b). The article 600 exemption at 40 CFR part 707.60( b ) would apply to this rule. P ersons who export or intend to 601 export articles containing chemical substances subject to this proposed rule would not be 602 required to submit no tice of export. The regulations that interpret TSCA section 12(b) appear at 603 40 CFR part 707, subpart D. Also, see Unit VII. 604
605 Persons who import a chemical substance identified in a final SNUR are subject to the 606 TSCA section 13 import requirements, codi fied at 19 CFR 12.118 through 12.127 ; see also 19 607
C FR 127.28. Such persons must certify that the shipment of the chem ical substance complies 608*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 15 of 91 with all applicable rules and orders under TS CA, including any SNUR requirements. The EPA 609

p olicy in support of import certification appears at 40 CFR part 707, subpart B. Also, see Unit 610
VIII. 611
612
613
2. Test Rule . General provisions for test rules ap pear under 40 CFR part 790 (subparts A, 614 B, C, and E), part 791, part 792, and part 799 (su bpart A). These provisions describe persons 615 subject to the rule, procedures for developing test rules, implementation, enforcement, and 616 modification of test rules, exemption from te sting, data reimbursement, and good laboratory 617 practice standards. Section 791.48( b) would not apply to this pr oposed test rule for the purpose 618 of defining production volume to determine fa ir reimbursement shares. Production volume 619 would be defined as including amounts of the test chemical imported in bulk form, in mixtures, 620 in articles, and the to tal domestic production of the chemi cal including that produced as a 621 byproduct or as an impurity. See 799.xxxx(f) of th e proposed rule. Also, persons described in 622 part 790.2 as subject to a test rule include, among others, importers and processors of a chemical 623 substance or mixture as part of an article. Submission of a SNUN would not affect a person’s 624 obligations under a test rule. 625
626 Persons who export or intend to export a chemical substance or mixture identified in a 627
final test rule are subj ect to the export notification pr ovisions of TSCA section 12(b). However, 628 persons who export or intend to export articles containing chemical substances or mixtures 629 subject to a final test rule would not be required to submit notice of export

. The regula tions that 630 interpret TSCA section 12(b) appe ar at 40 CFR part 707, subpart D. Also, see Unit VII. 631
632
III. Overview of PBDEs 633
634
A. Chemistry of PBDEs

. 635
636 The polybrominated diphenyl ethers (PBDEs) ar e a family of chemicals with a common 637 structure of a brominated diphenyl ether molecu le which may have anywhere from one to ten 638 bromine atoms attached. (Figure 1). 639
640 Figure 1. Brominated diphenyl molecule 641
642

O Br x Br y

x + y = 4 - 10 643 644 Each individual PBDE variant, distinguished from others by both the number of bromine 645 atoms and the placement of those atoms, is referre d to as a congener. For example, there are 42 646 tetrabromodiphenyl ether congeners, each with four bromine atoms in different configurations. 647 Specific congeners, also known as isomers, in which both the number and location of bromine 648 atoms is specified are given numbers, e.g., BDE-47. In theory, there could be as many as 209 649 PBDE congeners, but a much smaller numbe r of congeners are commonly found in the 650*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 16 of 91 commercial PBDE products and in measuremen ts of PBDEs in humans and the environment 651 (Table 1). Scientific studies, particularly thos e measuring presence of PBDEs in tissues and the 652 environment, often report th eir findings by BDE number. 653
654 PBDE congeners can be groupe d as homologs i.e., according to the number of bromine 655 atoms present in the molecule. TSCA inventory listings and regulations for PBDEs are based on 656 these homolog groups. (Table 1). The PBDE homol ogs used in flame retardants have between 657 four and ten bromine atoms. EPA regulations of PBDEs generally appl y to congeners grouped 658 according to homolog groups rather than speci fic congener/isomers designated by BDE number. 659
660 There are three types of commercial PBDE (c-PBDE) products, c-pentaBDE, c-octaBDE, 661 and c-decaBDE; each commercial product is a mi xture of PBDE congeners (see Table 2). 662
663 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
664 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
665

B

. Actions taken to understand and limit risk from use of PBDEs. 666
667 EPA has been concerned about the reported health and environmental effects of PBDEs 668 and potential exposure to PBDEs for some time, and has taken several actions to fully understand 669
their effects and to re duce exposure to them. Of particular note ar e the VCCEP, which was 670 announced in 2000 (Ref. 65), and the 2006 PBDE SNUR (Ref. 1). More recently, EPA 671 articulated its concerns regarding these eff ects in the 2009 action plan for PBDEs (Ref. 66). 672
673 C-PentaBDE, c-octaBDE, and c-decaBDE were among the chemicals evaluated in 674 VCCEP. That Program was designe d to collect health effects information on chemicals to which 675 children had a high likelihood of being exposed and to characterize the risk to children from that 676 exposure. Sponsors in VCCEP provided health effects and exposure information on a voluntary 677 basis. Through VCCEP the Agency identified data needs for all three c-PBDEs that were 678 beyond what was provided by the sponsors in the in itial chemical assessmen ts. The sponsors of 679*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 17 of 91 c-pentaBDE and c-octaBDE, however, declined to conduct testing to address the identified data 680 needs because of plans to discontinue manuf acture of these chemicals in 2004. Later the 681 sponsors of c-decaBDE also declined to conduct testing to provide the data needs identified 682 through VCCEP and subsequently decided to phas e out their activities wi th c-decaBDE. As a 683 result, the sponsoring companies did not meet the additional data needs identif ied through 684 VCCEP for any of the three c-PB DEs. Tests addressing those data needs are among the tests 685 proposed for c-pentaBDE, c-octaBDE, and c-decaBDE in this action. 686
687 C-pentaBDE and c-octaBDE had been widely used as additive flame retardants in a 688 number of applications until their sole U.S. ma nufacturer, the Great Lakes Chemical Corporation 689 (now Chemtura Corporation) voluntary phased out their production in 2004. C-PentaBDE was 690 used primarily in flexible polyurethane foams. C-OctaBDE was used in acrylonitrile-butadiene691 styrene (ABS) plastic which was used in applicat ions such as casing for certain electric and 692
electronic devices used in both offices and hom es. . When manufacture of c-pentaBDE and c693 octaBDE was discontinued, EPA promulgate d a SNUR (74 FR 34015, June 13, 2006) which 694 requires that any person who inte nds to manufacture or import a chemical substance containing 695 any of the congeners present in c-pentaBDE or c-octaBDE (namely tetraBDE, pentaBDE, 696 hexaBDE, heptaBDE, octaBDE, and nonaBDE), or any combination of these substances 697 resulting from a chemical reaction, to notify EPA at least 90 days in advance of manufacture or 698 import for any use on or after January 1, 2005. The SNUR does not address processing of 699 PBDEs, nor does it apply to import of articles wh ich contain any of the congeners present in c700 pentaBDE or c-octaBDE. 701
702 C-DecaBDE is still manufactured and widely used in the United States as an additive 703 flame retardant. The three majo r product categories in which c-de caBDE is used are: textiles, 704 electronic equipment, and building and construction materials. Its primary use is in high impact 705 polystyrene (HIPS) based products . However as a result of the voluntary phase-out announced 706 on December 17, 2009, (Refs. 68 – 70) EPA expects all manufacture and processing for most 707
uses of c-decaBDE except for military and transportation uses to be discontinued in the United 708 States by December 31, 2012, and all remaining uses including mili tary and transportation uses 709 to be discontinued by the end of 2013. 710

Other actions EPA has taken with PBDEs include (1) supporting he inclusion in 711 voluntary consensus standards of criteria restricting PBDE use as a product component (e.g., in 712 carpets, electronics, and furniture or use in manufacturing processes, and (2) working with and 713 through programs (i.e., Furniture Flame Retard ancy Partnership and the Green Suppliers 714 Network) to identify environmen tally safer approaches to meeti ng fire standards and to improve 715
awareness of concerns related to PBDEs. 716

C. Human Health Effects. 717
718 In 2008, EPA published peer-reviewed toxicolo gical reviews of tetraBDE (BDE-47), 719 pentaBDE (BDE-99), hexaBDE (BDE-153), and decaBDE (BDE-209) (Refs. 3-6), to support 720 summary information on EPA's Integrated Ri sk Information System (IRIS) database 721 (www.epa.gov/iris/ ). Developmental neurotoxicity was iden tified as the critical effect for each 722
of the four chemicals. EPA also concluded th at the database for decaBDE (BDE-209) provides 723 “suggestive evidence of carcinoge nic potential” (Ref. 6). 724*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 18 of 91 725 Through EPA’s Voluntary Children’s Chemi cal Evaluation Program(VCCEP), industry726 sponsored screening level risk assessments fo r c-pentaBDE, c-octaBDE and c-decaBDE were 727 developed to evaluate the poten tial risks to children and pr ospective parents from PBDE 728 exposures (Ref. 7). Adverse 65). EPA’s evaluation of these assessments considered adverse 729
neurobehavioral effects following exposure to PBDEs during the pos tnatal period are believed to 730 be the most sensitive health endpoint

. following postnatal exposure to PBDEs (Refs. 48 and 49). 731 Effects on spontaneous motor behavi or (locomotion, rearing, and tota l activity) were observed in 732 adult rats after postnatal exposure. Additional effects due to higher exposures to c-pentaBDE 733 were observed in the following studies: (1) Repeated-dose toxicity studies for c-pentaBDE 734 showed changes in liver enzyme activity, increased liver weight

, and histologic changes in the 735
liver. (2) Changes in thyroid hormone T 4 levels and thyroid hyperplasi a were noted in oral adult 736
rat studies. (3) In limited prenatal developm ental studies, decreases in T 4 levels were reported 737 for dams and offspring . The repeated (Ref. 48). Additional effects due to higher exposures to c738
octaBDE were observed in the fo llowing studies: (1) Repeated -dose toxicity studies for c

739
octaBDE showed changes in liver enzyme activ ity and increased liver weights. (2) In prenatal 740 developmental studies, decreased matern al and pup bodyweight and decreases in thyroid 741
hormone T 4 levels were reported for rat dams and their offspring. Evidence (Ref. 48). EPA 742
concluded there was evidence of developmental and reproductive effects was noted but from 743 exposure to c-pentaBDE and c-octaBDE, but that additional studies ar e needed to better 744 characterize potential risk s to children (Ref. 48)

. EPA through Through VCCEP , EPA identified 745 two-generation reproductive toxicity studi es with a satellite group for body burden 746
determinations as a data need for bot h c-pentaBDE and c-octaBDE (Ref. 48)

. Also through 747 VCCEP, EPA identified anaerobic debromination in aquatic sediments, anaerobic debromination 748 in sludge digesters, and photolysis in the indoo r environment as data needs for c-decaBDE to 749
better understand the chemical fate and thereby the potential exposure to decaBDE and lower 750 brominated congeners (Ref. 49)

. 751
752

D

. Environmental Hazard. 753
754 Laboratory studies have shown that c-pentaBDE is capable of producing adverse effects 755 in a variety of organisms includi ng birds, mammals, fish, and invert ebrates (Refs. 8-19). In some 756 cases, these effects were observed at exposure levels similar to levels found in the environment 757
758
E. Environmental Releases and Fate

. 759
760 The exact mechanisms or pathways by wh ich the PBDEs move into and through the 761 environment and allow humans to become expos ed are not fully understo od, but are likely to 762 include releases from manufacturing of the chem icals, processing c-PBDEs into products like 763 plastics or textiles, aging and wear of products like sofas and electronics, and releases at the end 764 of product life (disposal or recycling). In gene ral, levels of PBDE congeners in humans and the 765 environment are higher in North America than in other regions of the world, which may be 766 attributed to the greater use of c-PBDEs in North America ( Ref. 20 Refs. 74 and 75 ). The 767 concentration and distribution of congeners detect ed in the environment appear to depend on the 768 proximity to a source of the congener and the media tested. (Ref

. 74 20 ) 769
770 PBDE congeners with four to ten bromine atoms are highly persistent, based on a large 771*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 19 of 91 body of environmental monitoring data in both the United States and abroad (Refs 21-23). 772
Available data also indicate th at the tetra-, penta-, hexa- a nd heptaBDE congeners are highly 773 bioaccumulative (Ref. 24). After reviewing the available information, EPA has concluded that 774 decaBDE is a likely contributor to the form ation of bioaccumulative and/or potentially 775 bioaccumulative transformation products, such as lo wer brominated PBDEs, in organisms and in 776 the environment see, e.g., (Refs 25-28), but the overa ll impact of this process as a source of the 777 more toxic, lower brominated PBDE congeners has not been fully characterized. DecaBDE 778 undergoes photolytic and possibly microbial debr omination under certain conditions (Refs. 22 779 and 28). Photolysis is expected to be a significant transformation process for decaBDE 780 whenever the substance is significantly exposed to light. For example, it has been found that 781 decaBDE undergoes photolytic debromination in house dust (Ref. 29). DecaBDE would also be 782 exposed to light when waste sludg e containing PBDEs is used as a soil amendment, albeit only 783 on the soil surface (Ref. 30). Studies have show n that photodegradation of decaBDE may result 784 in PBDEs from tri- to nona-, although most photolysis studies were done under conditions that 785 do not allow direct extrapolation to environm ental conditions. Metabolism of decaBDE in 786 organisms results predominantly in nona-, octa- and heptaBDE formation (as reviewed in Ref. 787 22). Stapleton (Ref. 28) summarized the effects of decaB DE debromination, noting that the 788 formation potential for the pentaBDE and lower c ongeners was low, but that the formation of the 789 hepta, octa and nonaBDE congeners was environmentally relevant. 790
791 The atmosphere and marine currents can tr ansport PBDEs over relatively long distances 792 (> 1,000 km). Evidence for this comes from the pr esence of PBDEs in the tissues of deep ocean793 dwelling whales and other marine mamma ls far from anthropogenic sources (Ref. 23), as well as 794 from modeling (Ref. 30). The body burdens of PB DE congeners in a wide variety of biota, 795 indigenous to geographical areas ranging from the equator to th e poles also substantiate the 796 PBDE propensity for long-range transport (LRT), and constitute evid ence of environmental 797 persistence ( Ref. 24 ). 798
799

F

. Human Exposure

. 800
801 The use of c-PBDEs as flame retardants in consumer products is believed to be a source 802 of exposure. Dermal exposure may occur th rough direct contact with c-PBDE-containing 803 products such as computer housings and textiles (Ref. 31). The lower brominated tetra- and 804 penta- congeners have also been detected in the vapor phase of air samples while the higher 805 brominated congeners are found in associated pa rticulate matter, including house dust (Refs. 32 806 and 33). Lorber (Ref.33) and EPA (Ref. 31) reported that a signifi cant source of human 807 exposures to PBDEs appears to be their use in commercial products that are part of the indoor 808 environment (computer circuitry, foam cushions, fabrics in curtains, et c). They found that 809 food/water ingestion and inhala tion explained less than 20% of the body burden, based upon the 810 estimate of total exposure derived using a pharmac okinetic model. They stat ed that the remainder 811 of the estimated exposure likely came from house dust through the pathways of ingestion and 812 dermal contact, or some other, unknown source. Ot her literature indicates that inhalation may be 813 a significant potential route of exposure for the general populati on (Ref. 31). In addition, PBDE 814 exposure can occur by ingestion of foods that are contaminated (Ref. 35). PBDEs have been 815 detected in human tissue, blood (usua lly serum), and breast milk (Ref. 36)

. Exposures Exposure 816 to PBDEs in some occupational settings, such as in computer recycling, can be higher than those 817 of the general population (Ref. 37). PBDE use as flame retardants in many household products, 818*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 20 of 91 and subsequent exposure to indoor house dust co ntaining PBDEs, coupled with the elevated 819 ingestion potential due to increased intakes of food, water, and air pe r pound of body weight, as 820 well as childhood-specific exposure pathways such as breast milk consumption and increased 821 contact with the floor, make chil dren especially vulnerable. 822
823 Recent human biomonitoring data on PBDEs are available in CDC’s “Fourth National 824 Report on Human Exposure to Environmental Chemical” 825 (http://www.cdc.gov/exposurereport/). Chemicals” (Ref. 38). The PBDE data have also been 826 published in the peer-rev iewed literature (Ref. 38 37 ). The data were obtained from samples 827 from participants in the 2003-2004 National Hea lth and Nutrition Examination Survey (Ref. 828
39 38 ). Ten PBDE congeners (containing from thr ee to seven bromines) were included in the 829 analysis: BDE-17, BDE-28, BDE-47, BDE- 66, BDE-85, BDE-99, BDE-100, BDE-153, BDE830 154 and BDE-183; decaBDE was not included. Participants were aged 12 years and older. 831
BDE-47 was detected in serum from almost all of the participants a nd it was highest in 12-19 832 years old, and those over 59 years old. Furthermor e, serum levels were highest in 12-19 year 833 olds for other lower brominated congeners. In addition, these congeners were significantly 834 correlated with each other--concentration of individual congeners and total PBDE content in 835 blood serum steadily increased annu ally over a five year period, s uggesting a similar pathway of 836 exposure via diet, or via direct inhalation or dermal contact (Ref. 38).

. 837
838
G

. Environmental Exposure

. 839
840 The food chain is likely a larg e contributor to environmenta l exposures. In general, 841 PBDE concentrations are highest in sedi ment samples collected downstream from 842 industrial/urban areas, outfalls from sewage treatment plants, a nd urban locations without heavy 843
industries. The lowest PBDE concentrations are generally found in sediments collected in 844 remote and agricultural areas. DecaBDE (BDE-209) appears to dominate congener profiles of 845 aquatic sediments. Researchers have determin ed concentrations of PBDEs in waterways, 846 sediments, and biota from various locations such as the Great Lakes, the San Francisco Bay, and 847 near unnamed polyurethane foam manufacturing facility for which PBDE contamination was 848 known or suspected. (Ref. 31) 849
850
Some studies show evidence that concentra tions of PBDEs in biota have doubled every 3 851 to 6 years, the doubling time depending on species, lif e stage, and location. PBDE levels in trout 852
from the Great Lakes rose from non-detectab le in 1975, to approxima tely 50 nanograms/gram 853 (ng/g) in 1990, and to approxi mately 200 ng/gm in 2000 (Ref. 40)

. PBDE concentrations in 854 marine biota in North America are the highest in the world, and are increasing (Ref. 23). After 855 reviewing the available information, EPA has c oncluded that the extent of accumulation of 856 congeners in biota is directly re lated to dietary levels of PBDEs. Observed differences in PBDE 857 congener profiles in marine mammals from Californi a, Alaska, and the Gulf of Mexico indicate 858 that diet is a significan t source of PBDE exposure in marine wildlife (Ref.23)

. 859
860 DecaBDE has been found at high levels in pr edators such as peregrine falcons (Ref. 41)

. 861 Biomonitoring studies of wild mink from the Great Lakes region revealed th at margins of safety 862 for mink are small, and that PBDE concentratio ns in mink from Hamilton Harbor exceeded the 863
no observed adverse effect concentrations (Ref. 15 ). 864
865*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 21 of 91 Biomagnification is the process in which the concentration of a chemical in an organism 866 achieves a level that exceeds that in the organism ’s diet, due to dietary absorption (Ref. 42). 867 Biomagnification occurs as predators up the f ood chain ingest the accumulated PBDEs in the 868 bodies of their prey (Refs. 23, 43- 45). Environment Canada conclude d that the greatest potential 869
risks from PBDEs in the Canadian environment are the secondary poisoni ng of wildlife from the 870 consumption of prey containing elevated con centrations of PBDEs, and effects on benthic 871 organisms that may result from elevated con centrations of certain PBDEs in sediments ( Ref. 24 ). 872 Biomagnification of PBDEs has been observed in fi sh; PBDE levels in sediment were directly 873
related to increases and decreases in the PBDE levels measured in fish ( Ref. 46 ). Environment 874
Canada concluded that decaBDE is available fo r uptake in organisms, and may accumulate to 875 high and potentially problematic leve ls in certain species such as birds of prey or mammalian 876 predators (Ref. 22). 877
878 Although not conclusive, some data suggests that PBDEs may debrom inate in the bodies 879 of wild birds. Park, et al., (Ref. 40) found th at younger peregrine falcons had higher levels of 880 BDE-209 and other highly brominated congeners, wh ereas older birds had higher levels of the 881 less brominated (hexa) BDE-153, which could not be explained by the BDE-153 levels in diet. 882 Further, in eggs that were collected yearly fr om the same bird, PBDE congener concentrations 883 changed yearly, with levels of BDE-209 decreasing, and levels of BDE 153 increasing in the two 884 last years relative to the former four years (but no such obvious changes in polychlorinated 885 biphenyl (PCB) levels). The chemical measurem ents and comparison in this study are valuable 886 because a similar laboratory study would take ma ny years in similar long-lived avian species 887 (peregrines live 7-15 years or longer), and enviro nmental variables that affect PBDE uptake and 888 biomagnifications, including exposur e to other chemicals, might be difficult to simulate. Similar 889
evidence of debromination of decaBDE has been observed in carp (Refs. 28 and 47) and British 890 starlings (Ref. 47). 891
892 IV. Proposed Findings 893

A. SNUR. 894

Section 5(a)(2) of TSCA states that EPA' s determination that a use of a chemical 895 substance is a significant new us e must be made after consider ation of all relevant factors 896 including: 897
898 • The projected volume of manufacturing and processing of a ch emical substance. 899
900 • The extent to which a use changes the t ype or form of exposure of human beings 901
or the environment to a chemical substance. 902
903
• The extent to which a use increases th e magnitude and duration of exposure of 904 human beings or the environment to a chemical substance. 905
906 • The reasonably anticipated manner a nd methods of manufacturing, processing, 907 distribution, in commerce, and disposal of a chemical substance. 908
909
To determine what would constitute a si gnificant new use of PBDEs, EPA also 910*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 22 of 91 considered other relevant factors including inform ation about the toxicity of PBDEs as well as 911 exposures and environmental presence resulting from past use. 912
913 As discussed in Unit III, there is eviden ce that PBDEs may be toxic to humans and 914 wildlife. However, there is insufficient data to fully evaluate the significance of observed 915 exposures. EPA is also concerne d that the PBDEs included in thes e proposed amendments to the 916 SNUR are highly persistent in the environment. Some lower brominated PBDEs are highly 917 bioaccumulative, and others may debrominate to the lower brominated forms. In general, levels 918 of PBDEs in humans and the environment are highe r in North America than in other regions of 919 the world, which may be attributed to the grea ter use of PBDE in No rth America. Some 920 monitoring data show a steady incr ease from non-detectable levels when PBDEs first came into 921
use to current levels. The exact mechanisms or pathways by which the PBDEs move into and 922 through the environment and allow humans and wildlife to become exposed are not fully 923 understood, but are likely to include releases from manufacturing of the chemicals, processing 924 PBDEs into products like plastic s or textiles, aging and wear of products like sofas and 925 electronics, and releases at the end of product life (dis posal or recycling). 926
927 Once the manufacture and processing of PB DEs have been discontinued, EPA expects 928 their presence in humans and the environment to d ecline over time as has been observed in the 929 past when production and use of othe r persistent chemicals has ceased. 930
931
EPA is concerned that if manufacture and processing of PBDEs were to resume, the 932 anticipated decline in levels in humans and th e environment will be disrupted as PBDEs are 933 introduced into the environment at levels greate r than would otherwise oc cur. The result would 934 be that the magnitude and durat ion of exposure of humans and the environment in the future 935 would likely increase. 936
937

B . Test Rule. 938

Based on the data cited in Unit III.C. through III.G. of this preamble, EPA has made the 939 following preliminary determinations. First, c-pentaBDE, c-octaBDE, and c-decaBDE may 940 present a hazard to human health. C-pentaBDE, c-octaBDE and c-decaBDE were all reviewed 941 under EPA’s VCCEP program. Members of the p eer consultation panel for c-pentaBDE and c942
octaBDE noted that there are indi cations of thyroid toxicity in some rodent studies, and thyroid 943 toxicity can have adverse eff ects on reproductive success and fetal development (Ref. 48). For 944 c-decaBDE, VCCEP identified anaerobic debrom ination in aquatic sediments, anaerobic 945 debromination in sludge digesters, and photolysis in the indoor environment as a potential source 946 of human and environmental exposure to lower br ominated congeners (Ref. 49). Debromination 947 of decaBDE to form lower brominated, more toxi c congeners is potentially relevant to effects on 948
both human health and the environment. EPA’s IRIS database indicates that neurobehavioral 949 effects are critical endpoints of concern for components of c-pentaBDE and c-decaBDE. EPA 950 has also concluded that there is suggestiv e evidence of carcinogeni c potential for decaBDE 951 (BDE-209), which is the main component of c-decaBDE. 952

Second, c-pentaBDE and c-decaBDE may pres ent a hazard to the environment. 953 Laboratory studies have shown th at c-pentaBDE is capable of producing adverse effects in a 954 variety of organisms including birds, mammals, fi sh, and invertebrates. In some cases these 955*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 23 of 91 effects were observed at exposure levels similar to levels found in the environment. C-decaBDE 956 may contribute to these levels by debrominating to lower, more toxic brominated congeners in 957
the environment. 958

Third, pentaBDE, octaBDE, and decaBDE congeners, which are among the predominant 959 components of c-pentaBDE, c-octaBDE, and c- decaBDE respectively, are ubiquitous in soil, 960 sediments and living organisms (Ref. 50). Pent aBDE, octaBDE, and decaBDE congeners have 961 been found in human tissue, blood and breast milk (Ref. 51). These chemicals persist in the 962 environment and accumulate in organisms that inge st or inhale them. For example, high levels 963 of decaBDE have been found in high trophic leve l animals, e.g., predatory animals such as the 964 peregrine falcon. However, the predominant conge ners present in living organisms tend to be 965 the lower brominated, more toxic forms, which in clude pentaBDE (Refs. 52 and 53). Infants and 966 children, as well as people who ar e occupationally exposed, may be exposed at higher levels than 967 the general public. 968

Based on the evidence of human and envir onmental exposure to pentaBDE, octaBDE, 969 and decaBDE congeners, which derive from c- pentaBDE, c-octaBDE, and c-decaBDE, coupled 970
with the evidence of human and/or environmen tal hazard of c-pentaBDE, c-octaBDE, and c971 decaBDE, EPA preliminarily finds under TSCA section 4(a)(1)(A)(i) that the manufacture, 972 processing, distribution in comm erce, use, and disposal of c-pentaBDE, c-octaBDE, and c973 decaBDE, or any combination of such activities, may present an unreasonable risk of injury to 974
human health and the environment. 975
976 Through the testing of c-pentaBDE and c- octaBDE in VCCEP, EPA identified two977 generation reproductive toxicity studies with a satel lite group for body burden determinations as 978 a data need for c-pentaBDE and c-octaBDE (Ref. 48)

