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1 EO12866_PBDE -SNUR-Test_-NPRM_2010-12-08.docRevised_2012-02-15.docx

2 

3 Revised to address Interagency Comments received under EO 12866 Review.

4 BILLING CODE 6560–50–P

5 

6 ENVIRONMENTAL PROTECTION AGENCY 

7 

8 40 CFR Parts 721 and 799 

9 

10 EPA–HQ–OPPT–2009-03572010-1039; FRL–XXXX–X] 

11 

12 RIN 2070–AJ08

13 

14 Certain Polybrominated Diphenylethers; Significant New Use Rule (SNUR) and Test Rule 

15 

16 AGENCY: Environmental Protection Agency (EPA). 

17 ACTION: Proposed rule. 

18 SUMMARY: The Agency is proposing to amend the Toxic Substances Control Act (TSCA) 

19 section 5(a) Significant New Use Rule (SNUR), at 40 CFR 721.10000, that requires any person

20 who intends to manufacture or import tetrabromodiphenyl ether (CASRN 40088–47–9; 

21 Benzene, 1,1′-oxybis-, tetrabromo deriv.) (tetraBDE), pentabromodiphenyl ether (CASRN 

22 32534-81-9; Benzene, 1,1’-oxybis-, pentabromo deriv.) (pentaBDE), hexabromodiphenyl ether

23 (CASRN 36483–60–0; Benzene, 1,1′-oxybis-, hexabromo deriv.) (hexaBDE), 

24 heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1′-oxybis-, heptabromo deriv.)

25 (heptaBDE), octabromodiphenyl ether (CASRN 32536-52-0; Benzene, 1,1’-oxybis-, octabromo 

26 deriv.) (octaBDE), or nonabromodiphenyl ether (CASRN 63936–56–1; Benzene, pentabromo

27 (tetrabromophenoxy)-) (nonaBDE), or any combination for certain polybrominated diphenyl 

28 ethers (PBDEs) by: (1) designating processing of six PBDEs, or any combination -of these 

29 substances resulting from a chemical reaction, for any use on or after January 1, 2005, to notify 

30 EPA at least 90 days in advance. EPA is proposing to amend the SNUR by: (1) designating 

31 processing of the six polybrominated diphenyl ethers (PBDE)s, or any combination of these 

32 substances resulting from a chemical reaction, for any use as a significant new use, (2) 

33 designating manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl 

34 ether (CASRN 1163-19-5; Benzene, 1,1’-oxybis[2,3,4,5,6-pentabromo-)(decaBDE) for any use 

35 after December 31, 2012, except military and transportation uses, and for any use including 

36 military and transportation useswhich is not ongoing after December 31, 2013, as a significant 

37 new use, and (3) making inapplicable the article exemption at 721.45(f)for SNURs for this 
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38 action. AnyA person who intends to import or process any chemical substance subject toof the 

39 seven PBDEs included in the proposed SNUR, as part of an article for a significant new use 

40 would be subject to significant new use reporting. The purpose of amending the existing SNUR 

41 isrequired to notify EPA at least 90 days in advance to ensure that the Agency has an opportunity 

42 to review and, if necessary, take action to restrict or prohibit a new use, such as resumption of 

43 discontinued uses of PBDEs before they resume. EPA expects all manufacture and processing of 

44 PBDEs, except as impurities, to be discontinued by the dates specified above. it begins. EPA is 

45 also proposing a test rule under section 4(a)(1)(A) of TSCA that would require any person who 

46 manufactures or processes commercial pentaBDE (pentabromodiphenyl ether (c-pentaBDE), 

47 commercial octaBDE octabromodiphenyl ether (c-octaBDE), or commercial decaBDE (c48 decaBDE), including in articles, for any use after December 31, 2012, except for military and 

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

50 transportation uses of c-decaBDE 2013 to conduct testing to obtain dataon their effects on health 

51 effects, environmental effects, and chemical fate. The proposed test rule specifies that testing of

52 c-pentaBDE, c-octaBDE, and c-decaBDE be conducted on a representative commercial product

53 of each. The required testing would provide EPA with data necessary to determine the effects of 

54 manufacture, distribution in commerce, processing, use, and disposal of c-pentaBDE, c55 octaBDE, and c-decaBDE or any combination of such activities on health or and the 

56 environment. EPA is proposing to designate all discontinued uses of PBDEs as significant new 

57 uses. The test rule would only be promulgated if EPA determines that there are persons 

58 manufacturing, importingwho intend to manufacture, import, or processingprocess c-pentaBDE, 

59 c-octaBDE, or c-decaBDE, for any use, except as impuritiesincluding in articles, after the dates 

60 specified above. December 31, 2013.

61 

62 DATES: Comments must be received on or before [insert date 60 days after date of publication 

63 in the Federal Register].

64 ]

65 ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–

66 HQ–OPPT–2009-03572010-1039, by one of the following methods: 

67 • • Federal eRulemaking Portal: : http://www.regulations.gov. Follow the on-line 

68 instructions for submitting comments. 

69 • • Mail: Document Control Office (7407M), Office of Pollution Prevention and 

70 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 

71 DC 20460–0001. 

72 • • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 

73 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–

74 OPPT–2009-03572010-1039. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, 

75 excluding legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries 

76 are only accepted during the DCO’s normal hours of operation, and special arrangements should 

77 be made for deliveries of boxed information. 

78 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–2009-
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79 03572010-1039. EPA's policy is that all comments received will be included in the docket 

80 without change and may be made available on-line at http://www.regulations.gov, including any 

81 personal information provided, unless the comment includes information claimed to be 

82 Confidential Business Information (CBI) or other information whose disclosure is restricted by 

83 statute. Do not submit information that you consider to be CBI or otherwise protected through 

84 regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which 

85 means EPA will not know your identity or contact information unless you provide it in the body 

86 of your comment. If you send an e-mail comment directly to EPA without going through 

87 regulations.gov, your e-mail address will be automatically captured and included as part of the 

88 comment that is placed in the docket and made available on the Internet. If you submit an 

89 electronic comment, EPA recommends that you include your name and other contact information 

90 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 

91 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 

92 be able to consider your comment. Electronic files should avoid the use of special characters, 

93 any form of encryption, and be free of any defects or viruses. 

94 Docket: All documents in the docket are listed in the docket index available at 

95 http://www.regulations.gov.. Although listed in the index, some information is not publicly 

96 available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other 

97 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 

98 available docket materials are available electronically at http://www.regulations.gov,, or, if only 

99 available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 

100 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 

101 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 

102 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 

103 Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 

104 Docket visitors are required to show photographic identification, pass through a metal detector, 

105 and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and 

106 subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 

107 the building and returned upon departure. 

108 FOR FURTHER INFORMATION CONTACT: For technical information regarding the 

109 SNUR contact: John Bowser, Chemical Control Division, Office of Pollution Prevention and 

110 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

111 20460–0001; telephone number: 202-564-8082; e-mail addresses: 

112 bowser.john@epa.govbowser.john@epa.gov. 

113 For technical information regarding the test rule contact: Catherine Roman, Chemical Control 

114 Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 

115 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-8708; e116 mail addresses: roman.catherine@epa.gov.

117 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 

118 Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCA119 Hotline@epa.gov..

120 SUPPLEMENTARY INFORMATION:
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121 I. General Information 

122 A. Does this Action Apply to Me? 

123 You may be affected by this action if you manufacture or process tetraBDE, pentaBDE, 

124 hexaBDE, heptaBDE, octaBDE, nonaBDE, or decaBDE, or intend to, including as part of a 

125 mixture or article. TSCA defines manufacture to include import. Unless otherwise noted in this 

126 preamble, use of the term “manufacture” includes import. Manufacturers and processors in 

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

128 • Manufacturers and processors of subject chemical substances and mixtures with North 

129 American Industry Classification System (NAICS) codes 325 and 324110,, e.g., chemical 

130 manufacturing and petroleum refineries. 

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

132 • furniture manufacturers (NAICS code 337), 

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

134 • manufacturers of high impact polystyrene (HIPS) and acrylonitrile-butadiene-styrene (ABS) 

135 plastics (NAICS codes 325, 326140, and 3261), and 

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

137 This listing is not intended to be exhaustive, but rather provides a guide for 

138 readers regarding entities likely to be affected by this action. Other types of entities not listed in 

139 this unit could also be affected. The North American Industrial Classification System (NAICS) 

140 codes have been provided to assist you and others in determining whether this action might apply 

141 to certain entities. If you have any questions regarding the applicability of this action to a 

142 particular entity, consult the technical person listed under FOR FURTHER INFORMATION 

143 CONTACT..

144 This action may also affect certain entities through pre-existing import certification and 

145 export notification rules under TSCA. See Units VII and VIII for a discussion of how this action 

146 may affect import certification and export notification requirements. 

147 This action may also affect certain entities through pre-existing import certification and 

148 export notification rules under TSCA. Persons who import any chemical substance identified in

149 a final SNUR are subject to the TSCA section 13 import requirements, codified at 19 CFR 

150 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of 

151 the chemical substance complies with all applicable rules and orders under TSCA, including any 

152 SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 

153 707, subpart B. In addition, any persons who export or intend to export a chemical substance 

154 that is the subject of the proposed SNUR on or after [insert date 30 days after the date of 

155 publication in the Federal Register] are subject to the export notification provisions of TSCA 

156 section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply with the export

157 notification requirements in 40 CFR part 707, subpart D. Persons who export or intend to export 
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158 a chemical substance or mixture identified in the proposed test rule will be subject to the export 

159 notification provisions of TSCA section 12(b) if the test rule is finalized. However, persons who 

160 export or intend to export articles containing chemical substances or mixtures subject to a final 

161 test rule would not be required to submit notice of export. 

162 

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

164 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e165 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 

166 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD167 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 

168 information that is claimed as CBI. In addition to one complete version of the comment that 

169 includes information claimed as CBI, a copy of the comment that does not contain the 

170 information claimed as CBI must be submitted for inclusion in the public docket. Information so 

171 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 

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

173 i. Identify the document by docket ID number and other identifying information (subject 

174 heading, Federal Register date and page number). 

175 ii. Follow directions. The Agency may ask you to respond to specific questions or 

176 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 

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

178 your requested changes. 

179 iv. Describe any assumptions and provide any technical information and/or data that you 

180 used. 

181 v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 

182 sufficient detail to allow for it to be reproduced. 

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

184 vii. Explain your views as clearly as possible, avoiding the use of profanity or personal 

185 threats. 

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

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

188 You may submit a request for an opportunity to present oral comments on this proposed 

189 test rule. This request must be made in writing. If such a request is received on or before [insert 

190 date 90 days after date of publication in the Federal Register], EPA will hold a public meeting 

191 on this proposed test rule in Washington, DC. This written request must be submitted to the 

192 mailing or hand delivery addresses provided under ADDRESSES. If such a request is received, 

193 EPA will announce the scheduling of the public meeting in a subsequent document in the 

194 Federal Register. If a public meeting is announced, and if you are interested in attending or 
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195 presenting oral and/or written comments at the public meeting, you should follow the 

196 instructions provided in the subsequent Federal Register document announcing the public 

197 meeting.

198 II. Background 

199 A. What Action is the Agency Taking? 

200 The Agency is proposing to amend the SNUR at 40 CFR section 721.10000 (Ref. 1) that 

201 requires any person who intends to manufacture or import tetraBDE, pentaBDE, hexaBDE, 

202 heptaBDE, octaBDE, or nonaBDE, or any combination of these chemical substances that results 

203 from a chemical reaction, for any use on or after January 1, 2005, to notify EPA at least 90 days 

204 in advance. EPA is proposing to amend the SNUR by: (1) designating processing of any of the 

205 six PBDEs after December 31, 20122013 for any use which is not ongoing as a significant new 

206 use, (2) designating manufacturing, importing, and processing of a seventh PBDE, 

207 decabromodiphenyl ether (decaBDE) (CAS No. 1163-19-5) for any use except military and

208 transportation uses after December 31, 2012, and manufacture and processing of decaBDE for 

209 any use including military and transportationwhich is not ongoing after December 31, 2013, as a 

210 significant new usesuse, and (3) making inapplicable for this SNUR, the article exemption for 

211 SNURs at 40 CFR 721.45(f). A person that imports or processes any of the chemical substances 

212 identified in the proposed SNUR for a significant new use as part of an article would not be 

213 exempt fromsubject to the significant new use notification requirements. No person would be 

214 able to begin manufacturing, importing, or processing, including as contained in an article, any 

215 of the chemical substances identified in the proposed SNUR for a significant new use without 

216 first submitting a significant new use notification (SNUN) to EPA. Ongoing uses would be 

217 excluded from the SNUR.

218 

219 EPA will not designate ongoing uses as significant new uses. Persons who manufacture, 

220 import, or process any of the chemicals included in the proposed SNUR, including as contained 

221 in an article, for an ongoing use, would be free to continue without submitting a SNUN. Note, 

222 however, that uses not already ongoing as of [insert date of publication in the Federal Register] 

223 would not be considered ongoing uses if they later arise, even if they are in existence upon the

224 issuance of a final rule. Furthermore, uses that are ongoing as of [insert date of publication in 

225 the Federal Register] would not be considered ongoing uses if they have ceased by the date of 

226 issuance of a final rule. (See Unit V.C for further discussion of what constitutes an ongoing use.) 

227 

228 Persons who intend to begin (or resume) commercial manufacture or processing of the 

229 chemical substance(s), including in articles, for a significant new use, would have to comply 

230 with all applicable SNUN requirements. Under TSCA section 5(b)(1)(A), any person who is 

231 required to submit a SNUN for a chemical substance and who is also required to submit test data 

232 under a final test rule, must submit the test data at the time that the SNUN is submitted. 

233 

234 In this notice EPA is also proposing to issue a test rule under section 4(a)(1)(A) of the 

235 TSCA that would require any person who manufactures, imports, or processes c-pentaBDE or, c236 octaBDE including in articles for any use after December 31, 2012; or manufactures, imports, or 

237 processes , or c-decaBDE for any use except military and transportation uses including in articles 

238 after December 31, 2012; or manufactures, imports, or processes c-decaBDE for for any use, 
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239 including military and transportation uses, including in articles, after December 31, 2013 to 

240 conduct testing of such commercial PBDE mixtures to obtain data on health effects, 

241 environmental effects, and chemical fate in accordance with the test rule. Hereafter, Dec 31, 

242 2012 andThe effective date of the test rule will be after December 31, 2013, will be referred to as 

243 the relevant effective dates; see 799.xxxx(k). The proposed test rule specifies that testing of c244 pentaBDE, c-octaBDE, and c-decaBDE be conducted on representative forms of the relevant 

245 commercial mixtures. The commercial mixture, c-pentaBDE, typically contains tetraBDE, 

246 pentaBDE and hexaBDE as the predominant components; the commercial mixture, c-octaBDE, 

247 typically contains hexaBDE, heptaBDE, octaBDE and nonaBDE as the predominant 

248 components; and the commercial mixture, c-decaBDE, typically contains decaBDE in the 

249 highest percent composition. 

250 

251 If EPA finds that the proposed significant new uses have not ceased by the specified 

252 datesmanufacture, import or processing of c-pentaBDE, c-octaBDE or c-decaBDE for any 

253 purpose, including as contained in an article other than as an impurity, will occur after December 

254 31, 2013, EPA will promulgate a final test rule to require persons who manufacture or process c255 pentaBDE, c-octaBDE, or c-decaBDEthose mixtures to conduct testing to obtain data on health 

256 effects, environmental effects, and chemical fate of those mixtures. The test rule would apply to 

257 all uses, new or ongoing. The existence or absence of a SNUR does not affect a person’s 

258 obligations under a test rule. The required testing would provide EPA with data necessary to 

259 determine the effects on health and the environment if the manufacture and processing of those 

260 mixtures and thetheir associated use, distribution in commerce and disposal are not discontinued. 

261 

262 EPA is seeking public comment on both the proposed SNUR and test rule. Comments 

263 may address any aspect of the actionsaction being proposed today. Unit XI of this notice 

264 contains a list of specific issues for which the Agency is seeking comment. The actions EPA is 

265 proposing today are generally described in the PBDE Action Plan released December 30, 2009 

266 (www.epa.gov/oppt/existingchemicals/pubs/actionplans/pbde.html).

267 

268 

269 B. Why is the Agency Taking this Action?

270 

271 

272 

273 EPA is concerned about the effects PBDEs may have on human health and the 

274 environment. As discussed in Unit III and the PBDE Action Plan (Ref. 66), there is evidence that 

275 PBDEs may be toxic to both humans and wildlife. PBDEs have been found in human tissue, 

276 wildlife and the environment. (Refs. 15, 23, 31, and 41). However, a panel of experts in the 

277 VCCEP reported to EPA that there iswere insufficient data to fully evaluate the significance of 

278 observed exposures.exposure to pentaBDE, octaBDE, and decaBDE (Refs. 48 and 49). 

279 

280 EPA is also concerned that the PBDEs included in these proposed actions are highly 

281 persistent in the environment. Some lower brominated PBDEs are both toxic and highly 

282 bioaccumulative. Other, more highly brominated forms such as decaBDE may debrominate to 

283 the more toxic and bioaccumulative lower brominated forms. However, the overall impact of 

284 debromination of decaBDE as a source of the lower brominated PBDE congeners in the 

285 environment has not been fully characterized. DecaBDE has been found at high levels in 
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286 predators such as peregrine falcons. The environmental significance of such accumulations of 

287 decaBDE has not been fully characterized. The exact mechanisms or pathways by which the 

288 PBDEs, including those contained in articles, move into and through the environment and allow 

289 humans and wildlife to become exposed are not fully understood. The data produced by some of 

290 the tests included in the proposed test rule would be necessary to determine the effects on the 

291 environment if manufacture and processing of c-pentaBDE, c-octaBDE, and c-decaBDE and 

292 their associated use, distribution in commerce and disposal are not discontinued. 

293 

294 In December 2009, EPA received voluntary commitments from the principal 

295 manufacturers and importer of c-decaBDE to phase out manufacture and import for all uses by 

296 December 31, 2013. (Refs. 68 – 70). The phase out of c-decaBDE will be accomplished in two 

297 steps. No later than December 31, 2012, the manufacturers and the importer of c-decaBDE 

298 would cease manufacture and import for all uses, including in articles, with the exception of 

299 military and transportation uses. No later than December 31, 2013, they would cease 

300 manufacture and import for all uses including military and transportation uses, including in 

301 articles. The principal manufacturers and importer of c-decaBDE stated that the additional time 

302 required for phasing out military and transportation uses was due to the stringent engineering 

303 requirements and risks associated with these applications as well as the multiple levels of testing 

304 and certification required for such product changes. EPA believes these activitiesmanufacture 

305 and processing for most uses of decaBDE will ceasehave ceased by the specified datesDecember 

306 31, 2013 and is proposing to use its authority under section 5 of TSCA to designate 

307 themdiscontinued uses as significant new uses. Once an activity has been determined, by rule, to 

308 be a significant new use, persons may not manufacture or process the chemical substance for that 

309 activity without first submitting a significant new use notice (SNUN) to EPA. The Agency 

310 would then have an opportunity to review and if necessary take action to restrict or prohibit the 

311 new use. 

312 

313 C.

314 C. How would the proposed SNUR and Test Rule affect PBDEs contained in articles?

315 

316 The proposed SNUR includes a proposal to eliminate the article exemption for SNURs at 

317 40 CFR 721.45(f), for the covered PBDEs. See 40 CFR 721.10000(c)(1) of the proposed rule. 

318 In general, persons who import or process chemical substances contained in articles are exempt 

319 from significant new use notification requirements. However, as discussed in Unit III and the 

320 PBDE Action Plan (Ref. 66), there is growing evidence that people and the environment are 

321 exposed to PBDEs contained in articles, and that those PBDEs may have adverse effects on 

322 human health and the environment. The Agency is concerned that commencement of new uses 

323 of PBDEs or resumption of discontinued uses, including in articles, may lead to increased 

324 exposure of humans and the environment to these chemicals. Making the article exemption for 

325 SNURs inapplicable for this proposed SNUR would ensure that the Agency has an opportunity 

326 to review and, if necessary, take action to restrict or prohibit significant new uses of PBDEs in 

327 articles before they resume. Thus, anyone who intends to manufacture or process a PBDE for a 

328 significant new use, including persons who intend to import or process articles containing a 

329 PBDE for a significant new use, would have to submit a SNUN at least 90 days before 

330 commencing such activity. Any ongoing uses identified at the point of finalization, including 

331 import or processing of articles containing PBDEs, would not be designated as significant new 

332 uses. These activities would be allowed to continue without the submission of a SNUN. 
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333 Eliminating article importers’ and article processors’ exemption from the requirement to submit 

334 a SNUN, as described in this proposed rule, would have no effect on article importers’ general 

335 exemption from import certification requirements, or on the articles exemption described at 40 

336 CFR 707.60(b), respecting export notifications.

337 

338 The proposed test rule applies to certain commercial PBDE mixtures, including those 

339 contained in articles. See 799.xxxx(b)(1) of the proposed test rule. Importers of articles 

340 containing c- pentaBDE, c-octaBDE, or c-decaBDE are considered manufacturers of these 

341 mixtures and would be subject to the proposed test rule, along with persons who domestically 

342 manufacture these chemicals in bulk or as part of a mixture. Persons who process c-pentaBDE, 

343 c-octaBDE, or c-decaBDE, including persons who process articles containing these mixtures, 

344 would also be subject to the proposed test rule. (These testing requirements apply even in 

345 circumstances where the manufacture [including import] or processing is for purposes of export 

346 from the United States.) Persons who do not know or cannot reasonably ascertain that they 

347 manufacture or process a listed test rule mixture (based on all information in their possession or 

348 control, as well as all information that a reasonable person similarly situated might be expected 

349 to possess, control, or know, or could obtain without unreasonable burden), would not be subject 

350 to the rule for the listed mixtures. The proposed test rule would not require testing of articles

351 themselves. The testing would be required of a representative commercial form of the c-PBDE 

352 contained in the article. See 799.xxxx(a)(1) of the proposed test rule. Eliminating article 

353 importers’ and article processors’ exemption from the requirement to conduct testing of c354 PBDEs, as described in this proposed rule, would have no effect on article importers’ general 

355 exemption from import certification requirements, or on the articles exemption described at 40 

356 CFR 707.60(b), respecting export notifications. 

357 This proposed rulemaking would not affect the article exemption at 40 CFR 707.60(b) for 

358 notices of export under section 12(b). Thus, persons who export PBDEs contained in articles 

359 would remain exempt from the requirement to submit a notice of export respecting such PBDEs. 

360 See Unit VII.

361 

362 Furthermore, this proposed rulemaking would not alter the application of the import 

363 certification regulations at 19 CFR 12.118 through 12.127. PBDEs contained in articles would 

364 therefore continue to be exempt from import certification requirements under section 13(b). 

365 PBDEs imported in bulk or as part of a mixture would continue to be subject to import 

366 certification requirements under section 13(b), consistent with 19 CFR 12.120(b). See Unit VIII. 

367 

368 D. Why is EPA Proposing both a SNUR and a Test Rule?

369 EPA has found no evidence of manufacture or processing of c-pentaBDE or c-octaBDE 

370 except as impurities. The principal manufacturers and importer of c-decaBDE have informed the 

371 Agency that they intend to phase out manufacture and import of the chemical no later than 

372 December 31, 2013. (Refs. 68 – 70). EPA believes that other manufacturers and importers of 

373 decaBDE will also cease their activities by that date. EPA is proposing to amend the SNUR to 

374 ensure that after these activities have been discontinued, no one resumes them without notifying 

375 EPA in advance, thereby providing EPA with an opportunity to review the new uses before they 

376 commence. Before promulgating the amended SNUR, EPA will verify through comments on 

377 this action, or by other means, that the proposed significant new uses have ceased. EPA seeks 
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378 comment on whether anyone intends to manufacture, import or process any of the PBDEs 

379 included in the proposed SNUR, including in articles containing pentaBDE, octaBDE, or 

380 decaBDE except as impurities, for any of the proposed significant new uses.

381 

382 In the event that the activities proposed as significant new uses of pentaBDE, octaBDE, 

383 or decaBDE do not cease by the projected dates, EPA is proposing a test rule to obtain 

384 information needed to assess the effects on humans and the environment of the continued 

385 manufacture and, import or processing of c-pentaBDE, c-octaBDE, and or c-decaBDE and the 

386 associated use, distribution in commerce and disposal. the event these activities do not cease by 

387 December 31, 2013.

388 

389 DE. Why does the proposed test rule include three commercial PBDE mixtures while the SNUR 

390 includes seven PBDE congeners?

391 

392 The test rule is designed to provide the Agency with data relevant to commercial PBDE 

393 products actually in use or intended for use. There are three commercial PBDE products: c394 pentaBDE, c-octaBDE, and c-decaBDE. The test rule proposes that testing be conducted on a 

395 representative form of each commercial mixture to better understand their potential effects on 

396 health and the environment. Some of the data obtained by the test rule would address unmet data 

397 needs identified by EPA through the Voluntary Children’s Chemical Evaluation Program 

398 (VCCEP). All three of the commercial PBDE products are mixtures, but have different 

399 predominant components. Other PBDE congeners may be present in the mixtures in lesser 

400 amounts. 

401 

402 The SNUR is designed to provide the Agency with advance notice of manufacture or 

403 processing of any one or any combination of the seven PBDEs for a significant new use. Since 

404 the composition of any future commercial PBDE products may vary in terms of congener 

405 composition, the Agency determined that it would be more effective to include all seven of the 

406 individual PBDE congeners in the SNUR. Thus, all congeners in any future commercial PBDE 

407 product would be subject to the SNUR reporting requirements. 

408 

409 EF. Will EPA Promulgate both the SNURTest Rule and the Test RuleSNUR?

410 

411 EPA expects that the manufacture and processing of the c-PBDEs identified in this 

412 proposed action, except as impurities, including these c-PBDEs when contained in articles, will 

413 have been discontinued by the dates indicated in the proposed amendments to the SNUR. EPA 

414 intends tocould promulgate amendments to the SNUR designating both the test rule and the 

415 SNUR. EPA’s focus in this rulemaking is on the phase-out of the manufacture and processing 

416 for any use, including discontinuedimport of PDBEs for all uses, as a significant new use. 