. For c-decaBDE, VCCEP identified 979 anaerobic debromination in aquatic sediments, anaerobic debromination in sludge digesters, and 980 photolysis in the indoor environment as data needs (Ref. 49). Therefore, EPA also preliminarily 981 finds under TSCA section 4(a)(1)(A)(i i) that there are insufficient data upon which the effects of 982 such manufacture, processing, di stribution in commerce, use, a nd disposal of c-pentaBDE, c983 octaBDE, and c-decaBDE, or any combination of such activities, on health or the environment 984 can reasonably be determined or predicted. Under TSCA section 4(a)(1)(A)(iii), EPA 985 preliminarily finds that testing of c-pentaBDE, c-octaBDE, and c-decaBDE with respect to these 986
and other toxic effects is nece ssary to develop such data. 987
988
EPA has determined in accordance with secti on 4(a)(2) of TSCA that the effects of the 989 mixtures, c-pentaBDE, c-octaBDE, and c-decaB DE, may be reasonably and more efficiently 990 determined by testing the commercial products th emselves rather than the individual chemical 991 substances which comprise these mixtures. EPA be lieves that testing of the individual chemical 992 substances that are present in the commercial mixtures at different percentages would be a less 993
efficient mechanism to determine and less predictive of the effects of the commercial mixtures 994 than testing of representativ e forms of commercial products as they are manufactured. EPA 995 believes that testing the mixture will best refl ect the effects of exposure due to the possible 996 additive, synergistic, and/or an tagonistic effects resulting from the possible interaction of 997 congeners in a mixture. EPA believes that testin g the commercial products will be more efficient 998 than testing the individual components because fewer tests would be needed to address the 999 Agency’s concerns. Nonetheless, EPA is still requesting comment in Unit XI.B.4. through 1000*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 24 of 91 XI.B.7. on what the test substance shoul d be and how it should be defined. 1001
1002 V. Proposed Amendments to the SNUR 1003

A . Summary of proposed amendments to the SNUR. 1004

This proposed rule would amend the signi ficant new use rule at 40 CFR part 721.10000. 1005 Under the existing SNUR, any person who inte nds to manufacture certain PBDEs must notify 1006 EPA at least 90 days before commencing the manuf acture of any one or more of those chemical 1007 substances after January 1, 2005 for any use. Th e following chemicals substances are subject to 1008 reporting under the existing SNUR : tetraBDE, pentaBDE, hexaBD E, heptaBDE, octaBDE, and 1009 nonaBDE, or any combination of these substa nces resulting from a chemical reaction. 1010
1011 Among other activities, the use of a PBDE in the manufacture of an article is considered 1012 processing of the PBDE. In the existing SNUR, the Agency did not designate processing of the 1013 subject PBDEs as a significant new use because it believed that such activities were ongoing. 1014 The Agency now believes that processing of these chemical substances tetraBDE, pentaBDE, 1015 hexaBDE, heptaBDE, octaBDE, and nonaBDE has been discontinued and therefore is proposing 1016 to amend the SNUR to include processing as a significant new use. EPA believes that resumption 1017 of the practice of processing PBDEs would increa se exposure to PBDEs and releases of PBDEs 1018
to the environment. However, as explained in Unit II.F, if a person indicated that he is engaged 1019 in an activity proposed as a significant new us e for these PBDEs, EPA would promulgate the 1020 proposed amendments to the SNUR designating a ll other uses of that PBDE as significant new 1021 uses. EPA would exclude the ongoing use(s) fr om the final SNUR. The Agency requests 1022 comments on whether there is existing, ongoing processing on these chemicals. 1023
1024 On December 19, 2009 the princi ple U.S. manufacturers and importers importer of 1025 decaBDE committed to end production, and importati on of decaBDE in the United States for all 1026 uses except military uses and transportation uses by December 31, 2012, and for all uses 1027 including military and transpor tation uses by the end of 2013

. (Refs. 68 – 70). The Agency also 1028 expects all other manufacturers to discontinue manufacture and use of decaBDE by the end of 1029 2013. Therefore, the Agency is proposing to amend the SNUR by adding , after December 31, 1030 2013, decaBDE to the list of chemicals subject to reporting and by designating (again, after 1031 December 31, 2013) manufacture and processing of decaBDE for any u se except military and 1032 transportation use after December 31, 2012 discontinued use as a significant new use. The 1033 Agency is proposing to designate understands that some downst ream users of decaBDE would 1034
like the manufacture and processing of decaBDE for a ny use, including military and 1035 transportation some uses , after December 31, 2013

, a signifi cant new use. Military use means use 1036 by the armed forces of to continue after December 31, 2013. The Agency understands that these 1037
downstream users believe that there will continue to be critical military and aeronautical uses of 1038 decaBDE (some examples are use in insulation, ducting, electronic components) after December 1039 31, 2013. The Agency seeks comments on the United States, or preparati on of an article for use 1040 by extent to which these uses will continue despite the armed forces phase-out in the manufacture 1041 and import of the United States. Transportation use means preparation decaBDE and whether 1042 there are any other uses which will not be discontinued by December 31, 2013. Persons who 1043 comment are asked to specify both the functional application of an article for use as an integral 1044 component of a moving vehicle such as a car, truck, train, ship, or the article containing 1045*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 25 of 91 decaBDE, e.g. ductwork for aircraft

. , and the material to which the decaBDE is added, e.g. high 1046 impact polystyrene. Persons who comment shoul d also include definitions of terms where 1047 appropriate. 1048
1049 EPA’s immediate objective in proposing thes e amendments to the PBDE SNUR is to 1050 enable the Agency to review and, if necessar y, limit or prohibit resumption of any activities 1051
which could result in increasi ng the amount of PBDEs in commerce in the United States. 1052
1053 Under the general SNUR exemption provisions at 40 CFR part 721.45, a person that 1054 imports or processes a substance covere d by a SNUR identified in subpart E of 40 CFR part 721 1055 is not generally subject to th e notification re quirements of § 40 CFR part 721.25 for that 1056 substance, if the person imports or processes the substance as part of an article. However, EPA 1057
is concerned that if PBDEs cont ained in articles are exempt, th ey could be imported without a 1058
notification SNUN and thereby increase the amount of PBDEs in commerce in the United States 1059 without a review by EPA. Therefore, the Ag ency is proposing that the article exemption for 1060
SNURs at § 40 CFR part 721.45(f) not apply to this action. 1061
1062
1063
B. Alternatives to the Significant New Use Rule. 1064

Before proposing these amendments to the PBDE SNUR, EPA considered the following 1065 alternative regulatory actions: 1066
1067 1. Promulgate a TSCA s ection 8(a) reporting rule

. Under a TSCA section 8(a) rule, 1068 EPA could, among other things, generally require persons to report information to the Agency 1069 when they intend to manufacture or process a lis ted chemical for a specific use or any use. 1070 However, for polybrominated diphenyl ethers the use of TSCA section 8(a) rather than SNUR 1071 authority would have several limitations. First, if EPA was to require reporting under TSCA 1072 section 8(a) instead of TSCA s ection 5(a), EPA would not have the opportunity to review human 1073 and environmental hazards and exposures associat ed with the proposed significant new uses and, 1074 if necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to 1075 prohibit or limit the activity before it begins. In view of the le vel of health and environmental 1076 concerns about the chemicals subj ect to this proposed rule, if they were used for the proposed 1077 significant new uses, EPA believes that a TSCA s ection 8(a) rule for th is substance would not 1078 meet EPA's regulatory objectives. 1079
1080 2. Regulate under TSCA section 6. EPA may regulate under TSCA section 6 if "the 1081
Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, 1082 distribution in commerce, use or di sposal of a chemical substance or mixture “ . . presents or will 1083 present an unreasonable risk of injury to health or the environment." (TSCA section 6(a)). 1084
Given that the chemicals named in this proposed rule are no longer being manufactured or 1085 processed for the proposed significant new uses , or the activities are scheduled to be 1086 discontinued, EPA concluded th at risk management action un der TSCA section 6 is not 1087 necessary at this time. These proposed amendm ents to the SNUR would allow the Agency to 1088 address the potential risks associated with the proposed significant new use. If the EPA is 1089 proposing to require that persons who manufacture and processing of , import, or process c1090 pentaBDE or , c- octaBDE, including in articles, resumes or c-decaBDE after December 12, 2012, 1091*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 26 of 91 or if the manufacture and processing of decaBDE, including in articles, does not cease as 1092 anticipated, EPA is propos ing to require that persons e ngaging in those activities 31, 2013 1093 conduct testing in accordance with the proposed test rule which accompanies these proposed 1094
amendments to the SNUR. The data obtained through such testing will assist the Agency may 1095

pursue in determining whether additional regulatory action as is appropriate. 1096
1097
C. Applicability of the Signifi cant New Use Rule to Uses Occurring before Begun After the 1098 Effect ive Date Publication of the Final This Proposed Rule and Uses Begun Prior to the 1099 Publication of this Proposed Rule. 1100

As With respect to uses that are not ongoi ng as of the date of publication of the 1101 proposed rule, as discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 1102
decided that the intent of sect ion 5(a)(1)(B) of TSCA is best served by designating a use as a 1103 significant new use as of the date of publication of the proposed rule ra ther than as of the 1104
effective date of the final rule. If uses be gun after publication of th e proposed rule were 1105 considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice 1106 requirements, because a person could defeat the SNUR by initiating the proposed significant new 1107 use before the rule became final, and then argu e that the use was ongoing as of the effective date 1108
of the final rule. EPA has decided that a similar interpretation is appropriate for a SNUR that is 1109 premised in part on all uses ceasing between proposal and promulgation of a final rule. Thus, 1110 persons who begin commercial manufacture or processing of the chemical substance(s), or 1111 articles containing those chemical substances that would be regulated through this proposed rule, 1112 if finalized, would have to cease any such activity before the effective date of the rule if and 1113
when finalized

. , where such manufacture or processi ng was not ongoing at the time of proposal. 1114 This applies to all entities that do not currently engage in these activitie s; it does not apply to 1115 entities that are currently engaged in these activities

-- i.e., the entities EPA expects to terminate 1116 such activities by the proposed significant new use dates of the SNUR.

. To resume their 1117 activities, these person s would have to comply with all applicable SNUR notice requirements 1118 and wait until the notice review pe riod, including all ex tensions, expires. EPA has promulgated 1119 provisions (40 CFR 721.45(h)) to allow persons to comply with this SNUR submit a SNUN 1120
before the effective date of the SNUR . If a person were to meet the conditions of advance 1121 compliance un der 40 CFR section 721.45(h), that person would be considered to have met the 1122 requirements of the final SNUR for those activities , when that final SNUR became effective

. 1123
1124 In this action, EPA proposes to designate as significant new uses certain uses that are 1125 ongoing as of the date of publication of the propos ed rule, but for which there is a reasonable 1126 expectation that the use will be discontinued in the near future. Such uses would not be 1127 designated as significant new uses if they remain ongoing at the time the SNUR is finalized. 1128 EPA’s 1990 decision (55 FR 17376) regarding uses commenced after proposal and ongoing at 1129 the time the SNUR is finalized (i.e., that th ey may be designated as significant new uses, 1130 notwithstanding the fact th at they are ongoing at the time of fina lization) is inapplicable to uses 1131 that are ongoing as of the date of publication of the proposed rule. 1132
1133
D. Test Data and Other Information 1134

EPA recognizes that TSCA section 5 generally does not require the development of any 1135 particular test data before submission of a SNUN , however EPA is also pr oposing a test rule for 1136*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 27 of 91 c- pentaBDE, c- octaBDE, and c- decaBDE under TSCA section 4(a ). If )(1)(A). Under TSCA 1137 section 5(b)(1), if a chemical is subject to a test rule, persons submitting a significant new use 1138
notice SNUN are required to comply submit test data in accordance with data submission 1139 requirements under TSCA 5(b) (1)

. the test rule at the time the SNUN is submitted. In the 1140
absence of a test rule or a section 5(b)(4) rule (see TSCA section 5(b)(2)) covering the chemical 1141 substance, persons are required to submit test data in their possession or control and to describe 1142 any other data known to or reasonably ascertain able by them (see section 720.50). As a general 1143 matter, EPA recommends that SNUN submitters include data that would permit a reasoned 1144 evaluation of risks posed by the chemical substan ce during its manufacture, processing, or use. 1145 EPA encourages persons to consult with the Agen cy before submitting a SNUN. As part of this 1146 optional pre-notice consultation, EPA would discuss sp ecific data it believes may be useful in 1147 evaluating a significant new use. SNUNs submitte d for significant new uses without any test 1148 data may increase the likelihood th at EPA will take action under TS CA section 5(e) to prohibit 1149
or limit activities associated with this chemical. 1150
1151
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that 1152 provide detailed information on: 1153
1154 1. Human exposure and environmental releas es that may result from the significant new 1155
uses of the chemical substance. 1156
2. Potential benefits of the chemical substance. 1157 3. Information on risks posed by the chemical substances resulting from the significant new 1158 use compared to risks posed by pot ential substitutes. 1159
1160

E . SNUN Submissions. 1161

EPA recommends that submitters consult with the Agency prior to submitting a SNUN to 1162 discuss what data may be useful in evaluati ng a significant new use. Discussions with the 1163 Agency prior to submission can afford ample time to conduct any tests that might be helpful in 1164 evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a 1165 SNUN must comply with the same notice re quirements and EPA regulatory procedures as 1166 persons submitting a PMN, including submission of test data on health and environmental effects 1167
as described in 40 CFR 720.50. 1168
1169 According to 40 CFR 721.1(c), persons s ubmitting a SNUN must comply with the 1170 same notice requirements and EPA regulatory procedures as persons submitting a PMN, 1171 including submission of test data on health and environmental e ffects as described in 40 CFR 1172 part 720.50. SNUNs must be mailed to on EPA Form No. 7710–25, generated using e-PMN 1173 software, and submitted to the Environmental Protection Agency , OPPT Document Control 1174 Office (7407M), 1200 Pennsylvania Avenue, NW., Washington, D.C. 20460

- 0001. Information 1175
must be submitted in the form and manner in accordance with the procedures set forth in EPA 1176
Form No. 7710

- 25. This form is available from the Environmental Assistance Division 1177 (7408M), 1200 Pennsylvania Ave nue, NW., Washington, D.C. 20460

- 0001 (see 40 CFR 721.25 1178
and 720.40 ). Forms and information are also . E-PMN software is available electronically at 1179 http :// www.epa.gov/opptintr/newchems/pubs/pmnforms.htm

. http://www.epa.gov/opptintr/newch 1180
ems/

. 1181
1182*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 28 of 91 VI. Proposed Test Rule 1183

A . What Testing is Being Proposed in this Action? 1184

EPA is proposing specific testing an d reporting requirements for c-pentaBDE, c1185 octaBDE, and c-decaBDE. These requirements ar e presented in Table 3 of this unit. 1186

Table 3: Proposed Testing and Reporting Requirement s for PentaBDE, OctaBDE, and DecaBDE 1187

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

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

Page 29 of 91 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 1188 when toxicity to various organisms of sediment-associated contaminants is tested. 1189

2. ASTM E 1391-03 provides general guidance. 1190

3. ASTM E 1676-04 provides guidance for collecting laboratory soil. 1191

4. A developmental neurotoxicity study of decaBDE (R ef. 54) conducted according to OECD Guideline 426 and 1192 sponsored by the Bromine Science and Environmental Forum (BSEF) was submitted to EPA. If EPA considers the 1193 study to be adequately conducted and the study requirements of OECD 426 comparable to the study requirements 1194 of 40 CFR 799.9630, EPA will most lik ely accept the study and not finalize th e proposed requir ement to conduct 1195 developmental neurotoxicity testing of c-decaBDE. 1196

The proposed testing requirements are listed in § 40 CFR part 799.XXXX(h) and (i) of the 1197 proposed regulatory text and include the specific ation of test methods covering health effects 1198 testing, ecotoxicity testing, and chemical fate te sting. EPA's TSCA 799 test guidelines (40 CFR 1199 part 799, subpart H) and Office of Chemical Sa fety and Pollution Prevention (OCSPP) 835 series 1200 guidelines have been harmonized with the OECD test guidelines. However, EPA is specifying 1201 that the TSCA 799 test guidelines and OCSPP 835 guidelines, as well as American Society for 1202 Testing and Materials International (ASTM Internati onal) standards, be used rather than OECD 1203 test guidelines because the language in the TSCA 799 test guidelines, the OCSPP 835 series 1204 guidelines, and the ASTM Intern ational standards makes clear which steps are mandatory and 1205 which steps are only recommended. Accordingly, in order to comp ly with the testing required 1206 by a final rule, EPA is proposing that testing must be conducted in accordance with the specified 1207*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 30 of 91 TSCA 799, OCSPP series 835, and ASTM Internationa l test guidelines. In addition, EPA is 1208 proposing a guideline developed by the Agency to test for photolytic degradation. 1209

Most of the proposed testing re quirements for a particular endpoi nt are specified in one test 1210
standard. In the case of certain endpoints, however, additional guidance is provided in a second 1211 guideline and possibly a third guideline (e.g., ASTM E 1391-03 provides guidance in the 1212 collection, storage, characteriza tion, and manipulation of sediment s when toxicity to various 1213 organisms of sediment-associated contaminants is tested). The following testing endpoints and 1214 test standards are proposed to be required for one or more of the test substances in this rule. 1215

1. Ecotoxicity: 1216

a. Toxicity to freshwater inve rtebrates of sediment-associated contaminants conducted 1217 in accordance with ASTM E 1706-05e1 (Ref. 55) and following the guidance of ASTM E 1391- 1218 03 (Ref. 56)

. EPA proposes this guideline as appropriate to evaluate the toxi city to freshwater 1219
invertebrates of the test substance when associated with whole sediments. 1220

b. Laboratory soil toxicity and bioaccumulati on tests with the lumbricid earthworm 1221 Eisenia fetida and the enchytraeid potworm E nchytraeus albidu conducted in accordance with 1222 ASTM E 1676-04 (Ref. 57) and following the ge neral guidance of ASTM E 1391-03 (Ref. 56). 1223 EPA proposes this guideline as appropriate to evaluate the adverse e ffects and bioaccumulation 1224 in earthworms and potworms of the test substance when associated with soils. 1225

c. Toxicity to polychaetous anni lids of sediment-associated contaminants conducted in 1226 accordance with ASTM E 1611-00 (Ref. 58) and following the guidance of ASTM E 1391-03 1227 (Ref. 56). EPA proposes this guideline as appropri ate to evaluate the t oxicity to polychaetous 1228
annelids of the test substance when associated with sediment. 1229

d. Laboratory soil toxicity to nematode Caenorhabditis elegans conducted in 1230 accordance with ASTM E 2172-01 (Ref. 59) and following the general guidance of ASTM E 1231 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the adverse effects on 1232
nematodes of the test substance when associated with soils. 1233

e. Toxicity to estuarine and marine inverteb rates of sediment-associated contaminants 1234 conducted in accordance with ASTM E 1367-03 (Ref. 60) and following the guidance of ASTM 1235 E 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evalua te the toxicity to 1236 estuarine or marine organisms of the test subs tance when associated with whole sediments. 1237

2. Mammalian toxicity: 1238

a. Prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 1239 799.9370. EPA proposes this guideline as appropriat e to provide general information concerning 1240 the effects of exposure to the test substance on the pregnant test anim al and on the developing 1241 organism. 1242

b. Two-generation reproductive toxicity with a satellite group for body burden 1243
determinations conducted in accordance with 40 CFR 799.9380. EPA proposes this guideline as 1244 appropriate to provide general information co ncerning the effects of exposure to the test 1245*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 31 of 91 substance on the integrity and pe rformance of the male and fema le reproductive systems, and on 1246 the growth and development of the offspring. 1247

c. Immunotoxicity conducted in accordance with 40 CFR 799.9780. EPA proposes this 1248 guideline as appropriate to provide informati on on suppression of the immune system which 1249 might occur as a result of repeated exposure to a test chemical. 1250

d. Neurotoxicity screening batte ry, acute and subchronic, conducted in accordance with 1251 40 CFR 799.9620. EPA proposes this guideline as appropriate to provide information on gross 1252 functional deficits, level of ac tivity, and histopathologi cal changes in the cen tral and peripheral 1253 nervous systems of the test animals as a resu lt of acute and subchronic exposure to a test 1254
chemical. 1255

e. Developmental neurotoxicity conducted in accordance with 40 CFR 799.9630. EPA 1256 proposes this guideline as appropriate to develop data on the potential functional and 1257 morphological hazards to the nervous system whic h may arise in the offspring from exposure of 1258 the mother during pregnancy and lactation. 1259

f. Chronic toxicity/Carcinogenicity con ducted in accordance with 40 CFR 799.9430. 1260 EPA proposes this guideline as appropriate to id entify the majority of chronic and carcinogenic 1261 effects and determine dose-response relationshi ps in a mammalian species following prolonged 1262 and repeated exposure to a test substance. 1263

3. Chemical Fate: 1264

a. Anaerobic aquatic metabolism conducted in accordance with OCSPP 835.4400 as 1265 modified for c-decaBDE in section 799.XXXX(i)(2). EPA proposes this guideline as appropriate 1266
to assess transformation of decaBDE in anaerobic aquatic sediment systems. 1267

b. Biodegradation in anaerobic digester sl udge conducted in accordance with OCSPP 1268
835.3280 as modified for c-decaBDE in section 79 9.XXXX (i)(3). EPA propos es this guideline 1269 as appropriate to assess biotransform ation in anaerobic digester sludge. 1270

c. Photolytic degradation of c-decaBDE conducted in accordance with an EPA1271 developed method in section 799.X XXX(i)(4). EPA proposes this guideline as appropriate to 1272 assess whether PBDEs can migrate out of plastic s/fabrics by volatilizatio n; and if photolytic 1273 degradation can take place on the surfaces of plastics and fabrics. 1274

B. When Would any Testing Proposed by this Rule Begin? 1275

The testing requirements contained in this proposed rule are not effective until and unless 1276 the Agency issues a final rule. If an y manufacturer or pro cessor of c-pentaBDE or , c-octaBDE

, 1277
or c-decaBDE is subject to the test rule after December 31, 2012 2013 , the test sponsor may plan 1278 the initiation of any required te sting as appropriate to submit the required final report by the 1279
deadline indicated as the nu mber of months, shown in § 799.XXX(j) of the proposed regulatory 1280 text, after December 31, 2012

. If any manufacturer or processor of c

- decaBDE is subject to the 1281 test rule after Dec 31, 2012, the test sponsor need not begin testing until it is known whether 1282
there are manufacturers o r processors of c

- decaBDE for military and transportation uses that will 1283*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 32 of 91 be subject to the test rule after December 31, 2013. The test sponsor will then k now whether 1284 there are additional persons subject to th e rule after December 31, 2013, from the letter s of intent 1285 to test or exemption applications which would have to be filed by the deadline of January 30, 1286 2014 (30days after the relevant eff ective date of December 31, 2013). After December 31, 2013, 1287
all the test sponsor(s) for decaBDE may plan the testi ng as appropriate to submit the required 1288
final report s by the deadline s indicated as the number of months, shown in § 799.XXX X (j) of the 1289 final regulatory text, after December 31, 2013. 1290

40 CFR part 799.XXX(j) of the proposed regulatory text, after December 31, 2013. 1291

C. How Would the Studies Proposed unde r this Test Rule be Conducted? 1292

Persons required to comply with the fi nal rule would have to conduct the necessary 1293 testing in accordance with the testing and repor ting requirements establis hed in the regulatory 1294 text of the final rule, with 40 CFR Part 790—Procedures Governing Testing Consent 1295 Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) of § part 790.45; § part 1296 790.48; paragraph (a)(2) a nd paragraph (b) of § part 790.80; paragraph (e)(1) of § part 790.82; and 1297 § part 790.85), and with 40 CFR Part 792—G ood Laboratory Practice Standards. 1298

D. What Forms of Test Mixtures W ould be Tested Under this Rule? 1299

The test rule proposes that th e test mixtures be the repres entative forms of pentaBDE1300 containing commercial mixtures, octaBDE-containing commercial mixtures, and decaBDE1301 containing commercial mixt ures. To fully describe the three test mixtures, the percentage of 1302 each of the seven congeners present in each of th e three test mixtures must be identified by the 1303 test sponsor(s). 1304
1305 Each of the three proposed test mixtures is described by its predominant components. C1306 pentaBDE) is a mixture predominantly comprise d of pentaBDE, tetraBDE, and hexaBDE. C1307 octaBDE is a mixture predominantly compri sed of octaBDE, hexaBDE, heptaBDE, and 1308
nonaBDE. C-decaBDE is a mixture with decaBDE being present in the highest percentage. 1309 EPA believes that the proposed testing of c-pe ntaBDE, c-octaBDE, and c-decaBDE will provide 1310 EPA with data necessary to determine the e ffects of commercial PBDE products on human 1311
health and the environment. EPA is seeki ng comment on whether testing of c-pentaBDE, c1312
octaBDE and c-decaBDE should be conducted with the pure congener or each congener in each 1313 mixture instead of the commercial products. EPA is also seeking comment on whether its 1314 descriptions of the commercial mixtures to be tested accurately predict what commercial forms 1315 of pentaBDE, octaBDE, and decaBDE might be produced. Finally, EPA solicits comment on 1316
whether more than one commercial form each of c-pentaBDE, c-octaBDE, and c-decaBDE 1317
should be tested. 1318
1319
E. Would I Be Required to Test Under this Rule? 1320

Under TSCA section 4(a)(1)(A)(ii), EPA ha s made preliminary findings that there are 1321 insufficient data and experience to reasonably de termine or predict health and environmental 1322 effects resulting from the manufacture, proce ssing, use, and distribution in commerce of the 1323 mixtures listed in this proposed rule. As a re sult, under TSCA section 4(b)(3)(B), manufacturers 1324 and processors of mixtures listed in this propo sed rule, and those who intend to manufacture or 1325*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 33 of 91 process them, would be subject to the rule with regard to those listed mixtures which they 1326 manufacture or process. 1327

1. Would I be subject to this rule? You would be subject to this rule and may be required 1328 to test if you manufacture (which is defined by stat ute to include import) or process, or intend to 1329 manufacture or process, one or more mixtures listed in this pr oposed test rule during the time 1330 period discussed in Unit VI.E.2. Yo u would also be subject to th is rule if you manufacture or 1331 process the subject mixtures for export from the Un ited States. For this rule, importers of articles 1332 which include c-pentaBDE, c-octaBDE, or c-de caBDE would be considered manufacturers and 1333 subject to this rule. If you do not know or ca nnot reasonably ascertain that you manufacture or 1334 process a listed test rule mixture (based on all information in your possession or control, as well 1335
as all information that a reas onable person similarly situated might be expected to possess, 1336 control, or know, or could obt ain without unreasonable burden), you would not be subject to the 1337
rule for that listed mixtures. 1338

2. When would my manufacture or processing (o r my intent to do so) cause me to be 1339 subject to this rule? You would be subject to this rule if you manufacture or process, or intend to 1340 manufacture or process, a mixture liste d in the rule at any time from the relevant effective date in 1341 799.xxxx(k) of the final test rule to the end of the test data reimbursement period. The term 1342 “reimbursement period” is defi ned at 40 CFR 791.3(h) and may vary in length for each mixture 1343 to be tested under a final TSCA section 4(a) test rule, depending on what testing is required and 1344 when testing is completed. See Unit VI.E.4. 1345

3. Would I be required to test if I were subject to the rule? It depends on the nature of 1346 your activities. All persons who would be subjec t to this TSCA section 4(a) test rule, which, 1347 unless otherwise noted in the regulatory text, in corporates EPA’s generic procedures applicable 1348 to TSCA section 4(a) test rule s (contained within 40 CFR part 790), would fall into one of two 1349 groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who would have to 1350 initially comply with the final rule) would either: 1351

• Submit to EPA letters of intent to conduc t testing, conduct this testing, and submit the 1352 test data to EPA, or 1353

• Apply to and obtain from EPA exemptions from testing. 1354

Persons in Tier 2 (those who would not have to initially comply with the final rule) would 1355 not need to take any action unless they are no tified by EPA that they are required to do so 1356 (because, for example, no person in Tier 1 had subm itted a letter of intent to conduct testing), as 1357 described in Unit VI.E.3.d. Note that both person s in Tier 1 who obtain exemptions and persons 1358 in Tier 2 would nonetheless be subject to pr oviding reimbursement to persons who actually 1359 conduct the testing, as described in Unit VI.E.4. 1360

a. Who would be in Tier 1 and Tier 2? All persons who would be subject to the final rule 1361
are considered to be in Tier 1 un less they fall within Tier 2. Tabl e 4 of this unit describes who is 1362
in Tier 1 and Tier 2. 1363

Table 4.--Persons Subject to the Ru le: Persons in Tier 1 and Tier 2 Tier 1 (Persons initially required to Tier 2 (Persons not initially required to comply)*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 34 of 91 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)).

1364

Under 40 CFR 790.2, EPA may establish procedures applying to specif ic test rules that 1365 differ from the generic procedures governing TSCA section 4(a) test ru les in 40 CFR part 790. 1366 For purposes of this proposed rule, EPA is propos ing to establish certain requirements that differ 1367 from those under 40 CFR part 790. 1368

In this proposed test rule, EPA has conf igured the tiers in 40 CFR 790.42 as in certain 1369 previous test rules. In add ition to processors, manufacturers of less than 500 kg (1,100 lbs.) per 1370 year (‘‘small-volume manufacturer s’’), and manufacturers of small quantities for research and 1371 development (‘‘R&D manufacturers’’), EPA ha s added the following persons to Tier 2: 1372 Manufacturers of byproducts, manufacturers of impur ities, manufacturers of naturally occurring 1373 chemical substances, manufacturers of non-isol ated intermediates, and manufacturers of 1374 components of Class 2 chemical substances. The Agency took administrative burden and 1375 complexity into account in determining who was to be in Tier 1 in this proposed rule. EPA 1376 believes that those persons in Tier 1 who woul d conduct testing under this proposed rule, when 1377 finalized, would generally be large chemical manufacturers who, in the experience of the 1378 Agency, have traditionally conducted testing or pa rticipated in testing consortia under previous 1379 TSCA section 4(a) test rules. 1380

The Agency also believes that manufact urers of byproducts, impurities, naturally 1381 occurring chemical substances, manufacturers of non-isolated intermediate s, and manufacturers 1382 of components of Class 2 chemical substances hist orically have not themselves participated in 1383 testing or contributed to reim bursement of those persons who have conducted testing. EPA 1384*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 35 of 91 understands that these manufacturers may include persons for whom the marginal transaction 1385 costs involved in negotiating and administering testing arrangements are deemed likely to raise 1386 the expense and burden of testing to a level that is disproportional to the additional benefits of 1387 including these persons in Tier 1. Therefore, EPA is not proposi ng to burden these persons with 1388 Tier 1 requirements (e.g., submitting requests for exemptions). Nevertheless, these persons, 1389 along with all other persons in Tier 2, would be subject to reimbursement obligations to persons 1390 who actually conduct the testing, as described in Unit VI.E.4. 1391

TSCA section 4(b)(3)(B) requi res all manufacturers and/or pro cessors of a mixture to test 1392
that mixture if EPA has made fi ndings under TSCA sections 4(a)(1 )(A)(ii) or 4(a )(1)(B)(ii) for 1393 that mixture, and issued a TSCA section 4(a) test rule requiring testing. However, practicality 1394 must be a factor in determining who is subject to a particular te st rule. Thus, persons who do not 1395 know or cannot reasonably ascertai n that they are manufacturing or processing a mixture subject 1396 to this proposed rule, e.g., manufacturers or pro cessors of a mixture as a trace contaminant who 1397
are not aware of or cannot reasonab ly ascertain these activities, woul d not be subject to the rule. 1398
See Unit VI.E.1.and §799 40 CFR part799 .XXXX(b)(2) of the proposed regulatory text. 1399

EPA believes it is possible that there will be no persons in Tiers 1 and 2A that will be 1400 subject to the test rule. If EPA learns that th e only persons that would be subject to the rule 1401 would be persons that process c-pentaBDE, c-oc taBDE, or c-decaBDE as impurities contained in 1402 articles, EPA will not require testing because EPA has not determined whether this activity alone 1403 may present an unreasonable risk of injury to health or the environment. EPA is seeking 1404 comment on whether the Agency should address persons who manufacture or process PBDEs as 1405 impurities whether or not they are contained in articles, and whether such persons should be 1406 required to conduct testing. 1407
1408
b. Subdivision of Tier 2 entities . The Agency is proposing to prioritize which persons in 1409 Tier 2 would be required to perf orm testing, if needed. Specif ically, the Agency is proposing 1410
that Tier 2 entities be subdivided into: 1411

i. Tier 2A–manufacturers, i.e., those who manufacture, or intend to manufacture, a test 1412 rule chemical substance including in articles solely as one or more of the following: A 1413 byproduct, an impurity, a naturally occurring chemi cal substance, a non-isol ated intermediate, a 1414 component of a Class 2 chemical substance, in amounts less than 1,100 lbs. annually, or in small 1415 quantities solely for research and development. 1416

ii. Tier 2B–processors, i.e., those who process, or intend to process, a test rule mixture in 1417 any form including in articles. The terms ‘‘p rocess’’ and ‘‘processor’’ are defined by TSCA 1418 sections 3(10) and 3(11), respectively. 1419

If the Agency needs testing from persons in Tier 2, EPA would seek testing from persons 1420 in Tier 2A before proceeding to Ti er 2B. It is appropria te to require manufact urers in Tier 2A to 1421
submit letters of intent to test or exemption applications be fore processors are called upon 1422 because the Agency believes that testing costs are traditionally passed along by manufacturers to 1423 processors, enabling them to share in the costs of testing (Ref. 61). In addition, ‘‘[t]here are 1424 [typically] so many processors [of a given test rule chemical] that it would be difficult to include 1425
them all in the technical decisions about the te sts and in the financial decisions about how to 1426 allocate the costs’’ (Ref. 62, 48 FR 31786, July 11, 1983). 1427*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 36 of 91 c. When would it be appropriate for a person w ho would be required to comply with the 1428 rule to apply for an exemption rather than to submit a letter of inte nt to conduct testing? You 1429 may apply for an exemption if you believe that the required testing will be performed by another 1430 person (or a consortium of persons formed unde r TSCA section 4(b)(3)(A)). You can find 1431 procedures relating to exempti ons in 40 CFR 790.80 through 790.99, and § part 1432 799.XXXX(c)(2), (c)(5), (c)(7), a nd (c)(11) of the proposed regulat ory text. In this proposed 1433 rule, EPA would not require the submission of e quivalence data (i.e., data demonstrating that 1434 your chemical substance or mixture is equivalent to the chemical substance or mixture actually 1435 being tested) as a condition for approval of your exemption. Therefore, 40 CFR 790.82(e)(1) 1436 and 40 CFR 790.85 would not appl y to this proposed rule. 1437

d. What would happen if I submitted an exemption application? EPA believes that 1438 requiring the collection of duplicat ive data is unnecessarily burden some. As a result, if EPA has 1439
received a letter of intent to te st from another source or has rece ived (or expects to receive) the 1440 test data that would be required under this ru le, the Agency would conditionally approve your 1441 exemption application under 40 CFR 790.87. 1442

The Agency would terminate conditional ex emptions if a problem occurs with the 1443 initiation, conduct, or completion of the required testing, or with the submission of the required 1444 data to EPA. EPA may then require you to subm it a notice of intent to test or an exemption 1445 application. See 40 CFR part 790.93 and § part 799.XXXX(c)(8) of the proposed regulatory text. 1446 In addition, the Agency would termin ate a conditional exemption if no letter of intent to test has 1447 been received by persons required to comply with the rule. See, e.g., § part 799.XXXX(c)(6) of 1448 the proposed regulatory text. Note that the provisions at 40 CFR 790.48(b) have been 1449 incorporated into the regulatory text of this pr oposed rule; thus, persons su bject to this rule are 1450 not required to comply with 40 CFR 790.48 itself (see § part 799.XXXX(c)(4) through (c)(7) and 1451 § part 799.XXXX(d)(3) of the proposed regulatory text). Persons who obtain exemptions or 1452 receive automatic conditional exemptions would nonetheless be subject to providing 1453 reimbursement to persons who do actually cond uct the testing, as described in Unit VI.E.4. 1454

e. What would my obligations be if I were in Tier 2? If you are in Tier 2, you would be 1455 subject to the rule and you would be responsible for providing reimbursement to persons in Tier 1456 1, as described in Unit VI.E.4. There is no differe nce whether you are in Tier 2A or Tier 2B as 1457 regards reimbursement. EPA is not aware of any ci rcumstances in which test rule Tier 1 entities 1458 have sought reimbursement from Tier 2 entiti es either through private agreements or by 1459 soliciting the involvement of the Agency under the reimbursement regula tions at 40 CFR part 1460
791. 1461

Concerning testing, if you ar e in Tier 2, you are considered to have an automatic 1462 conditional exemption. You would not need to subm it a letter of inte nt to test or an exemption 1463 application unless you are notified by EPA that you are required to do so. As previously noted, 1464
Tier 2A manufacturers would be notified to test before Tier 2B processors (Unit VI.E.3.ii.). 1465

If a problem occurs with th e initiation, conduct, or completion of the re quired testing, or 1466 with the submission of the required data to EP A, the Agency may require you to submit a notice 1467 of intent to test or submit an exemption application. See 40 CFR part 790.93 and § part 1468 799.XXXX(c)(10) of the pr oposed regulatory text. 1469*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 37 of 91 In addition, you would need to submit a not ice of intent to test or an exemption 1470 application if: 1471

• No manufacturer in Tier 1 has notified EP A of its intent to conduct testing, and 1472

• EPA has published a Federal Register document directing persons in Tier 2 to submit 1473
to EPA letters of intent to conduct tes ting or exemption applications. See § 799.XXXX(c)(4), 1474 (c)(5), (c)(6), and (c)( 7) of the proposed regulatory text . The Agency would conditionally 1475 approve an exemption application under 40 CFR 790.87, if EPA has received a letter of intent to 1476 test or has received (or expects to receive) the test data required under this rule. 1477

f. What would happen if no one submitted a letter of intent to conduct testing? EPA 1478 anticipates that, if there were manufacturers or processors of t hose chemical substances subject 1479 to the final rule, it would receiv e letters of intent to conduct tes ting for all of the tests specified 1480 for each mixture from one of those persons. Howeve r, in the event it does not receive a letter of 1481 intent for one or more of the tests required by th e final rule for any of the mixtures in the final 1482 rule within 30 days af ter the publication of a Federal Register document notifying Tier 2 1483 processors of the obligation to submit a letter of intent to conduct testing or to apply for an 1484 exemption from testing, EPA would notify all manuf acturers and processors of the mixture of 1485 this fact by certified letter or by publishing a Federal Register document specifying the test(s) 1486
for which no letter of intent has been submitted. This letter or Federal Register document 1487 would additionally notify all manuf acturers and processors that all exemption applications 1488 concerning the test(s) have been denied, and woul d give them an opportun ity to take corrective 1489
action. If no one has notified EPA of its intent to conduct the required testing of the mixture 1490 within 30 days after rece ipt of the certified lett er or publication of the Federal Register 1491 document, all manufacturers and processors subject to the final rule with respect to that mixture 1492 who are not already in violation of the final rule would be in violation of the final rule. 1493

4. How do the reimbursement procedures work? In the past, persons subject to test 1494 rules have independently worked out among themse lves their respective fi nancial contributions 1495 to those persons who have actua lly conducted the testing. Howeve r, if persons are unable to 1496 agree privately on reimbursement, they may take advantage of EPA’s reimbursement procedures 1497 at 40 CFR part 791, promulgated un der the authority of TSCA sec tion 4(a). These procedures 1498 include: The opportunity for a hearing with the American Arbitration As sociation; publication 1499 by EPA of a document in the Federal Register concerning the request for a hearing; and the 1500 appointment of a hearing officer to propose an or der for fair and equitable reimbursement. The 1501 hearing officer may base his or her proposed or der on the production volume formula set out at 1502 40 CFR 791.48, but is not obligated to do so. The hearing officer’s proposed order may become 1503 the Agency’s final order, which is reviewab le in Federal court ( 40 CFR 791.60). Under this 1504 proposed rule, for the purpose of determining fair reimbursement shares if the hearing officer 1505 chooses to use a formula based on production vo lume, the total production volume will include 1506 amounts of a mixture produced as an im purity and amounts imported in articles. 1507

F. What Reporting Requirements ar e Proposed Under this Test Rule? 1508

If you were required to test, you would be requ ired to submit a final report for a specific 1509 test by the deadline indicated in Table 3 in Unit VI.A of this preamble as the number of months 1510
after the relevant effective date of the final rule; this deadline is also shown in § part 1511*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 38 of 91 799.XXXX(j) of the propos ed regulatory text. 1512

EPA is also proposing that a robust summary of the final report for each specific test be 1513 required to be submitted electronically in addition to and at the same time as the final report. 1514 The term “robust summary” is used to describe th e technical information necessary to adequately 1515 describe an experiment or study and includes th e objectives, methods, results, and conclusions of 1516 the full study report which can be either an e xperiment or in some cases an estimation or 1517 prediction method. Guidance for the compilati on of robust summaries is described in a 1518 document entitled “Draft Guidance on Developing Robust Summaries” (Ref. 63). 1519

G. What Would I Need to Do if I Cannot Comp lete the Testing Required by the Final Rule? 1520

A person who submits a letter of intent to te st under the final rule and who subsequently 1521 anticipates difficulties in completing the testing by the deadline set forth in the final rule may 1522 submit a modification request to the Agency, pursuant to 40 CFR 790.55. EPA will determine 1523
whether modification of the test schedule is a ppropriate, and may first seek public comment on 1524
the modification. 1525

H. Would There be Sufficient Test Facilities and Personnel to Undertake the Testing Proposed 1526
Under this Test Rule? 1527

EPA’s most recent analysis of laboratory capacity (Ref. 64 ) indicates that available test 1528 facilities and personnel would adequately accomm odate the testing proposed in this rule. 1529

I. Might EPA Seek Further Testing of the Chemicals in this Proposed Test Rule? 1530

If EPA determines that it needs additional data regarding any of th e chemical substances 1531 included in this proposed rule, the Agency woul d seek further health and/or environmental 1532 effects testing for these mixtures. Should the Agen cy decide to seek such additional testing via a 1533 test rule, EPA would initiate a separate action for this purpose. 1534

VII. Export Notification 1535

A. SNUR 1536

Any person who exports, or intends to export decaBDE on or after [insert date 30 days 1537 after the date of publication in the Federal Register ] will be subject to the export notification 1538 requirements in TSCA section 12(b)(2) (15 U.S.C. 2611(b)) and at 40 CFR part 707, subpart D 1539
when the rule is proposed . Any person who exports, or intend s to export, tetraBDE, pentaBDE, 1540 hexaBDE, heptaBDE, octaBDE, and nonaBDE becam e subject to those requirements with the 1541 proposal of the SNUR in 2004 (Ref. 7). Export notification is generally not required for articles 1542 under a SNUR, as provided by 40 CFR 707.60(b), and for these This proposed amendments to the 1543 SNUR, rulemaking would not affect the article exemption for at 40 CFR 707.60(b) for notices of 1544 export n otification would apply. under section 12(b). Persons who export PBDEs contained in 1545 articles would not be requir ed to submit a notice of e xport respecting such PBDEs. 1546
1547
B. Test Rule 1548

Any person who exports, or intends to export, one of the mixtures contained in this 1549*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 39 of 91 proposed test rule would be s ubject to the export no tification requirements in TSCA section 1550 12(b)(1) (15 U.S.C. 2611(b)) and at 40 CFR part 707, subpart D, but only after the final rule is 1551 promulgated and only if the mixture is contained in the final rule. Export notification This 1552 proposed rulemaking would not be required affect the article exemption at 40 CFR 707.60(b) for 1553 notices of export under section 12(b). Persons who export PB DE mixtures contained in articles 1554
under the proposed test rule. would not be required to submit a notice of export respecting such 1555
mixtures. 1556

C. Should Articles Containing PBDEs Be Exempt From Export Notification Requirements? 1557

The Agency believes that production and pro cessing of all PBDEs, including in articles, 1558 will have ceased in the United States by the e nd of 2013 but if there are any ongoing uses they 1559 would not be subject to a final SNUR. The pur pose of the proposed SNUR is to designate new 1560 and discontinued uses as significan t new uses and to ensure that the Agency has an opportunity 1561 to review and, if necessary, take action to restrict or prohibit significant new uses of PBDEs, 1562 including in articles, before th ey resume. The purpose of the pr oposed test rule is to provide 1563 EPA with data necessary to determine the e ffects on health and th e environment if the 1564 manufacture and processing of commercial PBDEs and the asso ciated use, distribution in 1565 commerce and disposal are not discontinued. The Agency believes that the above objectives will 1566 be adequately met with respect to articles by ma king article exemptions for SNURs and test rules 1567 inapplicable for this action. The Agency consid ered including provisions in the proposed SNUR 1568 and test rule requiring that the PBDEs contained in articles be subject to section 12(b) export 1569 notification requirements. However, the Agen cy does not believe that making exporters of 1570 PBDEs contained in articles subject to secti on 12(b) export notification requirements would 1571 significantly increase the effec tiveness of this proposed rule making. The Agency is concerned 1572 that the potential burdens associated with admi nistration and compliance with export notification 1573 requirements for PBDEs contained in articles could be significant. In view of the expected costs 1574 the Agency decided that PBDEs c ontained in articles should conti nue to be exempt from export 1575 notification requirements. The Agency is seek ing comment on the need for (and the cost of) 1576 making PBDEs contained in articles subj ect to export notific ation requirements. 1577

VIII. Import Certification 1578

A. SNUR 1579
1580 Persons who import a chemical substance identified in bulk or as part of a final 1581
SNUR mixture are subject to the TSCA section 13 (15 U.S.C. 2612) import requirements, 1582 codified at 19 CFR 12.118 through 12.127; see al so 19 CFR 127.28. Such persons must certify 1583 that the shipment of the chemi cal substance complies with all a pplicable rules and orders under 1584 TSCA, including any SNUR requirements. Chemical substances This rulemaking would not 1585 affect the exemption from import certific ation under section 13(b) for chemicals contained in 1586
articles are exempt from import certification. . Persons who import PBDEs contained in articles 1587 would not be subject to import cer tification requirements. PBDEs im ported in bulk or as part of 1588 a mixture would continue to be subject to im port certification requireme nts under section 13(b), 1589 consistent with 19 CFR 12.120(b). The EPA policy in support of import certification appears at 1590 40 CFR part 707, subpart B. For additional guidance, please refer to EPA’s TSCA Import 1591 Compliance Checklist (http://www.epa.gov/ oppt/import-export/pubs/checklist.pdf) 1592
1593*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 40 of 91 B. Test Rule 1594
1595 Section 13 import certificati on requirements do not pertain to Section 4 test rules. 1596 Although importers must satisfy all applicable re quirements of Sections 4, compliance with those 1597 provisions is not related to indi vidual chemical shipments and therefore does not affect import 1598
certification. 1599
1600
C. Should Articles Containing PBDEs Be Exempt From Import Certification Requirements? 1601

The Agency believes that manufacture, incl uding import, and processing of all PBDEs, 1602 including in articles, will have ceased in the United States by the end of 2013. The purpose of 1603 the proposed SNUR is to designate new and disc ontinued uses as significant new uses and to 1604 ensure that the Agency has an opportunity to revi ew and, if necessary, take action to restrict or 1605 prohibit significant new uses of PBDEs, including in articles, before they resume. The Agency 1606 believes that the above objective will be adequa tely met with respect to articles by making the 1607 article exemption for SNURs inapplicable for th is action. The Agency does not believe that 1608 making importers of PBDEs contained in article s subject to section 13 import certification 1609 requirements would significantly increase the effectiveness of this proposed rulemaking. 1610
1611 The Agency considered including provisions in the proposed SNUR requiring that the 1612 PBDEs contained in articles be subject to section 13 import certific ation requirements. 1613 However, the Agency is concerned that the pote ntial burdens associated with administration and 1614 compliance with import certification requirements could be significant. The Agency decided 1615
that PBDEs contained in articles should conti nue to be exempt from import certification 1616 requirements. The Agency is seeking comment on the need for (and the cost of) making PBDEs 1617 contained in articles subject to import certification requirements. 1618
1619
IX. The Dates that the SNUR, Proposed Am ended SNUR, and Proposed Test Rule 1620 Requirements Apply to the Seven PB DEs and the Three Commercial Mixtures 1621
1622 The SNUR that became effective on August 14, 2006, requires that persons that intend to 1623
manufacture , including import, any of six PBDEs (tetraBDE, pentaBDE, hexaBDE, heptaBDE, 1624 octaBDE, and nonaBDE) for any use after Ja nuary 1, 2005, submit a SNUN to EPA at least 90 1625 days in advance. Processing of the PBDEs was not designat ed as a significant new use because 1626
EPA believed that it was an ongoing ac tivity at the time the rule was proposed. Articles were 1627 exempt from that SNUR. EPA now believes that all import and processing of these six PBDEs 1628 for any use including as part of an article and import of articles containing them have been 1629 discontinued. These proposed amendments to th e SNUR would designate processing for any use 1630 after December 31, 2012 2013 , a significant new use. The pr oposed amended SNUR would also 1631 make inapplicable the article exemption at 40 CFR 721.45(f). Therefore, a person who intends 1632 to import or process any of the six PBDEs as part of an article after December 31, 2012 2013

, 1633 would not be exempt from submitting a significant new use notice. EPA will promulgate the 1634
amended SNUR after it has verified that th e proposed significant new uses have been 1635
discontinued. For a discussion of applicability of the si gnificant new use rule to uses begun after 1636 the publication of this pr oposed rule see Unit V.C

. 1637
1638 Any person who manufactures or processes or intends to manufacture or process c- 1639*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 41 of 91 pentaBDE, c-octaBDE, or c-decaBDE after the relevant proposed effective dates December 31, 1640
2013 would be subject to the test rule

. For a discussion of applicability of the significant new 1641

u se rule to uses occurring before the eff ective date of the final rule see Unit V .C

. 1642
1643 On December 2009, the principal manufactur ers and importer of decaBDE announced 1644 their intent to phase out their activities with decaBDE and committed to do so by December 31, 1645 2012 for all uses, except military and transp ortation, and by December 31, 2013, for all uses 1646 including military and transporta tion, with possibly an additional 6 months to sell remaining 1647 inventory of decaBDE

. (Refs. 68 – 70). The Agency does not believe that manufacturers would 1648 need additional time to sell remaining inventory or that processors woul d require any additional 1649 time to use existing stocks, and has not proposed any additional time in this action. EPA is 1650 seeking comment on this in Unit XI.A.2. 1651
1652
With this Pr oposed SNUR

- Test Rule action , EPA is also proposing to amend the 2006 1653
PBDE SNUR , after December 31, 2013, by designating manufacture and processing of 1654 decaBDE for any use except military and transportation uses which is not ongoing, including in 1655
articles after December 31, 2012 , and , as a significant new use. Persons that intend to 1656
manufacture and processing of or process decaBDE for all uses including military and 1657 transportation uses, including in articles after December 31, 2013, a significant new use s that use 1658
would require the submission of be required to submit a SNUN to EPA at least 90 days before 1659 commencing such activity. 1660
1661
If EPA determined that any persons engage i n such activities with person intends to 1662 manufacture or process c-pe ntaBDE c-octa BDE or c- decaBDE for any use after the relevant 1663 significant new use dates December 31, 2013 , EPA would promulgate th e test rule and they 1664 would be subject to the te st rule requirements. 1665
1666 Table 5 presents the date when the requirements of the existing SNUR applied to 1667

act ivities with certain PBDEs and the dates when the requirements of the proposed amendments 1668
to the SNUR and test rule , if promulgated, would apply to the manufacture and processing of the 1669 seven PBDEs depending on whether those activities are ongoing or have ceased

. 1670
1671
1672
Table 5: The Date SNUR
, Amended SNUR
, or Test Rule Requirements Apply to the 1673
Seven PBDEs and the Three Commercial Mixtures 1674
1675

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

SNUR applies

to non

ongoing: Amended
SNUR would apply to non

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

to non

ongoing: Test Rule would apply to ongoing:*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 42 of 91 tetraBDE
hexaBDE heptaBDE

nonaBDE pentaBDE
octaBDE Manufacture for any use. Processing for any use.
Manufacture
and

proces sing 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

a rticles.

c

pentaBDE
and c

octaBDE Manufacture
and processing for any use including in
articles.

c

decaBDE Manufacture
and processing for any use, except military and transportation

uses, including in
articles. Manufacture
and processing for any u se, including military and transportation

uses, including in
articles.