417 

418 If EPA were to learn through comments on the proposed amendments to the SNUR or 

419 test rule, or through other means, that a person who would be subject to the test rule intended to 

420 continue, resume, or commenceincluding in articles. EPA’s final action would depend on 

421 whether the manufacture or processing of c-pentaBDE, c-octaBDE, or c-decaBDE will continue 

422 after the relevant dates specifiedDecember 31, 2013, as explained in the proposed Unit II.F.1 and 

423 Unit II.F.2. The existence or absence of a SNUR does not affect a person’s obligations under a 

424 test rule in 799.xxxx(k),.
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425 

426 1. Reporting obligations if continuing existing uses of PBDEs. If EPA were to learn 

427 through comments on this proposed action, or through other means, that a person intended to 

428 manufacture or process c-pentaBDE, c-octaBDE, or c-decaBDE after December 31, 2013, EPA 

429 would promulgate the test rule. If a person indicated his intention to continue to engage in an 

430 activity proposed as a significant new use for any of these c-PBDEs, EPA would promulgate the 

431 proposed amendments to the SNUR designating all other uses of that PBDE as significant new 

432 uses. EPA would exclude the ongoing uses from the final SNUR. Therefore, a person who is 

433 manufacturing, importing or processing the c-PBDEs for an ongoing use after the effective date 

434 of the test rule would not need to submit a SNUN for that use and would be allowed to continue 

435 those activities while complying with the test rule. (See Unit V.C for further discussion of what 

436 constitutes an ongoing use.) However, if EPA were to learn that the only persons that would be 

437 subject to the test rule would be persons that process (rather than manufacture) c-pentaBDE, c438 octaBDE, or c-decaBDE as impurities contained in articles, EPA would not require testing 

439 because EPA has not determined whether this activity alone may present an unreasonable risk of 

440 injury to health or the environment. For example, persons who grind old plastic pallets 

441 containing decaBDE for the purpose of reusing the ground material in the fabrication of “new” 

442 plastic pallets would be considered processors of decaBDE as an impurity, if the decaBDE is 

443 unintentionally present in the recycled product (see Unit II.C.). If decaBDE is still being used as 

444 a flame retardant in a recycled product, it would have been considered to be processed.

445 

446 EPA could promulgate both the test rule the SNUR for the corresponding PDBE

447 congeners, i.e., pentaBDE, octaBDE, and decaBDE. If a person indicates his intention to 

448 continue to engage in an activity proposed as a significant new use for pentaBDE, octaBDE, or 

449 decaBDE, EPA intends to promulgate the proposed amendments to the SNUR designating all 

450 other uses of that PBDE as significant new uses, but would exclude the ongoing use from the 

451 SNUR. In that situation, EPA would also promulgate the test rule. Persons that manufacture or 

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

453 to the test rule.

454 

455 F2. Reporting obligations if initiating new uses of PBDEs, including resumption of 

456 discontinued uses. Uses not ongoing at the time of the proposal would be designated significant 

457 new uses in the final SNUR. Uses ongoing at the time of this proposal, but discontinued at the 

458 time the SNUR is finalized, would also be designated significant new uses. As required under 

459 TSCA section 5(b)(1)(A), if EPA has promulgated a final test rule for a chemical substance, any 

460 person who is required to submit a SNUN before beginning the manufacture or processing of 

461 that chemical substance is also required to submit test data under the final test rule for that 

462 substance at the time that the SNUN is submitted. Persons who intend to begin (or resume) 

463 commercial manufacture, import, or processing of the chemical substance(s), including in 

464 articles, for such uses would have to comply with all applicable SNUN requirements, including 

465 submission of data if a test rule is in effect, and wait until EPA’s statutorily-defined time period 

466 for its review of the SNUN expires before commencing those activities.

467 

468 EPA expects that the manufacture and processing of the PBDEs identified in this 

469 proposed action, except as impurities, including these PBDEs when contained in articles, will 

470 have been discontinued for most uses by the date indicated in the proposed amendments to the 

471 SNUR. EPA intends to promulgate amendments to the SNUR designating manufacture and 
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472 processing for any use which is not ongoing (including uses first arising after [insert date of 

473 publication in the Federal Register] and uses discontinued since [insert date of publication in 

474 the Federal Register]) as a significant new use. The proposed SNUR would not apply to any 

475 ongoing uses identified at the point of finalization (i.e., uses arising before [insert date of 

476 publication in the Federal Register] and which have not been discontinued as of the date of 

477 finalization). All other uses, including discontinued uses, would be designated as significant new 

478 uses. EPA recognizes that certain portions of the proposed significant new use may be still 

479 ongoing as of [insert date of publication in the Federal Register], and will verify whether they 

480 have been discontinued (i.e., whether they are indeed ongoing) before issuing a final SNUR that 

481 incorporates them. 

482 

483 

484 

485 G. What is the Agency's Authority for Taking this Action? 

486 

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

488 authorizes EPA to determine that a use of a chemical substance is a "significant new use." EPA 

489 must make this determination by rule after considering all relevant factors, including those listed 

490 in TSCA section 5(a)(2).). Once EPA determines that a use of a chemical substance is a 

491 significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use 

492 notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical 

493 substance for that use (15 U.S.C. 2604(a)(1)(B)). For purposes of section 5 of TSCA, the terms 

494 “manufacture” and “process” mean manufacturing or processing for commercial purposes. 

495 

496 2. Test Rule. Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states that it is the policy 

497 of the United States that ‘‘adequate data should be developed with respect to the effect of 

498 chemical substances and mixtures on health and the environment and that the development of 

499 such data should be the responsibility of those who manufacture [which is defined by statue to 

500 include import] and those who process such chemical substances and mixtures[.]’’ To implement 

501 this policy, TSCA section 4(a)(1)(A) (15 U.S.C. 2603(a)(1)(A)) directsprovides that EPA 

502 toshall require by rule that manufacturers and/or processors or both of chemical substances and 

503 mixtures conduct testing, if the EPA Administrator finds that:

504 makes the findings under either or both section 4(a)(1)( (A)() (an “A” finding) and 

505 section 4(a)(1)(B) (a “B” finding) in a final rule.

506 

507 Under section 4(a)(1)(A), the Administrator must find that:

508 (i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical 

509 substance or mixture, or that any combination of such activities, may present an unreasonable 

510 risk of injury to health or the environment,

511 (ii) there are insufficient data and experience upon which the effects of such 

512 manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture 

513 or of any combination of such activities on health or the environment can reasonably be 

514 determined or predicted, and 

515 (iii) testing of such substance or mixture with respect to such effects is necessary 

516 to develop such data [.]
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517 

518 Under Once the EPA Administrator has made a finding under TSCA section 4(a)(1)(A), 

519 EPA may require any type of health or environmental effects testing necessary to address 

520 unanswered questions about the effects of the B), the Administrator must find that:

521 (i) a chemical substance or mixture that are relevant to whetheris or will be produced in 

522 substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment 

523 in substantial quantities or (II) there is or may be significant or substantial human exposure to 

524 such substance or mixture, 

525 (ii) there are insufficient data and experience upon which the effects of the manufacture, 

526 distribution in commerce, processing, use, or disposal of the chemicalsuch substance or mixture,

527 or of any combination of such activities on health or the environment can reasonably be 

528 determined or predicted, and 

529 (iii) testing of such substance or mixture with respect to such effects is necessary to 

530 develop such data.

531 

532 Under section 4(a)(2), if the Administrator finds that, in the case of a mixture, the 

533 effects which the mixture’s manufacture, distribution in commerce, processing, use, or disposal

534 or any combination of such activities, presents may have on health or the environment may not 

535 be reasonably and more efficiently determined or predicted by testing the chemical substances 

536 which comprise the mixture; the Administrator shall by rule require that testing be conducted on 

537 such mixture.

538 The purpose of the testing would be to develop data with respect to the health and 

539 environmental effects for which there is an insufficiency of data and experience, and which are 

540 relevant to a determination that the manufacture, distribution in commerce, processing, use, or 

541 disposal of the substance or mixture, or that any combination of such activities, does or does not 

542 present an unreasonable risk of injury to health or the environment. 

543 

544 The extent to which such activities may affect health or the environment is dependent in 

545 part upon the human and environmental exposures to the chemical substance or mixture 

546 occasioned by those activities. As an example, TSCA section 4(b)(2)(A) specifically addresses 

547 testing for persistence of a substance. Testing to identify where and in what concentrations a 

548 chemical substance or mixture may become present in the environment contributes to an 

549 understanding of human and environmental exposures resulting from those activities.

550 

551 Once the Administrator has made the relevant findings under TSCA section 4(a), EPA 

552 may require any health or environmental effects testing for which data are insufficient and which 

553 are necessary to develop the data. EPA need not limit the scope of testing required to the factual 

554 basis for the TSCA section 4(a)(1)(A)(i) findings.or 4(a)(1)(B)(i) as long as EPA also finds that 

555 there are insufficient data and experience upon which the effects of the manufacture, distribution 

556 in commerce, processing, use, or disposal of such substance or mixture or of any combination of 

557 such activities on health or the environment can reasonably be determined or predicted, and that 

558 testing is necessary to develop such data. This approach is explained in more detail in EPA’s 

559 TSCA section 4(a)(1)(B) Final Statement of Policy (B Policy) (Ref. 2). published in the Federal 

560 Register issue of May 14, 1993 (58 FR 28736, 28738–28739). (Ref. 2). 

561 In this proposed test rule, based on a preliminary “A” finding, EPA would use its TSCA 
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562 authority under section 4(a) authorityof TSCA to obtain require the development of data 

563 necessary“which are relevant to determine whethera determination that the manufacture, 

564 processing, distribution in commerce, use, or disposal . . . or any combination of such activities” 

565 of any or all of the three commercial c-PBDE mixtures, i.e., c-pentaBDE, c-octaBDE, and c566 decaBDE, does or does not present an unreasonable risk of injury to health or the environment. 

567 

568 Pursuant to TSCA section 12(a)(2), EPA is also proposing to use its authority 

569 under TSCA section 124(a)(2) to require testing of mixtures named in this proposed test rule 

570 which would otherwise be exempted from TSCA under 12(a)(1). TSCA section 12(a)(1) 

571 exempts from TSCA the manufacture, processing, or distribution in commerce of a mixture for 

572 export from the United States in certain situations. Such testing would be for the purpose of 

573 determining whether or not the mixture presents an unreasonable risk of injury to health within 

574 the United States or to the environment of the United States .

575 

576 GH. Applicability of General Provisions. 

577 

578 1. SNUR. General provisions for SNURs appear under 40 CFR part 721, subpart A. 

579 These provisions describe persons subject to the rule, recordkeeping requirements, and 

580 exemptions to reporting requirements, and applicability of the rule to uses occurring before the 

581 effective date of the final rule. . 

582 

583 However, the article exemption for SNURs at 40 CFR part 721.45(f) would not apply to 

584 this proposed SNUR. A person who imports or processes a chemical substance that would be 

585 covered by this action as part of an article would not be exempt from submitting abe subject to

586 significant new use notice. reporting requirements. A person who manufactures or processes a 

587 PBDE only as an impurity would be exempt from the SNUR under 40 CFR part 721.45(d). 

588 

589 Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 

590 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA 

591 regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 

592 5(a)(1)(A). In particular, these requirements include the information submissions requirements 

593 of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 

594 (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 

595 may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on 

596 which it has received the SNUN. If EPA does not take action, EPA is required under TSCA 

597 section 5(g) to explain in the Federal Register its reasons for not taking action. 

598 

599 Persons who export or intend to export a chemical substance identified in a proposed or 

600 final SNUR are subject to the export notification provisions of TSCA section 12(b). The article 

601 exemption at 40 CFR part 707.60(b) would apply to this rule. Persons who export or intend to 

602 export articles containing chemical substances subject to this proposed rule would not be 

603 required to submit notice of export. The regulations that interpret TSCA section 12(b) appear at 

604 40 CFR part 707, subpart D. Also, see Unit VII.

605 

606 Persons who import a chemical substance identified in a final SNUR are subject to the 

607 TSCA section 13 import requirements, codified at 19 CFR 12.118 through 12.127; see also 19 

608 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies 
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609 with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA 

610 policy in support of import certification appears at 40 CFR part 707, subpart B. Also, see Unit 

611 VIII. 

612 

613 

614 2. Test Rule. General provisions for test rules appear under 40 CFR part 790 (subparts A, 

615 B, C, and E), part 791, part 792, and part 799 (subpart A). These provisions describe persons 

616 subject to the rule, procedures for developing test rules, implementation, enforcement, and 

617 modification of test rules, exemption from testing, data reimbursement, and good laboratory 

618 practice standards. Section 791.48(b) would not apply to this proposed test rule for the purpose 

619 of defining production volume to determine fair reimbursement shares. Production volume 

620 would be defined as including amounts of the test chemical imported in bulk form, in mixtures, 

621 in articles, and the total domestic production of the chemical including that produced as a 

622 byproduct or as an impurity. See 799.xxxx(f) of the proposed rule. Also, persons described in 

623 part 790.2 as subject to a test rule include, among others, importers and processors of a chemical 

624 substance or mixture as part of an article. Submission of a SNUN would not affect a person’s 

625 obligations under a test rule.

626 

627 Persons who export or intend to export a chemical substance or mixture identified in a 

628 final test rule are subject to the export notification provisions of TSCA section 12(b). However, 

629 persons who export or intend to export articles containing chemical substances or mixtures 

630 subject to a final test rule would not be required to submit notice of export. The regulations that 

631 interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Also, see Unit VII.

632 

633 III. Overview of PBDEs

634 

635 A. Chemistry of PBDEs. 

636 

637 The polybrominated diphenyl ethers (PBDEs) are a family of chemicals with a common 

638 structure of a brominated diphenyl ether molecule which may have anywhere from one to ten 

639 bromine atoms attached. (Figure 1). 

640 

641 Figure 1. Brominated diphenyl molecule 

642 

O

Br x Br y

643 x + y = 4 - 10

644 

645 Each individual PBDE variant, distinguished from others by both the number of bromine 

646 atoms and the placement of those atoms, is referred to as a congener. For example, there are 42 

647 tetrabromodiphenyl ether congeners, each with four bromine atoms in different configurations. 

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

649 atoms is specified are given numbers, e.g., BDE-47. In theory, there could be as many as 209 

650 PBDE congeners, but a much smaller number of congeners are commonly found in the 
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651 commercial PBDE products and in measurements of PBDEs in humans and the environment 

652 (Table 1). Scientific studies, particularly those measuring presence of PBDEs in tissues and the 

653 environment, often report their findings by BDE number. 

654 

655 PBDE congeners can be grouped as homologs i.e., according to the number of bromine 

656 atoms present in the molecule. TSCA inventory listings and regulations for PBDEs are based on 

657 these homolog groups. (Table 1). The PBDE homologs used in flame retardants have between 

658 four and ten bromine atoms. EPA regulations of PBDEs generally apply to congeners grouped 

659 according to homolog groups rather than specific congener/isomers designated by BDE number. 

660 

661 There are three types of commercial PBDE (c-PBDE) products, c-pentaBDE, c-octaBDE, 

662 and c-decaBDE; each commercial product is a mixture of PBDE congeners (see Table 2). 

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 

666 B. Actions taken to understand and limit risk from use of PBDEs. 

667 

668 EPA has been concerned about the reported health and environmental effects of PBDEs 

669 and potential exposure to PBDEs for some time, and has taken several actions to fully understand 

670 their effects and to reduce exposure to them. Of particular note are the VCCEP, which was 

671 announced in 2000 (Ref. 65), and the 2006 PBDE SNUR (Ref. 1). More recently, EPA 

672 articulated its concerns regarding these effects in the 2009 action plan for PBDEs (Ref. 66).

673 

674 C-PentaBDE, c-octaBDE, and c-decaBDE were among the chemicals evaluated in 

675 VCCEP. That Program was designed to collect health effects information on chemicals to which 

676 children had a high likelihood of being exposed and to characterize the risk to children from that 

677 exposure. Sponsors in VCCEP provided health effects and exposure information on a voluntary 

678 basis. Through VCCEP the Agency identified data needs for all three c-PBDEs that were 

679 beyond what was provided by the sponsors in the initial chemical assessments. The sponsors of 
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680 c-pentaBDE and c-octaBDE, however, declined to conduct testing to address the identified data 

681 needs because of plans to discontinue manufacture of these chemicals in 2004. Later the 

682 sponsors of c-decaBDE also declined to conduct testing to provide the data needs identified 

683 through VCCEP and subsequently decided to phase out their activities with c-decaBDE. As a 

684 result, the sponsoring companies did not meet the additional data needs identified through 

685 VCCEP for any of the three c-PBDEs. Tests addressing those data needs are among the tests 

686 proposed for c-pentaBDE, c-octaBDE, and c-decaBDE in this action. 

687 

688 C-pentaBDE and c-octaBDE had been widely used as additive flame retardants in a 

689 number of applications until their sole U.S. manufacturer, the Great Lakes Chemical Corporation 

690 (now Chemtura Corporation) voluntary phased out their production in 2004. C-PentaBDE was 

691 used primarily in flexible polyurethane foams. C-OctaBDE was used in acrylonitrile-butadiene692 styrene (ABS) plastic which was used in applications such as casing for certain electric and 

693 electronic devices used in both offices and homes. . When manufacture of c-pentaBDE and c694 octaBDE was discontinued, EPA promulgated a SNUR (74 FR 34015, June 13, 2006) which 

695 requires that any person who intends to manufacture or import a chemical substance containing 

696 any of the congeners present in c-pentaBDE or c-octaBDE (namely tetraBDE, pentaBDE, 

697 hexaBDE, heptaBDE, octaBDE, and nonaBDE), or any combination of these substances 

698 resulting from a chemical reaction, to notify EPA at least 90 days in advance of manufacture or 

699 import for any use on or after January 1, 2005. The SNUR does not address processing of 

700 PBDEs, nor does it apply to import of articles which contain any of the congeners present in c701 pentaBDE or c-octaBDE. 

702 

703 C-DecaBDE is still manufactured and widely used in the United States as an additive 

704 flame retardant. The three major product categories in which c-decaBDE is used are: textiles, 

705 electronic equipment, and building and construction materials. Its primary use is in high impact 

706 polystyrene (HIPS) based products. However as a result of the voluntary phase-out announced 

707 on December 17, 2009, (Refs. 68 – 70) EPA expects allmanufacture and processing for most

708 uses of c-decaBDE except for military and transportation uses to be discontinued in the United 

709 States by December 31, 2012, and all remaining uses including military and transportation uses

710 to be discontinued by the end of 2013. 

711 Other actions EPA has taken with PBDEs include (1) supporting he inclusion in 

712 voluntary consensus standards of criteria restricting PBDE use as a product component (e.g., in 

713 carpets, electronics, and furniture or use in manufacturing processes, and (2) working with and 

714 through programs (i.e., Furniture Flame Retardancy Partnership and the Green Suppliers 

715 Network) to identify environmentally safer approaches to meeting fire standards and to improve 

716 awareness of concerns related to PBDEs. 

717 C. Human Health Effects. 

718 

719 In 2008, EPA published peer-reviewed toxicological reviews of tetraBDE (BDE-47), 

720 pentaBDE (BDE-99), hexaBDE (BDE-153), and decaBDE (BDE-209) (Refs. 3-6), to support 

721 summary information on EPA's Integrated Risk Information System (IRIS) database 

722 (www.epa.gov/iris/). Developmental neurotoxicity was identified as the critical effect for each 

723 of the four chemicals. EPA also concluded that the database for decaBDE (BDE-209) provides 

724 “suggestive evidence of carcinogenic potential” (Ref. 6). 
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725 

726 Through EPA’s Voluntary Children’s Chemical Evaluation Program (VCCEP), industry727 sponsored screening level risk assessments for c-pentaBDE, c-octaBDE and c-decaBDE were 

728 developed to evaluate the potential risks to children and prospective parents from PBDE 

729 exposures (Ref. 7). Adverse65). EPA’s evaluation of these assessments considered adverse

730 neurobehavioral effects following exposure to PBDEs during the postnatal period are believed to 

731 be the most sensitive health endpoint. following postnatal exposure to PBDEs (Refs. 48 and 49). 

732 Effects on spontaneous motor behavior (locomotion, rearing, and total activity) were observed in 

733 adult rats after postnatal exposure. Additional effects due to higher exposures to c-pentaBDE 

734 were observed in the following studies: (1) Repeated-dose toxicity studies for c-pentaBDE 

735 showed changes in liver enzyme activity, increased liver weight, and histologic changes in the 

736 liver. (2) Changes in thyroid hormone T4 levels and thyroid hyperplasia were noted in oral adult 

737 rat studies. (3) In limited prenatal developmental studies, decreases in T4 levels were reported 

738 for dams and offspring. The repeated (Ref. 48). Additional effects due to higher exposures to c739 octaBDE were observed in the following studies: (1) Repeated-dose toxicity studies for c740 octaBDE showed changes in liver enzyme activity and increased liver weights. (2) In prenatal 

741 developmental studies, decreased maternal and pup bodyweight and decreases in thyroid 

742 hormone T4 levels were reported for rat dams and their offspring. Evidence(Ref. 48). EPA 

743 concluded there was evidence of developmental and reproductive effects was noted butfrom 

744 exposure to c-pentaBDE and c-octaBDE, but that additional studies are needed to better 

745 characterize potential risks to children (Ref. 48). EPA throughThrough VCCEP, EPA identified 

746 two-generation reproductive toxicity studies with a satellite group for body burden 

747 determinations as a data need for both c-pentaBDE and c-octaBDE (Ref. 48). Also through 

748 VCCEP, EPA identified anaerobic debromination in aquatic sediments, anaerobic debromination 

749 in sludge digesters, and photolysis in the indoor environment as data needs for c-decaBDE to 

750 better understand the chemical fate and thereby the potential exposure to decaBDE and lower 

751 brominated congeners (Ref. 49). 

752 

753 D. Environmental Hazard. 

754 

755 Laboratory studies have shown that c-pentaBDE is capable of producing adverse effects 

756 in a variety of organisms including birds, mammals, fish, and invertebrates (Refs. 8-19). In some 

757 cases, these effects were observed at exposure levels similar to levels found in the environment 

758 

759 E. Environmental Releases and Fate. 

760 

761 The exact mechanisms or pathways by which the PBDEs move into and through the 

762 environment and allow humans to become exposed are not fully understood, but are likely to 

763 include releases from manufacturing of the chemicals, processing c-PBDEs into products like 

764 plastics or textiles, aging and wear of products like sofas and electronics, and releases at the end 

765 of product life (disposal or recycling). In general, levels of PBDE congeners in humans and the 

766 environment are higher in North America than in other regions of the world, which may be 

767 attributed to the greater use of c-PBDEs in North America (Ref. 20Refs. 74 and 75). The 

768 concentration and distribution of congeners detected in the environment appear to depend on the 

769 proximity to a source of the congener and the media tested. (Ref. 74 20) 

770 

771 PBDE congeners with four to ten bromine atoms are highly persistent, based on a large 
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772 body of environmental monitoring data in both the United States and abroad (Refs 21-23). 

773 Available data also indicate that the tetra-, penta-, hexa- and heptaBDE congeners are highly 

774 bioaccumulative (Ref. 24). After reviewing the available information, EPA has concluded that 

775 decaBDE is a likely contributor to the formation of bioaccumulative and/or potentially 

776 bioaccumulative transformation products, such as lower brominated PBDEs, in organisms and in 

777 the environment see, e.g., (Refs 25-28), but the overall impact of this process as a source of the 

778 more toxic, lower brominated PBDE congeners has not been fully characterized. DecaBDE 

779 undergoes photolytic and possibly microbial debromination under certain conditions (Refs. 22 

780 and 28). Photolysis is expected to be a significant transformation process for decaBDE 

781 whenever the substance is significantly exposed to light. For example, it has been found that 

782 decaBDE undergoes photolytic debromination in house dust (Ref. 29). DecaBDE would also be 

783 exposed to light when waste sludge containing PBDEs is used as a soil amendment, albeit only 

784 on the soil surface (Ref. 30). Studies have shown that photodegradation of decaBDE may result 

785 in PBDEs from tri- to nona-, although most photolysis studies were done under conditions that 

786 do not allow direct extrapolation to environmental conditions. Metabolism of decaBDE in 

787 organisms results predominantly in nona-, octa- and heptaBDE formation (as reviewed in Ref. 

788 22). Stapleton (Ref. 28) summarized the effects of decaBDE debromination, noting that the 

789 formation potential for the pentaBDE and lower congeners was low, but that the formation of the 

790 hepta, octa and nonaBDE congeners was environmentally relevant. 

791 

792 The atmosphere and marine currents can transport PBDEs over relatively long distances 

793 (> 1,000 km). Evidence for this comes from the presence of PBDEs in the tissues of deep ocean794 dwelling whales and other marine mammals far from anthropogenic sources (Ref. 23), as well as 

795 from modeling (Ref. 30). The body burdens of PBDE congeners in a wide variety of biota, 

796 indigenous to geographical areas ranging from the equator to the poles also substantiate the 

797 PBDE propensity for long-range transport (LRT), and constitute evidence of environmental 

798 persistence (Ref. 24).

799 

800 F. Human Exposure. 

801 

802 The use of c-PBDEs as flame retardants in consumer products is believed to be a source 

803 of exposure. Dermal exposure may occur through direct contact with c-PBDE-containing 

804 products such as computer housings and textiles (Ref. 31). The lower brominated tetra- and 

805 penta- congeners have also been detected in the vapor phase of air samples while the higher 

806 brominated congeners are found in associated particulate matter, including house dust (Refs. 32 

807 and 33). Lorber (Ref.33) and EPA (Ref. 31) reported that a significant source of human 

808 exposures to PBDEs appears to be their use in commercial products that are part of the indoor 

809 environment (computer circuitry, foam cushions, fabrics in curtains, etc). They found that 

810 food/water ingestion and inhalation explained less than 20% of the body burden, based upon the 

811 estimate of total exposure derived using a pharmacokinetic model. They stated that the remainder 

812 of the estimated exposure likely came from house dust through the pathways of ingestion and 

813 dermal contact, or some other, unknown source. Other literature indicates that inhalation may be 

814 a significant potential route of exposure for the general population (Ref. 31). In addition, PBDE 

815 exposure can occur by ingestion of foods that are contaminated (Ref. 35). PBDEs have been 

816 detected in human tissue, blood (usually serum), and breast milk (Ref. 36). ExposuresExposure

817 to PBDEs in some occupational settings, such as in computer recycling, can be higher than those 

818 of the general population (Ref. 37). PBDE use as flame retardants in many household products, 
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819 and subsequent exposure to indoor house dust containing PBDEs, coupled with the elevated 

820 ingestion potential due to increased intakes of food, water, and air per pound of body weight, as 

821 well as childhood-specific exposure pathways such as breast milk consumption and increased 

822 contact with the floor, make children especially vulnerable. 

823 

824 Recent human biomonitoring data on PBDEs are available in CDC’s “Fourth National 

825 Report on Human Exposure to Environmental Chemical”

826 (http://www.cdc.gov/exposurereport/).Chemicals” (Ref. 38). The PBDE data have also been 

827 published in the peer-reviewed literature (Ref. 3837). The data were obtained from samples 

828 from participants in the 2003-2004 National Health and Nutrition Examination Survey (Ref. 

829 3938). Ten PBDE congeners (containing from three to seven bromines) were included in the 

830 analysis: BDE-17, BDE-28, BDE-47, BDE-66, BDE-85, BDE-99, BDE-100, BDE-153, BDE831 154 and BDE-183; decaBDE was not included. Participants were aged 12 years and older. 