1676
1677
X. Economic Considerations 1678
1679
A . SNUR 1680
1681 The proposed amendment to the SNUR would require persons intending to engage in 1682 significant new use to submit a Significant Ne w Use Notice (SNUN), incurring an estimated 1683 submission cost of $8,143 per chemical, plus other co sts (Ref. 72). In addition to the firms that 1684 make a SNUN submission, the proposed amendments to the SNUR may also impact firms that 1685 do not make a submission. By avoiding a signifi cant new use, a firm can avoid submission and 1686 testing costs but may incur other compliance costs. The firm may also incur “hidden” costs; for 1687 example, it could forego profitabl e opportunities to use th e chemical in an a pplication that would 1688*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 43 of 91 be a significant new use or limit production volume to avoid a si gnificant new use. Costs are 1689
estimated at the firm level and reflect the burden of a SNUR on the firms that make a 1690
submission. The hidden costs to the firms that do not make a submission are not quantified. 1691 EPA receives only a handful of SNUNs per year due to SNURs. However, the number of firms 1692 affected by not making submissions to EPA is not known; therefore, costs are not aggregated 1693
across the affected entities. 1694
1695
B. Test Rule 1696

EPA has prepared an economic assessment entitled Economic Impact Analysis for the 1697 Proposed Section 4 Test Rule for c-Pentabrom odiphenyl Ether, c-Octabr omodiphenyl Ether, and 1698 c-Decabromodiphenyl Ether (Ref. 73), a copy of wh ich has been placed in the docket for this 1699 rulemaking. The economic analysis evaluates the costs associated wi th the testing that would be 1700 required by a final test rule. The analysis looks at costs due to te sting all three mixtures and to 1701 each mixture separately. The total costs to industry of compliance, including testing and 1702 administrative costs, for all three mixtures are estimated under the low- and high-cost scenarios 1703 to be $9.68 million and $15.1 million, respectivel y. The testing cost (not including 1704 administrative costs) to comply with the test rule requirements for c-pentaBDE or c-octaBDE 1705 under the low- and high-cost scenarios woul d be $2.8 million and $4.7 million, respectively. 1706 The testing cost (not including admi nistrative costs) to comply with the test rule requirements for 1707 c-decaBDE under the low- and high-cost s cenarios would be $1.8 million and $2.5 million, 1708 respectively. (Ref. 73) These costs would onl y be incurred if ther e were entities that 1709 manufacture or process c-pentaB DE, c-octaBDE, or c-decaBDE, in cluding in articles, after the 1710 relevant dates specified in the proposed test rule in § 799.xxxx(k) of December 31, 2012 and 1711 December 31, 2013 effective date of the test rule

. 1712
1713 Currently, there are no known entities that manufacture or process c-pentaBDE or c1714 octaBDE in the United States except as impurities, so an economic impact analysis could not be 1715
done for these two chemicals. 1716
1717 EPA has identified six ultimate parent companies that manufacture or import c-decaBDE 1718
in the United States. The total annualized co mpliance costs for decaBDE are estimated to be, 1719 under low- and high-cost scenarios, $264,582 and $360,218, respectively. To evaluate the 1720 potential for an adverse economic impact of testing on manufacturer s and importers of c1721 decaBDE, EPA employed an initial screening appr oach that estimated the impact of testing 1722 requirements as a percentage of c-decaBDE’s sa le price. This measure compares annual 1723
revenues from the sale of a mixture to the annuali zed compliance cost for that mixture to assess 1724 the percentage of testing costs that can be accommodated by the revenue stream generated by 1725 that mixture over a number of years. Comp liance costs include costs of testing and 1726 administering the testing, as well as reporting cost s. In addition, they include the estimated cost 1727 of the TSCA section 12(b) expor t notification requirements, wh ich, under the final rule, would 1728 be required for the first export to a particular country of a mixtur e subject to the rule, estimated 1729 to range from $26.86 per notice to $85.70 per no tice (Ref. 72). Thes e export notification 1730 requirements (included in the tota l and annualized cost estimates) that would be triggered by the 1731 final rule are expected to have a negligible impact on exporters. 1732
1733 Annualized compliance costs divide testing e xpenditures into an e quivalent, constant 1734*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 44 of 91 yearly expenditure over a longer pe riod of time. To calculate th e percent price impact, testing 1735 costs (including laboratory and administrative expenditures) are annualiz ed over 15 years using a 1736 7% discount rate. These annualized testing co sts are then divided by the estimated annual 1737
revenue of the mixture to de rive a cost-to-sales ratio. 1738
1739 For five companies manufacturing or importing c-decaBDE, the cost-to-sales ratios is 3 1740 percent or less. One company was identified as a small business by TSCA’s employment-based 1741
definition and has a cost-to-sales ratio greater than 3 percent. Mixtures for which the price 1742 impact is expected to exceed 1% of the revenue from that chemical have a higher potential for 1743 adverse economic impact. However, EPA also compared the annualized cost of testing c1744 decaBDE to company revenue because, in some cases, companies may choose to use revenue 1745 sources other than the profits fr om the individual mixture to pay for testing. EPA estimates that 1746 the costs of testing will exceed 1% of company revenue for only one of the affected companies, 1747 i.e., the company identified as a small business. 1748
1749 While processors are legally subject to this test rule if they process c-decaBDE after 1750 December 31, 2012 2013 , processors of c-decaBDE would be required to comply with the 1751 requirements of the rule only if they are directed to do so by EPA as described in 1752 §799.XXXX(c)(6) and (c)(8) of the proposed re gulatory text. EPA would only require 1753 processors to test if no subject person in Tier 1 or Tier 2A has submitted a notice of its intent to 1754 conduct testing, or if under 40 CFR 790.93, a proble m occurs with the initiation, conduct, or 1755 completion of the required testing or the submi ssion of the required data to EPA. Because 1756 processors would not need to comp ly with the proposed rule initiall y if there are persons in Tiers 1757 1 or 2A subject to the rule , the economic assessment does not address processors. 1758
1759 The benefits resulting from this proposed test rule are discussed qualitatively in 1760 Economic Impact Analysis for the Proposed Secti on 4 Test rule for c-Pentabromodiphenyl Ether, 1761 c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether (Ref. 73). EPA believes the major 1762 benefits of the test rule will be the developmen t of hazard information on these chemicals and the 1763 use of this information by the public, industry, and government. 1764
1765 XI. Request for Public Comment 1766

A . Solicitation of Comments on the pr oposed amendments to the SNUR. 1767
1768 (1) EPA welcomes comments on any aspect of the proposed amendments to the SNUR, but is 1769 especially interested in comments regarding the designation of a new use of decaBDE as 1770 (1) possibility that manufacture and processing of decaBDE for any use except military and 1771 transportation some uses including in articles after December 31, 2012, and (2) manufacture and 1772 processing of decaBDE fo r any use including military and transportation uses, including in 1773
articles of decaBDE may continue after December 31, 2013. The Agency seeks information on 1774
such uses. 1775
1776 (2) EPA is projecting c-decaBDE will no longer be available and that processors will discontinue 1777 their activities by December 31, 2013. Should EPA a ssume that processors will continue their 1778 activities beyond that date? For example, should EPA assume th at processors will continue their 1779*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 45 of 91 activities for six months after manufacture of decaBDE ceases? Should EPA designate 1780 processing of decaBDE after June 30, 2014, or some other date, a significant new use? 1781
1782 (3) EPA welcomes comments on the designati on of a significant ne w use of tetraBDE, 1783 pentaBDE, hexaBDE, heptaBDE, octaBDE, a nd nonaBDE as manufacture and processing for 1784 any use including in articles after December 31, 2012 2013

. 1785
1786 (4) In this action, EPA is proposi ng to make inapplicab le the article exemption for SNURs at 40 1787 CFR part 721.45(f). A person who intends to pro cess a chemical substan ce identified in this 1788 section as part of an article, other than as an impurity, would not be exempt from submitting a 1789 significant new use notice. EPA welcomes co mment on this proposed course of action. 1790
1791 (5) EPA requests comment on when to finalize the proposed amendments to the SNUR. Should 1792 they be finalized before or after the phase-out dates of decaBDE? 1793
1794 (6) EPA requests comment on whether th e proposed significant new uses are still ongoing and 1795
will still be ongoing on the relevant dates of December 31, 2012 and after December 31, 2013. 1796
1797
B. Solicitation of Comments on the Proposed Test Rule. 1798

(1) EPA is soliciting comment rega rding additional information pertaining to potential exposure 1799 of the general population, consumers, and worker s to c-pentaBDE, c-octaBDE, and c-decaBDE. 1800 Also, the Agency solicits comment regarding ad ditional information pertaining to environmental 1801 releases of any of these three PBDE mixtures. 1802

(2) EPA is soliciting comments which identify existing studies that may satisfy the data needs 1803 identified in the proposed test rule . To the extent that data relevant to the testing specified in this 1804 proposed rule are known to exist, EPA strongly enc ourages the submission of this information as 1805 comments to the proposed rule. Such data submitted to EPA must be in the form of full copies of 1806 unpublished studies or full citations of publishe d studies, and accompanied by a robust summary 1807 (Ref. 63). To the extent that st udies proposed in this action are cu rrently available, and the data 1808 are judged sufficient by EPA, testing for the endpoint/mixture combination will not be required 1809
in a final test rule. 1810

(3) EPA is soliciting comment on what test s ubstances should be required for pentaBDE, 1811 octaBDE, and decaBDE. EPA is proposing that the test substances be the representative 1812 commercial forms with the percent congener co mposition identified by the test sponsor(s). 1813 Instead, should the test substances be the 99% pure pentaBDE, octaBDE, and decaBDE with an 1814 isomer composition identified for each? 1815

(4) EPA is soliciting comment on wh ether a purity level of 99% or greater can be attained for 1816 pentaBDE, octaBDE, and decaBDE. 1817

(5) EPA is soliciting comment on whether the de scriptions in section 799.XXXX(a) of the 1818 commercial mixtures to be tested adequately encompass the range of commercial forms of 1819 pentaBDE, octaBDE, and decaBDE that might be produced. 1820
1821 (6) EPA is soliciting comment on whether, for the purpose of the testing proposed in this action, 1822*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 46 of 91 a single commercial form each of pentaBDE, octa BDE, and decaBDE can be representative of 1823 the possible variations of those commercial mixtur es. If not, should more than one commercial 1824 form each of pentaBDE, octaBDE, and decaBDE be tested? How should those forms be 1825
determined? 1826
1827 (7) EPA is soliciting comment on whether testing should be requi red of tetraBDE, pentaBDE, 1828 hexaBDE, heptaBDE, octaBDE, nonaBDE, and d ecaBDE comparable to that proposed for c1829 pentaBDE, c-octaBDE, and c-decaBDE if they are present in commercial PBDE products. 1830

(8) EPA is also soliciting comment on the propo sed test methods, the proposed requirement for 1831 submission of robust summaries, the proposed deadlines to submit final reports, and the 1832 economic impact analysis detailing the burdens a nd costs that would resu lt from complying with 1833
a final test rule. 1834

(9) The Agency invites comment on the potential use of voluntary consensus standards in the 1835 proposed test rule, and, specifically, invites th e public to identify potentially applicable 1836 consensus standard(s) and to explain why such standard(s) should be used here. 1837

(10) EPA is interested in receiving comments on whether the Agency should consider 1838 establishing an alternate definition for small busin ess to use in the small entity impact analyses 1839 for future TSCA section 4(a) test rules, and what size cutoff may be appropriate. 1840
1841 (11) EPA is soliciting comment on whether, in a future rulema king, persons who manufacture or 1842 process c-PBDEs contained in articles as impurit ies should be required to conduct testing. EPA 1843 also solicits comment on whether persons w ho manufacture or process c-PBDEs as impurities 1844
not contained in articles s hould be required to test. 1845
1846
XII. References 1847

As indicated under ADDRESSES , a docket has been established for this rulemaking 1848 under docket ID number EPA–HQ–OPPT– 200 9

– 0 357 2010-1039 . The following is a listing of 1849 the documents that have been placed in th e docket for this rulemaking. The docket includes 1850 information considered by EPA in developing this proposed rule, including the documents listed 1851 in this unit, which are physica lly located in the docket. In addition, interested parties should 1852 consult documents that are referenced in the documents that EPA has placed in the docket, 1853 regardless of whether these referenced documents are physically located in the docket. For 1854 assistance in locating documents that are referenc ed in documents that EPA has placed in the 1855 docket, but that are not physica lly located in the docket, please consult either technical person 1856
listed under FOR FURTHER INFORMATION CONTACT . The docket is available for 1857 review as specified under ADDRESSES

. 1858

1. EPA. Significant New Use Rule for Certai n Polybrominated Diphenylethers. 40 CFR 1859
721.10000. 1860

2. EPA. TSCA Section 4(a)(1)(B) Fi nal Statement of Policy. Notice. Federal Register 1861 (58 FR 28736 at 28738–28739, May 14, 1993). 1862

3. EPA, 2008a. Toxicological Review of 2,2 ',4,4' -Tetrabromodiphenyl Ether (BDE-47), 1863*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 47 of 91 EPA/635/R-07/005F, June 2008. 1864

4. EPA, 2008b. Toxicological Review of 2,2',4,4',5-Pentabrom odiphenyl Ether (BDE1865 99), EPA/635/R-07/006F, June 2008. 1866

5. EPA, 2008c. Toxicological Review of 2,2',4,4',5,5’-Hexabromodiphenyl Ether (BDE1867 153), EPA/635/R-07/007F, June 2008. 1868

6. EPA, 2008d. Toxicological Review of Decabromodiphenyl Ether (BDE-209), 1869 EPA/635/R-07/008F, June 2008. 1870

7. EPA. Certain Polybrominated Diphenyl Ethers; Proposed Signifi cant New Use Rule. 1871 69 FR70404, December 6, 2004. 1872

8. Arkoosh MR, Boylen D, Dietrich J, Anulacion BF, Ylitalo G, Bravo CF, Johnson LL, 1873 Loge FJ, Collier TK, Disease susceptibility of salmon exposed to polybrominated diphenyl 1874 ethers (PBDEs). Aquatic Toxicology 98(1): 51-59. (2010) 1875
1876 9. McKernan MA, Rattner BA, et al. Toxicity of Polybrominated Diphenyl Ethers (De1877 71) In Chicken ( Gallus gallus ), Mallard ( Anas platyrhynchos ), and American Kestrel ( Falco 1878 sparverius ) Embryos and Hatchlings. Environmental Toxicology and Chemistry 28(5):1007- 1879
1017. 2009. 1880

10. Fernie KJ, Mayne G, Shutt LJ, Pekarick C, Grasman KA, Letcher RJ, Drouillard KG. 1881
Evidence of immunomodulation in nestling American kestrels ( Falco sparverius ) exposed to 1882 environmentally relevant PBDEs. Environmental Pollution. 138:485-493. 2005a. 1883

11. Fernie KJ, Shutt LJ, Mayne G, Hoffman DJ , Letcher RJ, Drouillard KG, Richie IJ. 1884 Exposure to polybrominated diphenyl ethers (PBDEs): Changes in thyroid, vitamin A, 1885 glutathione homeostasis, and oxidative stress in American kestrels ( Falco sparverius ). 1886 Toxicological Sciences. 88:375-383. 2005b. 1887

12. Fernie K, Shutt L, et al. The effects of exposure to polybrominated diphenyl ethers on 1888 reproductive performance and immune func tion in captive American Kestrels. Journal of 1889 Ornithology. 147(5): 92-92. 2006. 1890

13. Fernie KJ

, Marteinson

, S

, Shutt JL

, . C., Bird DM

, Letcher RJ

, Ritchie JI

. In ovo DE

1891
71 , D. M. et al. Multi-generational effects of polybrominated diphenylethers exposure: 1892 Embryonic exposure of male American kestrels : Reproductive (Falco sparverius ) to DE-71 alters 1893 reproductive success and behavioral effects. Presented at the 10th Workshop on Brominated 1894
Flame Retardants in the Environment

. 2008. behaviors. Environmental Toxicology and Chemistry 1895
29 (8): 1740-1747. 2010. 1896
1897 14. Fernie, KJ, Shutt JL, Letcher RJ, Ritchie IJ , and Bird DM. Environmentally Relevant 1898
Concentrations of DE-71 and HBCD Alter Eggshell Thickness and Reproductive Success of 1899
American Kestrels. Environmental Science & Technology. 43(6):2124-2130. 2009. 1900

15. Zhang S, Bursian SJ, Martin PA, Chan HM, Tomy G, Palace VP, Mayne GJ, Martin 1901*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 48 of 91 JW. Reproductive and developmental toxicity of a pentabrominated diphenyl ether mixture, DE1902 71, to ranch mink (Mustela vison) and hazard assessment for wild mink in the Great Lakes 1903 region. Toxicological Sciences. 110 (1):107-116. 2009. 1904

16. Timme-Laragy AR, Levin DE, Di Giulio RT . Developmental and behavioral effects 1905 of embryonic exposure to the polybrominated di phenylether mixture DE-71 in the killifish 1906 ( Fundulus heteroclitus ). Chemosphere. 62:1097-1104. 2006 1907

17. Lema SC, Schultz IR, Scholz NL, Incardona PJ, Swanson P. Neural defects and 1908 cardiac arrhythmia in fish larvae following embryonic exposure to 2,2’,4,4’-tetrabromodiphenyl 1909 ether (PBDE 47). Aquatic Toxicology. 82: 296-307. 2007. 1910

18. Kuiper RV, Vethaak AD, Cantón RF, An selmo H, Dubbeldam M. Toxicity of 1911 analytically cleaned pentabromodiphenylether af ter prolonged exposure in estuarine European 1912 flounder ( Platichthys flesus ), and partial life-cy cle exposure in fresh water zebrafish ( Danio 1913

rerio ). Chemosphere. 73:195-202. 2008. 1914

19. Nakari and Huht ala 2008. EPA, 2006. Polybrominat ed Diphenyl Ethers (PBDEs) 1915 Project Plan. March, 2006. Available at http://www.epa.gov/oppt/pbde/pubs/proj

- plan32906a.pdf 1916 (accessed Dec. 15, 2009). Nakari T, and Huhtala S. Compar ison of toxicity of congener-153 of 1917 PCB, PBB, and PBDE to Daphnia magna

. Ecotoxicol Environ Saf . 71:514–518, 2008. 1918

20. Vonderheide AP, Mueller KE, et al. Po lybrominated diphenyl ethers: Causes for 1919 concern and knowledge gaps regarding envi ronmental distribution, fate and toxicity . Science of 1920
the Total Environment. 400(1-3): 425-436. 2008. 1921

21. Environment Canada. Ecological State of the Science Report on Decabromodiphenyl 1922 Ether (decaBDE) Bioaccumulation and Transformation. 2010. Available from: 1923 http://www.ec.gc.ca/lcpe

- cepa/documents/substances/decabde/ess_report_decabde

1924 eng.pdf http://www.ec.gc.ca/lcpe-cepa/documents /substances/decabde/ess_report_decabde1925 eng.pdf 1926

22. Shaw SD, Kannan K. Polybrominated diphenyl ethers in marine ecosystems of the 1927
American continents: foresi ght from current knowledge. Reviews on Environmental Health. 1928
24 : 157-229. 2009. 1929

23. Environment Canada. Ecological Screen ing Assessment Report on Polybrominated 1930 Diphenyl Ethers (PBDEs). 2006. Available from: 1931 http://www.ec.gc.ca/CEPARegistry/documen ts/subs_list/PBDE_SAR/PBDEs_SAR_EC_June_2 1932 006_%28en%29.p df http://www.ec.gc.ca/CEPARegistry/doc uments/subs_list/PBDE_SAR/PBDE 1933 s_SAR_EC_June_2006_%28en%29.pdf

. 1934

24. Thuresson K, Bergman A, Jakobsson K. Occupational Exposur e to Commercial 1935 Decabromodiphenyl Ether in Workers Manufactu ring or Handling Flame-Retarded Rubber. 1936 Environmental Science & Technology. 39:1980-1986. 2005. 1937

25. Tokarz JA, Ahn MY, Leng J, Filley TR , Nies L. Reductive Debromination of 1938 Polybrominated Diphenyl Ethers in Anaerobi c Sediment and a Biomimetic System. 1939*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 49 of 91 Environmental Science & Technology. 42:1157-1164. 2008. 1940

26. La Guardia MJ, Hale RC, Harvey E. Evidence of Debromination of 1941 Decabromodiphenyl Ether (BDE-209) in Biota from a Wastewater Receiving Stream. 1942 Environmental Science & Technology. 41(19):6663-6670. 2007. 1943

27. Stapleton HM. Brominated flame retardan ts: assessing the decaBDE debromination in 1944
the environment. Health and Environmenta l Alliance (formerly the EPHA Environmental 1945 Network (EEN)). May 2006. 1946

28. Stapleton HM, Dodder NG. Photodegrada tion of decabromodiphenyl ether in house 1947 dust by natural sunlight. Environmental Toxicology and Chemistry. 27:306-312. 2008 1948

29. Wania F, Dugani CB. Assessing the long-rang e transport potential of polybrominated 1949 diphenyl ethers: a comparison of four multimedia models. Environmental Toxicology and 1950 Chemistry. 22:1252–1261. 2003. 1951

30. ATSDR. Agency for Toxic Substances a nd Disease Registry. Toxicological Profile 1952 for Polybrominated Diphenyl Ethers and Polybrominated Biphenyls. 2004. 1953 www.atsdr.cdc.gov/toxprofiles/tp68.html www.atsdr.cdc.gov/toxprofiles/tp68.html

. 1954

31. EPA. An exposure assessment of polybrom inated diphenyl ethe rs. National Center 1955 for Environmental Assessment, Washington, DC; EPA/600/R-08/086F. 2010. Available from the 1956
National Technical Information Servi ce, Springfield, VA, and online at 1957 http://www.epa.gov/ncea. 1958
1959 32. Allen JG, McClean MD, Stapleton HM, We bster TF. Critical factors in assessing 1960 exposure to PBDEs via house dust. Environment International. 34(8):1085-1091. November 1961
2008. 1962

33. Lorber M. Exposure of Americans to polybrominated diphenyl ethers. Journal of 1963 Exposure Science and Environmental Epidemiology. 18:2-19. 2008. 1964

34. Jones-Otazo HA, Clarke J, Diamond ML , Archbold J, Ferguson G, Harner T, 1965 Richardson SM, Jakeryan J, and Wilford BY. Is House Dust the Missing Exposure Pathway for 1966 PBDEs? An Analysis of the Urban Fate and Human Exposure to PBDEs. Environmental Science 1967 & Technology. 39: 5121-5130. 2005 1968

35. Hites RA. Polybrominated Diphenyl Ethe rs in the Environment and in People: A 1969 Meta-Analysis of Concentrations. Environmental Science & Technology. 38: 945. 2004 1970

36. Cal/EPA PBDE Workgroup. Polybrominated Diphenyl Ethers: Recommendations to 1971 Reduce Exposure in California. California E nvironmental Protection Agency, Sacramento, 1972 California. February 2006. Available at: http://oeha.ca.gov/pdf/ PBDEWrkgrpRptFeb06.pdf. 1973

37. Sjodin A, Wong LY, Jones RS, Park A, Zha ng Y, Hodge C, Dipiet ro E, McClure C, 1974 Turner W, Needham LL and Patterson DG. Seru m concentrations of polybrominated diphenyl 1975 ethers (PBDEs) and polybrominated biphenyl (P BB) in the United States population: 2003-2004. 1976 Environmental Science & Technology. 42:1377-1384. 2008. 1977*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 50 of 91 38. NHANES. Fourth National Report on Human Expos ure to Environmental Chemicals. 1978 Centers for Disease Control and Prevention, Atlanta (GA). December 2009. Available at: 1979 http://www.cdc.gov/exposurereport/faq.html http://www.cdc.gov/exposurereport/faq.html 1980

39. Environment Canada. Flame Retardan ts: A threat to the environment? Science & the 1981
Environment Bulletin. 30:5. May/June 2002. Available at: http://dsp

1982 psd.pwgsc.gc.ca/Collection/En1

- 28

- 1

- 2002

- 03E.pdf http://dsp-psd.pwgsc.gc.ca/Collection/En1- 1983 28-1-2002-03E.pdf 1984

40. Park JS, Holden A, et al. Time-Trends and Congener Profiles of PBDEs and PCBs in 1985 California Peregrine Falcons (Falco peregrinus). Environmental Science & Technology. 1986 43(23):8744-8751. 2009. 1987

41. Gobas FAPC and Morrison HA. Bioconcentra tion and biomagnification in the aquatic 1988
environment. In Handbook of Property Estimation Methods for Chemicals. Environmental and 1989
Health Sciences. pp. 189-231. RS Boethling and DMackay, Eds,

. Lewis/CRC, Boca Raton, FL 1990
USA. 2000. 1991

42. Chen D, Mai B, Song J, Sun Q, Luo Y, Luo X, Zeng EY, Hale RC. Polybrominated 1992 diphenyl ethers in birds of prey from Northern China. Environmental Science & Technology. 1993
41:1828-1833. 2007. 1994

43. Voorspoels S, Covaci A, Lepom P, Jaspers VLB, Neels H, Schepens P. 1995 Biomagnification of PBDEs in thre e small terrestrial food chains. Environmental Science & 1996 Technology. 41:411–-416. 2007. 1997

44. Stapleton HM, Baker JE. Compari ng polybrominated diphenyl ether and 1998 polychlorinated biphenyl bioaccumulation in a f ood web in Grand Traverse Bay, Lake Michigan. 1999 Archives of Environmental Contamination and Toxicology. 45 : 227–234. 2003. 2000

45. Gandhi et.al. Development of a Multich emical Food Web Model: Application to 2001 PBDEs in Lake Ellasjøe n, Bear Island, Norway. Environmental Science & Technology. 2002 40(15):4714–4721. 2006. 2003

46. Stapleton HM, Alaee M, Letcher RJ, Baker JE. Debromination of the flame retardant 2004 decabromodiphenyl ether by juvenile carp ( Cyprinus carpio ). Environmental Science & 2005 Technology. 38:112-119. 2004. 2006

47. Van den Steen E, Covaci A, Jaspers VLB, Dauwe T, Voorspoels S, Eens M, 2007 Pinxten R. Accumulation, tissue- specific distribution and biot ransformation of BDE 209 in 2008 European starlings ( Sturnus vulgaris ). Environmental Pollution. 148:648-653. 2007. 2009

48. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 2010 Document for Pentabromodiphenyl Ether and Oc tabromodiphenyl Ether. Prepared by Risk 2011 Assessment Division, OPPT. June 2005. 2012

49. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 2013 Document for Decabromodiphenyl Ether. Prepar ed by Risk Assessment Division, OPPT. June 2014
2005. 2015*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 51 of 91 50. Darnerud PO. Toxic effects of brominated flame retardants in man and in wildlife. 2016
Environment International. 29:841-853. 2003. 2017

51. Harley KG, et al. PBDE Concentrati ons in Women’s Seru m and Fecundability. 2018 Environmental Health Perspectives. 118(5): 699-704. May 2010. 2019

52. Costa LG, et al. Polybrominated diphenyl ether (PBDE) flame retardants: 2020 environmental contamination, human body burden and potential adverse health effects. Acta 2021
Biomed. 79:172-183. 2008. 2022

53. Herbstman JB, et al. Prenatal Ex posure to PBDEs and Neurodevelopment. 2023 Environmental Health Perspectives. 118(5):712-719. May 2010. 2024

54. Bromine Science and Environmental Fo rum. An Oral (gavage) Developmental 2025 Neurotoxicity Test of Decabromodiphenyl Oxide in Rats. Submitted to EPA on May 19, 2010. 2026

55. ASTM. Standard test method for measur ing the toxicity of sediment-associated 2027
contaminants with freshwater invertebrates. ASTM E 1706-05e1. 2028