832 BDE-47 was detected in serum from almost all of the participants and it was highest in 12-19 

833 years old, and those over 59 years old. Furthermore, serum levels were highest in 12-19 year 

834 olds for other lower brominated congeners. In addition, these congeners were significantly 

835 correlated with each other--concentration of individual congeners and total PBDE content in 

836 blood serum steadily increased annually over a five year period, suggesting a similar pathway of 

837 exposure via diet, or via direct inhalation or dermal contact (Ref. 38).. 

838 

839 G. Environmental Exposure. 

840 

841 The food chain is likely a large contributor to environmental exposures. In general, 

842 PBDE concentrations are highest in sediment samples collected downstream from 

843 industrial/urban areas, outfalls from sewage treatment plants, and urban locations without heavy 

844 industries. The lowest PBDE concentrations are generally found in sediments collected in 

845 remote and agricultural areas. DecaBDE (BDE-209) appears to dominate congener profiles of 

846 aquatic sediments. Researchers have determined concentrations of PBDEs in waterways, 

847 sediments, and biota from various locations such as the Great Lakes, the San Francisco Bay, and 

848 near unnamed polyurethane foam manufacturing facility for which PBDE contamination was 

849 known or suspected. (Ref. 31) 

850 

851 Some studies show evidence that concentrations of PBDEs in biota have doubled every 3 

852 to 6 years, the doubling time depending on species, life stage, and location. PBDE levels in trout 

853 from the Great Lakes rose from non-detectable in 1975, to approximately 50 nanograms/gram 

854 (ng/g) in 1990, and to approximately 200 ng/gm in 2000 (Ref. 40). PBDE concentrations in 

855 marine biota in North America are the highest in the world, and are increasing (Ref. 23). After 

856 reviewing the available information, EPA has concluded that the extent of accumulation of 

857 congeners in biota is directly related to dietary levels of PBDEs. Observed differences in PBDE 

858 congener profiles in marine mammals from California, Alaska, and the Gulf of Mexico indicate 

859 that diet is a significant source of PBDE exposure in marine wildlife (Ref.23). 

860 

861 DecaBDE has been found at high levels in predators such as peregrine falcons (Ref. 41). 

862 Biomonitoring studies of wild mink from the Great Lakes region revealed that margins of safety 

863 for mink are small, and that PBDE concentrations in mink from Hamilton Harbor exceeded the 

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

865 
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866 Biomagnification is the process in which the concentration of a chemical in an organism 

867 achieves a level that exceeds that in the organism’s diet, due to dietary absorption (Ref. 42). 

868 Biomagnification occurs as predators up the food chain ingest the accumulated PBDEs in the 

869 bodies of their prey (Refs. 23, 43-45). Environment Canada concluded that the greatest potential 

870 risks from PBDEs in the Canadian environment are the secondary poisoning of wildlife from the 

871 consumption of prey containing elevated concentrations of PBDEs, and effects on benthic 

872 organisms that may result from elevated concentrations of certain PBDEs in sediments (Ref. 24). 

873 Biomagnification of PBDEs has been observed in fish; PBDE levels in sediment were directly 

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

875 Canada concluded that decaBDE is available for uptake in organisms, and may accumulate to 

876 high and potentially problematic levels in certain species such as birds of prey or mammalian 

877 predators (Ref. 22). 

878 

879 Although not conclusive, some data suggests that PBDEs may debrominate in the bodies 

880 of wild birds. Park, et al., (Ref. 40) found that younger peregrine falcons had higher levels of 

881 BDE-209 and other highly brominated congeners, whereas older birds had higher levels of the 

882 less brominated (hexa) BDE-153, which could not be explained by the BDE-153 levels in diet. 

883 Further, in eggs that were collected yearly from the same bird, PBDE congener concentrations 

884 changed yearly, with levels of BDE-209 decreasing, and levels of BDE 153 increasing in the two 

885 last years relative to the former four years (but no such obvious changes in polychlorinated 

886 biphenyl (PCB) levels). The chemical measurements and comparison in this study are valuable 

887 because a similar laboratory study would take many years in similar long-lived avian species 

888 (peregrines live 7-15 years or longer), and environmental variables that affect PBDE uptake and 

889 biomagnifications, including exposure to other chemicals, might be difficult to simulate. Similar 

890 evidence of debromination of decaBDE has been observed in carp (Refs. 28 and 47) and British 

891 starlings (Ref. 47).

892 

893 IV. Proposed Findings 

894 A. SNUR. 

895 Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical 

896 substance is a significant new use must be made after consideration of all relevant factors 

897 including: 

898 

899 • The projected volume of manufacturing and processing of a chemical substance. 

900 

901 • The extent to which a use changes the type or form of exposure of human beings 

902 or the environment to a chemical substance. 

903 

904 • The extent to which a use increases the magnitude and duration of exposure of 

905 human beings or the environment to a chemical substance. 

906 

907 • The reasonably anticipated manner and methods of manufacturing, processing, 

908 distribution, in commerce, and disposal of a chemical substance. 

909 

910 To determine what would constitute a significant new use of PBDEs, EPA also 
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911 considered other relevant factors including information about the toxicity of PBDEs as well as 

912 exposures and environmental presence resulting from past use. 

913 

914 As discussed in Unit III, there is evidence that PBDEs may be toxic to humans and 

915 wildlife. However, there is insufficient data to fully evaluate the significance of observed 

916 exposures. EPA is also concerned that the PBDEs included in these proposed amendments to the 

917 SNUR are highly persistent in the environment. Some lower brominated PBDEs are highly 

918 bioaccumulative, and others may debrominate to the lower brominated forms. In general, levels 

919 of PBDEs in humans and the environment are higher in North America than in other regions of 

920 the world, which may be attributed to the greater use of PBDE in North America. Some 

921 monitoring data show a steady increase from non-detectable levels when PBDEs first came into 

922 use to current levels. The exact mechanisms or pathways by which the PBDEs move into and 

923 through the environment and allow humans and wildlife to become exposed are not fully 

924 understood, but are likely to include releases from manufacturing of the chemicals, processing 

925 PBDEs into products like plastics or textiles, aging and wear of products like sofas and 

926 electronics, and releases at the end of product life (disposal or recycling). 

927 

928 Once the manufacture and processing of PBDEs have been discontinued, EPA expects 

929 their presence in humans and the environment to decline over time as has been observed in the 

930 past when production and use of other persistent chemicals has ceased. 

931 

932 EPA is concerned that if manufacture and processing of PBDEs were to resume, the 

933 anticipated decline in levels in humans and the environment will be disrupted as PBDEs are 

934 introduced into the environment at levels greater than would otherwise occur. The result would 

935 be that the magnitude and duration of exposure of humans and the environment in the future 

936 would likely increase. 

937 

938 B. Test Rule. 

939 Based on the data cited in Unit III.C. through III.G. of this preamble, EPA has made the 

940 following preliminary determinations. First, c-pentaBDE, c-octaBDE, and c-decaBDE may 

941 present a hazard to human health. C-pentaBDE, c-octaBDE and c-decaBDE were all reviewed 

942 under EPA’s VCCEP program. Members of the peer consultation panel for c-pentaBDE and c943 octaBDE noted that there are indications of thyroid toxicity in some rodent studies, and thyroid 

944 toxicity can have adverse effects on reproductive success and fetal development (Ref. 48). For 

945 c-decaBDE, VCCEP identified anaerobic debromination in aquatic sediments, anaerobic 

946 debromination in sludge digesters, and photolysis in the indoor environment as a potential source 

947 of human and environmental exposure to lower brominated congeners (Ref. 49). Debromination 

948 of decaBDE to form lower brominated, more toxic congeners is potentially relevant to effects on 

949 both human health and the environment. EPA’s IRIS database indicates that neurobehavioral 

950 effects are critical endpoints of concern for components of c-pentaBDE and c-decaBDE. EPA 

951 has also concluded that there is suggestive evidence of carcinogenic potential for decaBDE 

952 (BDE-209), which is the main component of c-decaBDE. 

953 Second, c-pentaBDE and c-decaBDE may present a hazard to the environment. 

954 Laboratory studies have shown that c-pentaBDE is capable of producing adverse effects in a 

955 variety of organisms including birds, mammals, fish, and invertebrates. In some cases these 
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956 effects were observed at exposure levels similar to levels found in the environment. C-decaBDE 

957 may contribute to these levels by debrominating to lower, more toxic brominated congeners in 

958 the environment. 

959 Third, pentaBDE, octaBDE, and decaBDE congeners, which are among the predominant 

960 components of c-pentaBDE, c-octaBDE, and c-decaBDE respectively, are ubiquitous in soil, 

961 sediments and living organisms (Ref. 50). PentaBDE, octaBDE, and decaBDE congeners have 

962 been found in human tissue, blood and breast milk (Ref. 51). These chemicals persist in the 

963 environment and accumulate in organisms that ingest or inhale them. For example, high levels 

964 of decaBDE have been found in high trophic level animals, e.g., predatory animals such as the 

965 peregrine falcon. However, the predominant congeners present in living organisms tend to be 

966 the lower brominated, more toxic forms, which include pentaBDE (Refs. 52 and 53). Infants and 

967 children, as well as people who are occupationally exposed, may be exposed at higher levels than 

968 the general public. 

969 Based on the evidence of human and environmental exposure to pentaBDE, octaBDE, 

970 and decaBDE congeners, which derive from c-pentaBDE, c-octaBDE, and c-decaBDE, coupled 

971 with the evidence of human and/or environmental hazard of c-pentaBDE, c-octaBDE, and c972 decaBDE, EPA preliminarily finds under TSCA section 4(a)(1)(A)(i) that the manufacture, 

973 processing, distribution in commerce, use, and disposal of c-pentaBDE, c-octaBDE, and c974 decaBDE, or any combination of such activities, may present an unreasonable risk of injury to 

975 human health and the environment. 

976 

977 Through the testing of c-pentaBDE and c-octaBDE in VCCEP, EPA identified two978 generation reproductive toxicity studies with a satellite group for body burden determinations as 

979 a data need for c-pentaBDE and c-octaBDE (Ref. 48). For c-decaBDE, VCCEP identified 

980 anaerobic debromination in aquatic sediments, anaerobic debromination in sludge digesters, and 

981 photolysis in the indoor environment as data needs (Ref. 49). Therefore, EPA also preliminarily 

982 finds under TSCA section 4(a)(1)(A)(ii) that there are insufficient data upon which the effects of 

983 such manufacture, processing, distribution in commerce, use, and disposal of c-pentaBDE, c984 octaBDE, and c-decaBDE, or any combination of such activities, on health or the environment 

985 can reasonably be determined or predicted. Under TSCA section 4(a)(1)(A)(iii), EPA 

986 preliminarily finds that testing of c-pentaBDE, c-octaBDE, and c-decaBDE with respect to these 

987 and other toxic effects is necessary to develop such data. 

988 

989 EPA has determined in accordance with section 4(a)(2) of TSCA that the effects of the 

990 mixtures, c-pentaBDE, c-octaBDE, and c-decaBDE, may be reasonably and more efficiently 

991 determined by testing the commercial products themselves rather than the individual chemical 

992 substances which comprise these mixtures. EPA believes that testing of the individual chemical 

993 substances that are present in the commercial mixtures at different percentages would be a less 

994 efficient mechanism to determineand less predictive of the effects of the commercial mixtures 

995 than testing of representative forms of commercial products as they are manufactured. EPA 

996 believes that testing the mixture will best reflect the effects of exposure due to the possible 

997 additive, synergistic, and/or antagonistic effects resulting from the possible interaction of 

998 congeners in a mixture. EPA believes that testing the commercial products will be more efficient 

999 than testing the individual components because fewer tests would be needed to address the 

1000 Agency’s concerns. Nonetheless, EPA is still requesting comment in Unit XI.B.4. through 
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1001 XI.B.7. on what the test substance should be and how it should be defined. 

1002 

1003 V. Proposed Amendments to the SNUR 

1004 A. Summary of proposed amendments to the SNUR. 

1005 This proposed rule would amend the significant new use rule at 40 CFR part 721.10000. 

1006 Under the existing SNUR, any person who intends to manufacture certain PBDEs must notify 

1007 EPA at least 90 days before commencing the manufacture of any one or more of those chemical 

1008 substances after January 1, 2005 for any use. The following chemicals substances are subject to 

1009 reporting under the existing SNUR: tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, and 

1010 nonaBDE, or any combination of these substances resulting from a chemical reaction. 

1011 

1012 Among other activities, the use of a PBDE in the manufacture of an article is considered 

1013 processing of the PBDE. In the existing SNUR, the Agency did not designate processing of the 

1014 subject PBDEs as a significant new use because it believed that such activities were ongoing. 

1015 The Agency now believes that processing of these chemical substancestetraBDE, pentaBDE, 

1016 hexaBDE, heptaBDE, octaBDE, and nonaBDE has been discontinued and therefore is proposing 

1017 to amend the SNUR to include processing as a significant new use. EPA believes that resumption 

1018 of the practice of processing PBDEs would increase exposure to PBDEs and releases of PBDEs 

1019 to the environment. However, as explained in Unit II.F, if a person indicated that he is engaged

1020 in an activity proposed as a significant new use for these PBDEs, EPA would promulgate the 

1021 proposed amendments to the SNUR designating all other uses of that PBDE as significant new 

1022 uses. EPA would exclude the ongoing use(s) from the final SNUR. The Agency requests 

1023 comments on whether there is existing, ongoing processing on these chemicals.

1024 

1025 On December 19, 2009 the principle U.S. manufacturers and importersimporter of 

1026 decaBDE committed to end production, and importation of decaBDE in the United States for all 

1027 uses except military uses and transportation uses by December 31, 2012, and for all uses 

1028 including military and transportation uses by the end of 2013. (Refs. 68 – 70). The Agency also 

1029 expects all other manufacturers to discontinue manufacture and use of decaBDE by the end of 

1030 2013. Therefore, the Agency is proposing to amend the SNUR by adding, after December 31, 

1031 2013, decaBDE to the list of chemicals subject to reporting and by designating (again, after 

1032 December 31, 2013) manufacture and processing of decaBDE for any use except military and 

1033 transportation use after December 31, 2012 discontinued use as a significant new use. The 

1034 Agency is proposing to designate understands that some downstream users of decaBDE would 

1035 like the manufacture and processing of decaBDE for any use, including military and 

1036 transportationsome uses, after December 31, 2013, a significant new use. Military use means use 

1037 by the armed forces of to continue after December 31, 2013. The Agency understands that these 

1038 downstream users believe that there will continue to be critical military and aeronautical uses of 

1039 decaBDE (some examples are use in insulation, ducting, electronic components) after December 

1040 31, 2013. The Agency seeks comments on the United States, or preparation of an article for use 

1041 byextent to which these uses will continue despite the armed forcesphase-out in the manufacture 

1042 and import of the United States. Transportation use means preparationdecaBDE and whether 

1043 there are any other uses which will not be discontinued by December 31, 2013. Persons who 

1044 comment are asked to specify both the functional application of an article for use as an integral 

1045 component of a moving vehicle such as a car, truck, train, ship, or the article containing 
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1046 decaBDE, e.g. ductwork for aircraft., and the material to which the decaBDE is added, e.g. high 

1047 impact polystyrene. Persons who comment should also include definitions of terms where 

1048 appropriate.

1049 

1050 EPA’s immediate objective in proposing these amendments to the PBDE SNUR is to 

1051 enable the Agency to review and, if necessary, limit or prohibit resumption of any activities 

1052 which could result in increasing the amount of PBDEs in commerce in the United States. 

1053 

1054 Under the general SNUR exemption provisions at 40 CFR part 721.45, a person that 

1055 imports or processes a substance covered by a SNUR identified in subpart E of 40 CFR part 721 

1056 is not generally subject to the notification requirements of §40 CFR part 721.25 for that 

1057 substance, if the person imports or processes the substance as part of an article. However, EPA 

1058 is concerned that if PBDEs contained in articles are exempt, they could be imported without a 

1059 notificationSNUN and thereby increase the amount of PBDEs in commerce in the United States 

1060 without a review by EPA. Therefore, the Agency is proposing that the article exemption for 

1061 SNURs at §40 CFR part 721.45(f) not apply to this action. 

1062 

1063 

1064 B. Alternatives to the Significant New Use Rule. 

1065 Before proposing these amendments to the PBDE SNUR, EPA considered the following 

1066 alternative regulatory actions: 

1067 

1068 1. Promulgate a TSCA section 8(a) reporting rule. Under a TSCA section 8(a) rule, 

1069 EPA could, among other things, generally require persons to report information to the Agency 

1070 when they intend to manufacture or process a listed chemical for a specific use or any use. 

1071 However, for polybrominated diphenyl ethers the use of TSCA section 8(a) rather than SNUR 

1072 authority would have several limitations. First, if EPA was to require reporting under TSCA 

1073 section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human 

1074 and environmental hazards and exposures associated with the proposed significant new uses and, 

1075 if necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to 

1076 prohibit or limit the activity before it begins. In view of the level of health and environmental 

1077 concerns about the chemicals subject to this proposed rule, if they were used for the proposed 

1078 significant new uses, EPA believes that a TSCA section 8(a) rule for this substance would not 

1079 meet EPA's regulatory objectives. 

1080 

1081 2. Regulate under TSCA section 6. EPA may regulate under TSCA section 6 if "the 

1082 Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, 

1083 distribution in commerce, use or disposal of a chemical substance or mixture “ . . presents or will 

1084 present an unreasonable risk of injury to health or the environment." (TSCA section 6(a)). 

1085 Given that the chemicals named in this proposed rule are no longer being manufactured or 

1086 processed for the proposed significant new uses, or the activities are scheduled to be 

1087 discontinued, EPA concluded that risk management action under TSCA section 6 is not 

1088 necessary at this time. These proposed amendments to the SNUR would allow the Agency to 

1089 address the potential risks associated with the proposed significant new use. If theEPA is 

1090 proposing to require that persons who manufacture and processing of , import, or process c1091 pentaBDE or , c-octaBDE, including in articles, resumesor c-decaBDE after December 12, 2012, 
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1092 or if the manufacture and processing of decaBDE, including in articles, does not cease as 

1093 anticipated, EPA is proposing to require that persons engaging in those activities31, 2013

1094 conduct testing in accordance with the proposed test rule which accompanies these proposed 

1095 amendments to the SNUR. The data obtained through such testing will assist the Agency may 

1096 pursuein determining whether additional regulatory action asis appropriate.

1097 

1098 C. Applicability of the Significant New Use Rule to Uses Occurring beforeBegun After the 

1099 Effective DatePublication of the FinalThis Proposed Rule and Uses Begun Prior to the 

1100 Publication of this Proposed Rule.

1101 As With respect to uses that are not ongoing as of the date of publication of the 

1102 proposed rule, as discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 

1103 decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a 

1104 significant new use as of the date of publication of the proposed rule rather than as of the 

1105 effective date of the final rule. If uses begun after publication of the proposed rule were 

1106 considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice 

1107 requirements, because a person could defeat the SNUR by initiating the proposed significant new 

1108 use before the rule became final, and then argue that the use was ongoing as of the effective date 

1109 of the final rule. EPA has decided that a similar interpretation is appropriate for a SNUR that is 

1110 premised in part on all uses ceasing between proposal and promulgation of a final rule. Thus, 

1111 persons who begin commercial manufacture or processing of the chemical substance(s), or 

1112 articles containing those chemical substances that would be regulated through this proposed rule, 

1113 if finalized, would have to cease any such activity before the effective date of the rule if and 

1114 when finalized. , where such manufacture or processing was not ongoing at the time of proposal.

1115 This applies to all entities that do not currently engage in these activities; it does not apply to 

1116 entities that are currently engaged in these activities -- i.e., the entities EPA expects to terminate 

1117 such activities by the proposed significant new use dates of the SNUR. . To resume their 

1118 activities, these persons would have to comply with all applicable SNUR notice requirements 

1119 and wait until the notice review period, including all extensions, expires. EPA has promulgated 

1120 provisions (40 CFR 721.45(h)) to allow persons to comply with this SNURsubmit a SNUN

1121 before the effective date of the SNUR. If a person were to meet the conditions of advance 

1122 compliance under40 CFR section 721.45(h), that person would be considered to have met the 

1123 requirements of the final SNUR for those activities, when that final SNUR became effective. 

1124 

1125 In this action, EPA proposes to designate as significant new uses certain uses that are 

1126 ongoing as of the date of publication of the proposed rule, but for which there is a reasonable 

1127 expectation that the use will be discontinued in the near future. Such uses would not be 

1128 designated as significant new uses if they remain ongoing at the time the SNUR is finalized. 

1129 EPA’s 1990 decision (55 FR 17376) regarding uses commenced after proposal and ongoing at 

1130 the time the SNUR is finalized (i.e., that they may be designated as significant new uses, 

1131 notwithstanding the fact that they are ongoing at the time of finalization) is inapplicable to uses 

1132 that are ongoing as of the date of publication of the proposed rule.

1133 

1134 D. Test Data and Other Information

1135 EPA recognizes that TSCA section 5 generally does not require the development of any 

1136 particular test data before submission of a SNUN, however EPA is also proposing a test rule for 
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1137 c-pentaBDE, c-octaBDE, and c-decaBDE under TSCA section 4(a). If)(1)(A). Under TSCA 

1138 section 5(b)(1), if a chemical is subject to a test rule, persons submitting a significant new use 

1139 noticeSNUN are required to complysubmit test data in accordance with data submission 

1140 requirements under TSCA 5(b)(1). the test rule at the time the SNUN is submitted. In the 

1141 absence of a test rule or a section 5(b)(4) rule (see TSCA section 5(b)(2)) covering the chemical 

1142 substance, persons are required to submit test data in their possession or control and to describe 

1143 any other data known to or reasonably ascertainable by them (see section 720.50). As a general 

1144 matter, EPA recommends that SNUN submitters include data that would permit a reasoned 

1145 evaluation of risks posed by the chemical substance during its manufacture, processing, or use. 

1146 EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this 

1147 optional pre-notice consultation, EPA would discuss specific data it believes may be useful in 

1148 evaluating a significant new use. SNUNs submitted for significant new uses without any test 

1149 data may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit 

1150 or limit activities associated with this chemical. 

1151 

1152 SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that 

1153 provide detailed information on: 

1154 

1155 1. Human exposure and environmental releases that may result from the significant new 

1156 uses of the chemical substance. 

1157 2. Potential benefits of the chemical substance. 

1158 3. Information on risks posed by the chemical substances resulting from the significant new 

1159 use compared to risks posed by potential substitutes. 

1160 

1161 E. SNUN Submissions.

1162 EPA recommends that submitters consult with the Agency prior to submitting a SNUN to 

1163 discuss what data may be useful in evaluating a significant new use. Discussions with the 

1164 Agency prior to submission can afford ample time to conduct any tests that might be helpful in 

1165 evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a 

1166 SNUN must comply with the same notice requirements and EPA regulatory procedures as 

1167 persons submitting a PMN, including submission of test data on health and environmental effects 

1168 as described in 40 CFR 720.50. 

1169 

1170 According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the 

1171 same notice requirements and EPA regulatory procedures as persons submitting a PMN, 

1172 including submission of test data on health and environmental effects as described in 40 CFR 

1173 part 720.50. SNUNs must be mailed to on EPA Form No. 7710–25, generated using e-PMN 

1174 software, and submitted to the Environmental Protection Agency, OPPT Document Control 

1175 Office (7407M), 1200 Pennsylvania Avenue, NW., Washington, D.C. 20460-0001. Information 

1176 must be submitted in the form and manner in accordance with the procedures set forth in EPA 

1177 Form No. 7710-25. This form is available from the Environmental Assistance Division 

1178 (7408M), 1200 Pennsylvania Avenue, NW., Washington, D.C. 20460-0001 (see 40 CFR 721.25 

1179 and 720.40). Forms and information are also. E-PMN software is available electronically at 

1180 http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.http://www.epa.gov/opptintr/newch

1181 ems/.

1182 
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1183 VI. Proposed Test Rule 

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

1185 EPA is proposing specific testing and reporting requirements for c-pentaBDE, c1186 octaBDE, and c-decaBDE. These requirements are presented in Table 3 of this unit. 

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

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-

031

 X X X 12 

Laboratory soil toxicity and 

bioaccumulation tests with 

the lumbricid earthworm 

Eisenia fetidaand the 

enchytraeid potworm 

Enchytraeus albidu 

ASTM E 1676-04 

and ASTM E 1391-

032

 X X X 12 

Toxicity to polychaetous 

annilids of sedimentassociated contaminants 

ASTM E 1611-00 

and ASTM E 1391-

031

 X X X 12 

Laboratory soil toxicity to 

nematode Caenorhabditis 

elegans 

ASTM E 2172-01 

and ASTM E 1391-

032

 X X X 12 

Toxicity to estuarine and 

marine invertebrates of 

sediment-associated 

contaminants 

ASTM E 1367-03, 

ASTM E 1676-043

and ASTM E 1391-

031

 X X X 12 

Prenatal developmental 

toxicity in rabbits 

40 CFR 799.9370 X X X 12 
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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 X4 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 

1188 1. ASTM E 1391-03 provides guidance on the collection, storage, characterization, and manipulation of sediments 

1189 when toxicity to various organisms of sediment-associated contaminants is tested. 

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

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

1192 4. A developmental neurotoxicity study of decaBDE (Ref. 54) conducted according to OECD Guideline 426 and 

1193 sponsored by the Bromine Science and Environmental Forum (BSEF) was submitted to EPA. If EPA considers the 

1194 study to be adequately conducted and the study requirements of OECD 426 comparable to the study requirements 

1195 of 40 CFR 799.9630, EPA will most likely accept the study and not finalize the proposed requirement to conduct 

1196 developmental neurotoxicity testing of c-decaBDE. 

1197 The proposed testing requirements are listed in §40 CFR part 799.XXXX(h) and (i) of the 

1198 proposed regulatory text and include the specification of test methods covering health effects 

1199 testing, ecotoxicity testing, and chemical fate testing. EPA's TSCA 799 test guidelines (40 CFR 

1200 part 799, subpart H) and Office of Chemical Safety and Pollution Prevention (OCSPP) 835 series 

1201 guidelines have been harmonized with the OECD test guidelines. However, EPA is specifying 

1202 that the TSCA 799 test guidelines and OCSPP 835 guidelines, as well as American Society for 

1203 Testing and Materials International (ASTM International) standards, be used rather than OECD 

1204 test guidelines because the language in the TSCA 799 test guidelines, the OCSPP 835 series 

1205 guidelines, and the ASTM International standards makes clear which steps are mandatory and 

1206 which steps are only recommended. Accordingly, in order to comply with the testing required 

1207 by a final rule, EPA is proposing that testing must be conducted in accordance with the specified 
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1208 TSCA 799, OCSPP series 835, and ASTM International test guidelines. In addition, EPA is 

1209 proposing a guideline developed by the Agency to test for photolytic degradation. 

1210 Most of the proposed testing requirements for a particular endpoint are specified in one test 

1211 standard. In the case of certain endpoints, however, additional guidance is provided in a second 

1212 guideline and possibly a third guideline (e.g., ASTM E 1391-03 provides guidance in the 

1213 collection, storage, characterization, and manipulation of sediments when toxicity to various 

1214 organisms of sediment-associated contaminants is tested). The following testing endpoints and 

1215 test standards are proposed to be required for one or more of the test substances in this rule. 

1216 1. Ecotoxicity: 

1217 a. Toxicity to freshwater invertebrates of sediment-associated contaminants conducted 

1218 in accordance with ASTM E 1706-05e1 (Ref. 55) and following the guidance of ASTM E 1391-

1219 03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the toxicity to freshwater 

1220 invertebrates of the test substance when associated with whole sediments. 

1221 b. Laboratory soil toxicity and bioaccumulation tests with the lumbricid earthworm 

1222 Eisenia fetida and the enchytraeid potworm Enchytraeus albidu conducted in accordance with 

1223 ASTM E 1676-04 (Ref. 57) and following the general guidance of ASTM E 1391-03 (Ref. 56). 

1224 EPA proposes this guideline as appropriate to evaluate the adverse effects and bioaccumulation 

1225 in earthworms and potworms of the test substance when associated with soils. 

1226 c. Toxicity to polychaetous annilids of sediment-associated contaminants conducted in 

1227 accordance with ASTM E 1611-00 (Ref. 58) and following the guidance of ASTM E 1391-03 

1228 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the toxicity to polychaetous 

1229 annelids of the test substance when associated with sediment. 

1230 d. Laboratory soil toxicity to nematode Caenorhabditis elegans conducted in 

1231 accordance with ASTM E 2172-01 (Ref. 59) and following the general guidance of ASTM E 

1232 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the adverse effects on 

1233 nematodes of the test substance when associated with soils. 

1234 e. Toxicity to estuarine and marine invertebrates of sediment-associated contaminants 

1235 conducted in accordance with ASTM E 1367-03 (Ref. 60) and following the guidance of ASTM 

1236 E 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the toxicity to 

1237 estuarine or marine organisms of the test substance when associated with whole sediments. 

1238 2. Mammalian toxicity:

1239 a. Prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 

1240 799.9370. EPA proposes this guideline as appropriate to provide general information concerning 

1241 the effects of exposure to the test substance on the pregnant test animal and on the developing 

1242 organism. 

1243 b. Two-generation reproductive toxicity with a satellite group for body burden 

1244 determinations conducted in accordance with 40 CFR 799.9380. EPA proposes this guideline as 

1245 appropriate to provide general information concerning the effects of exposure to the test 
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1246 substance on the integrity and performance of the male and female reproductive systems, and on 

1247 the growth and development of the offspring. 

1248 c. Immunotoxicity conducted in accordance with 40 CFR 799.9780. EPA proposes this 

1249 guideline as appropriate to provide information on suppression of the immune system which 

1250 might occur as a result of repeated exposure to a test chemical. 

1251 d. Neurotoxicity screening battery, acute and subchronic, conducted in accordance with 

1252 40 CFR 799.9620. EPA proposes this guideline as appropriate to provide information on gross 

1253 functional deficits, level of activity, and histopathological changes in the central and peripheral 

1254 nervous systems of the test animals as a result of acute and subchronic exposure to a test 

1255 chemical. 

1256 e. Developmental neurotoxicity conducted in accordance with 40 CFR 799.9630. EPA 

1257 proposes this guideline as appropriate to develop data on the potential functional and 

1258 morphological hazards to the nervous system which may arise in the offspring from exposure of 

1259 the mother during pregnancy and lactation. 

1260 f. Chronic toxicity/Carcinogenicity conducted in accordance with 40 CFR 799.9430. 

1261 EPA proposes this guideline as appropriate to identify the majority of chronic and carcinogenic 

1262 effects and determine dose-response relationships in a mammalian species following prolonged 

1263 and repeated exposure to a test substance. 

1264 3. Chemical Fate: 

1265 a. Anaerobic aquatic metabolism conducted in accordance with OCSPP 835.4400 as 

1266 modified for c-decaBDE in section 799.XXXX(i)(2). EPA proposes this guideline as appropriate 

1267 to assess transformation of decaBDE in anaerobic aquatic sediment systems. 

1268 b. Biodegradation in anaerobic digester sludge conducted in accordance with OCSPP 

1269 835.3280 as modified for c-decaBDE in section 799.XXXX (i)(3). EPA proposes this guideline 

1270 as appropriate to assess biotransformation in anaerobic digester sludge. 

1271 c. Photolytic degradation of c-decaBDE conducted in accordance with an EPA1272 developed method in section 799.XXXX(i)(4). EPA proposes this guideline as appropriate to 

1273 assess whether PBDEs can migrate out of plastics/fabrics by volatilization; and if photolytic 

1274 degradation can take place on the surfaces of plastics and fabrics. 

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

1276 The testing requirements contained in this proposed rule are not effective until and unless 

1277 the Agency issues a final rule. If any manufacturer or processor of c-pentaBDE or, c-octaBDE , 

1278 or c-decaBDE is subject to the test rule after December 31, 20122013, the test sponsor may plan 

1279 the initiation of any required testing as appropriate to submit the required final report by the 

1280 deadline indicated as the number of months, shown in § 799.XXX(j) of the proposed regulatory 

1281 text, after December 31, 2012. If any manufacturer or processor of c-decaBDE is subject to the 

1282 test rule after Dec 31, 2012, the test sponsor need not begin testing until it is known whether 

1283 there are manufacturers or processors of c-decaBDE for military and transportation uses that will 
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1284 be subject to the test rule after December 31, 2013. The test sponsor will then know whether 

1285 there are additional persons subject to the rule after December 31, 2013, from the letters of intent 

1286 to test or exemption applications which would have to be filed by the deadline of January 30, 

1287 2014 (30days after the relevant effective date of December 31, 2013). After December 31, 2013, 

1288 all the test sponsor(s) for decaBDE may plan the testing as appropriate to submit the required 

1289 final reports by the deadlines indicated as the number of months, shown in § 799.XXXX(j) of the 

1290 final regulatory text, after December 31, 2013.

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

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

1293 Persons required to comply with the final rule would have to conduct the necessary 

1294 testing in accordance with the testing and reporting requirements established in the regulatory 

1295 text of the final rule, with 40 CFR Part 790—Procedures Governing Testing Consent 

1296 Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) of §part 790.45; §part

1297 790.48; paragraph (a)(2) and paragraph (b) of §part 790.80; paragraph (e)(1) of §part 790.82; and 

1298 §part 790.85), and with 40 CFR Part 792—Good Laboratory Practice Standards. 

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

1300 The test rule proposes that the test mixtures be the representative forms of pentaBDE1301 containing commercial mixtures, octaBDE-containing commercial mixtures, and decaBDE1302 containing commercial mixtures. To fully describe the three test mixtures, the percentage of 

1303 each of the seven congeners present in each of the three test mixtures must be identified by the 

1304 test sponsor(s). 

1305 

1306 Each of the three proposed test mixtures is described by its predominant components. C1307 pentaBDE) is a mixture predominantly comprised of pentaBDE, tetraBDE, and hexaBDE. C1308 octaBDE is a mixture predominantly comprised of octaBDE, hexaBDE, heptaBDE, and 

1309 nonaBDE. C-decaBDE is a mixture with decaBDE being present in the highest percentage. 

1310 EPA believes that the proposed testing of c-pentaBDE, c-octaBDE, and c-decaBDE will provide 

1311 EPA with data necessary to determine the effects of commercial PBDE products on human 

1312 health and the environment. EPA is seeking comment on whether testing of c-pentaBDE, c1313 octaBDE and c-decaBDE should be conducted with the pure congener or each congener in each 

1314 mixture instead of the commercial products. EPA is also seeking comment on whether its 

1315 descriptions of the commercial mixtures to be tested accurately predict what commercial forms 

1316 of pentaBDE, octaBDE, and decaBDE might be produced. Finally, EPA solicits comment on 

1317 whether more than one commercial form each of c-pentaBDE, c-octaBDE, and c-decaBDE 

1318 should be tested. 

1319 

1320 E. Would I Be Required to Test Under this Rule? 

1321 Under TSCA section 4(a)(1)(A)(ii), EPA has made preliminary findings that there are 

1322 insufficient data and experience to reasonably determine or predict health and environmental 

1323 effects resulting from the manufacture, processing, use, and distribution in commerce of the 

1324 mixtures listed in this proposed rule. As a result, under TSCA section 4(b)(3)(B), manufacturers 

1325 and processors of mixtures listed in this proposed rule, and those who intend to manufacture or 
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1326 process them, would be subject to the rule with regard to those listed mixtures which they 

1327 manufacture or process. 

1328 1. Would I be subject to this rule? You would be subject to this rule and may be required 

1329 to test if you manufacture (which is defined by statute to include import) or process, or intend to 

1330 manufacture or process, one or more mixtures listed in this proposed test rule during the time 

1331 period discussed in Unit VI.E.2. You would also be subject to this rule if you manufacture or 

1332 process the subject mixtures for export from the United States. For this rule, importers of articles 

1333 which include c-pentaBDE, c-octaBDE, or c-decaBDE would be considered manufacturers and 

1334 subject to this rule. If you do not know or cannot reasonably ascertain that you manufacture or 

1335 process a listed test rule mixture (based on all information in your possession or control, as well 

1336 as all information that a reasonable person similarly situated might be expected to possess, 

1337 control, or know, or could obtain without unreasonable burden), you would not be subject to the 

1338 rule for that listed mixtures. 

1339 2. When would my manufacture or processing (or my intent to do so) cause me to be 

1340 subject to this rule? You would be subject to this rule if you manufacture or process, or intend to 

1341 manufacture or process, a mixture listed in the rule at any time from the relevant effective date in 

1342 799.xxxx(k) of the final test rule to the end of the test data reimbursement period. The term 

1343 “reimbursement period” is defined at 40 CFR 791.3(h) and may vary in length for each mixture 

1344 to be tested under a final TSCA section 4(a) test rule, depending on what testing is required and 

1345 when testing is completed. See Unit VI.E.4. 

1346 3. Would I be required to test if I were subject to the rule? It depends on the nature of 

1347 your activities. All persons who would be subject to this TSCA section 4(a) test rule, which, 

1348 unless otherwise noted in the regulatory text, incorporates EPA’s generic procedures applicable 

1349 to TSCA section 4(a) test rules (contained within 40 CFR part 790), would fall into one of two 

1350 groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who would have to 

1351 initially comply with the final rule) would either: 

1352 • Submit to EPA letters of intent to conduct testing, conduct this testing, and submit the 

1353 test data to EPA, or 

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

1355 Persons in Tier 2 (those who would not have to initially comply with the final rule) would 

1356 not need to take any action unless they are notified by EPA that they are required to do so 

1357 (because, for example, no person in Tier 1 had submitted a letter of intent to conduct testing), as 

1358 described in Unit VI.E.3.d. Note that both persons in Tier 1 who obtain exemptions and persons 

1359 in Tier 2 would nonetheless be subject to providing reimbursement to persons who actually 

1360 conduct the testing, as described in Unit VI.E.4. 

1361 a. Who would be in Tier 1 and Tier 2? All persons who would be subject to the final rule 

1362 are considered to be in Tier 1 unless they fall within Tier 2. Table 4 of this unit describes who is 

1363 in Tier 1 and Tier 2. 

Table 4.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2

Tier 1 (Persons initially required to Tier 2 (Persons not initially required to comply) 
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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 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)). 

1364 

1365 Under 40 CFR 790.2, EPA may establish procedures applying to specific test rules that 

1366 differ from the generic procedures governing TSCA section 4(a) test rules in 40 CFR part 790. 

1367 For purposes of this proposed rule, EPA is proposing to establish certain requirements that differ 

1368 from those under 40 CFR part 790. 

1369 In this proposed test rule, EPA has configured the tiers in 40 CFR 790.42 as in certain 

1370 previous test rules. In addition to processors, manufacturers of less than 500 kg (1,100 lbs.) per 

1371 year (‘‘small-volume manufacturers’’), and manufacturers of small quantities for research and 

1372 development (‘‘R&D manufacturers’’), EPA has added the following persons to Tier 2: 

1373 Manufacturers of byproducts, manufacturers of impurities, manufacturers of naturally occurring 

1374 chemical substances, manufacturers of non-isolated intermediates, and manufacturers of 

1375 components of Class 2 chemical substances. The Agency took administrative burden and 

1376 complexity into account in determining who was to be in Tier 1 in this proposed rule. EPA 

1377 believes that those persons in Tier 1 who would conduct testing under this proposed rule, when 

1378 finalized, would generally be large chemical manufacturers who, in the experience of the 

1379 Agency, have traditionally conducted testing or participated in testing consortia under previous 

1380 TSCA section 4(a) test rules. 

1381 The Agency also believes that manufacturers of byproducts, impurities, naturally 

1382 occurring chemical substances, manufacturers of non-isolated intermediates, and manufacturers 

1383 of components of Class 2 chemical substances historically have not themselves participated in 

1384 testing or contributed to reimbursement of those persons who have conducted testing. EPA 
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1385 understands that these manufacturers may include persons for whom the marginal transaction 

1386 costs involved in negotiating and administering testing arrangements are deemed likely to raise 

1387 the expense and burden of testing to a level that is disproportional to the additional benefits of 

1388 including these persons in Tier 1. Therefore, EPA is not proposing to burden these persons with 

1389 Tier 1 requirements (e.g., submitting requests for exemptions). Nevertheless, these persons, 

1390 along with all other persons in Tier 2, would be subject to reimbursement obligations to persons 

1391 who actually conduct the testing, as described in Unit VI.E.4. 

1392 TSCA section 4(b)(3)(B) requires all manufacturers and/or processors of a mixture to test 

1393 that mixture if EPA has made findings under TSCA sections 4(a)(1)(A)(ii) or 4(a)(1)(B)(ii) for 

1394 that mixture, and issued a TSCA section 4(a) test rule requiring testing. However, practicality 

1395 must be a factor in determining who is subject to a particular test rule. Thus, persons who do not 

1396 know or cannot reasonably ascertain that they are manufacturing or processing a mixture subject 

1397 to this proposed rule, e.g., manufacturers or processors of a mixture as a trace contaminant who 

1398 are not aware of or cannot reasonably ascertain these activities, would not be subject to the rule. 

1399 See Unit VI.E.1.and §79940 CFR part799.XXXX(b)(2) of the proposed regulatory text. 

1400 EPA believes it is possible that there will be no persons in Tiers 1 and 2A that will be 

1401 subject to the test rule. If EPA learns that the only persons that would be subject to the rule 

1402 would be persons that process c-pentaBDE, c-octaBDE, or c-decaBDE as impurities contained in 

1403 articles, EPA will not require testing because EPA has not determined whether this activity alone 

1404 may present an unreasonable risk of injury to health or the environment. EPA is seeking 

1405 comment on whether the Agency should address persons who manufacture or process PBDEs as 

1406 impurities whether or not they are contained in articles, and whether such persons should be 

1407 required to conduct testing. 

1408 

1409 b. Subdivision of Tier 2 entities. The Agency is proposing to prioritize which persons in 

1410 Tier 2 would be required to perform testing, if needed. Specifically, the Agency is proposing 

1411 that Tier 2 entities be subdivided into: 

1412 i. Tier 2A–manufacturers, i.e., those who manufacture, or intend to manufacture, a test 

1413 rule chemical substance including in articles solely as one or more of the following: A 

1414 byproduct, an impurity, a naturally occurring chemical substance, a non-isolated intermediate, a 

1415 component of a Class 2 chemical substance, in amounts less than 1,100 lbs. annually, or in small 

1416 quantities solely for research and development. 

1417 ii. Tier 2B–processors, i.e., those who process, or intend to process, a test rule mixture in 

1418 any form including in articles. The terms ‘‘process’’ and ‘‘processor’’ are defined by TSCA 

1419 sections 3(10) and 3(11), respectively. 

1420 If the Agency needs testing from persons in Tier 2, EPA would seek testing from persons 

1421 in Tier 2A before proceeding to Tier 2B. It is appropriate to require manufacturers in Tier 2A to 

1422 submit letters of intent to test or exemption applications before processors are called upon 

1423 because the Agency believes that testing costs are traditionally passed along by manufacturers to 

1424 processors, enabling them to share in the costs of testing (Ref. 61). In addition, ‘‘[t]here are 

1425 [typically] so many processors [of a given test rule chemical] that it would be difficult to include 

1426 them all in the technical decisions about the tests and in the financial decisions about how to 

1427 allocate the costs’’ (Ref. 62, 48 FR 31786, July 11, 1983). 
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1428 c. When would it be appropriate for a person who would be required to comply with the 

1429 rule to apply for an exemption rather than to submit a letter of intent to conduct testing? You 

1430 may apply for an exemption if you believe that the required testing will be performed by another 

1431 person (or a consortium of persons formed under TSCA section 4(b)(3)(A)). You can find 

1432 procedures relating to exemptions in 40 CFR 790.80 through 790.99, and §part

1433 799.XXXX(c)(2), (c)(5), (c)(7), and (c)(11) of the proposed regulatory text. In this proposed 

1434 rule, EPA would not require the submission of equivalence data (i.e., data demonstrating that 

1435 your chemical substance or mixture is equivalent to the chemical substance or mixture actually 

1436 being tested) as a condition for approval of your exemption. Therefore, 40 CFR 790.82(e)(1) 

1437 and 40 CFR 790.85 would not apply to this proposed rule. 

1438 d. What would happen if I submitted an exemption application? EPA believes that 

1439 requiring the collection of duplicative data is unnecessarily burdensome. As a result, if EPA has 

1440 received a letter of intent to test from another source or has received (or expects to receive) the 

1441 test data that would be required under this rule, the Agency would conditionally approve your 

1442 exemption application under 40 CFR 790.87. 

1443 The Agency would terminate conditional exemptions if a problem occurs with the 

1444 initiation, conduct, or completion of the required testing, or with the submission of the required 

1445 data to EPA. EPA may then require you to submit a notice of intent to test or an exemption 

1446 application. See 40 CFR part 790.93 and §part 799.XXXX(c)(8) of the proposed regulatory text. 

1447 In addition, the Agency would terminate a conditional exemption if no letter of intent to test has 

1448 been received by persons required to comply with the rule. See, e.g., §part 799.XXXX(c)(6) of 

1449 the proposed regulatory text. Note that the provisions at 40 CFR 790.48(b) have been 

1450 incorporated into the regulatory text of this proposed rule; thus, persons subject to this rule are 

1451 not required to comply with 40 CFR 790.48 itself (see §part 799.XXXX(c)(4) through (c)(7) and 

1452 §part 799.XXXX(d)(3) of the proposed regulatory text). Persons who obtain exemptions or 

1453 receive automatic conditional exemptions would nonetheless be subject to providing 

1454 reimbursement to persons who do actually conduct the testing, as described in Unit VI.E.4. 

1455 e. What would my obligations be if I were in Tier 2? If you are in Tier 2, you would be 

1456 subject to the rule and you would be responsible for providing reimbursement to persons in Tier 

1457 1, as described in Unit VI.E.4. There is no difference whether you are in Tier 2A or Tier 2B as 

1458 regards reimbursement. EPA is not aware of any circumstances in which test rule Tier 1 entities 

1459 have sought reimbursement from Tier 2 entities either through private agreements or by 

1460 soliciting the involvement of the Agency under the reimbursement regulations at 40 CFR part 

1461 791. 

1462 Concerning testing, if you are in Tier 2, you are considered to have an automatic 

1463 conditional exemption. You would not need to submit a letter of intent to test or an exemption 

1464 application unless you are notified by EPA that you are required to do so. As previously noted, 

1465 Tier 2A manufacturers would be notified to test before Tier 2B processors (Unit VI.E.3.ii.). 

1466 If a problem occurs with the initiation, conduct, or completion of the required testing, or 

1467 with the submission of the required data to EPA, the Agency may require you to submit a notice 

1468 of intent to test or submit an exemption application. See 40 CFR part 790.93 and §part

1469 799.XXXX(c)(10) of the proposed regulatory text. 
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1470 In addition, you would need to submit a notice of intent to test or an exemption 

1471 application if: 

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

1473 • EPA has published a Federal Register document directing persons in Tier 2 to submit 

1474 to EPA letters of intent to conduct testing or exemption applications. See § 799.XXXX(c)(4), 

1475 (c)(5), (c)(6), and (c)(7) of the proposed regulatory text. The Agency would conditionally 

1476 approve an exemption application under 40 CFR 790.87, if EPA has received a letter of intent to 

1477 test or has received (or expects to receive) the test data required under this rule. 

1478 f. What would happen if no one submitted a letter of intent to conduct testing? EPA 

1479 anticipates that, if there were manufacturers or processors of those chemical substances subject 

1480 to the final rule, it would receive letters of intent to conduct testing for all of the tests specified 

1481 for each mixture from one of those persons. However, in the event it does not receive a letter of 

1482 intent for one or more of the tests required by the final rule for any of the mixtures in the final 

1483 rule within 30 days after the publication of a Federal Register document notifying Tier 2 

1484 processors of the obligation to submit a letter of intent to conduct testing or to apply for an 

1485 exemption from testing, EPA would notify all manufacturers and processors of the mixture of 

1486 this fact by certified letter or by publishing a Federal Register document specifying the test(s) 

1487 for which no letter of intent has been submitted. This letter or Federal Register document 

1488 would additionally notify all manufacturers and processors that all exemption applications 

1489 concerning the test(s) have been denied, and would give them an opportunity to take corrective 

1490 action. If no one has notified EPA of its intent to conduct the required testing of the mixture 

1491 within 30 days after receipt of the certified letter or publication of the Federal Register

1492 document, all manufacturers and processors subject to the final rule with respect to that mixture 

1493 who are not already in violation of the final rule would be in violation of the final rule. 

1494 4. How do the reimbursement procedures work? In the past, persons subject to test 

1495 rules have independently worked out among themselves their respective financial contributions 

1496 to those persons who have actually conducted the testing. However, if persons are unable to 

1497 agree privately on reimbursement, they may take advantage of EPA’s reimbursement procedures 

1498 at 40 CFR part 791, promulgated under the authority of TSCA section 4(a). These procedures 

1499 include: The opportunity for a hearing with the American Arbitration Association; publication 

1500 by EPA of a document in the Federal Register concerning the request for a hearing; and the 

1501 appointment of a hearing officer to propose an order for fair and equitable reimbursement. The 

1502 hearing officer may base his or her proposed order on the production volume formula set out at 

1503 40 CFR 791.48, but is not obligated to do so. The hearing officer’s proposed order may become 

1504 the Agency’s final order, which is reviewable in Federal court (40 CFR 791.60). Under this 

1505 proposed rule, for the purpose of determining fair reimbursement shares if the hearing officer 

1506 chooses to use a formula based on production volume, the total production volume will include 

1507 amounts of a mixture produced as an impurity and amounts imported in articles. 

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

1509 If you were required to test, you would be required to submit a final report for a specific 

1510 test by the deadline indicated in Table 3 in Unit VI.A of this preamble as the number of months 

1511 after the relevant effective date of the final rule; this deadline is also shown in §part
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1512 799.XXXX(j) of the proposed regulatory text. 

1513 EPA is also proposing that a robust summary of the final report for each specific test be 

1514 required to be submitted electronically in addition to and at the same time as the final report. 

1515 The term “robust summary” is used to describe the technical information necessary to adequately 

1516 describe an experiment or study and includes the objectives, methods, results, and conclusions of 

1517 the full study report which can be either an experiment or in some cases an estimation or 

1518 prediction method. Guidance for the compilation of robust summaries is described in a 

1519 document entitled “Draft Guidance on Developing Robust Summaries” (Ref. 63). 

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

1521 A person who submits a letter of intent to test under the final rule and who subsequently 

1522 anticipates difficulties in completing the testing by the deadline set forth in the final rule may 

1523 submit a modification request to the Agency, pursuant to 40 CFR 790.55. EPA will determine 

1524 whether modification of the test schedule is appropriate, and may first seek public comment on 

1525 the modification. 

1526 H. Would There be Sufficient Test Facilities and Personnel to Undertake the Testing Proposed 

1527 Under this Test Rule? 

1528 EPA’s most recent analysis of laboratory capacity (Ref. 64) indicates that available test 

1529 facilities and personnel would adequately accommodate the testing proposed in this rule. 

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

1531 If EPA determines that it needs additional data regarding any of the chemical substances 

1532 included in this proposed rule, the Agency would seek further health and/or environmental 

1533 effects testing for these mixtures. Should the Agency decide to seek such additional testing via a 

1534 test rule, EPA would initiate a separate action for this purpose. 

1535 VII. Export Notification 

1536 A. SNUR 

1537 Any person who exports, or intends to export decaBDE on or after [insert date 30 days 

1538 after the date of publication in the Federal Register]will be subject to the export notification 

1539 requirements in TSCA section 12(b)(2) (15 U.S.C. 2611(b))and at 40 CFR part 707, subpart D

1540 when the rule is proposed. Any person who exports, or intends to export, tetraBDE, pentaBDE, 

1541 hexaBDE, heptaBDE, octaBDE, and nonaBDE became subject to those requirements with the 

1542 proposal of the SNUR in 2004 (Ref. 7). Export notification is generally not required for articles 

1543 under a SNUR, as provided by 40 CFR 707.60(b), and for theseThis proposed amendments to the 

1544 SNUR,rulemaking would not affect the article exemption forat 40 CFR 707.60(b) for notices of

1545 export notification would apply.under section 12(b). Persons who export PBDEs contained in 

1546 articles would not be required to submit a notice of export respecting such PBDEs. 

1547 

1548 B. Test Rule

1549 Any person who exports, or intends to export, one of the mixtures contained in this 
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1550 proposed test rule would be subject to the export notification requirements in TSCA section 

1551 12(b)(1) (15 U.S.C. 2611(b)) and at 40 CFR part 707, subpart D, but only after the final rule is 

1552 promulgated and only if the mixture is contained in the final rule. Export notification This 

1553 proposed rulemaking would not be required affect the article exemption at 40 CFR 707.60(b) for 

1554 notices of export under section 12(b). Persons who export PBDE mixtures contained in articles 

1555 under the proposed test rule.would not be required to submit a notice of export respecting such 

1556 mixtures. 

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

1558 The Agency believes that production and processing of all PBDEs, including in articles, 

1559 will have ceased in the United States by the end of 2013 but if there are any ongoing uses they 

1560 would not be subject to a final SNUR. The purpose of the proposed SNUR is to designate new 

1561 and discontinued uses as significant new uses and to ensure that the Agency has an opportunity 

1562 to review and, if necessary, take action to restrict or prohibit significant new uses of PBDEs, 

1563 including in articles, before they resume. The purpose of the proposed test rule is to provide 

1564 EPA with data necessary to determine the effects on health and the environment if the 

1565 manufacture and processing of commercial PBDEs and the associated use, distribution in 

1566 commerce and disposal are not discontinued. The Agency believes that the above objectives will 

1567 be adequately met with respect to articles by making article exemptions for SNURs and test rules 

1568 inapplicable for this action. The Agency considered including provisions in the proposed SNUR 

1569 and test rule requiring that the PBDEs contained in articles be subject to section 12(b) export 

1570 notification requirements. However, the Agency does not believe that making exporters of 

1571 PBDEs contained in articles subject to section 12(b) export notification requirements would 

1572 significantly increase the effectiveness of this proposed rulemaking. The Agency is concerned 

1573 that the potential burdens associated with administration and compliance with export notification 

1574 requirements for PBDEs contained in articles could be significant. In view of the expected costs 

1575 the Agency decided that PBDEs contained in articles should continue to be exempt from export 

1576 notification requirements. The Agency is seeking comment on the need for (and the cost of)

1577 making PBDEs contained in articles subject to export notification requirements. 