56. ASTM. Standard guide for collection, stor age, characterization, and manipulation of 2029 sediments for toxicological tes ting and for selection of sample rs used to collect benthic 2030
invertebrates. ASTM E 1391-03. 2031

57. ASTM. Standard guide for conducting laboratory soil toxicity or bioaccumulation 2032
tests with the Lumbricid Earthworm Eisenia Fe tida and the Enchytraeid Potworm Enchytraeus 2033
albidus. ASTM E 1676-04. 2034

58. ASTM. Standard guide for conducting se diment toxicity tests with Polychaetous 2035
Annelids. ASTM E 1611-00. 2036

59. ASTM. Standard guide for conducting laboratory soil toxici ty tests with the 2037 Nematode Caenorhabditis elegans. ASTM E 2172-01. 2038

60. ASTM. Standard test method for measur ing the toxicity of sediment-associated 2039
contaminants with estuarine and marine invertebrates. ASTM E 1367-03. 2040

61. EPA. Toxic Substances; Test Rule Deve lopment and Exemption Procedures; Interim 2041
Final Rule. Federal Register (50 FR 20652, May 17, 1985). 2042

62. EPA. Toxic Substances Control Act; Data Reimbursement; Final Rule. Federal 2043 Register (48 FR 31786, July 11, 1983). 2044

63. EPA. OPPT. Draft Guidance on Developing Robust Summaries. October 22, 1999. 2045 Available on-line at http://www.epa .gov/chemrtk/pubs/general/robsumgd.htm. 2046

64. EPA. Analysis of Laboratory Ca pacity to Support U.S. EPA Chemical Testing 2047 Program Initiatives. Economic and Policy Analysis Branch. Washington, DC. August 2004. 2048

65. EPA. VCCEP Web s ite home page. (www.epa.gov/oppt/vccep). 2049*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 52 of 91 66. EPA, 2009. Polybrominated Diphe nyl Ethers (PBDEs) Action Plan. Available at: 2050 http://www.epa.gov/oppt/existingc hemicals/pubs/pbdes_ap_2009_1230_final.pdf 2051

67. Chemtura. Letter from Robert Cam pbell to Jim Willis, Director, CCD, OPPT, 2052 USEPA. January 6, 2006. 2053

68. Albermarle Corporation. Letter fro m David W. Clary, Albemarle Corp. to Lisa P. 2054 Jackson, USE EPA. EPA-Industry DecaBDE Phase-Out Initiative. Dec December 15, 2009. 2055

69. Chemtura Corporation. Letter from Craig A. Rogerson, Chemtura Corp. to Lisa P. 2056 Jackson, US EPA. DecaBDE Phase-Out Initiative. Dec December 17, 2009. 2057

70. ICL Industrial Products. Letter from Nissim Adar to Lisa P. Jackson, US EPA. 2058 Voluntary Phase-Out of DecaBDE. Dec December 15, 2009. 2059

71. Arnold & Porter LLP. Letter from Lawrence Culleen to Ward Penberthy, CCD, 2060 EPA. June 25, 2010. 2061

72. EPA. Economic Analysis of the Proposed Significant New Use Rule for 2062 Polybrominated Diphenyl Ethers. Prepared by Timothy Lehman and Abt Associates Inc. 2063 September 30, 2010. 2064

73. EPA. Economic Impact Analysis for the Proposed Section 4 Test Rule for c2065 Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether. 2066 Prepared by Timothy Lehman and Abt Associates Inc. September 30, 2010. 2067

74. Kimbrough KL, Johnson WE, Lauenstein GG, Christensen JD, and Apeti DA. An 2068 Assessment of Polybrominated Diphenyl Ethers (P BDEs) in Sediments and Bivalves of the U.S. 2069
Coastal Zone. NOAA Technical Memorandum NOS NCCOS 94. 2009. 2070
2071 75. EPA, Polybrominated Diphenyl Ethers (PBDEs) Project Plan. March, 2006. 2072 Available at http://www.epa.gov/oppt/pbde/pubs /proj-plan32906a.pdf (accessed Dec. 15, 2009). 2073

2074
2075 XIII. Statutory and Executive Order Reviews 2076

A. Executive Order 12866 2077

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 2078 October 4, 1993), this action has be en designated a “significant re gulatory action” by the Office 2079 of Management and Budget (OMB). Accordingl y, EPA submitted this action to OMB for review 2080 and any changes made in response to OMB r ecommendations have been documented in the 2081
docket for this action. 2082
2083 In addition, EPA has prepared two economic anal yses of the potentia l impacts associated 2084 with this action. A copy of th ese economic analyses, entitled Economic Impact Analysis for the 2085 Proposed Section 4 Test Rule for c-Pentabrom odiphenyl Ether, c-Octabromodiphenyl Ether, and 2086 c-Decabromodiphenyl Ether (Ref. 73) and Economic Analysis of the Proposed Significant New 2087*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 53 of 91 Use Rule for Polybrominated Diphenyl Ethers (Ref. 72), are available in the docket for this 2088 proposed rule and are summarized in Unit X. of this preamble. 2089
2090
B. Paperwork Reduction Act 2091

This proposed rule does not impose any pa perwork collection requirements that would 2092 require additional review and/or approval by OMB under the Paperwork Reduction Act (PRA), 2093
44 U.S.C. 3501 et. seq. The information collection requireme nts related to the proposed SNUR 2094 (i.e., the submission of a SNUN) have been approved by OMB pursuant to the PRA under OMB 2095 control number 2070-0038 (EPA ICR No. 1188). The information collection requirements 2096 related to the proposed test ru le have been approved by OMB pursuant to the PRA under OMB 2097 control number 2070-0033 (EPA ICR No. 1139). A lthough the test rule information collection 2098 activities are approved, the additional burden associat ed with this test rule is not yet covered by 2099 the approved ICR until the final rule is effective. In the context of developing a new test rule, 2100 the Agency must determine whether the total annual burden covered by the approved ICR needs 2101
to be amended to accommodate the burden associated with the new test rule. If so, the Agency 2102
must submit an Information Correction Worksh eet (ICW) to OMB and obtain OMB approval of 2103 an increase in the total approved an nual burden in the OMB inventory. 2104
2105
The information collection ac tivities related to export notification under TSCA section 2106 12(b)(1) are already approved under OMB control number 2070–0030 (EPA ICR No. 0795). 2107 This rulemaking does not propose any new or cha nges to the export notif ication requirements, 2108 and is not expected to result in any substantive changes in the burden estimates for EPA ICR No. 2109 0795 that would require additional re view and/or approval by OMB. 2110
2111 Under the PRA, an agency may not conduct or sponsor, and a person is not required to 2112 respond to, a collection of info rmation that is subject to approval under the PRA, unless it 2113 displays a currently valid OMB control number. The OMB control numbers for the EPA 2114 regulations codified in chapter 40 of the CFR, af ter appearing in the preamble of the final rule, 2115 are listed in 40 CFR part 9, displa yed either by publication in the Federal Register or by other 2116 appropriate means, such as on the related collect ion instrument or form, if applicable. The 2117 display of OMB control numbers in certain EPA regulations is c onsolidated in 40 CFR part 9. 2118
2119 To submit a SNUN, EPA estimates that the industry burden ho urs per chemical to be 92 2120 hours. (Ref. 72). The standard chemical testi ng program involves the submission of letters of 2121 intent to test (or exemption applications), study plans, semi-annual progress reports, test results, 2122 and administrative costs. For this proposed ru le, EPA estimates the total industry burden hours 2123 for all three mixtures to be 37,074 hours (56,717 hours) for the low (high) cost scenario. 2124 Average industry burden hours per mixture ar e estimated to be 12,358 hours (18,906 hours) in 2125 the low (high) cost s cenario. (Ref. 72). 2126
2127
The estimated burden of the information colle ction activities related to export notification 2128 is estimated to average 1 burden hour for each mixture/country combination for an initial 2129 notification and 0.5 hours for each subsequent noti fication (Ref. 72). In estimating the total 2130 burden hours approved for the information collecti on activities related to export notification, the 2131 Agency has included sufficient burden hours to accommodate any export no tifications that may 2132 be required by the Agency’s issuance of final test ru les. As such, EPA does not expect to need to 2133*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 54 of 91 request an increase in the total burden hours approved by OMB for export notifications. 2134
2135 As defined by PRA and 5 CFR 1320.3(b), ‘‘burden’’ means the total time, effort, or 2136 financial resources expended by persons to genera te, maintain, retain, or disclose or provide 2137 information to or for a Federal agency. This includes the time needed to : Review instructions; 2138 develop, acquire, install, and utilize technology and systems fo r the purposes of collecting, 2139 validating, and verifying information, processi ng and maintaining information, and disclosing 2140 and providing information; adjust the existing wa ys to comply with any previously applicable 2141 instructions and requirements; train personnel to be able to respond to a collection of 2142 information; search data sources; complete a nd review the collection of information; and 2143
transmit or otherwise disclose the information. 2144
2145 Comments are requested on the Agency’s need for this information, the accuracy of the 2146 provided burden estimates, and any suggest ed methods for minimizing respondent burden, 2147 including through the use of automa ted collection techniques. Send comments to EPA as part of 2148 your overall comments on this proposed act ion in the manner specified under ADDRESSES . In 2149 developing the final rule, the Agency will ad dress any comments received regarding the 2150 information collection requirement s contained in this proposal. 2151
2152
C . Regulatory Flexibility Act 2153

Pursuant to section 605(b) of the Regulat ory Flexibility Act (RFA), 5 U.S.C. 601 et seq.
, 2154 after considering the potential economic impacts of this proposed rule on small entities, the 2155 Agency hereby certifies that this proposed rule does not have a signifi cant adverse economic 2156 impact on a substantial number of small enti ties. The factual basis for the Agency’s 2157 determination is presented in the small entity imp act analysis prepared as part of the economic 2158 analyses for this proposed rule (Refs. 72 and 73), which are su mmarized in Unit X. of this 2159 document, and copies of which are available in the docket for this rulemaking. The following is 2160 a brief summary of the factual basis for this certification. 2161
2162 Under the RFA, small entities include small businesses, small organizations, and small 2163 governmental jurisdictions. For purposes of asse ssing the impacts of this proposed rule on small 2164 entities, small entity is defined in accordance w ith the RFA as: 1) A small business as defined 2165 by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201; 2) A small 2166 governmental jurisdiction that is a government of a city, county, town, school district, or special 2167 district with a population of le ss than 50,000; and 3) A small orga nization that is any not-for2168 profit enterprise which is indepe ndently owned and operated and is not dominant in its field. 2169
2170 Based on the industry profile that EPA prepared as part of the economic analysis for this 2171 rulemaking (Ref. 73), EPA has determined that this proposed rule is not expected to impact any 2172 small not-for-profit organizations or small governmental jurisdic tions. As such, the Agency’s 2173 analysis presents only the estimated potential impacts on small business. 2174
2175
Two factors are examined in EPA’s small en tity impact analysis (Ref. 73) in order to 2176 characterize the potential small en tity impacts of this proposed rule on small business: 1) The 2177 size of the adverse economic impact (measured as the ratio of the cost-to-sales or cost-to2178 revenue), and 2) The total number of small entities that experience the adverse economic 2179*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 55 of 91 impact. 2180
2181 Section 601(3) of the RFA establishes as th e default definition of “small business” the 2182
definition used in section 3 of the Small Bu siness Act, 15 U.S.C. 632, under which the Small 2183 Business Administration (SBA) establishes small business size standards (13 CFR 121.201). For 2184 this rulemaking, EPA has analyzed the potential small business impacts using the size standards 2185
established under this default definition. The SB A size standards, which are primarily intended 2186 to determine whether a business entity is el igible for government pr ograms and preferences 2187 reserved for small businesses (13 CFR 121.101), “seek to ensure that a concern that meets a 2188 specific size standard is not dominant in it s field of operation.” (13 CFR 121.102(b)). See 2189 section 632(a)(1) of the Small Business Act. In analyzing potential impacts, the RFA recognizes 2190 that it may be appropriate at times to use an al ternate definition of sma ll business. As such, 2191 section 601(3) of the RFA provides that an agency may establish a different definition of small 2192
business after consultation with the SBA Office of Advocacy and after notice and an opportunity 2193 for public comment. Even though the Agency has used the default SBA definition of small 2194 business to conduct its analysis of potential small busin ess impacts for this proposed rule, EPA 2195
does not believe that the SBA si ze standards are generally the be st size standards to use in 2196 assessing potential small entity impacts with regard to TSCA secti on 4(a) test rules. 2197
2198 The SBA size standard is generally based on the number of employe es an entity in a 2199 particular industrial sector may have. For exam ple, in the chemical manufacturing industrial 2200 sector (i.e., NAICS 325 and NAICS 324110), approximately 98% of the firms would be 2201
classified as small businesses under the default SBA definition. The SBA size standard for 75% 2202 of this industry sector is 500 empl oyees, and the size standard for 23% of this industry sector is 2203 either 750, 1,000, or 1,500 employees. When assessi ng the potential impacts of test rules on 2204 chemical manufacturers, EPA believe s that a standard based on to tal annual sales may provide a 2205 more appropriate means to judge the ability of a chemical manufacturing firm to support 2206 chemical testing without si gnificant costs or burdens. 2207
2208 EPA is currently determining what level of annual sales woul d provide the most 2209 appropriate size cutoff with regard to various segments of the chemical industry usually 2210 impacted by TSCA section 4(a) test rules, but has not yet reached a determination. As stated 2211 above, therefore, the factual basis for the RFA de termination for this proposed rule is based on 2212 an analysis using the default SBA size standard s. Although EPA is not currently proposing to 2213
establish an alternate definition for use in the analysis conducted for this proposed rule, the 2214 analysis for this proposed rule also presents the results of calculations using a standard based on 2215 total annual sales (40 CFR 704.3). EPA is intere sted in receiving comments on whether the 2216 Agency should consider establishing an alternate definition for small business to use in the small 2217 entity impact analyses for future TSCA section 4(a) test rules, and what size cutoff may be 2218 appropriate. 2219
2220 The SBA has developed 6 digit NAICS code-specific size standards based on 2221 employment thresholds. These size standards range from 500 to 1,500 employees for the various 2222 6 digit NAICS codes that are potentially impacted (Ref. 73). For a conservative estimate of the 2223
number of small businesses affect ed by this rule, the Agency c hose an employment threshold of 2224 less than 1,500 employees for a ll businesses regardless of the NAIC-specific threshold to 2225
determine small business status. 2226*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 56 of 91 2227 For manufacturers and importers of decaBDE covered by this proposed rule, six parent 2228 companies (ultimate corporate entity, or UCE) we re identified and sales and employment data 2229 were obtained for companies where data were pub licly available. Parent company sales data 2230 were used to identify companies that qualified as a “small business” for purposes of the RFA 2231 analysis. Based on the TSCA employment stan dard (1,500 employees or less), one company 2232 was identified as small. This company had cost -to-sales ratios of greater than 3% under both the 2233 low- and high-cost scenarios. Gi ven these results, the Agency has determined that there is not a 2234 significant economic impact on a substantial number of small entities as a re sult of this proposed 2235 rule, if finalized. 2236
2237 The estimated cost of the TSCA section 12(b) (1) export notification, wh ich, as a result of 2238 the final rule, would be required fo r the first export to a particular country of a mixture subject to 2239 the rule, is estimated to be $85.70 for the first time that an exporter must comply with TSCA 2240 section 12(b)(1) export notification requirements, and $26.86 for each subsequent export 2241 notification submitted by that exporter (Ref. 72). EPA has concluded that the costs of TSCA 2242 section 12(b)(1) export no tification would have a negligible impact on exporters of the mixtures 2243 in the final rule, regardless of the size of the exporter. 2244
2245 Any comments regarding the impacts that th is action may impose on small entities, or 2246 regarding whether the Agency should consider establishing an alternate definition of small 2247 business to be used for analytical purposes fo r future test rules and what size cutoff may be 2248 appropriate, should be submitted to the Agency in the manner specified under ADDRESSES

. 2249
2250
D. Unfunded Mandates Reform Act 2251

This action does not contain any Federal manda tes for State, local, or tribal governments 2252 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 2253 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory ac tion will not result in 2254 annual expenditures of $100 million or more for St ate, local, and tribal governments, in the 2255 aggregate, or for the private sector. For the privat e sector, it is estimated that the total aggregate 2256 costs of this proposed rule would be $15.1 million. The total annualized costs of this proposed 2257 rule to the private sector are estimated to be $5.34 and 5.75 million using a 3% and 7% discount 2258 rate over 3 years (high cost scen ario). In addition, since EPA does not have any information to 2259 indicate that any State, local , or tribal government manufactur es or processes the mixtures 2260 covered by this action such that this rule would apply directly to State, local, or tribal 2261 governments, EPA has determined that this propo sed rule would not significantly or uniquely 2262 affect small governments. Accordingly, this propos ed rule is not subject to the requirements of 2263 sections 202, 203, 204, and 205 of UMRA. 2264
2265

E . Executive Order 13132 2266

Under Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), 2267 EPA has determined that this proposed rule doe s not have “federalism implications” because it 2268 will not have substantial direct effects on the States, on the relationship between the national 2269 government and the States, or on the distribution of power and responsibilities among the various 2270 levels of government, as specified in the Ex ecutive Order. The proposed test rule would 2271*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 57 of 91 establish testing and recordkeeping requireme nts that apply to ma nufacturers (including 2272 importers) and processors of cer tain mixtures. The proposed am endments to the SNUR would 2273 establish notification and submission requireme nts that apply to manufacturers (including 2274 importers) before certain chemicals may be ma nufactured or imported. Because EPA has no 2275 information to indicate that any State or lo cal government manufactures or processes the 2276 chemical substances and mixtures covered by th is action, the proposed SNUR-Test Rule does not 2277 apply directly to States and lo calities and will not affect State and local governments. Thus, 2278 Executive Order 13132 does not apply to this proposed rule. 2279

F . Executive Order 13175 2280

Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 2281
Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule 2282 does not have tribal implications because it will not have any affect effect on tribal governments, 2283 on the relationship between the Federal Government and the Indian tribes, or on the distribution 2284 of power and responsibilit ies between the Federal Government a nd Indian tribes, as specified in 2285 the Executive Order. As indicated previously, EP A has no information to indicate that any tribal 2286 government manufactures or processes the chemi cal substances or mixtures covered by this 2287 action. Thus, Executive Order 13175 does not apply to this proposed rule. 2288

G . Executive Order 13045 2289

EPA interprets Executive Order 13045, entitled Protection of Children from 2290
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 2291 those regulatory actions that con cern health or safety risks, such that the analysis required under 2292
section 5-501 of Executive Order 13045 has the potential to influe nce the regulation. This action 2293 is not subject to Executive Order 13045 because it does not establish an environmental standard 2294 intended to mitigate health or safety risks. Nevertheless, the information obtained by this 2295 proposed rule could inform the Agency’s decisi on-making process regarding mixtures to which 2296 children may be disproportionately exposed. The proposed test rule woul d establish testing and 2297 recordkeeping requirements that apply to manufac turers (including importe rs) and processors of 2298 certain mixtures, and would resu lt in the development of data about those mixture substances 2299 that can subsequently be used to assist the Agency and others in determining whether the 2300 mixtures in the proposed test rule present potentia l risks, allowing the Agency and others to take 2301 appropriate action to investigate and mitigate th ose risks. Similarly, the proposed amendments 2302
to the SNUR would allow EPA to review availabl e information to identify and take action to 2303 address potential risk because it would requir e manufacturers to submit notification and hazard 2304
information in the form of a SNUN to EPA befo re a chemical may be manufactured or imported. 2305

H. Executive Order 13211 2306

This action is not a “significant energy action” as defined in Executive Order 13211, 2307
entitled Actions Concerning Regulations that Signific antly Affect Energy Supply, Distribution, or 2308

Use (66 FR 28355, May 22, 2001), because it is not likel y to have a significant adverse effect on 2309 the supply, distribution, or use of en ergy as described in the Order. 2310

I. National Technology Trans fer and Advancement Act 2311*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 58 of 91 Section 12(d) of the Nati onal Technology Transfer and Advancement Act (NTTAA), 15 2312 U.S.C. 272 note, directs EPA to use voluntary co nsensus standards in its regulatory activities 2313
unless to do so would be inconsis tent with applicable law or ot herwise impractical. Voluntary 2314
consensus standards are technical standards (e.g., materials specifi cations, test methods, 2315 sampling procedures, and business practices) that are developed or adopted by voluntary 2316
consensus standards bodies. The NTTAA dir ects EPA to provide Congress, through OMB, 2317 explanations when the Agency decides not to use available and applic able voluntary consensus 2318
standards. 2319

The proposed test rule involves technical st andards because it proposes to require the use 2320 of particular test methods. If the Agency makes findings under TSCA section 4(a), EPA is 2321 required by TSCA section 4(b) to in clude specific standards or test methods that are to be used 2322 for the development of the data required in the test rules issued under TSCA section 4. For 2323 some of the testing that would be required by the final rule, EPA is proposing the use of 2324 voluntary consensus standards is sued by ASTM International and ISO which evaluate the same 2325 type of toxicity as the TSCA 799 test guideline s and OECD test guidelines, where applicable. 2326 Copies of the ASTM International standards re ferenced in the proposed regulatory text at § 2327 799.XXXX (h)(2)(i) through (v) have been placed in the docket for this proposed rule where they 2328 are available for reading, but not copying. Y ou may obtain copies of the ASTM International 2329 standards from the American Society for Testin g and Materials Internat ional, 100 Bar Harbor 2330 Dr., West Conshohocken, PA 19428–2959. In the final rule, EPA intends to seek approval from 2331
the Director of the Federal Register for the incorporation by reference of the ASTM 2332
International and ISO standards used in the final rule in accordance with 5 U.S.C. 552(a) and 1 2333 CFR part 51. 2334

EPA is not aware of any potentially app licable voluntary consensus standards which 2335 evaluate prenatal developmenta l toxicity, two-generation reproduc tive toxicity, developmental 2336 neurotoxicity, immunotoxicity, or chronic toxicity/carcinogenicity, or screen for neurotoxicity 2337 which could be considered in lieu of the TSCA 799 test guidelines, 40 CFR 799.9370, 799.9380, 2338 799.9630, 799.9780, 799.9430, and 799.9620, respectively, upon which the test standards in the 2339 proposed rule are based. 2340

EPA is also not aware of any potentially app licable voluntary consensus standards which 2341 evaluate anaerobic aquatic metabolism, biode gradation in anaerobic digester sludge, or 2342 photolytic degradation in the indoor environment. As a result, EPA is proposing the use of three 2343 guidelines which are published in full in the proposed regulatory text at § 799.XXXX (h)(3) (ii) 2344 through (iv). 2345

The Agency invites comment on the potential use of voluntary consen sus standards in the 2346 proposed test rule, and, specifically, invites th e public to identify potentially applicable 2347 consensus standard(s) and to explain why such standard(s) should be used here. 2348

J. Executive Order 12898 2349

This proposed rule does not have an a dverse impact on the envi ronmental and health 2350 conditions in low-income and minority communiti es that require specia l consideration by the 2351 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 2352 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 2353*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 59 of 91 The Agency believes that the information collect ed under this proposed rule, if finalized, will 2354 assist EPA and others in determining the potential hazards and risks associat ed with the mixtures 2355 covered by this proposed rule. Although not dire ctly impacting environmental justice-related 2356 concerns, this information will enable the Agen cy to better protect human health and the 2357 environment, including in low-income and minority communities. 2358

K. Executive Order 12630 2359

EPA has complied with Executive Order 12630, entitled G overnment Actions and 2360 Interference with Constitutionally Pr otected Property Rights (Takings) (53 FR 8859, March 15, 2361 1988), by examining the takings implications of this proposed rule in accordance with the 2362 “Attorney General’s Supplemental Guidelines for the Evaluation of Risk and Avoidance of 2363 Unanticipated Takings” issued under the Executive Order. 2364

L. Executive Order 12988 2365

In issuing this proposed rule, EPA has take n the necessary steps to eliminate drafting 2366 errors and ambiguity, minimize potential litigat ion, and provide a clear legal standard for 2367 affected conduct, as required by sec tion 3 of Executive Order 12988, entitled Civil Justice 2368 Reform (61 FR 4729, February 7, 1996). 2369

List of Subjects in 40 CFR Part 721 2370

Environmental protection, Chemicals, Hazardous substances, Premanufacture 2371 notification, Reporting and r ecordkeeping requirements. 2372

List of Subjects in 40 CFR Part 799. 2373
2374 Environmental protection, Chemicals, Hazardous substances, Laboratories, Reporting 2375 and recordkeeping requirements. 2376

Dated: __________________ 2377
2378

_____________________________ 2379 Assistant Administrator, Office of Ch emical Safety and Pollution Prevention. 2380*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 60 of 91 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 2381
2382 PART 721---[AMENDED] 2383

1. The authority citation for part 721 continues to read as follows: 2384

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

. 2385
2386 2. By amending 721.10000 to read as follows : 2387

§ 721. 10000 Certain Polybrominated Diphenylethers

. 2388
2389 (a) Definitions . The definitions in § 721.3 apply to th is section. In a ddition, the following 2390 definitions app ly: 2391 (1) M ilitary use means use by the armed forces of the United States

. 2392 (2) Transportation use means preparation of an article for use as an integral component 2393 of a moving vehicle such as a car, truck, train, ship, or aircraft. 2394 ( b 2395 (a ) Chemical substances subject to significant new use reporting

. 2396 (1) The chemical substances identified as tetrabromodiphenyl ether (CAS No. 40088–47– 2397 9; Benzene, 1,1 ′ -oxybis-, tetrabromo deriv.), pentab romodiphenyl ether (CAS No. 32534–81–9; 2398 Benzene, 1,1 ′ -oxybis-, pentabromo deriv.), hexabr omodiphenyl ether (CAS No. 36483–60–0; 2399 Benzene, 1,1 ′ -oxybis-, hexabromo deriv.), heptabro modiphenyl ether (CAS No. 68928–80–3; 2400 Benzene, 1,1 ′ -oxybis-, heptabromo deriv.), octabr omodiphenyl ether (CAS No. 32536–52–0; 2401 Benzene, 1,1 ′ -oxybis-, octabromo deriv.), and nona bromodiphenyl ether (CAS No. 63936–56–1; 2402 Benzene, pentabromo(tetrabromophenoxy)-), or any combination of these substances resulting 2403
from a chemical reaction are s ubject to reporting under this sec tion for the significant new uses 2404 described in paragraph (c )(2) of this section. 2405 (2) Decabromodiphenyl ether (CAS No. 1163-19-5; Benzene, 1,1'-oxybis[2,3,4,5,6- 2406 pentabromo-) 2407 ( c b ) Significant new uses