1578 VIII. Import Certification 

1579 A. SNUR 

1580 

1581 Persons who import a chemical substance identified in bulk or as part of a final 

1582 SNURmixture are subject to the TSCA section 13 (15 U.S.C. 2612) import requirements, 

1583 codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such persons must certify 

1584 that the shipment of the chemical substance complies with all applicable rules and orders under 

1585 TSCA, including any SNUR requirements. Chemical substances This rulemaking would not 

1586 affect the exemption from import certification under section 13(b) for chemicals contained in 

1587 articles are exempt from import certification.. Persons who import PBDEs contained in articles 

1588 would not be subject to import certification requirements. PBDEs imported in bulk or as part of 

1589 a mixture would continue to be subject to import certification requirements under section 13(b), 

1590 consistent with 19 CFR 12.120(b). The EPA policy in support of import certification appears at 

1591 40 CFR part 707, subpart B. For additional guidance, please refer to EPA’s TSCA Import 

1592 Compliance Checklist (http://www.epa.gov/oppt/import-export/pubs/checklist.pdf) 

1593 
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1594 B. Test Rule

1595 

1596 Section 13 import certification requirements do not pertain to Section 4 test rules.

1597 Although importers must satisfy all applicable requirements of Sections 4, compliance with those 

1598 provisions is not related to individual chemical shipments and therefore does not affect import 

1599 certification. 

1600 

1601 C. Should Articles Containing PBDEs Be Exempt From Import Certification Requirements?

1602 The Agency believes that manufacture, including import, and processing of all PBDEs, 

1603 including in articles, will have ceased in the United States by the end of 2013. The purpose of 

1604 the proposed SNUR is to designate new and discontinued uses as significant new uses and to 

1605 ensure that the Agency has an opportunity to review and, if necessary, take action to restrict or 

1606 prohibit significant new uses of PBDEs, including in articles, before they resume. The Agency 

1607 believes that the above objective will be adequately met with respect to articles by making the 

1608 article exemption for SNURs inapplicable for this action. The Agency does not believe that 

1609 making importers of PBDEs contained in articles subject to section 13 import certification 

1610 requirements would significantly increase the effectiveness of this proposed rulemaking.

1611 

1612 The Agency considered including provisions in the proposed SNUR requiring that the 

1613 PBDEs contained in articles be subject to section 13 import certification requirements. 

1614 However, the Agency is concerned that the potential burdens associated with administration and 

1615 compliance with import certification requirements could be significant. The Agency decided 

1616 that PBDEs contained in articles should continue to be exempt from import certification 

1617 requirements. The Agency is seeking comment on the need for (and the cost of) making PBDEs 

1618 contained in articles subject to import certification requirements. 

1619 

1620 IX. The Dates that the SNUR, Proposed Amended SNUR, and Proposed Test Rule 

1621 Requirements Apply to the Seven PBDEs and the Three Commercial Mixtures

1622 

1623 The SNUR that became effective on August 14, 2006, requires that persons that intend to 

1624 manufacture, including import, any of six PBDEs (tetraBDE, pentaBDE, hexaBDE, heptaBDE, 

1625 octaBDE, and nonaBDE) for any use after January 1, 2005, submit a SNUN to EPA at least 90 

1626 days in advance. Processing of the PBDEs was not designated as a significant new use because 

1627 EPA believed that it was an ongoing activity at the time the rule was proposed. Articles were 

1628 exempt from that SNUR. EPA now believes that all import and processing of these six PBDEs 

1629 for any use including as part of an articleand import of articles containing them have been 

1630 discontinued. These proposed amendments to the SNUR would designate processing for any use 

1631 after December 31, 20122013, a significant new use. The proposed amended SNUR would also 

1632 make inapplicable the article exemption at 40 CFR 721.45(f). Therefore, a person who intends 

1633 to import or process any of the six PBDEs as part of an article after December 31, 20122013, 

1634 would not be exempt from submitting a significant new use notice. EPA will promulgate the 

1635 amended SNUR after it has verified that the proposed significant new uses have been 

1636 discontinued. For a discussion of applicability of the significant new use rule to uses begun after 

1637 the publication of this proposed rule see Unit V.C.

1638 

1639 Any person who manufactures or processes or intends to manufacture or process c-
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1640 pentaBDE, c-octaBDE, or c-decaBDE after the relevant proposed effective datesDecember 31, 

1641 2013 would be subject to the test rule. For a discussion of applicability of the significant new 

1642 use rule to uses occurring before the effective date of the final rule see Unit V.C.

1643 

1644 On December 2009, the principal manufacturers and importer of decaBDE announced 

1645 their intent to phase out their activities with decaBDE and committed to do so by December 31, 

1646 2012 for all uses, except military and transportation, and by December 31, 2013, for all uses 

1647 including military and transportation, with possibly an additional 6 months to sell remaining 

1648 inventory of decaBDE. (Refs. 68 – 70). The Agency does not believe that manufacturers would 

1649 need additional time to sell remaining inventory or that processors would require any additional 

1650 time to use existing stocks, and has not proposed any additional time in this action. EPA is 

1651 seeking comment on this in Unit XI.A.2. 

1652 

1653 With this Proposed SNUR-Test Ruleaction, EPA is also proposing to amend the 2006 

1654 PBDE SNUR , after December 31, 2013, by designating manufacture and processing of 

1655 decaBDE for any use except military and transportation useswhich is not ongoing, including in 

1656 articles after December 31, 2012, and , as a significant new use. Persons that intend to 

1657 manufacture and processing ofor process decaBDE for all uses including military and 

1658 transportation uses, including in articles after December 31, 2013,a significant new uses thatuse

1659 would require the submission ofbe required to submit a SNUN to EPA at least 90 days before 

1660 commencing such activity. 

1661 

1662 If EPA determined that any persons engage in such activities with person intends to 

1663 manufacture or process c-pentaBDE c-octa BDE or c-decaBDE for any use after the relevant 

1664 significant new use datesDecember 31, 2013, EPA would promulgate the test rule and they 

1665 would be subject to the test rule requirements. 

1666 

1667 Table 5 presents the date when the requirements of the existing SNUR applied to 

1668 activities with certain PBDEs and the dates when the requirements of the proposed amendments 

1669 to the SNUR and test rule, if promulgated, would apply to the manufacture and processing of the 

1670 seven PBDEs depending on whether those activities are ongoing or have ceased. 

1671 

1672 

1673 Table 5: The Date SNUR, Amended SNUR, or Test Rule Requirements Apply to the 

1674 Seven PBDEs and the Three Commercial Mixtures

1675 

PBDE On or After 

Jan 1, 2005

After Dec 31, 2012 After Dec 31, 2013

SNUR applies 

to nonongoing:

Amended 

SNUR would 

apply to nonongoing:

Test Rule 

would apply 

to ongoing:

Amended 

SNUR 

would apply 

to nonongoing:

Test Rule 

would apply 

to ongoing:
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tetraBDE

hexaBDE

heptaBDE

nonaBDE

pentaBDE

octaBDE

Manufacture 

for any use.

Processing 

for any use. 

Manufacture 

and 

processing 

including in 

articles for 

any use.

decaBDE Manufacture 

and 

processing 

for any use, 

except 

military and 

transportation 

uses, 

including in 

articles.

Manufacture 

and 

processing 

for any use, 

including 

military and 

transportation 

uses, 

including in 

articles.

cpentaBDE 

and coctaBDE

Manufacture 

and 

processing 

for any use 

including in 

articles.

cdecaBDEManufacture 

and 

processing 

for any use, 

except 

military and 

transportation 

uses, 

including in 

articles.

Manufacture 

and 

processing 

for any use, 

including 

military and 

transportation 

uses, 

including in 

articles.

1676 

1677 

1678 X. Economic Considerations

1679 

1680 A. SNUR

1681 

1682 The proposed amendment to the SNUR would require persons intending to engage in 

1683 significant new use to submit a Significant New Use Notice (SNUN), incurring an estimated 

1684 submission cost of $8,143 per chemical, plus other costs (Ref. 72). In addition to the firms that 

1685 make a SNUN submission, the proposed amendments to the SNUR may also impact firms that 

1686 do not make a submission. By avoiding a significant new use, a firm can avoid submission and 

1687 testing costs but may incur other compliance costs. The firm may also incur “hidden” costs; for 

1688 example, it could forego profitable opportunities to use the chemical in an application that would 
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1689 be a significant new use or limit production volume to avoid a significant new use. Costs are 

1690 estimated at the firm level and reflect the burden of a SNUR on the firms that make a 

1691 submission. The hidden costs to the firms that do not make a submission are not quantified. 

1692 EPA receives only a handful of SNUNs per year due to SNURs. However, the number of firms 

1693 affected by not making submissions to EPA is not known; therefore, costs are not aggregated 

1694 across the affected entities. 

1695 

1696 B. Test Rule 

1697 EPA has prepared an economic assessment entitled Economic Impact Analysis for the 

1698 Proposed Section 4 Test Rule for c-Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and 

1699 c-Decabromodiphenyl Ether (Ref. 73), a copy of which has been placed in the docket for this 

1700 rulemaking. The economic analysis evaluates the costs associated with the testing that would be 

1701 required by a final test rule. The analysis looks at costs due to testing all three mixtures and to 

1702 each mixture separately. The total costs to industry of compliance, including testing and 

1703 administrative costs, for all three mixtures are estimated under the low- and high-cost scenarios 

1704 to be $9.68 million and $15.1 million, respectively. The testing cost (not including 

1705 administrative costs) to comply with the test rule requirements for c-pentaBDE or c-octaBDE 

1706 under the low- and high-cost scenarios would be $2.8 million and $4.7 million, respectively. 

1707 The testing cost (not including administrative costs) to comply with the test rule requirements for 

1708 c-decaBDE under the low- and high-cost scenarios would be $1.8 million and $2.5 million, 

1709 respectively. (Ref. 73) These costs would only be incurred if there were entities that 

1710 manufacture or process c-pentaBDE, c-octaBDE, or c-decaBDE, including in articles, after the 

1711 relevant dates specified in the proposed test rule in §799.xxxx(k) of December 31, 2012 and 

1712 December 31, 2013effective date of the test rule. 

1713 

1714 Currently, there are no known entities that manufacture or process c-pentaBDE or c1715 octaBDE in the United States except as impurities, so an economic impact analysis could not be 

1716 done for these two chemicals. 

1717 

1718 EPA has identified six ultimate parent companies that manufacture or import c-decaBDE 

1719 in the United States. The total annualized compliance costs for decaBDE are estimated to be, 

1720 under low- and high-cost scenarios, $264,582 and $360,218, respectively. To evaluate the 

1721 potential for an adverse economic impact of testing on manufacturers and importers of c1722 decaBDE, EPA employed an initial screening approach that estimated the impact of testing 

1723 requirements as a percentage of c-decaBDE’s sale price. This measure compares annual 

1724 revenues from the sale of a mixture to the annualized compliance cost for that mixture to assess 

1725 the percentage of testing costs that can be accommodated by the revenue stream generated by 

1726 that mixture over a number of years. Compliance costs include costs of testing and 

1727 administering the testing, as well as reporting costs. In addition, they include the estimated cost 

1728 of the TSCA section 12(b) export notification requirements, which, under the final rule, would 

1729 be required for the first export to a particular country of a mixture subject to the rule, estimated 

1730 to range from $26.86 per notice to $85.70 per notice (Ref. 72). These export notification 

1731 requirements (included in the total and annualized cost estimates) that would be triggered by the 

1732 final rule are expected to have a negligible impact on exporters. 

1733 

1734 Annualized compliance costs divide testing expenditures into an equivalent, constant 
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1735 yearly expenditure over a longer period of time. To calculate the percent price impact, testing 

1736 costs (including laboratory and administrative expenditures) are annualized over 15 years using a 

1737 7% discount rate. These annualized testing costs are then divided by the estimated annual 

1738 revenue of the mixture to derive a cost-to-sales ratio. 

1739 

1740 For five companies manufacturing or importing c-decaBDE, the cost-to-sales ratios is 3 

1741 percent or less. One company was identified as a small business by TSCA’s employment-based 

1742 definition and has a cost-to-sales ratio greater than 3 percent. Mixtures for which the price 

1743 impact is expected to exceed 1% of the revenue from that chemical have a higher potential for 

1744 adverse economic impact. However, EPA also compared the annualized cost of testing c1745 decaBDE to company revenue because, in some cases, companies may choose to use revenue 

1746 sources other than the profits from the individual mixture to pay for testing. EPA estimates that 

1747 the costs of testing will exceed 1% of company revenue for only one of the affected companies, 

1748 i.e., the company identified as a small business. 

1749 

1750 While processors are legally subject to this test rule if they process c-decaBDE after 

1751 December 31, 20122013, processors of c-decaBDE would be required to comply with the 

1752 requirements of the rule only if they are directed to do so by EPA as described in 

1753 §799.XXXX(c)(6) and (c)(8) of the proposed regulatory text. EPA would only require 

1754 processors to test if no subject person in Tier 1 or Tier 2A has submitted a notice of its intent to 

1755 conduct testing, or if under 40 CFR 790.93, a problem occurs with the initiation, conduct, or 

1756 completion of the required testing or the submission of the required data to EPA. Because 

1757 processors would not need to comply with the proposed rule initially if there are persons in Tiers 

1758 1 or 2A subject to the rule, the economic assessment does not address processors. 

1759 

1760 The benefits resulting from this proposed test rule are discussed qualitatively in 

1761 Economic Impact Analysis for the Proposed Section 4 Test rule for c-Pentabromodiphenyl Ether, 

1762 c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether (Ref. 73). EPA believes the major 

1763 benefits of the test rule will be the development of hazard information on these chemicals and the 

1764 use of this information by the public, industry, and government. 

1765 

1766 XI. Request for Public Comment 

1767 A. Solicitation of Comments on the proposed amendments to the SNUR. 

1768 

1769 (1) EPA welcomes comments on any aspect of the proposed amendments to the SNUR, but is 

1770 especially interested in comments regarding the designation of a new use of decaBDE as 

1771 (1)possibility that manufacture and processing of decaBDE for any use except military and 

1772 transportationsome uses including in articles after December 31, 2012, and (2) manufacture and 

1773 processing of decaBDE for any use including military and transportation uses, including in 

1774 articlesof decaBDE may continue after December 31, 2013. The Agency seeks information on 

1775 such uses.

1776 

1777 (2) EPA is projecting c-decaBDE will no longer be available and that processors will discontinue 

1778 their activities by December 31, 2013. Should EPA assume that processors will continue their 

1779 activities beyond that date? For example, should EPA assume that processors will continue their 
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1780 activities for six months after manufacture of decaBDE ceases? Should EPA designate 

1781 processing of decaBDE after June 30, 2014, or some other date, a significant new use? 

1782 

1783 (3) EPA welcomes comments on the designation of a significant new use of tetraBDE, 

1784 pentaBDE, hexaBDE, heptaBDE, octaBDE, and nonaBDE as manufacture and processing for 

1785 any use including in articles after December 31, 20122013. 

1786 

1787 (4) In this action, EPA is proposing to make inapplicable the article exemption for SNURs at 40 

1788 CFR part 721.45(f). A person who intends to process a chemical substance identified in this 

1789 section as part of an article, other than as an impurity, would not be exempt from submitting a 

1790 significant new use notice. EPA welcomes comment on this proposed course of action. 

1791 

1792 (5) EPA requests comment on when to finalize the proposed amendments to the SNUR. Should 

1793 they be finalized before or after the phase-out dates of decaBDE? 

1794 

1795 (6) EPA requests comment on whether the proposed significant new uses are still ongoing and 

1796 will still be ongoing on the relevant dates of December 31, 2012 andafter December 31, 2013. 

1797 

1798 B. Solicitation of Comments on the Proposed Test Rule. 

1799 (1) EPA is soliciting comment regarding additional information pertaining to potential exposure 

1800 of the general population, consumers, and workers to c-pentaBDE, c-octaBDE, and c-decaBDE. 

1801 Also, the Agency solicits comment regarding additional information pertaining to environmental 

1802 releases of any of these three PBDE mixtures. 

1803 (2) EPA is soliciting comments which identify existing studies that may satisfy the data needs 

1804 identified in the proposed test rule. To the extent that data relevant to the testing specified in this 

1805 proposed rule are known to exist, EPA strongly encourages the submission of this information as 

1806 comments to the proposed rule. Such data submitted to EPA must be in the form of full copies of 

1807 unpublished studies or full citations of published studies, and accompanied by a robust summary 

1808 (Ref. 63). To the extent that studies proposed in this action are currently available, and the data 

1809 are judged sufficient by EPA, testing for the endpoint/mixture combination will not be required 

1810 in a final test rule. 

1811 (3) EPA is soliciting comment on what test substances should be required for pentaBDE, 

1812 octaBDE, and decaBDE. EPA is proposing that the test substances be the representative 

1813 commercial forms with the percent congener composition identified by the test sponsor(s). 

1814 Instead, should the test substances be the 99% pure pentaBDE, octaBDE, and decaBDE with an 

1815 isomer composition identified for each?

1816 (4) EPA is soliciting comment on whether a purity level of 99% or greater can be attained for 

1817 pentaBDE, octaBDE, and decaBDE. 

1818 (5) EPA is soliciting comment on whether the descriptions in section 799.XXXX(a) of the 

1819 commercial mixtures to be tested adequately encompass the range of commercial forms of 

1820 pentaBDE, octaBDE, and decaBDE that might be produced. 

1821 

1822 (6) EPA is soliciting comment on whether, for the purpose of the testing proposed in this action, 
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1823 a single commercial form each of pentaBDE, octaBDE, and decaBDE can be representative of 

1824 the possible variations of those commercial mixtures. If not, should more than one commercial 

1825 form each of pentaBDE, octaBDE, and decaBDE be tested? How should those forms be 

1826 determined? 

1827 

1828 (7) EPA is soliciting comment on whether testing should be required of tetraBDE, pentaBDE, 

1829 hexaBDE, heptaBDE, octaBDE, nonaBDE, and decaBDE comparable to that proposed for c1830 pentaBDE, c-octaBDE, and c-decaBDE if they are present in commercial PBDE products. 

1831 (8) EPA is also soliciting comment on the proposed test methods, the proposed requirement for 

1832 submission of robust summaries, the proposed deadlines to submit final reports, and the 

1833 economic impact analysis detailing the burdens and costs that would result from complying with 

1834 a final test rule. 

1835 (9) The Agency invites comment on the potential use of voluntary consensus standards in the 

1836 proposed test rule, and, specifically, invites the public to identify potentially applicable 

1837 consensus standard(s) and to explain why such standard(s) should be used here. 

1838 (10) EPA is interested in receiving comments on whether the Agency should consider 

1839 establishing an alternate definition for small business to use in the small entity impact analyses 

1840 for future TSCA section 4(a) test rules, and what size cutoff may be appropriate. 

1841 

1842 (11) EPA is soliciting comment on whether, in a future rulemaking, persons who manufacture or 

1843 process c-PBDEs contained in articles as impurities should be required to conduct testing. EPA 

1844 also solicits comment on whether persons who manufacture or process c-PBDEs as impurities 

1845 not contained in articles should be required to test. 

1846 

1847 XII. References 

1848 As indicated under ADDRESSES, a docket has been established for this rulemaking 

1849 under docket ID number EPA–HQ–OPPT–2009–03572010-1039. The following is a listing of 

1850 the documents that have been placed in the docket for this rulemaking. The docket includes 

1851 information considered by EPA in developing this proposed rule, including the documents listed 

1852 in this unit, which are physically located in the docket. In addition, interested parties should 

1853 consult documents that are referenced in the documents that EPA has placed in the docket, 

1854 regardless of whether these referenced documents are physically located in the docket. For 

1855 assistance in locating documents that are referenced in documents that EPA has placed in the 

1856 docket, but that are not physically located in the docket, please consult either technical person 

1857 listed under FOR FURTHER INFORMATION CONTACT. The docket is available for 

1858 review as specified under ADDRESSES. 

1859 1. EPA. Significant New Use Rule for Certain Polybrominated Diphenylethers. 40 CFR 

1860 721.10000. 

1861 2. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy. Notice. Federal Register 

1862 (58 FR 28736 at 28738–28739, May 14, 1993). 

1863 3. EPA, 2008a. Toxicological Review of 2,2',4,4' -Tetrabromodiphenyl Ether (BDE-47), 
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1864 EPA/635/R-07/005F, June 2008. 

1865 4. EPA, 2008b. Toxicological Review of 2,2',4,4',5-Pentabromodiphenyl Ether (BDE1866 99), EPA/635/R-07/006F, June 2008. 

1867 5. EPA, 2008c. Toxicological Review of 2,2',4,4',5,5’-Hexabromodiphenyl Ether (BDE1868 153), EPA/635/R-07/007F, June 2008. 

1869 6. EPA, 2008d. Toxicological Review of Decabromodiphenyl Ether (BDE-209), 

1870 EPA/635/R-07/008F, June 2008. 

1871 7. EPA. Certain Polybrominated Diphenyl Ethers; Proposed Significant New Use Rule. 

1872 69 FR70404, December 6, 2004. 

1873 8. Arkoosh MR, Boylen D, Dietrich J, Anulacion BF, Ylitalo G, Bravo CF, Johnson LL, 

1874 Loge FJ, Collier TK, Disease susceptibility of salmon exposed to polybrominated diphenyl 

1875 ethers (PBDEs). Aquatic Toxicology 98(1): 51-59. (2010) 

1876 

1877 9. McKernan MA, Rattner BA, et al. Toxicity of Polybrominated Diphenyl Ethers (De1878 71) In Chicken (Gallus gallus), Mallard (Anas platyrhynchos), and American Kestrel (Falco 

1879 sparverius) Embryos and Hatchlings. Environmental Toxicology and Chemistry 28(5):1007-

1880 1017. 2009. 

1881 10. Fernie KJ, Mayne G, Shutt LJ, Pekarick C, Grasman KA, Letcher RJ, Drouillard KG. 

1882 Evidence of immunomodulation in nestling American kestrels (Falco sparverius) exposed to 

1883 environmentally relevant PBDEs. Environmental Pollution. 138:485-493. 2005a. 

1884 11. Fernie KJ, Shutt LJ, Mayne G, Hoffman DJ, Letcher RJ, Drouillard KG, Richie IJ. 

1885 Exposure to polybrominated diphenyl ethers (PBDEs): Changes in thyroid, vitamin A, 

1886 glutathione homeostasis, and oxidative stress in American kestrels (Falco sparverius). 

1887 Toxicological Sciences. 88:375-383. 2005b. 

1888 12. Fernie K, Shutt L, et al. The effects of exposure to polybrominated diphenyl ethers on 

1889 reproductive performance and immune function in captive American Kestrels. Journal of 

1890 Ornithology. 147(5): 92-92. 2006. 

1891 13. Fernie KJ, Marteinson, S, Shutt JL,. C., Bird DM, Letcher RJ, Ritchie JI. In ovo DE1892 71 , D. M. et al. Multi-generational effects of polybrominated diphenylethers exposure: 

1893 Embryonic exposure of male American kestrels: Reproductive (Falco sparverius) to DE-71 alters 

1894 reproductive success and behavioral effects. Presented at the 10th Workshop on Brominated 

1895 Flame Retardants in the Environment. 2008.behaviors. Environmental Toxicology and Chemistry

1896 29(8): 1740-1747. 2010.

1897 

1898 14. Fernie, KJ, Shutt JL, Letcher RJ, Ritchie IJ, and Bird DM. Environmentally Relevant 

1899 Concentrations of DE-71 and HBCD Alter Eggshell Thickness and Reproductive Success of 

1900 American Kestrels. Environmental Science & Technology. 43(6):2124-2130. 2009. 

1901 15. Zhang S, Bursian SJ, Martin PA, Chan HM, Tomy G, Palace VP, Mayne GJ, Martin 
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1902 JW. Reproductive and developmental toxicity of a pentabrominated diphenyl ether mixture, DE1903 71, to ranch mink (Mustela vison) and hazard assessment for wild mink in the Great Lakes 

1904 region. Toxicological Sciences. 110 (1):107-116. 2009.

1905 16. Timme-Laragy AR, Levin DE, Di Giulio RT. Developmental and behavioral effects 

1906 of embryonic exposure to the polybrominated diphenylether mixture DE-71 in the killifish 

1907 (Fundulus heteroclitus). Chemosphere. 62:1097-1104. 2006

1908 17. Lema SC, Schultz IR, Scholz NL, Incardona PJ, Swanson P. Neural defects and 

1909 cardiac arrhythmia in fish larvae following embryonic exposure to 2,2’,4,4’-tetrabromodiphenyl 

1910 ether (PBDE 47). Aquatic Toxicology. 82: 296-307. 2007. 

1911 18. Kuiper RV, Vethaak AD, Cantón RF, Anselmo H, Dubbeldam M. Toxicity of 

1912 analytically cleaned pentabromodiphenylether after prolonged exposure in estuarine European 

1913 flounder (Platichthys flesus), and partial life-cycle exposure in fresh water zebrafish (Danio 

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

1915 19. Nakari and Huhtala 2008. EPA, 2006. Polybrominated Diphenyl Ethers (PBDEs) 

1916 Project Plan. March, 2006. Available at http://www.epa.gov/oppt/pbde/pubs/proj-plan32906a.pdf 

1917 (accessed Dec. 15, 2009).Nakari T, and Huhtala S. Comparison of toxicity of congener-153 of 

1918 PCB, PBB, and PBDE to Daphnia magna. Ecotoxicol Environ Saf. 71:514–518, 2008. 

1919 20. Vonderheide AP, Mueller KE, et al. Polybrominated diphenyl ethers: Causes for 

1920 concern and knowledge gaps regarding environmental distribution, fate and toxicity. Science of 

1921 the Total Environment. 400(1-3): 425-436. 2008. 

1922 21. Environment Canada. Ecological State of the Science Report on Decabromodiphenyl 

1923 Ether (decaBDE) Bioaccumulation and Transformation. 2010. Available from: 

1924 http://www.ec.gc.ca/lcpe-cepa/documents/substances/decabde/ess_report_decabde1925 eng.pdfhttp://www.ec.gc.ca/lcpe-cepa/documents/substances/decabde/ess_report_decabde1926 eng.pdf

1927 22. Shaw SD, Kannan K. Polybrominated diphenyl ethers in marine ecosystems of the 

1928 American continents: foresight from current knowledge. Reviews on Environmental Health. 

1929 24:157-229. 2009. 

1930 23. Environment Canada. Ecological Screening Assessment Report on Polybrominated 

1931 Diphenyl Ethers (PBDEs). 2006. Available from: 

1932 http://www.ec.gc.ca/CEPARegistry/documents/subs_list/PBDE_SAR/PBDEs_SAR_EC_June_2

1933 006_%28en%29.pdfhttp://www.ec.gc.ca/CEPARegistry/documents/subs_list/PBDE_SAR/PBDE

1934 s_SAR_EC_June_2006_%28en%29.pdf. 

1935 24. Thuresson K, Bergman A, Jakobsson K. Occupational Exposure to Commercial 

1936 Decabromodiphenyl Ether in Workers Manufacturing or Handling Flame-Retarded Rubber. 

1937 Environmental Science & Technology. 39:1980-1986. 2005. 

1938 25. Tokarz JA, Ahn MY, Leng J, Filley TR, Nies L. Reductive Debromination of 

1939 Polybrominated Diphenyl Ethers in Anaerobic Sediment and a Biomimetic System. 
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1940 Environmental Science & Technology. 42:1157-1164. 2008. 

1941 26. La Guardia MJ, Hale RC, Harvey E. Evidence of Debromination of 

1942 Decabromodiphenyl Ether (BDE-209) in Biota from a Wastewater Receiving Stream. 

1943 Environmental Science & Technology. 41(19):6663-6670. 2007. 

1944 27. Stapleton HM. Brominated flame retardants: assessing the decaBDE debromination in 

1945 the environment. Health and Environmental Alliance (formerly the EPHA Environmental 

1946 Network (EEN)). May 2006. 

1947 28. Stapleton HM, Dodder NG. Photodegradation of decabromodiphenyl ether in house 

1948 dust by natural sunlight. Environmental Toxicology and Chemistry. 27:306-312. 2008 

1949 29. Wania F, Dugani CB. Assessing the long-range transport potential of polybrominated 

1950 diphenyl ethers: a comparison of four multimedia models. Environmental Toxicology and 

1951 Chemistry. 22:1252–1261. 2003. 

1952 30. ATSDR. Agency for Toxic Substances and Disease Registry. Toxicological Profile 

1953 for Polybrominated Diphenyl Ethers and Polybrominated Biphenyls. 2004. 

1954 www.atsdr.cdc.gov/toxprofiles/tp68.htmlwww.atsdr.cdc.gov/toxprofiles/tp68.html. 

1955 31. EPA. An exposure assessment of polybrominated diphenyl ethers. National Center 

1956 for Environmental Assessment, Washington, DC; EPA/600/R-08/086F. 2010. Available from the 

1957 National Technical Information Service, Springfield, VA, and online at 

1958 http://www.epa.gov/ncea. 

1959 

1960 32. Allen JG, McClean MD, Stapleton HM, Webster TF. Critical factors in assessing 

1961 exposure to PBDEs via house dust. Environment International. 34(8):1085-1091. November 

1962 2008. 

1963 33. Lorber M. Exposure of Americans to polybrominated diphenyl ethers. Journal of 

1964 Exposure Science and Environmental Epidemiology. 18:2-19. 2008. 

1965 34. Jones-Otazo HA, Clarke J, Diamond ML, Archbold J, Ferguson G, Harner T, 

1966 Richardson SM, Jakeryan J, and Wilford BY. Is House Dust the Missing Exposure Pathway for 

1967 PBDEs? An Analysis of the Urban Fate and Human Exposure to PBDEs. Environmental Science 

1968 & Technology. 39: 5121-5130. 2005 

1969 35. Hites RA. Polybrominated Diphenyl Ethers in the Environment and in People: A 

1970 Meta-Analysis of Concentrations. Environmental Science & Technology. 38: 945. 2004 

1971 36. Cal/EPA PBDE Workgroup. Polybrominated Diphenyl Ethers: Recommendations to 

1972 Reduce Exposure in California. California Environmental Protection Agency, Sacramento, 

1973 California. February 2006. Available at: http://oeha.ca.gov/pdf/PBDEWrkgrpRptFeb06.pdf. 

1974 37. Sjodin A, Wong LY, Jones RS, Park A, Zhang Y, Hodge C, Dipietro E, McClure C, 

1975 Turner W, Needham LL and Patterson DG. Serum concentrations of polybrominated diphenyl 

1976 ethers (PBDEs) and polybrominated biphenyl (PBB) in the United States population: 2003-2004. 

1977 Environmental Science & Technology. 42:1377-1384. 2008. 
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1978 38. NHANES. Fourth National Report on Human Exposure to Environmental Chemicals. 

1979 Centers for Disease Control and Prevention, Atlanta (GA). December 2009. Available at: 

1980 http://www.cdc.gov/exposurereport/faq.htmlhttp://www.cdc.gov/exposurereport/faq.html

1981 39. Environment Canada. Flame Retardants: A threat to the environment? Science & the 

1982 Environment Bulletin. 30:5. May/June 2002. Available at: http://dsp1983 psd.pwgsc.gc.ca/Collection/En1-28-1-2002-03E.pdfhttp://dsp-psd.pwgsc.gc.ca/Collection/En1-

1984 28-1-2002-03E.pdf

1985 40. Park JS, Holden A, et al. Time-Trends and Congener Profiles of PBDEs and PCBs in 

1986 California Peregrine Falcons (Falco peregrinus). Environmental Science & Technology.

1987 43(23):8744-8751. 2009. 

1988 41. Gobas FAPC and Morrison HA. Bioconcentration and biomagnification in the aquatic 

1989 environment. In Handbook of Property Estimation Methods for Chemicals. Environmental and 

1990 Health Sciences. pp. 189-231. RS Boethling and DMackay, Eds,. Lewis/CRC, Boca Raton, FL 

1991 USA. 2000. 

1992 42. Chen D, Mai B, Song J, Sun Q, Luo Y, Luo X, Zeng EY, Hale RC. Polybrominated 

1993 diphenyl ethers in birds of prey from Northern China. Environmental Science & Technology. 

1994 41:1828-1833. 2007. 

1995 43. Voorspoels S, Covaci A, Lepom P, Jaspers VLB, Neels H, Schepens P. 

1996 Biomagnification of PBDEs in three small terrestrial food chains. Environmental Science & 

1997 Technology. 41:411–-416. 2007. 

1998 44. Stapleton HM, Baker JE. Comparing polybrominated diphenyl ether and 

1999 polychlorinated biphenyl bioaccumulation in a food web in Grand Traverse Bay, Lake Michigan. 

2000 Archives of Environmental Contamination and Toxicology. 45:227–234. 2003. 

2001 45. Gandhi et.al. Development of a Multichemical Food Web Model: Application to 

2002 PBDEs in Lake Ellasjøen, Bear Island, Norway. Environmental Science & Technology. 

2003 40(15):4714–4721. 2006. 

2004 46. Stapleton HM, Alaee M, Letcher RJ, Baker JE. Debromination of the flame retardant 

2005 decabromodiphenyl ether by juvenile carp (Cyprinus carpio). Environmental Science & 

2006 Technology. 38:112-119. 2004. 

2007 47. Van den Steen E, Covaci A, Jaspers VLB, Dauwe T, Voorspoels S, Eens M, 

2008 Pinxten R. Accumulation, tissue-specific distribution and biotransformation of BDE 209 in 

2009 European starlings (Sturnus vulgaris). Environmental Pollution. 148:648-653. 2007.

2010 48. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 

2011 Document for Pentabromodiphenyl Ether and Octabromodiphenyl Ether. Prepared by Risk 

2012 Assessment Division, OPPT. June 2005. 

2013 49. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 

2014 Document for Decabromodiphenyl Ether. Prepared by Risk Assessment Division, OPPT. June 

2015 2005. 
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2016 50. Darnerud PO. Toxic effects of brominated flame retardants in man and in wildlife. 

2017 Environment International. 29:841-853. 2003. 

2018 51. Harley KG, et al. PBDE Concentrations in Women’s Serum and Fecundability. 

2019 Environmental Health Perspectives. 118(5): 699-704. May 2010. 

2020 52. Costa LG, et al. Polybrominated diphenyl ether (PBDE) flame retardants: 

2021 environmental contamination, human body burden and potential adverse health effects. Acta 

2022 Biomed. 79:172-183. 2008. 

2023 53. Herbstman JB, et al. Prenatal Exposure to PBDEs and Neurodevelopment. 

2024 Environmental Health Perspectives. 118(5):712-719. May 2010. 

2025 54. Bromine Science and Environmental Forum. An Oral (gavage) Developmental 

2026 Neurotoxicity Test of Decabromodiphenyl Oxide in Rats. Submitted to EPA on May 19, 2010. 

2027 55. ASTM. Standard test method for measuring the toxicity of sediment-associated 

2028 contaminants with freshwater invertebrates. ASTM E 1706-05e1. 

2029 56. ASTM. Standard guide for collection, storage, characterization, and manipulation of 

2030 sediments for toxicological testing and for selection of samplers used to collect benthic 

2031 invertebrates. ASTM E 1391-03. 

2032 57. ASTM. Standard guide for conducting laboratory soil toxicity or bioaccumulation 

2033 tests with the Lumbricid Earthworm Eisenia Fetida and the Enchytraeid Potworm Enchytraeus 

2034 albidus. ASTM E 1676-04. 

2035 58. ASTM. Standard guide for conducting sediment toxicity tests with Polychaetous 

2036 Annelids. ASTM E 1611-00. 

2037 59. ASTM. Standard guide for conducting laboratory soil toxicity tests with the 

2038 Nematode Caenorhabditis elegans. ASTM E 2172-01. 

2039 60. ASTM. Standard test method for measuring the toxicity of sediment-associated 

2040 contaminants with estuarine and marine invertebrates. ASTM E 1367-03. 

2041 61. EPA. Toxic Substances; Test Rule Development and Exemption Procedures; Interim 

2042 Final Rule. Federal Register (50 FR 20652, May 17, 1985). 

2043 62. EPA. Toxic Substances Control Act; Data Reimbursement; Final Rule. Federal 

2044 Register (48 FR 31786, July 11, 1983). 

2045 63. EPA. OPPT. Draft Guidance on Developing Robust Summaries. October 22, 1999. 

2046 Available on-line at http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm. 

2047 64. EPA. Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing 

2048 Program Initiatives. Economic and Policy Analysis Branch. Washington, DC. August 2004. 

2049 65. EPA. VCCEP Web site home page. (www.epa.gov/oppt/vccep). 
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2050 66. EPA, 2009. Polybrominated Diphenyl Ethers (PBDEs) Action Plan. Available at: 

2051 http://www.epa.gov/oppt/existingchemicals/pubs/pbdes_ap_2009_1230_final.pdf 

2052 67. Chemtura. Letter from Robert Campbell to Jim Willis, Director, CCD, OPPT, 

2053 USEPA. January 6, 2006. 

2054 68. Albermarle Corporation. Letter from David W. Clary, Albemarle Corp. to Lisa P. 

2055 Jackson, USE EPA. EPA-Industry DecaBDE Phase-Out Initiative. DecDecember 15, 2009. 

2056 69. Chemtura Corporation. Letter from Craig A. Rogerson, Chemtura Corp. to Lisa P. 

2057 Jackson, US EPA. DecaBDE Phase-Out Initiative. DecDecember 17, 2009. 

2058 70. ICL Industrial Products. Letter from Nissim Adar to Lisa P. Jackson, US EPA. 

2059 Voluntary Phase-Out of DecaBDE. DecDecember 15, 2009. 

2060 71. Arnold & Porter LLP. Letter from Lawrence Culleen to Ward Penberthy, CCD, 

2061 EPA. June 25, 2010. 

2062 72. EPA. Economic Analysis of the Proposed Significant New Use Rule for 

2063 Polybrominated Diphenyl Ethers. Prepared by Timothy Lehman and Abt Associates Inc. 

2064 September 30, 2010. 

2065 73. EPA. Economic Impact Analysis for the Proposed Section 4 Test Rule for c2066 Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether. 

2067 Prepared by Timothy Lehman and Abt Associates Inc. September 30, 2010. 

2068 74. Kimbrough KL, Johnson WE, Lauenstein GG, Christensen JD, and Apeti DA. An 

2069 Assessment of Polybrominated Diphenyl Ethers (PBDEs) in Sediments and Bivalves of the U.S. 

2070 Coastal Zone. NOAA Technical Memorandum NOS NCCOS 94. 2009.

2071 

2072 75. EPA, Polybrominated Diphenyl Ethers (PBDEs) Project Plan. March, 2006. 

2073 Available at http://www.epa.gov/oppt/pbde/pubs/proj-plan32906a.pdf (accessed Dec. 15, 2009).

2074 

2075 

2076 XIII. Statutory and Executive Order Reviews 

2077 A. Executive Order 12866 

2078 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

2079 October 4, 1993), this action has been designated a “significant regulatory action” by the Office 

2080 of Management and Budget (OMB). Accordingly, EPA submitted this action to OMB for review 

2081 and any changes made in response to OMB recommendations have been documented in the 

2082 docket for this action. 

2083 

2084 In addition, EPA has prepared two economic analyses of the potential impacts associated 

2085 with this action. A copy of these economic analyses, entitled Economic Impact Analysis for the 

2086 Proposed Section 4 Test Rule for c-Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and 

2087 c-Decabromodiphenyl Ether (Ref. 73) and Economic Analysis of the Proposed Significant New 
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2088 Use Rule for Polybrominated Diphenyl Ethers (Ref. 72), are available in the docket for this 

2089 proposed rule and are summarized in Unit X. of this preamble. 

2090 

2091 B. Paperwork Reduction Act 

2092 This proposed rule does not impose any paperwork collection requirements that would 

2093 require additional review and/or approval by OMB under the Paperwork Reduction Act (PRA), 

2094 44 U.S.C. 3501 et. seq. The information collection requirements related to the proposed SNUR 

2095 (i.e., the submission of a SNUN) have been approved by OMB pursuant to the PRA under OMB 

2096 control number 2070-0038 (EPA ICR No. 1188). The information collection requirements 

2097 related to the proposed test rule have been approved by OMB pursuant to the PRA under OMB 

2098 control number 2070-0033 (EPA ICR No. 1139). Although the test rule information collection 

2099 activities are approved, the additional burden associated with this test rule is not yet covered by 

2100 the approved ICR until the final rule is effective. In the context of developing a new test rule, 

2101 the Agency must determine whether the total annual burden covered by the approved ICR needs 

2102 to be amended to accommodate the burden associated with the new test rule. If so, the Agency 

2103 must submit an Information Correction Worksheet (ICW) to OMB and obtain OMB approval of 

2104 an increase in the total approved annual burden in the OMB inventory. 

2105 

2106 The information collection activities related to export notification under TSCA section 

2107 12(b)(1) are already approved under OMB control number 2070–0030 (EPA ICR No. 0795). 

2108 This rulemaking does not propose any new or changes to the export notification requirements, 

2109 and is not expected to result in any substantive changes in the burden estimates for EPA ICR No. 

2110 0795 that would require additional review and/or approval by OMB. 

2111 

2112 Under the PRA, an agency may not conduct or sponsor, and a person is not required to 

2113 respond to, a collection of information that is subject to approval under the PRA, unless it 

2114 displays a currently valid OMB control number. The OMB control numbers for the EPA 

2115 regulations codified in chapter 40 of the CFR, after appearing in the preamble of the final rule, 

2116 are listed in 40 CFR part 9, displayed either by publication in the Federal Register or by other 

2117 appropriate means, such as on the related collection instrument or form, if applicable. The 

2118 display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9. 

2119 

2120 To submit a SNUN, EPA estimates that the industry burden hours per chemical to be 92 

2121 hours. (Ref. 72). The standard chemical testing program involves the submission of letters of 

2122 intent to test (or exemption applications), study plans, semi-annual progress reports, test results, 

2123 and administrative costs. For this proposed rule, EPA estimates the total industry burden hours 

2124 for all three mixtures to be 37,074 hours (56,717 hours) for the low (high) cost scenario. 

2125 Average industry burden hours per mixture are estimated to be 12,358 hours (18,906 hours) in 

2126 the low (high) cost scenario. (Ref. 72). 

2127 

2128 The estimated burden of the information collection activities related to export notification 

2129 is estimated to average 1 burden hour for each mixture/country combination for an initial 

2130 notification and 0.5 hours for each subsequent notification (Ref. 72). In estimating the total 

2131 burden hours approved for the information collection activities related to export notification, the 

2132 Agency has included sufficient burden hours to accommodate any export notifications that may 

2133 be required by the Agency’s issuance of final test rules. As such, EPA does not expect to need to 
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2134 request an increase in the total burden hours approved by OMB for export notifications. 

2135 

2136 As defined by PRA and 5 CFR 1320.3(b), ‘‘burden’’ means the total time, effort, or 

2137 financial resources expended by persons to generate, maintain, retain, or disclose or provide 

2138 information to or for a Federal agency. This includes the time needed to: Review instructions; 

2139 develop, acquire, install, and utilize technology and systems for the purposes of collecting, 

2140 validating, and verifying information, processing and maintaining information, and disclosing 

2141 and providing information; adjust the existing ways to comply with any previously applicable 

2142 instructions and requirements; train personnel to be able to respond to a collection of 

2143 information; search data sources; complete and review the collection of information; and 

2144 transmit or otherwise disclose the information. 

2145 

2146 Comments are requested on the Agency’s need for this information, the accuracy of the 

2147 provided burden estimates, and any suggested methods for minimizing respondent burden, 

2148 including through the use of automated collection techniques. Send comments to EPA as part of 

2149 your overall comments on this proposed action in the manner specified under ADDRESSES. In 

2150 developing the final rule, the Agency will address any comments received regarding the 

2151 information collection requirements contained in this proposal. 

2152 

2153 C. Regulatory Flexibility Act

2154 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 

2155 after considering the potential economic impacts of this proposed rule on small entities, the 

2156 Agency hereby certifies that this proposed rule does not have a significant adverse economic 

2157 impact on a substantial number of small entities. The factual basis for the Agency’s 

2158 determination is presented in the small entity impact analysis prepared as part of the economic 

2159 analyses for this proposed rule (Refs. 72 and 73), which are summarized in Unit X. of this 

2160 document, and copies of which are available in the docket for this rulemaking. The following is 

2161 a brief summary of the factual basis for this certification. 

2162 

2163 Under the RFA, small entities include small businesses, small organizations, and small 

2164 governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small 

2165 entities, small entity is defined in accordance with the RFA as: 1) A small business as defined 

2166 by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201; 2) A small 

2167 governmental jurisdiction that is a government of a city, county, town, school district, or special 

2168 district with a population of less than 50,000; and 3) A small organization that is any not-for2169 profit enterprise which is independently owned and operated and is not dominant in its field. 

2170 

2171 Based on the industry profile that EPA prepared as part of the economic analysis for this 

2172 rulemaking (Ref. 73), EPA has determined that this proposed rule is not expected to impact any 

2173 small not-for-profit organizations or small governmental jurisdictions. As such, the Agency’s 

2174 analysis presents only the estimated potential impacts on small business. 

2175 

2176 Two factors are examined in EPA’s small entity impact analysis (Ref. 73) in order to 

2177 characterize the potential small entity impacts of this proposed rule on small business: 1) The 

2178 size of the adverse economic impact (measured as the ratio of the cost-to-sales or cost-to2179 revenue), and 2) The total number of small entities that experience the adverse economic 
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2180 impact. 

2181 

2182 Section 601(3) of the RFA establishes as the default definition of “small business” the 

2183 definition used in section 3 of the Small Business Act, 15 U.S.C. 632, under which the Small 

2184 Business Administration (SBA) establishes small business size standards (13 CFR 121.201). For 

2185 this rulemaking, EPA has analyzed the potential small business impacts using the size standards 

2186 established under this default definition. The SBA size standards, which are primarily intended 

2187 to determine whether a business entity is eligible for government programs and preferences 

2188 reserved for small businesses (13 CFR 121.101), “seek to ensure that a concern that meets a 

2189 specific size standard is not dominant in its field of operation.” (13 CFR 121.102(b)). See 

2190 section 632(a)(1) of the Small Business Act. In analyzing potential impacts, the RFA recognizes 

2191 that it may be appropriate at times to use an alternate definition of small business. As such, 

2192 section 601(3) of the RFA provides that an agency may establish a different definition of small 

2193 business after consultation with the SBA Office of Advocacy and after notice and an opportunity 

2194 for public comment. Even though the Agency has used the default SBA definition of small 

2195 business to conduct its analysis of potential small business impacts for this proposed rule, EPA 

2196 does not believe that the SBA size standards are generally the best size standards to use in 

2197 assessing potential small entity impacts with regard to TSCA section 4(a) test rules. 

2198 

2199 The SBA size standard is generally based on the number of employees an entity in a 

2200 particular industrial sector may have. For example, in the chemical manufacturing industrial 

2201 sector (i.e., NAICS 325 and NAICS 324110), approximately 98% of the firms would be 

2202 classified as small businesses under the default SBA definition. The SBA size standard for 75% 

2203 of this industry sector is 500 employees, and the size standard for 23% of this industry sector is 

2204 either 750, 1,000, or 1,500 employees. When assessing the potential impacts of test rules on 

2205 chemical manufacturers, EPA believes that a standard based on total annual sales may provide a 

2206 more appropriate means to judge the ability of a chemical manufacturing firm to support 

2207 chemical testing without significant costs or burdens. 

2208 

2209 EPA is currently determining what level of annual sales would provide the most 

2210 appropriate size cutoff with regard to various segments of the chemical industry usually 

2211 impacted by TSCA section 4(a) test rules, but has not yet reached a determination. As stated 

2212 above, therefore, the factual basis for the RFA determination for this proposed rule is based on 

2213 an analysis using the default SBA size standards. Although EPA is not currently proposing to 

2214 establish an alternate definition for use in the analysis conducted for this proposed rule, the 

2215 analysis for this proposed rule also presents the results of calculations using a standard based on 

2216 total annual sales (40 CFR 704.3). EPA is interested in receiving comments on whether the 

2217 Agency should consider establishing an alternate definition for small business to use in the small 

2218 entity impact analyses for future TSCA section 4(a) test rules, and what size cutoff may be 

2219 appropriate. 

2220 

2221 The SBA has developed 6 digit NAICS code-specific size standards based on 

2222 employment thresholds. These size standards range from 500 to 1,500 employees for the various 

2223 6 digit NAICS codes that are potentially impacted (Ref. 73). For a conservative estimate of the 

2224 number of small businesses affected by this rule, the Agency chose an employment threshold of 

2225 less than 1,500 employees for all businesses regardless of the NAIC-specific threshold to 

2226 determine small business status. 
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2227 

2228 For manufacturers and importers of decaBDE covered by this proposed rule, six parent 

2229 companies (ultimate corporate entity, or UCE) were identified and sales and employment data 

2230 were obtained for companies where data were publicly available. Parent company sales data 

2231 were used to identify companies that qualified as a “small business” for purposes of the RFA 

2232 analysis. Based on the TSCA employment standard (1,500 employees or less), one company 

2233 was identified as small. This company had cost-to-sales ratios of greater than 3% under both the 

2234 low- and high-cost scenarios. Given these results, the Agency has determined that there is not a 

2235 significant economic impact on a substantial number of small entities as a result of this proposed 

2236 rule, if finalized. 

2237 

2238 The estimated cost of the TSCA section 12(b)(1) export notification, which, as a result of 

2239 the final rule, would be required for the first export to a particular country of a mixture subject to 

2240 the rule, is estimated to be $85.70 for the first time that an exporter must comply with TSCA 

2241 section 12(b)(1) export notification requirements, and $26.86 for each subsequent export 

2242 notification submitted by that exporter (Ref. 72). EPA has concluded that the costs of TSCA 

2243 section 12(b)(1) export notification would have a negligible impact on exporters of the mixtures 

2244 in the final rule, regardless of the size of the exporter. 

2245 

2246 Any comments regarding the impacts that this action may impose on small entities, or 

2247 regarding whether the Agency should consider establishing an alternate definition of small 

2248 business to be used for analytical purposes for future test rules and what size cutoff may be 

2249 appropriate, should be submitted to the Agency in the manner specified under ADDRESSES. 

2250 

2251 D. Unfunded Mandates Reform Act 

2252 This action does not contain any Federal mandates for State, local, or tribal governments 

2253 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 

2254 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in 

2255 annual expenditures of $100 million or more for State, local, and tribal governments, in the 

2256 aggregate, or for the private sector. For the private sector, it is estimated that the total aggregate 

2257 costs of this proposed rule would be $15.1 million. The total annualized costs of this proposed 

2258 rule to the private sector are estimated to be $5.34 and 5.75 million using a 3% and 7% discount 

2259 rate over 3 years (high cost scenario). In addition, since EPA does not have any information to 

2260 indicate that any State, local, or tribal government manufactures or processes the mixtures 

2261 covered by this action such that this rule would apply directly to State, local, or tribal 

2262 governments, EPA has determined that this proposed rule would not significantly or uniquely 

2263 affect small governments. Accordingly, this proposed rule is not subject to the requirements of 

2264 sections 202, 203, 204, and 205 of UMRA. 

2265 

2266 E. Executive Order 13132 

2267 Under Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), 

2268 EPA has determined that this proposed rule does not have “federalism implications” because it 

2269 will not have substantial direct effects on the States, on the relationship between the national 

2270 government and the States, or on the distribution of power and responsibilities among the various 

2271 levels of government, as specified in the Executive Order. The proposed test rule would 
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2272 establish testing and recordkeeping requirements that apply to manufacturers (including 

2273 importers) and processors of certain mixtures. The proposed amendments to the SNUR would 

2274 establish notification and submission requirements that apply to manufacturers (including 

2275 importers) before certain chemicals may be manufactured or imported. Because EPA has no 

2276 information to indicate that any State or local government manufactures or processes the 

2277 chemical substances and mixtures covered by this action, the proposed SNUR-Test Rule does not 

2278 apply directly to States and localities and will not affect State and local governments. Thus, 

2279 Executive Order 13132 does not apply to this proposed rule. 

2280 F. Executive Order 13175 

2281 Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 

2282 Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule 

2283 does not have tribal implications because it will not have any affecteffect on tribal governments, 

2284 on the relationship between the Federal Government and the Indian tribes, or on the distribution 

2285 of power and responsibilities between the Federal Government and Indian tribes, as specified in 

2286 the Executive Order. As indicated previously, EPA has no information to indicate that any tribal 

2287 government manufactures or processes the chemical substances or mixtures covered by this 

2288 action. Thus, Executive Order 13175 does not apply to this proposed rule. 