. 2408 (1) The significant new uses for chemicals identified in paragraph ( b a )(1) of this section 2409

are: 2410 (i) Manufacture or import for any use on or after January 1, 2005, and 2411 (ii) Processing for any use after December 31, 2012 2013

. 2412 (2) The significant new uses for the chemical identified in paragraph ( b a )(2) of this 2413
section are: 2414 (i) Manufacture, import or processing for any use except military and transportation uses 2415 after December 31, 2012, and 2416 (ii) M anufacture

, import or process ing for a ny use including military or transportation 2417

uses after December 31, 2013. (ii) Reserved} 2418 ( d c ) Specific requirements. The provisions of subpart A of this part apply to this section 2419 except as modified by this paragraph. 2420 (1) Revocation of certain notification exemptions . The provisions of § 721.45(f) do not 2421 apply to this section. A person who imports or pr ocesses a chemical substa nce identified in this 2422 section as part of an article is not exempt from submitting a significant new use notice. 2423

(2) [Reserved] 2424*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 61 of 91 2425

PART 799---[AMENDED] 2426

3. The authority citation for part 799 continues to read as follows: 2427

Authority: 15 U.S.C. 2603, 2611, 2625 2428
2429 4. By adding § 799.XXXX to subpart D to read as follows: 2430

§ 799.XXXX Certain polybrominated diphenylethers. 2431
2432 (a) What mixtures will be tested under this section? The chemical mixtures that must be 2433
tested under this section are three representative commercial forms of pentabromodiphenyl ether, 2434 octabromodiphenyl ether, and decabro modiphenyl ether, as follows: 2435 (1) commercial pentabromodiphenyl ether (c-p entaBDE), whose predominant components are 2436 tetrabromodiphenyl ether (CASRN 40088–47–9; Benzene, 1,1 ′ -oxybis-, tetrabromo deriv.), 2437 pentabromodiphenyl ether (CASRN 32534-81-9; Ben zene, 1,1’-oxybis-, pentabromo deriv.), and 2438 hexabromodiphenyl ether (C ASRN 36483–60–0; Benzene, 1,1 ′ -oxybis-, hexabromo deriv.), 2439
2440 (2) commercial octabromodiphe nyl ether (c-octaBDE), whose predominant components are 2441 heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1 ′ -oxybis-, heptabromo deriv.), 2442 octabromodiphenyl ether (CAS N o. 32536-52-0; Benzene, 1,1’- oxybis-, octabromo deriv.), and 2443 nonabromodiphenyl ether (CAS RN 63936–56–1; Benzene, pentabromo (tetrabromophenoxy)-), 2444
and 2445
2446 (3) commercial decabromodiphenyl ether (c-dec aBDE), whose component with the highest 2447 percent composition is decabromodiphenyl ether (CASRN 1163-19-5; Benzene, 1,1’- 2448 oxybis[2,3,4,5,6-pentabromo-), aka BDE-209. 2449
2450 The test sponsor(s) must identify the percentage of each of the seven PBDE congeners present in 2451 each of the representative commercial mixtures that will be tested. 2452
2453 (b) Am I subject to this section? (1) If you manufacture (inc luding import) or process c2454 pentaBDE or , c-octaBDE for any use including in articles at any time after December 31, 2012; 2455

or manufacture or process c

- , or c- decaBDE for any use except for military and transportation 2456 uses including in articles at any time after December 31, 2012; or manufacture (including 2457 import) or process c

- decaBDE for any use including military or transportation uses including in 2458 articles at any time after December 31, 2013, until the end of the test data reimbursement period 2459 as defined in 40 CFR 791.3(h), you ar e subject to this sect ion with respect to that mixture. You 2460 are also subject to this rule if you manufacture (including impor t) or process c-pentaBDE, c2461 octaBDE, or c-decaBDE for export from the United States. For this rule, importers of articles 2462 containing c- pentaBDE, c-octa BDE, or c-decaBDE are considered manufacturers and are 2463 subject to this rule. 2464

(2) If you do not know or cannot reasonably as certain that you manuf acture or process a 2465 mixture listed in paragraph (a) of this secti on during the time period described in paragraph 2466 (b)(1) of this section (b ased on all information in your possession or control, as well as all 2467*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 62 of 91 information that a reasonable person similarly situ ated might be expected to possess, control, or 2468 know, or could obtain without unreasonable burden) , you are not subject to this section with 2469 respect to that mixture. 2470

(c) If I am subject to this secti on, when must I comply with it? (1) (i) Persons subject to 2471 this section are divided into two groups, as set fort h in Table 1 of this paragraph: Tier 1 (persons 2472 initially required to comply) and Tier 2 (pers ons not initially required to comply). If you are 2473 subject to this section, y ou must determine if you fall within Ti er 1 or Tier 2, based on Table 1 of 2474 this paragraph. 2475

Table 1.--Persons Subject to the Ru le: Persons in Tier 1 and Tier 2 2476

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)).

2477

(ii) Table 1 of paragraph (c)(1)(i) of this se ction expands the list of persons in Tier 2, that 2478 is those persons specified in § 790.42(a)(2), (a)(4) and (a)(5) of th is chapter, who, while legally 2479 subject to this section, must comply with the requirements of this section only if directed to do so 2480 by EPA under the circumstances set forth in paragraphs (c)(4), (c)( 5), (c)(6), (c)(7), and (c)(10) 2481
of this section. 2482*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 63 of 91 (2) If you are in Tier 1 with respect to a mi xture listed in paragra ph (a) of this section, 2483 you must, for each test required under this section for that mixture, either submit to EPA a letter 2484 of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 2485 exemption application must be received by EPA no later than 30 days after the relevant effective 2486 date in paragraph (k ) of this section. 2487

(3) If you are in Tier 2 with respect to a mi xture listed in paragra ph (a) of this section, 2488 you are considered to have an automatic condi tional exemption and you will be required to 2489 comply with this section with regard to that mixture only if directed to do so by EPA under 2490 paragraphs (c)(5), (c)(7), or (c)(10) of this section. 2491

(4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests 2492 required by this section on any mixture listed in pa ragraph (a) of this sec tion within 30 days after 2493
the relevant effective date in paragraph (k) of this section, EPA will publish a Federal Register 2494 document that would specify the test(s) and the mi xture (s) for which no letter of intent has been 2495 submitted and notify manufacturers in Tier 2A of their obligation to submit a letter of intent to 2496 test or to apply for an exemption from testing. 2497

(5) If you are in Tier 2A (as specified in Ta ble 1 in paragraph (c) of this section) with 2498 respect to a chemical substance listed in paragraph (a) of this section, and if you manufacture, or 2499 intend to manufacture, this ch emical substance after the relevant effective date in paragraph (k) 2500 of this section, or within 30 days after publication of the Federal Register document described 2501 in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance 2502 in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of 2503 intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 2504 exemption application must be received by EPA no later than 30 days af ter publication of the 2505 Federal Register document described in paragr aph (c)(4) of this section. 2506

(6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one 2507 or more of the tests required by this section on a ny chemical substance listed in paragraph (a) of 2508 this section within 30 days after the publication of the Federal Register document described in 2509 paragraph (c)(4) of this s ection, EPA will publish another Federal Register document that 2510 would specify the test(s) and the chemical substa nce(s) for which no letter of intent has been 2511 submitted, and notify processors in Tier 2B of their obligation to submit a letter of intent to test 2512 or to apply for an exemption from testing. 2513

(7) If you are in Tier 2B (as specified in Ta ble 1 in paragraph (c) of this section) with 2514 respect to a mixture listed in pa ragraph (a) of this section, an d if you process, or intend to 2515 process, this mixture after the relevant effective date in paragraph (k ) of this section, or within 30 2516 days after publication of the Federal Register document described in paragraph (c)(6) of this 2517 section, you must, for each test spec ified for that mixture in the Federal Register document 2518 described in paragraph (c)(6) of th is section, either submit to EPA a letter of intent to test or 2519 apply to EPA for an exemption from testing. The letter of intent to test or the exemption 2520 application must be received by EPA no la ter than 30 days after publication of the Federal 2521 Register document described in para graph (c)(6) of this section. 2522

(8) If no manufacturer or pro cessor has notified EPA of its in tent to conduct one or more 2523 of the tests required by this section for any of the mixtures listed in paragr aph (a) of this section 2524*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 64 of 91 within 30 days after the publication of the Federal Register document described in paragraph 2525 (c)(6) of this section, EPA will notify all manufacture rs and processors of those mixtures of this 2526 fact by certified lette r or by publishing a Federal Register document specifying the test(s) for 2527
which no letter of intent has been submitted. This letter or Federal Register document will 2528 additionally notify all manufacturers and processors that all exemption applications concerning 2529 the test(s) have been denied, and will give the ma nufacturers and processors of the mixture (s) an 2530 opportunity to take corrective action. 2531

(9) If no manufacturer or pro cessor has notified EPA of its in tent to conduct one or more 2532 of the tests required by this section for any of the mixtures listed in paragr aph (a) of this section 2533 within 30 days after rece ipt of the certified lett er or publication of the Federal Register 2534 document described in paragraph (c)(8) of this section, all manufacturers and processors subject 2535 to this section with respect to that mixture who ar e not already in violation of this section will be 2536
in violation of this section. 2537

(10) If a problem occurs with the initiati on, conduct, or completion of the required testing 2538 or the submission of the required data with respec t to a mixture listed in paragraph (a) of this 2539 section, under the procedures in §§ 790.93 and 790.97 of this chapter, EPA may initiate 2540 termination proceedings for all testing exemptions with respect to that mixture and may notify 2541 persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption 2542 applications within a specified period of time. 2543

(11) If you are required to comply with th is section, but your manu facture or processing 2544 of, or intent to manufacture or process, a mixtur e listed in paragraph (a) of this section begins 2545 after the applicable compliance date referred to in paragraphs (c)(2), (c)( 5), or (c)(7) of this 2546 section, you must either submit a le tter of intent to test or appl y to EPA for an exemption. The 2547 letter of intent to test or the exemption applic ation must be received by EPA no later than the day 2548 you begin manufacture or processing. 2549

(d) What must I do to comply with this section? (1) To comply with this section you 2550
must either submit to EPA a letter of intent to test, or apply to and obtain from EPA an 2551 exemption from testing. 2552

(2) For each test with respect to which you submit to EPA a letter of intent to test, you 2553 must conduct the testing specified in paragraphs (h) and (i) of th is section and submit the test 2554
data to EPA. 2555

(3) You must also comply with the procedur es governing test rule requirements in part 2556 790 of this chapter, as modified by this section, including the submission of letters of intent to 2557 test or exemption applications, the submission of study plans prior to testing, the conduct of 2558 testing, and the submission of data; Part 792—G ood Laboratory Practice Standards of this 2559 chapter; and this section. The following provi sions of 40 CFR part 790 do not apply to this 2560 section: Paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; paragraph (a)(2) and paragraph (b) 2561 of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85. 2562
2563 (e) If I do not comply with this section, when will I be considered in violation of it? You 2564
will be considered in violation of this section as of 1 day after the date by which you are required 2565 to comply with this section. 2566*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 65 of 91 (f) How are EPA’s data reimbursement proced ures affected for purposes of this 2567
section? If persons subject to this section are unable to agree on the amount or method of 2568 reimbursement for test data development for one or more mixtures included in this section, any 2569 person may request a hearing as described in 40 CFR part 791. In the determination of fair 2570
reimbursement shares under this section, if the hearing officer c hooses to use a formula based on 2571 production volume, the total production volume amount will include amounts of a mixture 2572 manufactured and processed as impuriti es and amounts imported in articles. 2573

(g) Who must comply with the export notification requirements? Any person who 2574 exports, or intends to export, a mi xture listed in paragraph (a) of this section is subject to part 2575 707, subpart D, of this chapter except when the mixture is in articles. 2576

(h) How must I conduct my testi ng of c-pentaBDE and c-octaBDE? The tests that are 2577 required for c-pentaBDE and c-octaBDE and the test methods that must be followed are listed in 2578 subparagraphs (1) through (11) of paragraph (h) of this secti on. All tests must be conducted in 2579 accordance with the requirements described in 40 CFR Part 792—Good Laboratory Practice 2580
Standards. 2581

(1) toxicity to freshwater invertebrates of sediment-associated contaminants conducted in 2582 accordance with ASTM E 1706-05e1 and following the guidance of ASTM E 1391-03, 2583

(2) Laboratory soil toxicity and bioaccumul ation tests with the lumbricid earthworm 2584 Eisenia fetida and the enchytraeid potworm E nchytraeus albidu conducted in accordance with 2585 ASTM E 1676-04 and following general guidance in ASTM E 1391-03, 2586

(3) toxicity to polychaetous annilids of sediment-associated contaminants conducted in 2587 accordance with ASTM E 1611-00 and following the guidance of ASTM E 1391-03, 2588

(4) laboratory soil toxicity to nematode Caenorhabditis elegans conducted in accordance 2589 with ASTM E 2172-01 and following guidance fo r collecting laboratory soil in ASTM E 1676- 2590 04, and following general guidance in ASTM E 1391-03, 2591

(5) toxicity to estuarine and marine invert ebrates of sediment-associated contaminants 2592 conducted in accordance with ASTM E 1367-03 and following the guidance of ASTM E 1391- 2593 03, 2594

(6) prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 2595 799.9370, 2596

(7) two-generation reproductive toxicity with a satellite group for body burden 2597 determinations conducted in accordance with 40 CFR 799.9380, 2598

(8) immunotoxicity conducted in accordance with 40 CFR 799.9780, 2599

(9) neurotoxicity screening battery, acute a nd subchronic, conducted in accordance with 2600 40 CFR 799.9620, 2601

(10) developmental neurotoxicity co nducted in accordance with 40 CFR 799.9630, 2602*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 66 of 91 (11) chronic toxicity/carcinogenicity conducted in accordance with 40 CFR 799.9430. 2603

(i) How must I conduct my testing of c-decaBDE? The tests that are required for c2604 decaBDE and the test methods that must be followed are listed in subparagraphs (1) through (4) 2605 of paragraph (i) of this section. The use of the term “test substance” in the guidelines listed in 2606 subparagraphs (2) through (4) of paragraph (i) of this secti on, should be unde rstood to mean c2607 decaBDE or test mixture where appropriate. All tests must be conducted in accordance with the 2608 requirements described in 40 CFR Part 792—Good Laboratory Practice Standards. 2609

(1) The tests and test methods listed in para graphs (h)(1) through (h)(1 0) of this section. 2610

(2) anaerobic aquatic metabolism conducted in accordance with th e following guideline: 2611

(i) Title . Decabromodiphenyl ether: Anaerobic Aquatic Metabolism 2612

(ii) Source . U.S. Environmental Protection Agen cy, Series 835 – Fate, Transport and 2613 Transformation Test Guidelines, OCSPP Guideline 835.4400—Anaerobic Aquatic Metabolism. 2614

(iii) Introduction. Chemicals can enter shallow or deep surface waters by a wide variety 2615 of routes including direct application, run-o ff, groundwater seepage drainage, waste disposal, 2616 industrial or agricu ltural effluent and atmospheric depos ition. This study plan describes a 2617 proposed laboratory test method to assess transf ormation of the test substance in anaerobic 2618 aquatic sediment systems. 2619
2620 (iv) Objectives

. The objectives of the study are to 1) measure the rate of transformation 2621 of the test substance, decabromodiphenyl et her; 2) identify and qua ntify all detectable 2622 degradation products; 3) identify and quantify the transformation pa thways and rate of formation 2623 and degradation of intermediate products in th e water, vapor and sediment phases; and 4) 2624
measure the distribution of the te st substance and degradation pr oducts and intermediates within 2625
each phase in the test system. 14 C-labeled decabromodiphenyl ether sh all be used to help ensure 2626
mass balance over time. 2627
2628 (v) Experimental design. The test shall be conducted using six sediments and their 2629
associated waters at two concentrations ( one trace; the other significantly higher), using 14 C2630
labeled test substance. Sediment s shall be selected to include a variety of sediment types and 2631 shall include sediments known to contain po lybrominated diphenyl ethers (PBDEs) and 2632 polychlorinated biphenyls (PCBs). 2633
2634
Untreated live and killed controls and test substance-dosed biotic and abiotic systems 2635 shall be prepared for each sediment type. Ba sed on published studies on the biodegradation of 2636 decabromodiphenyl ether in sediments, the half -life of decabromodiphenyl ether may be long. 2637 Tokarz (2008) reported sediment ha lf-lives ranging from 6-50 years with an average of 14 years. 2638 Therefore, it is expected that untreated control, test substance-dosed li ve, and killed control 2639 systems will be incubated at approximately 20° C for at least 36 months. However, the actual 2640 study duration shall be dependent on the analytical results for initi al sampling periods. The total 2641 duration and interval for later samples may be changed depending on the observed rate of 2642 degradation. 2643*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 67 of 91 Duplicate test vessels for each treatment (i.e. treated a nd control) option, each test 2644
substance concentration and each sediment shall be s acrificed at appropriate time intervals. Test 2645 substance-dosed systems shall be used for quant ification of parent material and degradation 2646 products. Untreated controls shall be used to de termine background levels of the parent material 2647 and other PBDEs over time. Sampling shall be performed at time zero and seven times 2648 thereafter. Additional sample vessels may be pr epared for additional analyses, if necessary. 2649 These vessels shall be sampled at the request of the sponsor in consultation with EPA. 2650
Additional untreated chambers shal l be prepared for use as matrix fortification samples, water2651 sediment characterizations and viability controls, as necessary. 2652
2653 (vi) Materials and methods . (A) The test system and st udy conditions are selected to 2654 comply with the Fate, Transport and Transformation Test Guidelines, OCSPP 835.4400 (at 2655 paragraph (i)(2)(xii)(B) of this section) with appropriate modifi cations, if any, for decaBDE. 2656
2657 (B) Test substance . Information on the characterizati on of test, control or reference 2658 substances is required by Good Laboratory Pr actice (GLP) Standards and Principles. Ring2659

labeled, 14 C-labeled test substance sha ll be used. The Sponsor is responsible for providing the 2660
test substance and verification th at it has been characterized acco rding to GLP requirements prior 2661 to its use in the study. If verifi cation of GLP test substance char acterization is not provided, it 2662 shall be noted in the compliance statement of the final report. The Sponsor is responsible for all 2663 information related to the test substance including the following descriptions of the radiolabeled 2664 form of the test substance: name, lot numb er, specific activity, radiochemical purity, sample 2665 form, solubility in water, and storage conditions. For the nonlabeled form of the test substance, 2666 the Sponsor is responsible for th e following descriptions: name, lot number, purity, sample form, 2667 solubility in water, and storage conditions. Th e Sponsor must agree to accept any unused test 2668
substance and/or test substance containe rs remaining at th e end of the study. 2669
2670 (C) Test substance preparation and administration . A dispersal powder of test substance 2671 shall be prepared using an inert carrier (e.g. sili ca gel, quartz sand). Radi olabeled test substance 2672 shall be placed in a round bottom flask and di ssolved with an appropr iate solvent (i.e., 2673 tetrahydrofuran). The inert carrie r shall be added to the flask and the solvent shall be evaporated 2674 using a rotary evaporator until the carrier is dry. This method of creating a dispersal powder is 2675 an appropriate route of administration for poorly water-soluble materials. Prior to the test, 2676 characteristics of sorption of the test substance on various carriers shall be evaluated. 2677
2678 (D) Sediments and associated waters . Sediments and associated water shall be obtained 2679 from at least six different sites known or susp ected to be contaminated with polybrominated 2680 diphenyl ethers including, but not limited to decab romodiphenyl ether, and PCBs. Selection and 2681 approval of the collection sites shall be the responsibility of the study Sponsor and must be 2682 approved by EPA. 2683
2684
Sediments shall be collected and handled usi ng strict anaerobic procedures (for example 2685 see Loveley and Phillips (1986) at paragraph (i)(2)(xii)(A ) of this section). They shall be 2686 immediately sealed under nitrogen and transporte d and stored to mainta in anaerobic conditions. 2687
All collection containers shall be stored in a nitrogen atmosphere until and during use. In 2688 addition, the containers shall be purged with nitr ogen in the field after collection. The anaerobic 2689
sediment and associated waters shall be taken from the same lo cation. The reduction potential or 2690*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 68 of 91 Redox potential (Eh) of the sediment shall be me asured prior to collection and should be less 2691 than –150 mV. The dissolved oxygen concentration of the overlying wate r shall be measured 2692 and should be less than 0.5 mg/L. The sediments and water shall be tran sported to the lab under 2693
anaerobic conditions. The sediment s and associated waters may be stored at room temperature 2694 in sealed containers for up to 7 days. If longer storage is necessary, the sediments and associated 2695 waters may be stored in sealed c ontainers in a refrigerator for up to 4 weeks. Prior to use, the 2696 sediment shall be settled, then separated from the water by decanting. The settled sediment shall 2697 be wet-sieved using a 2 mm sieve. All handling of anaerobic sediment after collection and prior 2698 to testing shall be performed unde r a constant flow of nitrogen. 2699 At a minimum, the following properties of the sediment shall be determined: 2700 • Particle size (i.e., percentage of sand, silt and clay) 2701 • Organic carbon content 2702
• Microbial biomass 2703 • Nitrate, sulfate and iron species 2704
• Percent water 2705 • Microbial biomass (fumigation extraction method) 2706 • pH 2707
• Concentration of humic material 2708 • Concentrations of electron acceptors including me thane, nitrate, nitrite, sulfate, sulfide, 2709 and iron species. 2710 Similar characterization of the aqueous phase shall be performed prio r to the start of the 2711 test. Prior to the test, resazurin shall be added to the water at a nominal concentration of 1 mg/L. 2712 The water shall be sparged with nitrogen until a light pink color is obtained and the dissolved 2713 oxygen concentration is less than 0.1 mg/L. Re dox conditions in the test vessels shall be 2714 monitored by measuring dissolved hydrogen gas and Eh at each sampling. The test vessels shall 2715 be stored under nitrogen or other inert atmosphere throughout the test. 2716
2717 (E) Test apparatus and conditions . The test vessels shall be 1-L glass bottles sealed with 2718 butyl rubber septa and screw caps. Prior to begi nning the study, the integr ity of the test vessels 2719 and caps and their ability to maintain anaer obic conditions and pr event leakage of H 2 and other 2720 gas species for long periods shall be verified. The test vessels shall be identified by project 2721 number, test substance ID, test concentration, and a unique identifie r. The test vessels shall be 2722 incubated under an atmosphere of nitrogen at approximately 20°C in a anaerobic glove box. Test 2723 temperatures shall be recorded each working day using a min/max thermometer. The need for 2724 venting of the test systems shall be evaluated pr ior to the start of the study. The procedure for 2725 venting and frequency shall be a dded to the study protocol, if necessary, prior to beginning the 2726 study. 2727
2728 (F) Preparation of the test chambers and acclimation. Test chambers shall be prepared 2729 in an anaerobic glove box or under a constant fl ow of nitrogen. Appropriate amounts of sediment 2730
and water shall be added to each test chamber so the resulting water:sediment volume ratio is 2731 between approximately 1:3 and 1:4. The dept h of the sediment layer shall depend upon the 2732 characteristics of the specific sediment. As a practical example, 200 g dry weight equivalent of 2733 sediment and 250 mL of associated water typically result in a sediment layer of 6.5 cm and a 2734 water layer of 2.5 cm. Amounts of sediment and wa ter to be added may be determined prior to 2735 the preparation of the test chambers. The sedi ment/water samples shall be acclimated under the 2736
same conditions as in the test for at least 7 days prior to the start of the test. 2737*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 69 of 91 2738 (G) Characterization of wa ter-sediment systems . The pH, total organic carbon 2739 concentration, dissolved oxygen concentration, redox potential of the water and sediment 2740 (including microbial biomass), and other paramete rs characteristics of th e water-sediment media 2741
in the test vessels shall be measured at each sa mpling period noted in Table 1 of this paragraph. 2742 The sediment and water shall be kept anaerobi c with a redox potential lower than –100 mV. 2743
2744
Table 1: Measurements at Various Stages of the Test Procedure 2745
2746

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

2747 (H) Application of the test substance. Chambers containing th e sediment/water systems 2748
shall be fortified at the start of the test with th e test substance by applying the test material to the 2749 water layer. Methods for mixing the test material with sediment shall be evaluated prior to the 2750
start of the test. Methods to be evaluated sha ll include but are not lim ited to mixing by hand and 2751 the use of roller and tumbling mixers. 2752
2753 (I) Preparation of abiotic systems. Test substance-dosed abio tic controls shall be heat2754 sterilized (autoclaved three times at 120 °C fo r 60 minutes on three consecutive days). A 2755 preliminary evaluation of the effects of heat ster ilization on the test subs tance shall be conducted 2756 prior to the start of the study. If this method is found to be un satisfactory, irradiation shall be 2757 used to sterilize the test systems. 2758
2759 (J) Sample collection. Proposed sampling intervals are day 0 and months 3, 6, 12, 18, 24, 2760 30, and 36. If analysis of initial sampling results suggests more rapid degradation, the sampling 2761 interval may be modified after consultation with EPA using procedures sp ecified in the ECA. 2762 The actual sampling intervals shall be documented in the study records and in the final report. 2763 Duplicate test vessels for each treatment (i.e. treated and control) option, each test substance 2764*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 70 of 91 concentration and each sediment shall be sacr ificed at appropriate time intervals. 2765
2766 (K) Headspace analysis. The headspace of the treated systems shall be analyzed for 2767

radiolabeled mineraliza tion products including 14 CO2- hydrocarbons and 14 CO2 and 14 CH4 using 2768 purge and trap methods. At each sampling time prio r to extraction of the test system, the septum 2769 shall be pierced using a needle connected to an appropriate trap and the vessel headspace shall be 2770 purged and trapped using a hydrocarbon trap follow ed by a mineralization trapping apparatus. 2771 The headspace within each of test chamber shall be continuo usly purged with a flow of nitrogen 2772 for a minimum of 1 hour and pa ssed through a gas collection system consisting of a hydrocarbon 2773 trap and two sets of CO2 traps and a combustion apparatus. The displaced gases shall initially 2774 pass through a sorption tube containing appropr iate solid phase to trap any hydrocarbon 2775 degradation products present, then one empt y bottle followed by two more bottles, each 2776 containing approximately 100 mL of 1.5N KOH (CO2 trapping solution), followed by another 2777 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 2778 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 2779
furnace to combust methane to CO2. Because Br may poison the surface of the cupric oxide, a 2780 preliminary experiment shall be run to test this, and the protocol adjusted if necessary. The gas 2781 exiting the combustion column shall be pa ssed through an empty bottle followed by two 2782 additional CO2 traps. 2783
2784 (L) Sample processing and analysis for total radioactivity. After purging, the overlying 2785
water shall be removed with minimal disturba nce to the sediment and assayed for total 2786 radioactivity by liquid scintillati on counting (LSC). Sediment samples shall be analyzed using 2787 combustion followed by LSC counting to determine to total amount of radioactivity associated 2788 with the sediment. Water and sediment samples shall be extracted following aggressive methods 2789 designed to extract the maximum am ount of parent and degradation products from the sediment. 2790 These shall be evaluated and verified and approv ed by EPA prior to the st art of the study. These 2791 methods shall be able to detect and quantify pa rent and degradates at least as well as those 2792 reported in the literature for PBDE analysis. The extraction method shall be robust, for example 2793 sequential extraction by solvent washing, soxhlet ex traction and supercritical fluid extraction, but 2794 shall not substantially change th e test substance or degradation products, or the structure of the 2795
matrix itself. Solvent extracts and extracted soli ds shall be analyzed to determine total residual 2796 radioactivity. Untreated controls shall be extracted in the same manner as the test substance 2797 treated systems. 2798
2799 (M) Characterization of extra cted radioactivity. Water and sediment extracts from the 2800 treated and untreated systems sha ll be analyzed for radiolabeled test substance and degradation 2801 products using high performance liquid chromat ography (HPLC) and gas chromatography (GC) 2802 with mass spectrometry (MS) and radiochemical dete ction. Methods of analysis shall be verified 2803 prior to the start of the study a nd shall be at least as sensitiv e and accurate as reported in the 2804 literature for analysis of PBDEs and products. 2805
2806 (N) Quantification of test subs tance and degradation products. Water and sediment 2807
extracts from the untreated cont rols and treated systems shall be analyzed for quantification of 2808 BDE-209 (decaBDE) and trace level lower brominat ed diphenyl ethers including but not limited 2809 to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE-201 (octaBDE), as well as, brominated 2810 dibenzofurans. This analysis shall be c onducted using gas chromat ography/electron capture 2811*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 71 of 91 negative chemical ionization mass spectrometry (G C/ECNI-MS). Expected limits of detection 2812 (LOD) and quantitation (LOQ) fo r reasonably anticipated products shall be determined and 2813 reported to EPA prior to starting the test. All debromination produc ts shall be measured in each 2814 sample, including background and time zero samples, and both biotic systems and abiotic 2815 (inhibited) controls. 2816
2817 (O) Viability controls. The assessment of the metabolic activity of untreated 2818 sediment/water systems shall be conducted w ithin one week of each sampling interval. 2819 Duplicate incubation vessels for each sediment, wh ich have been incubate d in parallel under the 2820 same conditions, shall be dosed at approxima tely 100 mg/kg sediment dry weight with a 2821
combination of radiolabeled and nonlabeled substa nce suitable (i.e. glucose, benzoic acid) for 2822 viability determination. The methods and procedur es used shall be documented in study protocol 2823 prior to beginning the study. 2824
2825 (P) Treatment of results. Total mass balance of radioactiv ity shall be calculated at each 2826 sampling interval. Results shall be reported as total and percenta ge of added radioactivity. The 2827 behavior of the test substance and major and minor metabolites in the whole system as well as 2828 water, gas and sediment compartments shall be ev aluated. Regression analys is of the percentage 2829 of test substance and major metabolites as a function of time shall be performed and the time for 2830 50% degradation (DT50) and the time for 90% de gradation (DT90) of the test substance and 2831 major metabolites shall be calculated, when po ssible. The ratio of BDE-209 (decaBDE) to all 2832 detected degradation products shall be determine d. All analytical results and all raw data shall 2833 be submitted to EPA, including the mass of each analyte at each time. 2834
2835 (vii) Records to be maintained. Records to be submitted to EPA shall include, but are not 2836 limited to, the following: 2837
2838 (A) The original signed protocol and any amendments. 2839
2840 (B) Identification and charac terization of the test substa nce as provided by Sponsor. 2841
2842 ( C) Experiment initiation and termination dates. 2843
2844 (D) Stock solution concen tration calculations a nd solution preparation. 2845
2846 (E) Inoculum source and pretreatment data. 2847
2848 (F) Results of LSC and HPLC and/or ot her analysis (e.g. GC or GC/ECNI-MS). 2849
2850 (G) Temperature data reco rded during test period. 2851
2852 (H) Copy of final report. 2853
2854 (viii) Final report. A final report of the results of the study shall be prepared and 2855 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 2856
2857 (A) Name and address of facility performing the study. 2858*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 72 of 91 2859 (B) Dates on which the study was initiated and completed. 2860
2861 (C) Objectives and procedures stated in th e approved protocol, including any changes in 2862 the original protocol. 2863
2864 (D) Identification and charac terization of the test substa nce as provided by Sponsor. 2865
2866 (E) A summary and analysis of the data a nd a statement of the conclusions drawn from 2867 the analysis. 2868
2869 (F) A description of the transformations and calculations performed on the data. 2870
2871 (G) A description of the methods used and reference to any standard method employed. 2872
2873 (H) A description of the test system. 2874
2875 (I) A description of the preparation of the te st solutions, the testing concentrations, and 2876
the duration of the test. 2877
2878 (J) A description of sampling and analytical methods, including leve l of detection, level 2879 of quantification, and references. 2880
2881 (K) A description of the te st results including measured values for individual PBDE 2882 congeners and PBDF homolog group. 2883
2884 (L) A description of all circumstances that may affect the quality or integrity of the data. 2885
2886 (M) The name of the study director, the names of other scientists or professionals, and the 2887 names of all supervisory pe rsonnel involved in the study. 2888
2889 (N) The signed and dated reports of each of the individual scientists or other 2890 professionals involved in the study, if applicable. 2891
2892 (O) The location where the raw data a nd final report are to be stored. 2893
2894 (P) A statement prepared by the Quality Assu rance Unit listing the types of inspections, 2895 the dates that the study inspections were made and the findings reported to the Study Director 2896 and Management. 2897
2898 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks and 2899
data sheets etc. 2900
2901 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 2902 final report after it has been accepted, such change s shall be made in the form of an amendment 2903 issued by the Study Director. The amendment shall clearly identify the part of the study that is 2904 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 2905*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 73 of 91 Study Director and Laboratory QA officer. 2906
2907 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 2908 written amendments signed by the Study Director and approved by the Sponsor’s Representative 2909 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 2910 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 2911 form of written deviations signed by the Study Dire ctor and filed with the raw data. All changes 2912 to the protocol shall be indicated in the final re port. Changes to the teststandard require prior 2913 approval from EPA using procedures in 40 CFR 790.55. 2914
2915 (xi) Good laboratory practices. This study shall be conducted in accordance with Good 2916 Laboratory Practice Standards for EPA and shall be consistent w ith OECD Principles of Good 2917 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 2918 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 2919 Operating Procedures, and the specified prot ocol. A statement of compliance with Good 2920 Laboratory Practices shall be prepared for all portions of the study c onducted by the testing 2921 facility. The Sponsor is re sponsible for compliance with Good Laboratory Practices for 2922 procedures that may be performed by other laborat ories (e.g., residue analyses). Raw data for all 2923 work performed at the testing facility and a c opy of the final report sh all be filed by project 2924
number in archives located on the fa cility’s site or at an alternativ e location to be specified in the 2925 final report. 2926
2927 (xii) Literature cited. 2928
2929 (A) Lovley DR, Phillips EJP. Organic matte r mineralization with reduction of ferric iron 2930
in anaerobic sediments. Applied Environmental Microbiology 51 :683–689. 1986. 2931
2932 (B) U.S. Environmental Protection Agency. Series 835-Fate, Transport and 2933
Transformation Test Guidelines. OCSPP Nu mber 835.4400: Anaerobic Aquatic Metabolism. 2934
EPA 712-C-08-019. June 2008. 2935
2936 (C) Tokarz JA, III, Ahn MY , Leng J, Filley TR, Nies L. Reductive debromination of 2937 polybrominated diphenyl ethers in anaerobi c-sediment and a biomimetic system. Environmental 2938 Science & Technology 42:1157-1164. 2008. 2939

(3) Biodegradation in anaerobic digester sl udge conducted in accordance with the 2940 following guideline : 2941

(i) Title . Decabromodiphenyl ether: Biodegrad ation in Anaerobic Digester Sludge 2942
2943 (ii) Source. U.S. Environmental Protection Agency Series 835 - Fate, Transport and 2944 Transformation Test Guidelines, OCSPP guideli ne 835.3280—Simulation test to assess primary 2945 and ultimate biodegradability of chemicals di scharged to wastewat er: Mineralization and 2946 transformation in digester sludge. 2947
2948 (iii) Introduction. Anaerobic digesters are commonly used in municipal wastewater 2949 treatment plants to stabilize various plant sludge s. The digestion proce ss reduces the amount of 2950*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 74 of 91 solids present in the sludge, destroys pathoge nic bacteria and viru ses, and removes the 2951 biodegradable portion of the sludg e. A test for biodegradation during anaerobic sludge digestion 2952 is particularly relevant for sorbing substances, which partition to primary and secondary sludge. 2953 This test is useful for determining the concentra tion of a substance present in the sludge leaving a 2954 treatment plant as well as demonstrating the pote ntial for anaerobic biodegr adation. The test is 2955 characterized by reducing conditi ons, a high level of anaerobic bi omass, and a level of test 2956 substance based on expected wastewater concentr ations and partitioning behavior. The test is 2957 designed to assess the extent to which a substance can be degraded during anaerobic digestion. 2958 This protocol describes the methods employed in determining the biodegradability of the test 2959
substance in anaerobic digester sludge. 2960
2961 (iv) Objectives . The objective of the study is to assess the potential for mineralization 2962 and transformation of decabromodiphenyl ether in anaerobic digester sludge, and the quantity 2963 and identity of degradants (if present). 2964
2965 (v) Experimental design. The test shall be conducted us ing digester sludge from six 2966
different sources. Untreated control and test su bstance-dosed systems shall be prepared for each 2967 sludge source. Additionally, an abiotic control sh all be prepared. The test substance treatment 2968 systems shall be dosed at two concentrations with 14 C-labeled test or a combination of 2969
radiolabeled and nonlabeled forms of the test subs tance. A very low concentration is used to 2970 establish environmentally releva nt transformation kinetics; wher eas a higher concentration is 2971 required to quantify product formation. The test systems shall be inc ubated at approximately 2972 35°C for approximately 10 months; e.g. approxi mately 300 days. Studies using anaerobic 2973 digester sludge normally involve incubating sludge for 60 days, wh ich is about twice the normal 2974 residence time of sludge in anaerobic digesters. The extended length of this study is based on a 2975 half-life of the test substance in sludge w ithout added primers of 1400 days as reported by 2976 Gerecke et al. at paragraphs (i)(3)(xii)(A ) and (B) of this se ction, and the general 2977
recommendation that test duration be at le ast 20% of the antici pated half-life. 2978
2979 Based on the length of the study, bench-sc ale anaerobic reactor systems with semi2980 continuous feeding shall be used. A system c onsists of a 5-L glass reactor containing an 2981 anaerobic digester sludge mixture incubated at 35° C and gas collection bladder. On a weekly 2982 basis, supernatant shall be removed from the reactor and replaced with an anoxic mixture of 2983 settled activated sludge solids (s econdary sludge) and fresh anaer obic digester sludge solids. 2984
2985 Test substance-dosed systems shall be used for quantification of parent material and 2986 degradation products. Untreated controls shall be used to determine ba ckground levels of the 2987 parent material and other polybrom inated diphenyl ethers. Samp ling shall be performed at time 2988
zero and seven times thereafter. 2989
2990 (vi) Materials and methods . The test system and study conditions are selected to comply 2991 with the Fate, Transport and Transformati on Test Guidelines, OCSPP 835.3280 at paragraph 2992 (i)(3)(xii)(C) of this section. 2993

(A) Test Substance. Information on the characterization of test, control or reference 2994 substances is required by Good Laboratory Pr actice (GLP) Standards and Principles. The 2995 Sponsor is responsible for providing verification that the test substance has been characterized 2996*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 75 of 91 according to GLP requirements prior to its use in the study. If verification of GLP test substance 2997 characterization is not provided, it shall be noted in the compliance statement of the final report. 2998 The Sponsor is responsible for all information related to the test substance. Following are 2999 descriptions of the radiolabeled form of the test substance: na me, lot number, specific activity, 3000 radiochemical purity, radiolabel position, identities and perc entages of all brominated 3001 diphenylethers, sample form, solubility in water, and storage c onditions. Following are 3002 descriptions of the nonlabeled form of the test substance: name, lot number, purity, identities and 3003 percentages of all brominated di phenyl ethers, sample form, sol ubility in water, and storage 3004 conditions. The Sponsor must agree to accept any unused test substance and/or test substance 3005 containers remaining at the end of the study. 3006

(B) Test substance preparation and administration. A dispersal powder of test substance 3007 shall be prepared using an inert carrier (e .g. silica gel, quartz sand). A combination of 3008
radiolabeled and nonlabeled test substance sha ll be placed in a round bottom flask and dissolved 3009 with an appropriate solvent (i.e. tetrahydrofuran). The inert carrier shall be added to the flask 3010 and the solvent shall be evaporated using a rota ry evaporator until the sediment is dry. This 3011 method of creating a dispersal powder is an approp riate route of administ ration for poorly water3012 soluble materials. Prior to the test, the adsorpti on characteristics of the test substance on various 3013
carriers shall be evaluated. 3014

(C) Test inoculum. Anaerobic digester sludge shall be ob tained from at least six different 3015
sites. Selection of the collec tion sites shall be the responsibil ity of the study Sponsor, with 3016 review and final approval by the EPA. All collec tion containers shall be purged with nitrogen 3017 and immediately sealed prior to us e. In addition, purging the contai ners with nitrogen in the field 3018 after collection shall be perfor med if possible. Sludge shall be screened using a 2 mm mesh 3019 screen to remove debris and may be held for up to 7 days prior to the start of the test. The total 3020 solids level of the digester sludge shall be measured and should be in the range of 4-6% (40,000- 3021 60,000 mg/L). On the day the test is to start, th e inoculum shall be diluted with mineral salts 3022
solution to an initial solids le vel of approximately 25,000 mg/L. If the solids concentration is too 3023 low, the solids can be allowed to settle, the supernatant decanted, and the sludge resuspended in 3024
mineral salts solution. A final so lids level and pH shall then be determined. All handling of 3025 anaerobic sludge after collection an d prior to testing sh all be performed under a constant flow of 3026 nitrogen or in an anaerobic glove box. 3027

(D) Mineral salts solution. A mineral salts solution shall be prepared using high quality 3028
water as described below. All chemicals used in the preparation of the solution shall be reagent 3029 grade or better, if available. The solution sha ll be autoclaved for 30 min and allowed to cool 3030 overnight in an anaerobic chamber or under an an aerobic atmosphere. The solution shall contain 3031 the following constituents per liter of high quality water: 3032

• Anhydrous potassium dihydrogen phosphate (KH 2 PO 4 ) 0.27 g 3033

• Disodium hydrogen phosphate dodecahydrate (Na 2 HPO 4 •12H 2 O) 1.12 g 3034

• Ammonium chloride (NH 4 Cl) 0.53 g 3035

• Calcium chloride dihydrate (CaCl 2 •2H 2 O) 0.075 g 3036*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 76 of 91 • Magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.10 g 3037

• Iron (II) chloride tetrahydrate (FeC1 2 •4H 2 O) 0.02 g 3038

• Resazurin (oxygen indicator) 0.001 g 3039

• Sodium sulphide nonahydrate (Na 2 S•9H 2 O) 0.10 g 3040

(E) Digester sludge feed. The source guideline for this study, OCSPP 835.3280, has no 3041 provision for feeding. However, due to the length of the study, peri odic feeding is needed. The 3042 anaerobic digester sludg e shall be fed an anoxic mixture of settled activated sludge solids 3043 (secondary sludge) and fresh anaerobic digester sludge solids. Activated sludge shall be 3044 collected from a sewage treatment plant receiving waste from predominantly domestic sources. 3045 The sludge shall be sieved using a 2 mm mesh sc reen to remove debris, then dewatered using 3046 filtration. A feed solution shall be prepared at a sludge solids concentration of approximately 50 3047 g/L using mineral salts solution. The feed so lution shall be stored under nitrogen and 3048 refrigerated. In addition, freshly prepared solutio ns should be stored for at least 1 week prior to 3049

use. 3050

(F) Test apparatus and conditions. The test reactors shall be 5-L glass bottles and shall 3051 be identified by project number, te st substance ID, test concentrat ion, and unique identifier. The 3052
reactors shall be sealed with black rubber stoppers with stopcock ports and connections used for 3053 the addition of feed sludge, sample removal and gas collection bag. The test reactors shall be 3054
incubated at 35 ± 3 °C and in the dark. Reactor contents shall be mixed for at least 10 min every 3055 day using a magnetic stirrer and test temperatur es shall be measured each working day using a 3056
min/max thermometer. 3057

(G) Preparation of the test reactors. Working under a constant fl ow of nitrogen, 1.5 L of 3058 anaerobic digester sludge (4 -6% solids), mineral salts solution to achieve an initial solids level of 3059 approximately 25,000 mg/L, and test substance dispersal powder shall be combined in the 3060 reactor. The headspace in the reactor shall be purged with nitrogen, then the reactor sealed and 3061
transferred to the incubator. 3062

(H) Reactor maintenance, The contents of the reactors (anaerobic sludge and mineral 3063
salts solution at a solids level of approx. 25,000 mg/L) shall be fed on a weekly basis. Prior to 3064 mixing, approximately 75 mL of supernatant shall be removed from the reactor and replaced 3065 with an equal volume of digester sludge feed solution. The solids added in this way are expected 3066 to be approximately equivalent to 10% of the total digester so lids reasonably expected to be 3067 present. The amount of digest er sludge feed solution added may be adjusted based on the 3068 observed level of gas production. The activity of the supernatant removed shall be measured 3069 using liquid scintillation counting (LSC). 3070

(I) Abiotic control. An abiotic control shall be included. Biological activity is inhibited 3071 in the abiotic control, which is used for es timating mineralization by difference, establishing 3072 extraction efficiency and recovery of the test substance, and quantifying other loss processes 3073 such as hydrolysis, oxidation, volatilization or sorp tion to test apparatus. The preparation of the 3074 abiotic system is typically performed using a comb ination of chemical and heat sterilization. A 3075 proven approach is to add mercuric chloride (1 g/l) to the sludge, which is then autoclaved for at 3076*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 77 of 91 least 90 min. Typically the volum e of medium is less than or e qual to half the volume of the 3077 container being autoclaved (e.g. 500 ml sludge in a 1-liter container). Af ter cooling, the pH of 3078 the abiotic system should be measured and adju sted to match that of the biologically active 3079 system. Alternative approaches to deac tivate the system can also be used. 3080

(J) Sample collection schedule. Proposed sampling times are day 0 and months 1, 2, 4, 6, 3081 8, 9, and 10, but the actual sampling times shall be documented in the study records and in the 3082 final report. The timing of the sampling may be altered at the discreti on of the Study Director, 3083 and more frequent sampling may be conducted. Ba sed on the analytical method that is selected, 3084 the minimum change in the initial concentration of the test substance that can be detected shall 3085 be estimated, then applied to help determine the sampling schedule and assess the need for 3086 additional samples. As an example, if the mini mum reliably detectable change is 5% relative to 3087 the starting concentration, and if this has already occurred at th e first suggested sampling time (1 3088 month), then measurements should be made mont hly up to 10 months. The solids concentration 3089 of sludge shall be measured at each sampling interval. 3090

(K) Evolved gas and headspace analysis. The evolved gas and headspace of the treated 3091 systems shall be analyzed for radiolabeled mineralization products ( 14 CO 2 and 14 CH 4 ). At 3092 intervals throughout the study, evolve d gases shall be analyzed by pa ssing the contents of the gas 3093 collection bags through the mineralization appa ratus described below. Reactor headspace 3094 analysis shall be performed at the end of the st udy. The headspace gases w ithin the reactor shall 3095 be continuously purged with a flow of nitr ogen for a minimum of 2 hours and passed through a 3096 gas collection system consisting of two sets of CO 2 traps and a combustion apparatus. The 3097 displaced gases shall initiall y pass through one empty bottle followed by two bottles each 3098 containing approximately 100 mL of 1.5N KOH (CO 2 trapping solution) followed by another 3099 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 3100 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 3101
furnace to combust methane to CO 2 . The gas exiting the combus tion column shall be passed 3102 through an empty bottle followed by two additional CO 2 traps. 3103

(L) Sample processing and analysis for total radioactivity. Treated digester sludge 3104 samples shall be analyzed using a combin ation of LCS and combustion followed by LSC 3105 counting to determine the total amount of radioactivity associ ated with the sludge. At each 3106 sampling interval, replicate (minimum 3) one mL aliquots of well mixed digester sludge shall be 3107 placed into microcentrifuge tubes and centr ifuged at 10,000 x g for 15 min. The activity 3108 associated with the supernatant shall be meas ured by LSC. Solids shall be analyzed using 3109 combustion followed by LSC to determine to total amount of radioactivity associated with the 3110 sludge solids. 3111

Digester sludge shall be ex tracted following methods evalua ted and verified prior to the 3112 start of the study. These methods shall be able to detect and qua ntify parent and degradates at 3113 least as well as those reported in the literature for PBDE analysis. The extraction method shall 3114 be robust, for example sequential extracti on by solvent washing, s oxhlet extraction and 3115 supercritical fluid extraction, but shall not substantially change th e test substance or degradation 3116 products, or the structure of the matrix itself. Solvent extracts and ex tracted solids shall be 3117 analyzed to determine total radioactivity. Untr eated controls shall be extracted in the same 3118 manner as the test substance-treated systems, but will not be analyzed for radioactivity. 3119*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 78 of 91 (M) Characterization of extra cted radioactivity. Digester sludge extracts from the treated 3120 systems shall be analyzed for radiolabeled te st substance and degrad ation products using high 3121 performance liquid chromatography with radiochemi cal detection. Methods of analysis shall be 3122 verified prior to the start of the study. 3123

3124 (N) Quantification of test subs tance and degradation products. Digester sludge extracts 3125 from the untreated control, abiotic control and treated systems shall be analyzed for 3126 quantification of BDE-209 (decaBDE) and trace level lower brominated diphenyl ethers 3127 including but not limited to BDE-202 (o ctaBDE), BDE-197 (octaBDE), and BDE3128 201(octaBDE), as well as brominated dibenzofurans. 3129 Methods for analysis shall be evaluated and verified prior to the start of the study and 3130 shall reference available best practi ce techniques for the type of an alyte. This analysis shall be 3131 conducted using gas chromatography/electron capture negative chemical ionization mass 3132 spectrometry (GC/ECNI-MS). Expected limits of detection (LOD) and quantitation (LOQ) for 3133 reasonably anticipated products sh all be determined and reported to EPA prior to starting the 3134

test. 3135 All debromination products shall be measured in each sample, including background and 3136 time zero samples, and both biotic syst ems and abiotic (inhibited) controls. 3137
3138 (O) Treatment of results. Total mass balance of radioactivit y shall be calculated at each 3139 sampling interval. Results shall be reported as a percentage of added ra dioactivity. Regression 3140 analysis of the percentage of te st substance and major metabolites as a function of time shall be 3141 performed and the time for 50% degradation (DT 50 ) and the time for 90% degradation (DT 90) of 3142 the test substance and major metabolites shall be calculated, when appropr iate. The ratio of 3143 BDE-197 (octaBDE) to BDE-201 (octaBDE) sh all be determined, if present. 3144

(vii) Records to be maintained. Records to be maintained shall include, but are not 3145 limited to, the following: 3146

(A) The original signed protocol and any amendments. 3147

(B) Identification and charac terization of the test substa nce as provided by Sponsor. 3148

(C) Experiment initiation and termination dates. 3149

(D) Stock solution concen tration calculations a nd solution preparation. 3150

(E) Inoculum source and pretreatment data. 3151

(F) Results of LSC and/or ot her (e.g. GC/ECNI-MS) analyses. 3152

(G) Temperature data reco rded during test period. 3153

(H) Copy of final report. 3154

(viii) Final report. A final report of the results of the study shall be prepared by the 3155 testing facility. The report sha ll include, but is not limited to the following, when applicable: 3156*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 79 of 91 (A) Name and address of facility performing the study. 3157

(B) Dates on which the study was initiated and completed. 3158

(C) Objectives and procedures stated in th e approved protocol, including any changes in 3159 the original protocol. 3160

(D) Identification and charac terization of the test substa nce as provided by Sponsor. 3161

(E) A summary and analysis of the data a nd a statement of the conclusions drawn from 3162 the analysis. 3163

(F) A description of the transformations and calculations performed on the data. 3164

(G) A description of the methods used and reference to any standard method employed. 3165

(H) A description of the test system. 3166

(I) A description of the preparation of the te st solutions, the testing concentrations, and 3167
the duration of the test. 3168
3169 (J) A description of sampling and analytical methods, including leve l of detection, level 3170 of quantification, and references. 3171
3172 (K) A description of the te st results including measured values for individual PBDE 3173 congeners and polybrominated di oxin/furan (PBDF) homolog group. 3174
3175 (L) A description of all circumstances that may affect the quality or integrity of the data. 3176

(M) The name of the study director, the names of other scientists or professionals, and the 3177 names of all supervisory pe rsonnel involved in the study. 3178
3179 (N) The signed and dated reports of each of the individual scientists or other 3180 professionals involved in the study, if applicable. 3181

(O) The location where the raw data a nd final report are to be stored. 3182

(P) A statement prepared by the Quality Assu rance Unit listing the types of inspections, 3183 the dates that the study inspections were made and the findings reported to the Study Director 3184 and Management. 3185
3186 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks, 3187
and data sheets etc. 3188
3189 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 3190 final report after it has been accepted, such change s shall be made in the form of an amendment 3191 issued by the Study Director. The amendment shall clearly identify the part of the study that is 3192 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 3193 Study Director and Laboratory QA officer. 3194*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 80 of 91 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 3195 written amendments signed by the Study Director and approved by the Sponsor's Representative 3196 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 3197 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 3198 form of written deviations signed by the Study Dire ctor and filed with the raw data. All changes 3199 to the protocol shall be indicated in the final re port. Changes to the teststandard require prior 3200 approval from EPA using procedures in 40 CFR 790.55. 3201

(xi) Good laboratory practices. This study shall be conducted in accordance with Good 3202 Laboratory Practice Standards for EPA and shall be consistent w ith OECD Principles of Good 3203 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 3204 the facility's quality assuran ce unit for compliance with Good Laboratory Practices, Standard 3205 Operating Procedures, and the specified prot ocol. A statement of compliance with Good 3206 Laboratory Practices shall be prepared for all portions of the study c onducted by the testing 3207 facility. The Sponsor is re sponsible for compliance with Good Laboratory Practices for 3208 procedures that may be performed by other laborat ories (e.g., residue analyses). Raw data for all 3209 work performed at the testing facility and a c opy of the final report sh all be filed by project 3210
number in archives located on the fa cility's site or at an alternative location to be specified in the 3211 final report. 3212