2289 G. Executive Order 13045 

2290 EPA interprets Executive Order 13045, entitled Protection of Children from 

2291 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 

2292 those regulatory actions that concern health or safety risks, such that the analysis required under 

2293 section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action

2294 is not subject to Executive Order 13045 because it does not establish an environmental standard 

2295 intended to mitigate health or safety risks. Nevertheless, the information obtained by this 

2296 proposed rule could inform the Agency’s decision-making process regarding mixtures to which 

2297 children may be disproportionately exposed. The proposed test rule would establish testing and 

2298 recordkeeping requirements that apply to manufacturers (including importers) and processors of 

2299 certain mixtures, and would result in the development of data about those mixture substances 

2300 that can subsequently be used to assist the Agency and others in determining whether the 

2301 mixtures in the proposed test rule present potential risks, allowing the Agency and others to take 

2302 appropriate action to investigate and mitigate those risks. Similarly, the proposed amendments 

2303 to the SNUR would allow EPA to review available information to identify and take action to 

2304 address potential risk because it would require manufacturers to submit notification and hazard 

2305 information in the form of a SNUN to EPA before a chemical may be manufactured or imported. 

2306 H. Executive Order 13211 

2307 This action is not a “significant energy action” as defined in Executive Order 13211, 

2308 entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 

2309 Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 

2310 the supply, distribution, or use of energy as described in the Order. 

2311 I. National Technology Transfer and Advancement Act 
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2312 Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA), 15 

2313 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its regulatory activities 

2314 unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary 

2315 consensus standards are technical standards (e.g., materials specifications, test methods, 

2316 sampling procedures, and business practices) that are developed or adopted by voluntary 

2317 consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, 

2318 explanations when the Agency decides not to use available and applicable voluntary consensus 

2319 standards. 

2320 The proposed test rule involves technical standards because it proposes to require the use 

2321 of particular test methods. If the Agency makes findings under TSCA section 4(a), EPA is 

2322 required by TSCA section 4(b) to include specific standards or test methods that are to be used 

2323 for the development of the data required in the test rules issued under TSCA section 4. For 

2324 some of the testing that would be required by the final rule, EPA is proposing the use of 

2325 voluntary consensus standards issued by ASTM International and ISO which evaluate the same 

2326 type of toxicity as the TSCA 799 test guidelines and OECD test guidelines, where applicable. 

2327 Copies of the ASTM International standards referenced in the proposed regulatory text at §

2328 799.XXXX (h)(2)(i) through (v) have been placed in the docket for this proposed rule where they 

2329 are available for reading, but not copying. You may obtain copies of the ASTM International 

2330 standards from the American Society for Testing and Materials International, 100 Bar Harbor 

2331 Dr., West Conshohocken, PA 19428–2959. In the final rule, EPA intends to seek approval from 

2332 the Director of the Federal Register for the incorporation by reference of the ASTM 

2333 International and ISO standards used in the final rule in accordance with 5 U.S.C. 552(a) and 1 

2334 CFR part 51. 

2335 EPA is not aware of any potentially applicable voluntary consensus standards which 

2336 evaluate prenatal developmental toxicity, two-generation reproductive toxicity, developmental 

2337 neurotoxicity, immunotoxicity, or chronic toxicity/carcinogenicity, or screen for neurotoxicity 

2338 which could be considered in lieu of the TSCA 799 test guidelines, 40 CFR 799.9370, 799.9380, 

2339 799.9630, 799.9780, 799.9430, and 799.9620, respectively, upon which the test standards in the 

2340 proposed rule are based. 

2341 EPA is also not aware of any potentially applicable voluntary consensus standards which 

2342 evaluate anaerobic aquatic metabolism, biodegradation in anaerobic digester sludge, or 

2343 photolytic degradation in the indoor environment. As a result, EPA is proposing the use of three 

2344 guidelines which are published in full in the proposed regulatory text at § 799.XXXX (h)(3) (ii) 

2345 through (iv). 

2346 The Agency invites comment on the potential use of voluntary consensus standards in the 

2347 proposed test rule, and, specifically, invites the public to identify potentially applicable 

2348 consensus standard(s) and to explain why such standard(s) should be used here. 

2349 J. Executive Order 12898 

2350 This proposed rule does not have an adverse impact on the environmental and health 

2351 conditions in low-income and minority communities that require special consideration by the 

2352 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 

2353 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 
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2354 The Agency believes that the information collected under this proposed rule, if finalized, will 

2355 assist EPA and others in determining the potential hazards and risks associated with the mixtures 

2356 covered by this proposed rule. Although not directly impacting environmental justice-related 

2357 concerns, this information will enable the Agency to better protect human health and the 

2358 environment, including in low-income and minority communities. 

2359 K. Executive Order 12630

2360 EPA has complied with Executive Order 12630, entitled Government Actions and 

2361 Interference with Constitutionally Protected Property Rights (Takings) (53 FR 8859, March 15, 

2362 1988), by examining the takings implications of this proposed rule in accordance with the 

2363 “Attorney General’s Supplemental Guidelines for the Evaluation of Risk and Avoidance of 

2364 Unanticipated Takings” issued under the Executive Order. 

2365 L. Executive Order 12988

2366 In issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting 

2367 errors and ambiguity, minimize potential litigation, and provide a clear legal standard for 

2368 affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice 

2369 Reform (61 FR 4729, February 7, 1996). 

2370 List of Subjects in 40 CFR Part 721 

2371 Environmental protection, Chemicals, Hazardous substances, Premanufacture 

2372 notification, Reporting and recordkeeping requirements. 

2373 List of Subjects in 40 CFR Part 799. 

2374 

2375 Environmental protection, Chemicals, Hazardous substances, Laboratories, Reporting 

2376 and recordkeeping requirements. 

2377 Dated: __________________ 

2378 

2379 _____________________________ 

2380 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
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2381 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 

2382 

2383 PART 721---[AMENDED] 

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

2385 Authority: [15 U.S.C. 2604, 2607, and 2625(c).]. 

2386 

2387 2. By amending 721.10000 to read as follows: 

2388 § 721. 10000 Certain Polybrominated Diphenylethers. 

2389 

2390 (a) Definitions. The definitions in § 721.3 apply to this section. In addition, the following 

2391 definitions apply: 

2392 (1) Military use means use by the armed forces of the United States.

2393 (2) Transportation use means preparation of an article for use as an integral component 

2394 of a moving vehicle such as a car, truck, train, ship, or aircraft.

2395 (b

2396 (a) Chemical substances subject to significant new use reporting. 

2397 (1) The chemical substances identified as tetrabromodiphenyl ether (CAS No. 40088–47–

2398 9; Benzene, 1,1′-oxybis-, tetrabromo deriv.), pentabromodiphenyl ether (CAS No. 32534–81–9; 

2399 Benzene, 1,1′-oxybis-, pentabromo deriv.), hexabromodiphenyl ether (CAS No. 36483–60–0; 

2400 Benzene, 1,1′-oxybis-, hexabromo deriv.), heptabromodiphenyl ether (CAS No. 68928–80–3; 

2401 Benzene, 1,1′-oxybis-, heptabromo deriv.), octabromodiphenyl ether (CAS No. 32536–52–0; 

2402 Benzene, 1,1′-oxybis-, octabromo deriv.), and nonabromodiphenyl ether (CAS No. 63936–56–1; 

2403 Benzene, pentabromo(tetrabromophenoxy)-), or any combination of these substances resulting 

2404 from a chemical reaction are subject to reporting under this section for the significant new uses 

2405 described in paragraph (c)(2) of this section. 

2406 (2) Decabromodiphenyl ether (CAS No. 1163-19-5; Benzene, 1,1'-oxybis[2,3,4,5,6-

2407 pentabromo-) 

2408 (cb) Significant new uses. 

2409 (1) The significant new uses for chemicals identified in paragraph (ba)(1) of this section 

2410 are: 

2411 (i) Manufacture or import for any use on or after January 1, 2005, and 

2412 (ii) Processing for any use after December 31, 20122013. 

2413 (2) The significant new uses for the chemical identified in paragraph (ba)(2) of this 

2414 section are: 

2415 (i) Manufacture, import or processing for any use except military and transportation uses 

2416 after December 31, 2012, and

2417 (ii) Manufacture, import or processing for any use including military or transportation 

2418 uses after December 31, 2013. (ii) Reserved}

2419 (dc) Specific requirements. The provisions of subpart A of this part apply to this section 

2420 except as modified by this paragraph. 

2421 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) do not 

2422 apply to this section. A person who imports or processes a chemical substance identified in this 

2423 section as part of an article is not exempt from submitting a significant new use notice. 

2424 (2) [Reserved] 
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2425 

2426 PART 799---[AMENDED] 

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

2428 Authority: 15 U.S.C. 2603, 2611, 2625 

2429 

2430 4. By adding § 799.XXXX to subpart D to read as follows: 

2431 § 799.XXXX Certain polybrominated diphenylethers. 

2432 

2433 (a) What mixtures will be tested under this section? The chemical mixtures that must be 

2434 tested under this section are three representative commercial forms of pentabromodiphenyl ether, 

2435 octabromodiphenyl ether, and decabromodiphenyl ether, as follows: 

2436 (1) commercial pentabromodiphenyl ether (c-pentaBDE), whose predominant components are 

2437 tetrabromodiphenyl ether (CASRN 40088–47–9; Benzene, 1,1′-oxybis-, tetrabromo deriv.), 

2438 pentabromodiphenyl ether (CASRN 32534-81-9; Benzene, 1,1’-oxybis-, pentabromo deriv.), and 

2439 hexabromodiphenyl ether (CASRN 36483–60–0; Benzene, 1,1′-oxybis-, hexabromo deriv.), 

2440 

2441 (2) commercial octabromodiphenyl ether (c-octaBDE), whose predominant components are 

2442 heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1′-oxybis-, heptabromo deriv.), 

2443 octabromodiphenyl ether (CAS No. 32536-52-0; Benzene, 1,1’-oxybis-, octabromo deriv.), and 

2444 nonabromodiphenyl ether (CASRN 63936–56–1; Benzene, pentabromo (tetrabromophenoxy)-), 

2445 and 

2446 

2447 (3) commercial decabromodiphenyl ether (c-decaBDE), whose component with the highest 

2448 percent composition is decabromodiphenyl ether (CASRN 1163-19-5; Benzene, 1,1’-

2449 oxybis[2,3,4,5,6-pentabromo-), aka BDE-209. 

2450 

2451 The test sponsor(s) must identify the percentage of each of the seven PBDE congeners present in 

2452 each of the representative commercial mixtures that will be tested. 

2453 

2454 (b) Am I subject to this section? (1) If you manufacture (including import) or process c2455 pentaBDE or, c-octaBDE for any use including in articles at any time after December 31, 2012; 

2456 or manufacture or process c-, or c-decaBDE for any use except for military and transportation 

2457 uses including in articles at any time after December 31, 2012; or manufacture (including 

2458 import) or process c-decaBDE for any use including military or transportation uses including in 

2459 articles at any time after December 31, 2013, until the end of the test data reimbursement period 

2460 as defined in 40 CFR 791.3(h), you are subject to this section with respect to that mixture. You 

2461 are also subject to this rule if you manufacture (including import) or process c-pentaBDE, c2462 octaBDE, or c-decaBDE for export from the United States. For this rule, importers of articles 

2463 containing c- pentaBDE, c-octaBDE, or c-decaBDE are considered manufacturers and are 

2464 subject to this rule. 

2465 (2) If you do not know or cannot reasonably ascertain that you manufacture or process a 

2466 mixture listed in paragraph (a) of this section during the time period described in paragraph 

2467 (b)(1) of this section (based on all information in your possession or control, as well as all 
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2468 information that a reasonable person similarly situated might be expected to possess, control, or 

2469 know, or could obtain without unreasonable burden), you are not subject to this section with 

2470 respect to that mixture. 

2471 (c) If I am subject to this section, when must I comply with it? (1) (i) Persons subject to 

2472 this section are divided into two groups, as set forth in Table 1 of this paragraph: Tier 1 (persons 

2473 initially required to comply) and Tier 2 (persons not initially required to comply). If you are 

2474 subject to this section, you must determine if you fall within Tier 1 or Tier 2, based on Table 1 of 

2475 this paragraph. 

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

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 

2478 (ii) Table 1 of paragraph (c)(1)(i) of this section expands the list of persons in Tier 2, that 

2479 is those persons specified in § 790.42(a)(2), (a)(4) and (a)(5) of this chapter, who, while legally 

2480 subject to this section, must comply with the requirements of this section only if directed to do so 

2481 by EPA under the circumstances set forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) 

2482 of this section. 
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2483 (2) If you are in Tier 1 with respect to a mixture listed in paragraph (a) of this section, 

2484 you must, for each test required under this section for that mixture, either submit to EPA a letter 

2485 of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 

2486 exemption application must be received by EPA no later than 30 days after the relevant effective 

2487 date in paragraph (k) of this section. 

2488 (3) If you are in Tier 2 with respect to a mixture listed in paragraph (a) of this section, 

2489 you are considered to have an automatic conditional exemption and you will be required to 

2490 comply with this section with regard to that mixture only if directed to do so by EPA under 

2491 paragraphs (c)(5), (c)(7), or (c)(10) of this section. 

2492 (4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests 

2493 required by this section on any mixture listed in paragraph (a) of this section within 30 days after 

2494 the relevant effective date in paragraph (k) of this section, EPA will publish a Federal Register

2495 document that would specify the test(s) and the mixture (s) for which no letter of intent has been 

2496 submitted and notify manufacturers in Tier 2A of their obligation to submit a letter of intent to 

2497 test or to apply for an exemption from testing. 

2498 (5) If you are in Tier 2A (as specified in Table 1 in paragraph (c) of this section) with 

2499 respect to a chemical substance listed in paragraph (a) of this section, and if you manufacture, or 

2500 intend to manufacture, this chemical substance after the relevant effective date in paragraph (k) 

2501 of this section, or within 30 days after publication of the Federal Register document described 

2502 in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance 

2503 in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of 

2504 intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 

2505 exemption application must be received by EPA no later than 30 days after publication of the 

2506 Federal Register document described in paragraph (c)(4) of this section. 

2507 (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one 

2508 or more of the tests required by this section on any chemical substance listed in paragraph (a) of 

2509 this section within 30 days after the publication of the Federal Register document described in 

2510 paragraph (c)(4) of this section, EPA will publish another Federal Register document that 

2511 would specify the test(s) and the chemical substance(s) for which no letter of intent has been 

2512 submitted, and notify processors in Tier 2B of their obligation to submit a letter of intent to test 

2513 or to apply for an exemption from testing. 

2514 (7) If you are in Tier 2B (as specified in Table 1 in paragraph (c) of this section) with 

2515 respect to a mixture listed in paragraph (a) of this section, and if you process, or intend to 

2516 process, this mixture after the relevant effective date in paragraph (k) of this section, or within 30 

2517 days after publication of the Federal Register document described in paragraph (c)(6) of this 

2518 section, you must, for each test specified for that mixture in the Federal Register document 

2519 described in paragraph (c)(6) of this section, either submit to EPA a letter of intent to test or 

2520 apply to EPA for an exemption from testing. The letter of intent to test or the exemption 

2521 application must be received by EPA no later than 30 days after publication of the Federal 

2522 Register document described in paragraph (c)(6) of this section. 

2523 (8) If no manufacturer or processor has notified EPA of its intent to conduct one or more 

2524 of the tests required by this section for any of the mixtures listed in paragraph (a) of this section 
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2525 within 30 days after the publication of the Federal Register document described in paragraph 

2526 (c)(6) of this section, EPA will notify all manufacturers and processors of those mixtures of this 

2527 fact by certified letter or by publishing a Federal Register document specifying the test(s) for 

2528 which no letter of intent has been submitted. This letter or Federal Register document will 

2529 additionally notify all manufacturers and processors that all exemption applications concerning 

2530 the test(s) have been denied, and will give the manufacturers and processors of the mixture (s) an 

2531 opportunity to take corrective action. 

2532 (9) If no manufacturer or processor has notified EPA of its intent to conduct one or more 

2533 of the tests required by this section for any of the mixtures listed in paragraph (a) of this section 

2534 within 30 days after receipt of the certified letter or publication of the Federal Register

2535 document described in paragraph (c)(8) of this section, all manufacturers and processors subject 

2536 to this section with respect to that mixture who are not already in violation of this section will be 

2537 in violation of this section. 

2538 (10) If a problem occurs with the initiation, conduct, or completion of the required testing 

2539 or the submission of the required data with respect to a mixture listed in paragraph (a) of this 

2540 section, under the procedures in §§ 790.93 and 790.97 of this chapter, EPA may initiate 

2541 termination proceedings for all testing exemptions with respect to that mixture and may notify 

2542 persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption 

2543 applications within a specified period of time. 

2544 (11) If you are required to comply with this section, but your manufacture or processing 

2545 of, or intent to manufacture or process, a mixture listed in paragraph (a) of this section begins 

2546 after the applicable compliance date referred to in paragraphs (c)(2), (c)(5), or (c)(7) of this 

2547 section, you must either submit a letter of intent to test or apply to EPA for an exemption. The 

2548 letter of intent to test or the exemption application must be received by EPA no later than the day 

2549 you begin manufacture or processing. 

2550 (d) What must I do to comply with this section? (1) To comply with this section you 

2551 must either submit to EPA a letter of intent to test, or apply to and obtain from EPA an 

2552 exemption from testing. 

2553 (2) For each test with respect to which you submit to EPA a letter of intent to test, you 

2554 must conduct the testing specified in paragraphs (h) and (i) of this section and submit the test 

2555 data to EPA. 

2556 (3) You must also comply with the procedures governing test rule requirements in part 

2557 790 of this chapter, as modified by this section, including the submission of letters of intent to 

2558 test or exemption applications, the submission of study plans prior to testing, the conduct of 

2559 testing, and the submission of data; Part 792—Good Laboratory Practice Standards of this 

2560 chapter; and this section. The following provisions of 40 CFR part 790 do not apply to this 

2561 section: Paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; paragraph (a)(2) and paragraph (b) 

2562 of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85. 

2563 

2564 (e) If I do not comply with this section, when will I be considered in violation of it? You 

2565 will be considered in violation of this section as of 1 day after the date by which you are required 

2566 to comply with this section. 
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2567 (f) How are EPA’s data reimbursement procedures affected for purposes of this 

2568 section? If persons subject to this section are unable to agree on the amount or method of 

2569 reimbursement for test data development for one or more mixtures included in this section, any 

2570 person may request a hearing as described in 40 CFR part 791. In the determination of fair 

2571 reimbursement shares under this section, if the hearing officer chooses to use a formula based on 

2572 production volume, the total production volume amount will include amounts of a mixture 

2573 manufactured and processed as impurities and amounts imported in articles. 

2574 (g) Who must comply with the export notification requirements? Any person who 

2575 exports, or intends to export, a mixture listed in paragraph (a) of this section is subject to part 

2576 707, subpart D, of this chapter except when the mixture is in articles. 

2577 (h) How must I conduct my testing of c-pentaBDE and c-octaBDE? The tests that are 

2578 required for c-pentaBDE and c-octaBDE and the test methods that must be followed are listed in 

2579 subparagraphs (1) through (11) of paragraph (h) of this section. All tests must be conducted in 

2580 accordance with the requirements described in 40 CFR Part 792—Good Laboratory Practice 

2581 Standards. 

2582 (1) toxicity to freshwater invertebrates of sediment-associated contaminants conducted in 

2583 accordance with ASTM E 1706-05e1 and following the guidance of ASTM E 1391-03, 

2584 (2) Laboratory soil toxicity and bioaccumulation tests with the lumbricid earthworm 

2585 Eisenia fetidaand the enchytraeid potworm Enchytraeus albidu conducted in accordance with 

2586 ASTM E 1676-04 and following general guidance in ASTM E 1391-03, 

2587 (3) toxicity to polychaetous annilids of sediment-associated contaminants conducted in 

2588 accordance with ASTM E 1611-00 and following the guidance of ASTM E 1391-03, 

2589 (4) laboratory soil toxicity to nematode Caenorhabditis elegans conducted in accordance 

2590 with ASTM E 2172-01 and following guidance for collecting laboratory soil in ASTM E 1676-

2591 04, and following general guidance in ASTM E 1391-03, 

2592 (5) toxicity to estuarine and marine invertebrates of sediment-associated contaminants 

2593 conducted in accordance with ASTM E 1367-03 and following the guidance of ASTM E 1391-

2594 03, 

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

2596 799.9370, 

2597 (7) two-generation reproductive toxicity with a satellite group for body burden 

2598 determinations conducted in accordance with 40 CFR 799.9380, 

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

2600 (9) neurotoxicity screening battery, acute and subchronic, conducted in accordance with 

2601 40 CFR 799.9620, 

2602 (10) developmental neurotoxicity conducted in accordance with 40 CFR 799.9630, 
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2603 (11) chronic toxicity/carcinogenicity conducted in accordance with 40 CFR 799.9430. 

2604 (i) How must I conduct my testing of c-decaBDE? The tests that are required for c2605 decaBDE and the test methods that must be followed are listed in subparagraphs (1) through (4) 

2606 of paragraph (i) of this section. The use of the term “test substance” in the guidelines listed in 

2607 subparagraphs (2) through (4) of paragraph (i) of this section, should be understood to mean c2608 decaBDE or test mixture where appropriate. All tests must be conducted in accordance with the 

2609 requirements described in 40 CFR Part 792—Good Laboratory Practice Standards. 

2610 (1) The tests and test methods listed in paragraphs (h)(1) through (h)(10) of this section. 

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

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

2613 (ii) Source. U.S. Environmental Protection Agency, Series 835 – Fate, Transport and 

2614 Transformation Test Guidelines, OCSPP Guideline 835.4400—Anaerobic Aquatic Metabolism. 

2615 (iii) Introduction. Chemicals can enter shallow or deep surface waters by a wide variety 

2616 of routes including direct application, run-off, groundwater seepage drainage, waste disposal, 

2617 industrial or agricultural effluent and atmospheric deposition. This study plan describes a 

2618 proposed laboratory test method to assess transformation of the test substance in anaerobic 

2619 aquatic sediment systems. 

2620 

2621 (iv) Objectives. The objectives of the study are to 1) measure the rate of transformation 

2622 of the test substance, decabromodiphenyl ether; 2) identify and quantify all detectable 

2623 degradation products; 3) identify and quantify the transformation pathways and rate of formation 

2624 and degradation of intermediate products in the water, vapor and sediment phases; and 4) 

2625 measure the distribution of the test substance and degradation products and intermediates within 

each phase in the test system. 

14

2626 C-labeled decabromodiphenyl ether shall be used to help ensure 

2627 mass balance over time. 

2628 

2629 (v) Experimental design. The test shall be conducted using six sediments and their 

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

14

2630 C2631 labeled test substance. Sediments shall be selected to include a variety of sediment types and 

2632 shall include sediments known to contain polybrominated diphenyl ethers (PBDEs) and 

2633 polychlorinated biphenyls (PCBs). 

2634 

2635 Untreated live and killed controls and test substance-dosed biotic and abiotic systems 

2636 shall be prepared for each sediment type. Based on published studies on the biodegradation of 

2637 decabromodiphenyl ether in sediments, the half-life of decabromodiphenyl ether may be long. 

2638 Tokarz (2008) reported sediment half-lives ranging from 6-50 years with an average of 14 years. 

2639 Therefore, it is expected that untreated control, test substance-dosed live, and killed control 

2640 systems will be incubated at approximately 20°C for at least 36 months. However, the actual 

2641 study duration shall be dependent on the analytical results for initial sampling periods. The total 

2642 duration and interval for later samples may be changed depending on the observed rate of 

2643 degradation. 
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2644 Duplicate test vessels for each treatment (i.e. treated and control) option, each test 

2645 substance concentration and each sediment shall be sacrificed at appropriate time intervals. Test 

2646 substance-dosed systems shall be used for quantification of parent material and degradation 

2647 products. Untreated controls shall be used to determine background levels of the parent material 

2648 and other PBDEs over time. Sampling shall be performed at time zero and seven times 

2649 thereafter. Additional sample vessels may be prepared for additional analyses, if necessary. 

2650 These vessels shall be sampled at the request of the sponsor in consultation with EPA. 

2651 Additional untreated chambers shall be prepared for use as matrix fortification samples, water2652 sediment characterizations and viability controls, as necessary. 

2653 

2654 (vi) Materials and methods. (A) The test system and study conditions are selected to 

2655 comply with the Fate, Transport and Transformation Test Guidelines, OCSPP 835.4400 (at 

2656 paragraph (i)(2)(xii)(B) of this section) with appropriate modifications, if any, for decaBDE. 

2657 

2658 (B) Test substance. Information on the characterization of test, control or reference 

2659 substances is required by Good Laboratory Practice (GLP) Standards and Principles. Ringlabeled, 

14

2660 C-labeled test substance shall be used. The Sponsor is responsible for providing the 

2661 test substance and verification that it has been characterized according to GLP requirements prior 

2662 to its use in the study. If verification of GLP test substance characterization is not provided, it 

2663 shall be noted in the compliance statement of the final report. The Sponsor is responsible for all 

2664 information related to the test substance including the following descriptions of the radiolabeled 

2665 form of the test substance: name, lot number, specific activity, radiochemical purity, sample 

2666 form, solubility in water, and storage conditions. For the nonlabeled form of the test substance, 

2667 the Sponsor is responsible for the following descriptions: name, lot number, purity, sample form, 

2668 solubility in water, and storage conditions. The Sponsor must agree to accept any unused test 

2669 substance and/or test substance containers remaining at the end of the study. 

2670 

2671 (C) Test substance preparation and administration. A dispersal powder of test substance 

2672 shall be prepared using an inert carrier (e.g. silica gel, quartz sand). Radiolabeled test substance 

2673 shall be placed in a round bottom flask and dissolved with an appropriate solvent (i.e., 

2674 tetrahydrofuran). The inert carrier shall be added to the flask and the solvent shall be evaporated 

2675 using a rotary evaporator until the carrier is dry. This method of creating a dispersal powder is 

2676 an appropriate route of administration for poorly water-soluble materials. Prior to the test, 

2677 characteristics of sorption of the test substance on various carriers shall be evaluated. 

2678 

2679 (D) Sediments and associated waters. Sediments and associated water shall be obtained 

2680 from at least six different sites known or suspected to be contaminated with polybrominated 

2681 diphenyl ethers including, but not limited to decabromodiphenyl ether, and PCBs. Selection and 

2682 approval of the collection sites shall be the responsibility of the study Sponsor and must be 

2683 approved by EPA. 

2684 

2685 Sediments shall be collected and handled using strict anaerobic procedures (for example 

2686 see Loveley and Phillips (1986) at paragraph (i)(2)(xii)(A) of this section). They shall be 

2687 immediately sealed under nitrogen and transported and stored to maintain anaerobic conditions. 

2688 All collection containers shall be stored in a nitrogen atmosphere until and during use. In 

2689 addition, the containers shall be purged with nitrogen in the field after collection. The anaerobic 

2690 sediment and associated waters shall be taken from the same location. The reduction potential or 
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2691 Redox potential (Eh) of the sediment shall be measured prior to collection and should be less 

2692 than –150 mV. The dissolved oxygen concentration of the overlying water shall be measured 

2693 and should be less than 0.5 mg/L. The sediments and water shall be transported to the lab under 

2694 anaerobic conditions. The sediments and associated waters may be stored at room temperature 

2695 in sealed containers for up to 7 days. If longer storage is necessary, the sediments and associated 

2696 waters may be stored in sealed containers in a refrigerator for up to 4 weeks. Prior to use, the 

2697 sediment shall be settled, then separated from the water by decanting. The settled sediment shall 

2698 be wet-sieved using a 2 mm sieve. All handling of anaerobic sediment after collection and prior 

2699 to testing shall be performed under a constant flow of nitrogen. 