(xii) Literature cited : 3213

(A) Gerecke AC, Hartmann PC, Heeb NV, K ohler H-PE, Giger W, Schmid P, Zennegg 3214 M, Kohler M. Anaerobic degrada tion of decabromodiphenyl ether. Environmental Science & 3215 Technology 39:1078-1083. 2005 3216
3217 (B) Gerecke AC, Giger W, Hartmann PC, H eeb NV, Kohler H-PE, Schmid P, Zennegg 3218 M, Kohler M. Anaerobic degr adation of brominated flame re tardants in sewage sludge. 3219 Chemosphere 64:311-317. 2006. 3220
3221 (C) U.S. Environmental Protection Ag ency. Series 835-Fate, Transport and 3222
Transformation Test Guidelines. OCSPP Number 835.3280: Simulation test to assess primary 3223 and ultimate biodegradability of chemicals di scharged to wastewat er: Mineralization and 3224 transformation in digester sludge. 2008. 3225
3226 (4) photolytic degradation of decabromodipheny l ether in the indoor environment in 3227
accordance with the following guideline : 3228

(i) Title: Photolytic Degradation Testing of Decabromodiphenyl Ether (CAS No. 1163- 3229 19-5) in the Indoor Environment. 3230
3231 (ii) Source. US EPA, based on a method in an article entitled “Photodegradation of 3232 decabromodiphenyl ether in house dust by natu ral sunlight” by Stapleton and Dodder (2008) 3233 reported in Environmental Toxicology and Chemistry 27:306–312. 3234
3235 (iii) Introduction. Recent studies have found elevat ed levels of polybrominated 3236 diphenylethers (PBDEs) in indoor air and house dust, suggesting the presence of indoor sources. 3237 It has also been observed that photolytic degr adation of BDE-209 (decabromodiphenyl ether) can 3238*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 81 of 91 take place in house dust when exposed to sunlight, forming debrominated products. It is not well 3239 understood, however, how PBDEs are transferred fr om the sources to indoor media (e.g., house 3240 dust) and whether photolytic degradation can occur under indoor lightin g conditions. Most 3241 Americans spend over 85% of their time indoors. Elderly and young children tend to stay indoors 3242 even longer. Therefore, understa nding indoor exposure is a key to exposure assessment and risk 3243 reduction. This guideline describes test methods to characterize poten tial sources of these 3244 emerging contaminants in the indoor environment. 3245
3246 (iv) PBDE off-gassing and photolytic degradation. 3247
3248 (A) Objectives. The objectives of this first part of the investigation are to determine (1 ) if 3249 PBDEs can migrate out of plastics/ fabrics by volatilization; and 3250
3251 (2 ) determine if photolytic degradation can take place on the surfaces of plastics and 3252 fabrics and quantify these processes. 3253
3254 (B) Experimental Design. Accelerated aging tests shall be conducted in an 3255 environmental chamber. PBDE off-gassing will be determined by taking integrated air samples 3256 and potential photolytic degrada tion by taking wipe samples on the surface of test specimens. 3257 The chamber system must meet the following criteria: 3258
3259 (1 ) It has uniform UV-A light irradiation sources; 3260
3261 (2 ) The light intensity is no less th an 5 Watts per square meter (W/m 2 ) incident to the test 3262 specimen; 3263
3264 (3 ) The chamber has a constant air fl ow to allow air sampling; and 3265
3266 (4 ) The moisture content in the ai r flow is no less than 10 g/m 3 (i.e., 50% relative 3267 humidity at 23 °C). 3268
3269 (5) The light source shall be operated according to ASTM G 151-09, Standard Practice 3270 for Exposing Nonmetallic Materials in Accelerat ed Test Devices that Use Laboratory Light 3271
Sources. 3272
3273 (6) Window-filtered sunlight shall be simulated according to ASTM D 4459-06, 3274 Standard Practice for Xenon-Arc Exposure of Plasti cs Intended for Indoor Applications. ASTM 3275 D 4459-06 is intended to simulate the effects pr oduced by exposure to solar irradiation through 3276 glass. A chamber system conforming to D4459-06 can provide spectral irradiance of 3277 approximately 0.3 W/m 2 /nm at 340 nm (i.e., peak emission) when operated in the continuous 3278 light-on mode without water spray. This light s ource satisfies the light intensity requirement of 5 3279
W/m 2 as specified above. 3280
3281 (C) Materials and methods. 3282
3283 (1 ) Test specimens. The test specimens shall include BDE-209-containing high impact 3284 polystyrene (HIPS) coupons and commercial fabric swatches. HIPS coupons shall be prepared 3285*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 82 of 91 using typical commercial extrusion and injec tion molding conditions fo r the manufacture of 3286
HIPS television cabinet backs. High purity (99% or greater) BDE-209 shall be used in making 3287 the coupons. The high purity will assist in det ection of any lower brominated diphenyl ethers 3288 formed as degradants. The coupons shall be ma nufactured using high impac t polystyrene resin, 3289 12 wt% BDE-209, antimony oxide (4% by weight), and the typical additives of television cabinet 3290 backs (UV inhibitors, antioxidants, colorants, etc. ). A total of 36 coupons shall be prepared for 3291 tests listed in Table 1. Each coupon shall have an area of at least 100 cm 2 (one-side). 3292
Fabric swatches shall be obtai ned from a commercial source, depending on availability, or 3293 manufactured using 99+% BDE-209 as the flame reta rdant. A total of 36 swatches shall be 3294 prepared for tests listed in Table 1. Each swatch shall have an area of at least 100 cm 2 (one3295 side). 3296
3297 (2) Test matrix. 3298
3299
A total of six tests listed in Table 1 shall be conducted. 3300
3301
Table 1. Test matrix for PBDE off- gassing and photolytic degradation 3302
3303 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

3304
3305 (3 ) Test procedure. 3306
3307 (i ) Prepare 12 identical coupons (or swatches) for an aging test 3308
3309 (ii ) Put aside 3 coupons (or swatches) for taking wipe samples. These wipe samples 3310 represent no-exposure conditions. To take a wipe sample of fabric, use the California roller 3311 method per Ross, et al. (1991) in paragraph (i)(4)(xi)(F). 3312
3313 (iii ) Clean the chamber by wiping the interior surfaces with ethanol-soaked paper towel 3314
3315 (iv ) Take two wipe samples for chamber walls (100 cm 2 area each) 3316
3317 (v ) Place three passive air samplers (PUF di sks) on supporting cradle about half chamber 3318 height and away from inlet air 3319
3320 (vi ) Place the remaining 9 coupons (or swatches ) on chamber floor or rack, depending on 3321 the type of chamber used 3322
3323 (vii ) Close chamber door and, for light-on tests, turn on the UV light, and start the test 3324*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 83 of 91 3325 (viii ) At 300 elapsed hours, turn off the UV light and then open the chamber door 3326
3327 (ix) Remove three coupons (or swatches) from the chamber for taking wipe samples 3328
3329 (x ) Remove one PUF disk for determination of time-integrated air concentrations of 3330 BDE-209, lower PBDE congeners, and pol ybrominated dibenzofurans (PBDFs) 3331
3332 (xi ) Close chamber door and turn on the UV light 3333
3334 (xii ) At 600 elapsed hours, turn off the UV light and then open the chamber door 3335
3336 (xiii ) Remove three coupons (or swatches) from the chamber for taking wipe samples 3337
3338 (xiv) Remove one PUF disk for determination of time-integrated air concentrations of 3339 BDE-209, lower PBDE congeners, and PBDFs 3340
3341 (xv ) Close chamber door and turn on the UV light 3342
3343 (xvi ) At 900 elapsed hours, turn off the UV light and then open the chamber door 3344
3345 (xvii ) Remove the last three coupons (or swat ches) from the chamber for taking wipe 3346 samples 3347
3348 (xviii ) Remove one PUF disk for determination of time-integrated air concentrations of 3349 BDE-209, lower PBDE congeners, and PBDFs 3350
3351 (xix ) Take two wipe samples for chamber walls (100 cm 2 area each) 3352
3353 (4) Sampling and analytical methods. 3354
3355 (i ) Surface sampling for HIPS coupons. ASTM D-6661, Standard Practice for Field 3356 Collection of Organic Compounds from Surfaces Using Wipe Sampling, or an equivalent 3357 method, shall be used for surface sampling on HIPS coupons. The wipe samples shall be 3358 extracted (Stapleton et al. (2008) in paragraph (i)(4)(xi)(F) of this section) and then analyzed for 3359 BDE-209, lower PBDE congeners, and PBDFs. 3360
3361 (ii ) Surface sampling for fabric swatches. A modified ASTM D-6661 method, as 3362 described below, shall be used for surface samp ling on fabric swatches. Modified procedure: 3363

Use 10 × 10 cm 2 heavy filter paper instead of cotton gauze pad; Place the fabric swatch on pre3364 cleaned flat surface; Place the solvent-wetted filter paper on the fabr ic swatch; Place a 10 × 10 3365

cm 2 stainless steel (or aluminum) plate on the paper filter; Add a dditional weights on the plate 3366 such that the total weight is 2 lbs; Wait for 5 minutes; Remove plate and weights; Extract the 3367 paper filter. 3368
3369 (iii ) Air sampling. Time-integrated air samples shall be collected by using passive air 3370 samplers (PUF disks; see Harrad, et al, 2006 (in paragraph(i)(4)(xi)(D) of this section) and 3371*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 84 of 91 references therein). 3372
3373 (iv ) Analytical method. High sensitivity is a key factor in selecting the analytical method. 3374 A method based on chromatography/mass spectrome try in electron capture negative ionization 3375 mode (GC/MS-ECNI) shall be used. The analytes shall include BDEs and PBDFs as listed in 3376 Bezares-Cruz et al. 2004 in paragraph (i)(4)(xi)(B ) of this section; Stapleton and Dodder 2008 in 3377 paragraph (i)(4)(xi)(G) of this section; and Gell er et al. 2006 in paragra ph (i)(4)(xi)(C) of this 3378
section. 3379
3380 (v) Accelerated aging tests for HIPS coupons and fabric swatches with house dust. 3381
3382 (A) Objectives. The objectives of this, second part of the investigation are to determine 3383 (1 ) if PBDEs or PBDF can migrate from plas tics/fabrics to settled house dust by direct 3384 partitioning; and (2) determine if the particle-bound PBDEs are s ubject to photolytic degradation 3385 and quantify these processes. 3386
3387 (B) Experimental design. HIPS coupons and used TV cabinets shall be subjected to 3388 accelerated aging in a test chamber in the presen ce of standard house dust, National Institute of 3389 Standards Technology, Standard Reference Mate rial 2583 (NIST SRM 2583) , free of BDE-209. 3390 This investigation shall be perf ormed as described in (iv) with the exception of the addition of 3391 pre-cleaned house dust to the surface of the HI PS coupons and fabric swatches. Accelerated 3392 aging under simulated sunlight and fluorescen t lighting, exposure durations, and sample 3393
collections shall be identical to those describe d in (iv), with the a ddition of collection and 3394 analysis of the added house dust. This experiment requires that the coup ons are sufficiently large 3395 (500 cm 2 or larger) that there is enough house dust for sampling while the dust layer is not too 3396
thick. 3397 The house dust can be deposited on test spec imens by using a separate dust deposition 3398 chamber or spiked manually on test specimens (A shley et al. 2007 in pa ragraph (i)(4)(xi)(A) of 3399 this section). The test samples and dust shal l then be exposed to accelerated aging for 300, 600, 3400 and 900 hours, the dust collected by vacuum, an d analyzed for content of BDE-209, lower 3401 BDEs, and PBDFs. 3402
3403 (C) Materials and methods. 3404
3405 (1) Test specimens. HIPS coupons and used TV cabinets shall be used in this 3406 investigation. The procedure for prepar ing HIPS coupons described in (iv)(C)(1 ) shall be 3407 followed except that the size of th e coupon shall be at least 500 cm 2 , such that an adequate 3408 amount of house dust can be spiked on the surfa ce without forming a thick layer of dust. The 3409 target dust load is between 0.5 and 1 mg/cm 2 coupon. 3410
Two used TV sets shall be vacuumed and the dust analyzed for PBDEs and PBDFs as 3411 previously described. Samples of the backcover shall be analyzed by Fourier transform infrared 3412 spectroscopy (FT-IR) to identify the plastic and the flame retardant. Ground samples shall be 3413 prepared for determination of PBDE and PBDF content. 3414 The requirements for the test chamber are the sa me as described in (iv)(B) unless indicated 3415
otherwise. 3416
3417 (2 ) Test matrix. A total of five tests listed in Table 2 shall be conducted. 3418*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 85 of 91 3419 Table 2. Test matrix for PBDE migration from source to house dust and photolytic degradation 3420
3421 Test No. Material UV light Durations (h) 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

3422 (3 ) Test procedure for HIPS coupons. 3423
3424 (i ) Prepare HIPS coupons 3425
3426 (ii ) Determine PBDE content in test sp ecimens by preparing and analyzing ground 3427 samples 3428
3429 (iii ) Evenly spike approximately 0.25 to 0.5 g NIST standard house dust SRM 2583 on 3430 each of the six HIPS coupons. This can be done e ither manually (Ashley et al. 2007 in paragraph 3431 (i)(4)(xi)(A) of this section) or in a particle deposition chamber. The targeted dust load is 3432 between 0.5 and 1 mg/cm 2 coupon 3433
3434 (iv ) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 3435
towel 3436
3437 (v ) Take two wipe samples from chamber walls (100 cm 2 area each); the PBDE and 3438
PBDF content shall be below the method detection limit 3439
3440 (vi ) Open the chamber door, place six coupons on chamber floor (or rack), and close the 3441
door 3442
3443 (vii ) Set the chamber temperature at 55 °C a nd air change rate between 0.3 to 0.5 air 3444 changes per hour, or the lowest air cha nge flow the chamber system allows 3445
3446 (viii ) Close chamber door and start the test. 3447
3448 (ix ) At 300 elapsed hours, remove 2 coupons for dust sampling, restart chamber 3449
3450 (x ) Repeat the above step at 600 and 900 elapsed hours. 3451
3452 (4 ) Test procedure for used TV cabinets. 3453
3454 (i ) Open the TV set and collect settled dust from the interior surfaces (see Takigami et al. 3455 (2008) in paragra ph (i)(4)(xi)(I)). 3456*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 86 of 91 3457 (ii ) Determine the PBDE and PBDF content in the settled dust 3458
3459 (iii ) Clean the backcover by soft cloth and air jet; do not clean it with solvents 3460
3461 (iv ) Determine PBDE and PBDF content in test specimen by preparing and analyzing 3462 ground samples 3463
3464 (v ) Divide the backcover evenly into two pieces (designated a and b in Table 2), one for 3465 test with light and the other without light 3466
3467 (vi ) For each half, cut flat areas into rectangular panels for te sting; the total area of the 3468 flat panels shall be no less than 1000 cm 2 3469
3470 (vii ) Evenly spike NIST standard house dus t SRM 2583 on the interior side of the 3471 backcover panels for a targeted dust load between 0.5 to 1 mg/cm 2 3472
3473 (viii ) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 3474
towel 3475
3476 (ix ) Take two wipe samples from chamber walls (100 cm 2 area each); the PBDE and 3477
PBDF content shall be below the method detection limit 3478
3479 (x ) Open the chamber door, place the half backcover with NIST house dust on chamber 3480 floor (or rack) 3481
3482 (xi ) Set the chamber temperatur e at 55 °C and air change rate between 0.3 to 0.5 air 3483 changes per hour, or the lowest air cha nge flow the chamber system allows 3484
3485 (xii ) Close chamber door and start test 3486
3487 (xiii ) At 600 elapsed hours, remove the backc over panels from chamber, collect and 3488 extract dust samples 3489
3490 (5 ) Sampling and analytical methods. Dust samples shall be collected by micro3491 vacuuming (Ashley et al. 2007 in paragraph (i)( 4)(xi)(A) of this sec tion or ASTM 7114). 3492 The method described by Staplet on and Dodder (2008) in paragraph (i)(4)(xi)(F) of this section 3493
shall be used to determine the PBDE content in dust samples. Wipe and air sampling methods 3494 are described in (iv)(C)(4 ). 3495
3496 (vi) Records to be maintained . Records to be submitted to EPA shall include, but are not 3497 limited to, the following: 3498
3499 (A) The original signed protocol and any amendments. 3500
3501 (B) Identification and charac terization of the test substa nce as provided by Sponsor. 3502
3503*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 87 of 91 (C) Experiment initiation and termination dates. 3504
3505 (D) Stock solution concentra tion calculations and solution preparation, if applicable. 3506
3507 (E) Results of LSC and HPLC and/or ot her analysis (e.g. GC or GC/ECNI-MS). 3508
3509 (F) Data on temperature, air flow and inlet air moisture content. 3510
3511 (G) Copy of final report. 3512
3513 (vii) Final report. A final report of the results of the study shall be prepared and 3514 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 3515
3516 (A) Name and address of facility performing the study. 3517
3518 (B) Dates on which the study was initiated and completed. 3519
3520 (C) Objectives and procedures stated in th e approved protocol, including any changes in 3521 the original protocol. 3522
3523 (D) Identification and charac terization of the test substa nce as provided by Sponsor. 3524
3525 (E) A summary and analysis of the data a nd a statement of the conclusions drawn from 3526 the analysis. 3527
3528 (F) A description of the transformations and calculations performed on the data. 3529
3530 (G) A description of the methods used and reference to any standard method employed. 3531
3532 (H) A description of the test system a nd test chamber(s), including chamber type, 3533 dimensions and light source; and spectral irra diance inside the chamber if applicable. 3534
3535 (I) A description of the preparation of the te st solutions, the testing concentrations, and 3536
the duration of the test. 3537
3538 (J) A description of sampling and analytical methods, including leve l of detection, level 3539 of quantification, and references. 3540
3541 (K) A description of test specimens and test matrix. 3542
3543 (L) A description of the te st results including measured values for individual PBDE 3544 congeners and PBDF homolog group for each matrix, exposure condition, and exposure 3545
duration. 3546
3547 (M) A description of all circumstances that may affect the quality or in tegrity of the data. 3548
3549 (N) The name of the study director, the names of other scientists or professionals, and the 3550*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 88 of 91 names of all supervisory pe rsonnel involved in the study. 3551
3552 (O) The signed and dated reports of each of the individual scientists or other 3553 professionals involved in the study, if applicable. 3554
3555 (P) The location where the raw data a nd final report are to be stored. 3556
3557 (Q) A statement prepared by the Quality A ssurance Unit listing the types of inspections, 3558 the dates that the study inspections were made and the findings reported to the Study Director 3559 and Management. 3560
3561 (R) A copy of all raw data including but not limited to chromatograms, lab notebooks and 3562
data sheets etc. 3563
3564 (viii) Changes to the final report. If it is necessary to make corrections or additions to the 3565 final report after it has been accepted, such change s shall be made in the form of an amendment 3566 issued by the Study Director. The amendment shall clearly identify the part of the study that is 3567 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 3568 Study Director and Laboratory QA officer. 3569
3570 (ix) Changes to the protocol . Planned changes to the protocol shall be in the form of 3571 written amendments signed by the Study Director and approved by the Sponsor’s Representative 3572 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 3573 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 3574 form of written deviations signed by the Study Dire ctor and filed with the raw data. All changes 3575 to the protocol shall be indicated in the final re port. Changes to the test standard require prior 3576 approval from EPA using procedures in 40 CFR 790.55. 3577
3578 (x) Good laboratory practices . This study shall be conducted in accordance with Good 3579 Laboratory Practice Standards for EPA and shall be consistent w ith OECD Principles of Good 3580 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 3581 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 3582 Operating Procedures, and the specified prot ocol. A statement of compliance with Good 3583 Laboratory Practices shall be prepared for all portions of the study c onducted by the testing 3584 facility. The Sponsor is re sponsible for compliance with Good Laboratory Practices for 3585 procedures that may be performed by other laborat ories (e.g., residue analyses). Raw data for all 3586 work performed at the testing facility and a c opy of the final report sh all be filed by project 3587
number in archives located on the fa cility’s site or at an alternativ e location to be specified in the 3588 final report. 3589
3590 (xi) Literature cited. 3591
3592 (A) Ashley K, Applegate GT, Wise TJ, Fernback JE, Goldcamp MJ. Evaluation of a 3593
standardized micro-vacuum sampling method for collection of surface dust. Journal of 3594 Occupational and Environmental Hygiene 4:215–223. 2007. 3595
3596 (B) Bezares-Cruz J, Jafvert CT, Hua I.. Solar photodecomposition of decabromodiphenyl 3597*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 89 of 91 ether: products and quantum yield. Environmental Science & Technology 38:4149-4156. 2004 3598
3599 (C) Geller AM, Krüger HU, Palm WU, Zets ch C. Identification of polybrominated 3600 dibenzofurans from photolysis of decabromodi phenyl ether by UV spectroscopy. Abstract from 3601
DIOXIN 2006 , Oslo, Norway, August 21-24, 2006. 3602
3603 (D) Harrad S, Hazrati S, Ibarra C. Concentr ations of polychlorinat ed biphenyls in indoor 3604 air and polybrominated diphenyl ethers in i ndoor air and dust in Birmingham, United Kingdom: 3605 implications for human exposure. Environmental Science & Technology 40:4633-4638. 2006. 3606
3607 (E) Ross, J.; Fong, H.; Thongsinthusak,T.: Margetich, S.; Krieger, R. Measuring 3608 potential dermal transfer of su rface pesticide residue generated fr om indoor fogger use: using the 3609 CDFA roller method interim report II. Chemosphere 22:975-984. 1991. 3610
3611 (F) Stapleton HM, Kelly SM, Allen JG, McClean MD, Webster TF. Measurement of 3612 polybrominated diphenyl ethers on hand wipes: estimating exposure from hand-to-mouth 3613

contact. Environmental Science & Technology 42:3329–3334. 2008. 3614
3615 (G) Stapleton HM, Dodder NG. 2008. Photode gradation of decabromodiphenyl ether in 3616 house dust by natural sunlight . Environmental Toxicology and Chemistry 27:306–312. 3617
3618 (H) Strandberg B, Dodder NG, Basu I, Hites RA. 2001. Concentrations and spatial 3619 variations of polybrominated diphenyl ethers and other organohalogen compounds in Great 3620
Lakes air. Environmental Science & Technol nology Technology 35: 1078-(missing page). 3621
3622 (I) Takigami H, Suzuki G, Hirai Y, Sakai S. Transfer of brominated flame retardants 3623 from components into dust inside television cabinets. Chemosphere 73:161–169. 2008. 3624

(j) Reporting requirements . For c-pentaBDE and c-octaBDE, or c-decaBDE a final 3625 report for each specific test for each subject mixture must be r eceived by EPA by the number of 3626 months designated for that test in this paragraph after December 31, 2 012

, unless an extension is 3627 granted in writing pursuant to 40 CFR 790.55. For c

- decaBDE, a final report for each specific 3628 test must be received by EPA by th e number of months designated fo r that test in this paragraph 3629 after December 31, 2013, unless an extension is grante d in writing pursuant to 40 CFR 790.55. 3630

A robust summary of the final report for each speci fic test shall be submitted electronically in 3631
addition to and at the same time as the final report. The term “robust summary” is used to 3632 describe the technical information necessary to adequately describe an experiment or study and 3633 includes the objectives, methods, results, and conc lusions of the full study report which can be 3634 either an experiment or in some cases an estimation or prediction method. Guidance for the 3635 compilation of robust summaries is described in a document entitled “Draft Guidance on 3636 Developing Robust Summaries” wh ich is available on-line at: 3637 http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm

. 3638

(1) The final report on toxicity to freshw ater invertebrates of sediment-associated 3639 contaminants shall be received by EPA by (12 months after the relevant effective date in 3640 paragraph (k) of this section). 3641*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 90 of 91 (2) The final report on Laboratory soil toxicity and bioaccumulation tests with the 3642
lumbricid earthworm Eisenia fetida and the enchytraeid potworm E nchytraeus albidu shall be 3643 received by EPA by (12 months after the relevant effective date in paragra ph (k) of this section). 3644

(3) The final report on toxicity to polyc haetous annilids of sediment-associated 3645 contaminants shall be received by EPA by (12 months after the relevant effective date in 3646 paragraph (k) of this section). 3647

(4) The final report on toxicity to nematode Caenorhabditis elegans of sediment3648
associated contaminants shall be re ceived by EPA by (12 months after the relevant effective date 3649 in paragraph (k) of this section). 3650

(5) The final report on toxicity to estuar ine and marine invertebrates of sediment3651
associated contaminants shall be re ceived by EPA by (12 months after the rele vant effective date 3652 in paragraph (k) of this section). 3653

(6) The final report on prenatal developmenta l toxicity in rabbits shall be received by 3654 EPA by (12 months after the relevant effective date in paragra ph (k) of this section.). 3655

(7) The final report on two-generation reproduc tive toxicity with a satellite group for 3656 body burden shall be received by EPA by (29 months after the relevant effective date in 3657 paragraph (k) of this section). 3658

(8) The final report on immunotoxicity shall be received by EPA by (12 months after the 3659
relevant effective date in paragraph (k) of this section). 3660

(9) The final report on the neur otoxicity screening battery, acute and subchronic, shall be 3661 received by EPA by (21 months after the relevant effective date in paragra ph (k) of this section). 3662

(10) The final report on developmental ne urotoxicity shall be received by EPA by (21 3663
months after the relevant effective date in paragra ph (k) of this section). 3664

(11) The final report for the chronic toxici ty/carcinogenicity test shall be received by 3665 EPA by (60 months after the relevant effective date in paragra ph (k) of this section). 3666

(12) The final report fo r anaerobic aquatic metabolism shall be received by EPA by (60 3667
months after the relevant effective date in paragra ph (k) of this section). 3668

(13) The final report for biodegradation in anaerobic digester sludge shall be received by 3669 EPA by (24 months after the relevant effective date in paragra ph (k) of this section). 3670

(14) The final report for photolytic degrada tion of c-decaBDE in the indoor environment 3671 shall be received by EPA by (24 months after the relevant effective date in paragraph (k) of this 3672 section). 3673

(k) Effective date . This section is effective after : 3674

(1) December 31, 2012 for manufacturers (including importers) a nd processors of c

3675 pentaBDE and c

- octaBDE except as impurities , including c

- pentaBDE and c

- octaBDE in 3676*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

Page 91 of 91 articles, for any use, and for manufacturers (including importers) and processors of c

- decaBDE 3677 except as impurities , including c

- decaBDE in articles, for any use except military and 3678 transportation uses. 3679

(2) December 31, 2013 for manufacturers (inclu ding importers) and processors of c3680 pentaBDE, c-octaBDE, and c- decaBDE except as impurities

, for any use including c

- decaBDE in 3681
articles , for all uses including military and transportation uses

. . 3682

3683 [FR Doc. ??–????? Filed ??–??–??; 8:45 am] 3684
3685