2700 At a minimum, the following properties of the sediment shall be determined: 

2701 • Particle size (i.e., percentage of sand, silt and clay) 

2702 • Organic carbon content 

2703 • Microbial biomass 

2704 • Nitrate, sulfate and iron species 

2705 • Percent water 

2706 • Microbial biomass (fumigation extraction method) 

2707 • pH 

2708 • Concentration of humic material 

2709 • Concentrations of electron acceptors including methane, nitrate, nitrite, sulfate, sulfide, 

2710 and iron species. 

2711 Similar characterization of the aqueous phase shall be performed prior to the start of the 

2712 test. Prior to the test, resazurin shall be added to the water at a nominal concentration of 1 mg/L. 

2713 The water shall be sparged with nitrogen until a light pink color is obtained and the dissolved 

2714 oxygen concentration is less than 0.1 mg/L. Redox conditions in the test vessels shall be 

2715 monitored by measuring dissolved hydrogen gas and Eh at each sampling. The test vessels shall 

2716 be stored under nitrogen or other inert atmosphere throughout the test. 

2717 

2718 (E) Test apparatus and conditions. The test vessels shall be 1-L glass bottles sealed with 

2719 butyl rubber septa and screw caps. Prior to beginning the study, the integrity of the test vessels 

2720 and caps and their ability to maintain anaerobic conditions and prevent leakage of H2 and other 

2721 gas species for long periods shall be verified. The test vessels shall be identified by project 

2722 number, test substance ID, test concentration, and a unique identifier. The test vessels shall be 

2723 incubated under an atmosphere of nitrogen at approximately 20°C in a anaerobic glove box. Test 

2724 temperatures shall be recorded each working day using a min/max thermometer. The need for 

2725 venting of the test systems shall be evaluated prior to the start of the study. The procedure for 

2726 venting and frequency shall be added to the study protocol, if necessary, prior to beginning the 

2727 study. 

2728 

2729 (F) Preparation of the test chambers and acclimation. Test chambers shall be prepared 

2730 in an anaerobic glove box or under a constant flow of nitrogen. Appropriate amounts of sediment 

2731 and water shall be added to each test chamber so the resulting water:sediment volume ratio is 

2732 between approximately 1:3 and 1:4. The depth of the sediment layer shall depend upon the 

2733 characteristics of the specific sediment. As a practical example, 200 g dry weight equivalent of 

2734 sediment and 250 mL of associated water typically result in a sediment layer of 6.5 cm and a 

2735 water layer of 2.5 cm. Amounts of sediment and water to be added may be determined prior to 

2736 the preparation of the test chambers. The sediment/water samples shall be acclimated under the 

2737 same conditions as in the test for at least 7 days prior to the start of the test. 
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2738 

2739 (G) Characterization of water-sediment systems. The pH, total organic carbon 

2740 concentration, dissolved oxygen concentration, redox potential of the water and sediment 

2741 (including microbial biomass), and other parameters characteristics of the water-sediment media 

2742 in the test vessels shall be measured at each sampling period noted in Table 1 of this paragraph. 

2743 The sediment and water shall be kept anaerobic with a redox potential lower than –100 mV. 

2744 

2745 Table 1: Measurements at Various Stages of the Test Procedure 

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 

O2 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 

2748 (H) Application of the test substance. Chambers containing the sediment/water systems 

2749 shall be fortified at the start of the test with the test substance by applying the test material to the 

2750 water layer. Methods for mixing the test material with sediment shall be evaluated prior to the 

2751 start of the test. Methods to be evaluated shall include but are not limited to mixing by hand and 

2752 the use of roller and tumbling mixers. 

2753 

2754 (I) Preparation of abiotic systems. Test substance-dosed abiotic controls shall be heat2755 sterilized (autoclaved three times at 120 °C for 60 minutes on three consecutive days). A 

2756 preliminary evaluation of the effects of heat sterilization on the test substance shall be conducted 

2757 prior to the start of the study. If this method is found to be unsatisfactory, irradiation shall be 

2758 used to sterilize the test systems. 

2759 

2760 (J) Sample collection. Proposed sampling intervals are day 0 and months 3, 6, 12, 18, 24, 

2761 30, and 36. If analysis of initial sampling results suggests more rapid degradation, the sampling 

2762 interval may be modified after consultation with EPA using procedures specified in the ECA. 

2763 The actual sampling intervals shall be documented in the study records and in the final report. 

2764 Duplicate test vessels for each treatment (i.e. treated and control) option, each test substance 
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2765 concentration and each sediment shall be sacrificed at appropriate time intervals. 

2766 

2767 (K) Headspace analysis. The headspace of the treated systems shall be analyzed for 

radiolabeled mineralization products including 

14

CO2- hydrocarbons and 

14

CO2 and 

14

2768 CH4 using 

2769 purge and trap methods. At each sampling time prior to extraction of the test system, the septum 

2770 shall be pierced using a needle connected to an appropriate trap and the vessel headspace shall be 

2771 purged and trapped using a hydrocarbon trap followed by a mineralization trapping apparatus. 

2772 The headspace within each of test chamber shall be continuously purged with a flow of nitrogen 

2773 for a minimum of 1 hour and passed through a gas collection system consisting of a hydrocarbon 

2774 trap and two sets of CO2 traps and a combustion apparatus. The displaced gases shall initially 

2775 pass through a sorption tube containing appropriate solid phase to trap any hydrocarbon 

2776 degradation products present, then one empty bottle followed by two more bottles, each 

2777 containing approximately 100 mL of 1.5N KOH (CO2 trapping solution), followed by another 

2778 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 

2779 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 

2780 furnace to combust methane to CO2. Because Br may poison the surface of the cupric oxide, a 

2781 preliminary experiment shall be run to test this, and the protocol adjusted if necessary. The gas 

2782 exiting the combustion column shall be passed through an empty bottle followed by two 

2783 additional CO2 traps. 

2784 

2785 (L) Sample processing and analysis for total radioactivity. After purging, the overlying 

2786 water shall be removed with minimal disturbance to the sediment and assayed for total 

2787 radioactivity by liquid scintillation counting (LSC). Sediment samples shall be analyzed using 

2788 combustion followed by LSC counting to determine to total amount of radioactivity associated 

2789 with the sediment. Water and sediment samples shall be extracted following aggressive methods 

2790 designed to extract the maximum amount of parent and degradation products from the sediment. 

2791 These shall be evaluated and verified and approved by EPA prior to the start of the study. These 

2792 methods shall be able to detect and quantify parent and degradates at least as well as those 

2793 reported in the literature for PBDE analysis. The extraction method shall be robust, for example 

2794 sequential extraction by solvent washing, soxhlet extraction and supercritical fluid extraction, but 

2795 shall not substantially change the test substance or degradation products, or the structure of the 

2796 matrix itself. Solvent extracts and extracted solids shall be analyzed to determine total residual 

2797 radioactivity. Untreated controls shall be extracted in the same manner as the test substance 

2798 treated systems. 

2799 

2800 (M) Characterization of extracted radioactivity. Water and sediment extracts from the 

2801 treated and untreated systems shall be analyzed for radiolabeled test substance and degradation 

2802 products using high performance liquid chromatography (HPLC) and gas chromatography (GC) 

2803 with mass spectrometry (MS) and radiochemical detection. Methods of analysis shall be verified 

2804 prior to the start of the study and shall be at least as sensitive and accurate as reported in the 

2805 literature for analysis of PBDEs and products. 

2806 

2807 (N) Quantification of test substance and degradation products. Water and sediment 

2808 extracts from the untreated controls and treated systems shall be analyzed for quantification of 

2809 BDE-209 (decaBDE) and trace level lower brominated diphenyl ethers including but not limited 

2810 to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE-201 (octaBDE), as well as, brominated 

2811 dibenzofurans. This analysis shall be conducted using gas chromatography/electron capture 
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2812 negative chemical ionization mass spectrometry (GC/ECNI-MS). Expected limits of detection 

2813 (LOD) and quantitation (LOQ) for reasonably anticipated products shall be determined and 

2814 reported to EPA prior to starting the test. All debromination products shall be measured in each 

2815 sample, including background and time zero samples, and both biotic systems and abiotic 

2816 (inhibited) controls. 

2817 

2818 (O) Viability controls. The assessment of the metabolic activity of untreated 

2819 sediment/water systems shall be conducted within one week of each sampling interval. 

2820 Duplicate incubation vessels for each sediment, which have been incubated in parallel under the 

2821 same conditions, shall be dosed at approximately 100 mg/kg sediment dry weight with a 

2822 combination of radiolabeled and nonlabeled substance suitable (i.e. glucose, benzoic acid) for 

2823 viability determination. The methods and procedures used shall be documented in study protocol 

2824 prior to beginning the study. 

2825 

2826 (P) Treatment of results. Total mass balance of radioactivity shall be calculated at each 

2827 sampling interval. Results shall be reported as total and percentage of added radioactivity. The 

2828 behavior of the test substance and major and minor metabolites in the whole system as well as 

2829 water, gas and sediment compartments shall be evaluated. Regression analysis of the percentage 

2830 of test substance and major metabolites as a function of time shall be performed and the time for 

2831 50% degradation (DT50) and the time for 90% degradation (DT90) of the test substance and 

2832 major metabolites shall be calculated, when possible. The ratio of BDE-209 (decaBDE) to all 

2833 detected degradation products shall be determined. All analytical results and all raw data shall 

2834 be submitted to EPA, including the mass of each analyte at each time. 

2835 

2836 (vii) Records to be maintained. Records to be submitted to EPA shall include, but are not 

2837 limited to, the following: 

2838 

2839 (A) The original signed protocol and any amendments. 

2840 

2841 (B) Identification and characterization of the test substance as provided by Sponsor. 

2842 

2843 (C) Experiment initiation and termination dates. 

2844 

2845 (D) Stock solution concentration calculations and solution preparation. 

2846 

2847 (E) Inoculum source and pretreatment data. 

2848 

2849 (F) Results of LSC and HPLC and/or other analysis (e.g. GC or GC/ECNI-MS). 

2850 

2851 (G) Temperature data recorded during test period. 

2852 

2853 (H) Copy of final report. 

2854 

2855 (viii) Final report. A final report of the results of the study shall be prepared and 

2856 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 

2857 

2858 (A) Name and address of facility performing the study. 
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2859 

2860 (B) Dates on which the study was initiated and completed. 

2861 

2862 (C) Objectives and procedures stated in the approved protocol, including any changes in 

2863 the original protocol. 

2864 

2865 (D) Identification and characterization of the test substance as provided by Sponsor. 

2866 

2867 (E) A summary and analysis of the data and a statement of the conclusions drawn from 

2868 the analysis. 

2869 

2870 (F) A description of the transformations and calculations performed on the data. 

2871 

2872 (G) A description of the methods used and reference to any standard method employed. 

2873 

2874 (H) A description of the test system. 

2875 

2876 (I) A description of the preparation of the test solutions, the testing concentrations, and 

2877 the duration of the test. 

2878 

2879 (J) A description of sampling and analytical methods, including level of detection, level 

2880 of quantification, and references. 

2881 

2882 (K) A description of the test results including measured values for individual PBDE 

2883 congeners and PBDF homolog group. 

2884 

2885 (L) A description of all circumstances that may affect the quality or integrity of the data. 

2886 

2887 (M) The name of the study director, the names of other scientists or professionals, and the 

2888 names of all supervisory personnel involved in the study. 

2889 

2890 (N) The signed and dated reports of each of the individual scientists or other 

2891 professionals involved in the study, if applicable. 

2892 

2893 (O) The location where the raw data and final report are to be stored. 

2894 

2895 (P) A statement prepared by the Quality Assurance Unit listing the types of inspections, 

2896 the dates that the study inspections were made and the findings reported to the Study Director 

2897 and Management. 

2898 

2899 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks and 

2900 data sheets etc. 

2901 

2902 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 

2903 final report after it has been accepted, such changes shall be made in the form of an amendment 

2904 issued by the Study Director. The amendment shall clearly identify the part of the study that is 

2905 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 
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2906 Study Director and Laboratory QA officer. 

2907 

2908 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 

2909 written amendments signed by the Study Director and approved by the Sponsor’s Representative 

2910 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 

2911 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 

2912 form of written deviations signed by the Study Director and filed with the raw data. All changes 

2913 to the protocol shall be indicated in the final report. Changes to the test standard require prior 

2914 approval from EPA using procedures in 40 CFR 790.55. 

2915 

2916 (xi) Good laboratory practices. This study shall be conducted in accordance with Good 

2917 Laboratory Practice Standards for EPA and shall be consistent with OECD Principles of Good 

2918 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 

2919 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 

2920 Operating Procedures, and the specified protocol. A statement of compliance with Good 

2921 Laboratory Practices shall be prepared for all portions of the study conducted by the testing 

2922 facility. The Sponsor is responsible for compliance with Good Laboratory Practices for 

2923 procedures that may be performed by other laboratories (e.g., residue analyses). Raw data for all 

2924 work performed at the testing facility and a copy of the final report shall be filed by project 

2925 number in archives located on the facility’s site or at an alternative location to be specified in the 

2926 final report. 

2927 

2928 (xii) Literature cited. 

2929 

2930 (A) Lovley DR, Phillips EJP. Organic matter mineralization with reduction of ferric iron 

2931 in anaerobic sediments. Applied Environmental Microbiology 51:683–689. 1986. 

2932 

2933 (B) U.S. Environmental Protection Agency. Series 835-Fate, Transport and 

2934 Transformation Test Guidelines. OCSPP Number 835.4400: Anaerobic Aquatic Metabolism. 

2935 EPA 712-C-08-019. June 2008. 

2936 

2937 (C) Tokarz JA, III, Ahn MY, Leng J, Filley TR, Nies L. Reductive debromination of 

2938 polybrominated diphenyl ethers in anaerobic-sediment and a biomimetic system. Environmental 

2939 Science & Technology 42:1157-1164. 2008. 

2940 (3) Biodegradation in anaerobic digester sludge conducted in accordance with the 

2941 following guideline: 

2942 (i) Title. Decabromodiphenyl ether: Biodegradation in Anaerobic Digester Sludge 

2943 

2944 (ii) Source. U.S. Environmental Protection Agency Series 835 - Fate, Transport and 

2945 Transformation Test Guidelines, OCSPP guideline 835.3280—Simulation test to assess primary 

2946 and ultimate biodegradability of chemicals discharged to wastewater: Mineralization and 

2947 transformation in digester sludge. 

2948 

2949 (iii) Introduction. Anaerobic digesters are commonly used in municipal wastewater 

2950 treatment plants to stabilize various plant sludges. The digestion process reduces the amount of 
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2951 solids present in the sludge, destroys pathogenic bacteria and viruses, and removes the 

2952 biodegradable portion of the sludge. A test for biodegradation during anaerobic sludge digestion 

2953 is particularly relevant for sorbing substances, which partition to primary and secondary sludge. 

2954 This test is useful for determining the concentration of a substance present in the sludge leaving a 

2955 treatment plant as well as demonstrating the potential for anaerobic biodegradation. The test is 

2956 characterized by reducing conditions, a high level of anaerobic biomass, and a level of test 

2957 substance based on expected wastewater concentrations and partitioning behavior. The test is 

2958 designed to assess the extent to which a substance can be degraded during anaerobic digestion. 

2959 This protocol describes the methods employed in determining the biodegradability of the test 

2960 substance in anaerobic digester sludge. 

2961 

2962 (iv) Objectives. The objective of the study is to assess the potential for mineralization 

2963 and transformation of decabromodiphenyl ether in anaerobic digester sludge, and the quantity 

2964 and identity of degradants (if present). 

2965 

2966 (v) Experimental design. The test shall be conducted using digester sludge from six 

2967 different sources. Untreated control and test substance-dosed systems shall be prepared for each 

2968 sludge source. Additionally, an abiotic control shall be prepared. The test substance treatment 

systems shall be dosed at two concentrations with 14 2969 C-labeled test or a combination of 

2970 radiolabeled and nonlabeled forms of the test substance. A very low concentration is used to 

2971 establish environmentally relevant transformation kinetics; whereas a higher concentration is 

2972 required to quantify product formation. The test systems shall be incubated at approximately 

2973 35°C for approximately 10 months; e.g. approximately 300 days. Studies using anaerobic 

2974 digester sludge normally involve incubating sludge for 60 days, which is about twice the normal 

2975 residence time of sludge in anaerobic digesters. The extended length of this study is based on a 

2976 half-life of the test substance in sludge without added primers of 1400 days as reported by 

2977 Gerecke et al. at paragraphs (i)(3)(xii)(A) and (B) of this section, and the general 

2978 recommendation that test duration be at least 20% of the anticipated half-life. 

2979 

2980 Based on the length of the study, bench-scale anaerobic reactor systems with semi2981 continuous feeding shall be used. A system consists of a 5-L glass reactor containing an 

2982 anaerobic digester sludge mixture incubated at 35° C and gas collection bladder. On a weekly 

2983 basis, supernatant shall be removed from the reactor and replaced with an anoxic mixture of 

2984 settled activated sludge solids (secondary sludge) and fresh anaerobic digester sludge solids. 

2985 

2986 Test substance-dosed systems shall be used for quantification of parent material and 

2987 degradation products. Untreated controls shall be used to determine background levels of the 

2988 parent material and other polybrominated diphenyl ethers. Sampling shall be performed at time 

2989 zero and seven times thereafter. 

2990 

2991 (vi) Materials and methods. The test system and study conditions are selected to comply 

2992 with the Fate, Transport and Transformation Test Guidelines, OCSPP 835.3280 at paragraph 

2993 (i)(3)(xii)(C) of this section. 

2994 (A) Test Substance. Information on the characterization of test, control or reference 

2995 substances is required by Good Laboratory Practice (GLP) Standards and Principles. The 

2996 Sponsor is responsible for providing verification that the test substance has been characterized 
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2997 according to GLP requirements prior to its use in the study. If verification of GLP test substance 

2998 characterization is not provided, it shall be noted in the compliance statement of the final report. 

2999 The Sponsor is responsible for all information related to the test substance. Following are 

3000 descriptions of the radiolabeled form of the test substance: name, lot number, specific activity, 

3001 radiochemical purity, radiolabel position, identities and percentages of all brominated 

3002 diphenylethers, sample form, solubility in water, and storage conditions. Following are 

3003 descriptions of the nonlabeled form of the test substance: name, lot number, purity, identities and 

3004 percentages of all brominated diphenyl ethers, sample form, solubility in water, and storage 

3005 conditions. The Sponsor must agree to accept any unused test substance and/or test substance 

3006 containers remaining at the end of the study. 

3007 (B) Test substance preparation and administration. A dispersal powder of test substance 

3008 shall be prepared using an inert carrier (e.g. silica gel, quartz sand). A combination of 

3009 radiolabeled and nonlabeled test substance shall be placed in a round bottom flask and dissolved 

3010 with an appropriate solvent (i.e. tetrahydrofuran). The inert carrier shall be added to the flask 

3011 and the solvent shall be evaporated using a rotary evaporator until the sediment is dry. This 

3012 method of creating a dispersal powder is an appropriate route of administration for poorly water3013 soluble materials. Prior to the test, the adsorption characteristics of the test substance on various 

3014 carriers shall be evaluated. 

3015 (C) Test inoculum. Anaerobic digester sludge shall be obtained from at least six different 

3016 sites. Selection of the collection sites shall be the responsibility of the study Sponsor, with 

3017 review and final approval by the EPA. All collection containers shall be purged with nitrogen 

3018 and immediately sealed prior to use. In addition, purging the containers with nitrogen in the field 

3019 after collection shall be performed if possible. Sludge shall be screened using a 2 mm mesh 

3020 screen to remove debris and may be held for up to 7 days prior to the start of the test. The total 

3021 solids level of the digester sludge shall be measured and should be in the range of 4-6% (40,000-

3022 60,000 mg/L). On the day the test is to start, the inoculum shall be diluted with mineral salts 

3023 solution to an initial solids level of approximately 25,000 mg/L. If the solids concentration is too 

3024 low, the solids can be allowed to settle, the supernatant decanted, and the sludge resuspended in 

3025 mineral salts solution. A final solids level and pH shall then be determined. All handling of 

3026 anaerobic sludge after collection and prior to testing shall be performed under a constant flow of 

3027 nitrogen or in an anaerobic glove box. 

3028 (D) Mineral salts solution. A mineral salts solution shall be prepared using high quality 

3029 water as described below. All chemicals used in the preparation of the solution shall be reagent 

3030 grade or better, if available. The solution shall be autoclaved for 30 min and allowed to cool 

3031 overnight in an anaerobic chamber or under an anaerobic atmosphere. The solution shall contain 

3032 the following constituents per liter of high quality water: 

3033 • Anhydrous potassium dihydrogen phosphate (KH2PO4) 0.27 g 

3034 • Disodium hydrogen phosphate dodecahydrate (Na2HPO4•12H2O) 1.12 g 

3035 • Ammonium chloride (NH4Cl) 0.53 g 

3036 • Calcium chloride dihydrate (CaCl2•2H2O) 0.075 g 
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3037 • Magnesium chloride hexahydrate (MgCl2•6H2O) 0.10 g 

3038 • Iron (II) chloride tetrahydrate (FeC12•4H2O) 0.02 g 

3039 • Resazurin (oxygen indicator) 0.001 g 

3040 • Sodium sulphide nonahydrate (Na2S•9H2O) 0.10 g 

3041 (E) Digester sludge feed. The source guideline for this study, OCSPP 835.3280, has no 

3042 provision for feeding. However, due to the length of the study, periodic feeding is needed. The 

3043 anaerobic digester sludge shall be fed an anoxic mixture of settled activated sludge solids 

3044 (secondary sludge) and fresh anaerobic digester sludge solids. Activated sludge shall be 

3045 collected from a sewage treatment plant receiving waste from predominantly domestic sources. 

3046 The sludge shall be sieved using a 2 mm mesh screen to remove debris, then dewatered using 

3047 filtration. A feed solution shall be prepared at a sludge solids concentration of approximately 50 

3048 g/L using mineral salts solution. The feed solution shall be stored under nitrogen and 

3049 refrigerated. In addition, freshly prepared solutions should be stored for at least 1 week prior to 

3050 use. 

3051 (F) Test apparatus and conditions. The test reactors shall be 5-L glass bottles and shall 

3052 be identified by project number, test substance ID, test concentration, and unique identifier. The 

3053 reactors shall be sealed with black rubber stoppers with stopcock ports and connections used for 

3054 the addition of feed sludge, sample removal and gas collection bag. The test reactors shall be 

3055 incubated at 35 ± 3 °C and in the dark. Reactor contents shall be mixed for at least 10 min every 

3056 day using a magnetic stirrer and test temperatures shall be measured each working day using a 

3057 min/max thermometer. 

3058 (G) Preparation of the test reactors. Working under a constant flow of nitrogen, 1.5 L of 

3059 anaerobic digester sludge (4-6% solids), mineral salts solution to achieve an initial solids level of 

3060 approximately 25,000 mg/L, and test substance dispersal powder shall be combined in the 

3061 reactor. The headspace in the reactor shall be purged with nitrogen, then the reactor sealed and 

3062 transferred to the incubator. 

3063 (H) Reactor maintenance, The contents of the reactors (anaerobic sludge and mineral 

3064 salts solution at a solids level of approx. 25,000 mg/L) shall be fed on a weekly basis. Prior to 

3065 mixing, approximately 75 mL of supernatant shall be removed from the reactor and replaced 

3066 with an equal volume of digester sludge feed solution. The solids added in this way are expected 

3067 to be approximately equivalent to 10% of the total digester solids reasonably expected to be 

3068 present. The amount of digester sludge feed solution added may be adjusted based on the 

3069 observed level of gas production. The activity of the supernatant removed shall be measured 

3070 using liquid scintillation counting (LSC). 

3071 (I) Abiotic control. An abiotic control shall be included. Biological activity is inhibited 

3072 in the abiotic control, which is used for estimating mineralization by difference, establishing 

3073 extraction efficiency and recovery of the test substance, and quantifying other loss processes 

3074 such as hydrolysis, oxidation, volatilization or sorption to test apparatus. The preparation of the 

3075 abiotic system is typically performed using a combination of chemical and heat sterilization. A 

3076 proven approach is to add mercuric chloride (1 g/l) to the sludge, which is then autoclaved for at 
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3077 least 90 min. Typically the volume of medium is less than or equal to half the volume of the 

3078 container being autoclaved (e.g. 500 ml sludge in a 1-liter container). After cooling, the pH of 

3079 the abiotic system should be measured and adjusted to match that of the biologically active 

3080 system. Alternative approaches to deactivate the system can also be used. 

3081 (J) Sample collection schedule. Proposed sampling times are day 0 and months 1, 2, 4, 6, 

3082 8, 9, and 10, but the actual sampling times shall be documented in the study records and in the 

3083 final report. The timing of the sampling may be altered at the discretion of the Study Director, 

3084 and more frequent sampling may be conducted. Based on the analytical method that is selected, 

3085 the minimum change in the initial concentration of the test substance that can be detected shall 

3086 be estimated, then applied to help determine the sampling schedule and assess the need for 

3087 additional samples. As an example, if the minimum reliably detectable change is 5% relative to 

3088 the starting concentration, and if this has already occurred at the first suggested sampling time (1 

3089 month), then measurements should be made monthly up to 10 months. The solids concentration 

3090 of sludge shall be measured at each sampling interval. 

3091 (K) Evolved gas and headspace analysis. The evolved gas and headspace of the treated 

systems shall be analyzed for radiolabeled mineralization products (14CO2 and 14 3092 CH4). At 

3093 intervals throughout the study, evolved gases shall be analyzed by passing the contents of the gas 

3094 collection bags through the mineralization apparatus described below. Reactor headspace 

3095 analysis shall be performed at the end of the study. The headspace gases within the reactor shall 

3096 be continuously purged with a flow of nitrogen for a minimum of 2 hours and passed through a 

3097 gas collection system consisting of two sets of CO2 traps and a combustion apparatus. The 

3098 displaced gases shall initially pass through one empty bottle followed by two bottles each 

3099 containing approximately 100 mL of 1.5N KOH (CO2 trapping solution) followed by another 

3100 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 

3101 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 

3102 furnace to combust methane to CO2. The gas exiting the combustion column shall be passed 

3103 through an empty bottle followed by two additional CO2 traps. 

3104 (L) Sample processing and analysis for total radioactivity. Treated digester sludge 

3105 samples shall be analyzed using a combination of LCS and combustion followed by LSC 

3106 counting to determine the total amount of radioactivity associated with the sludge. At each 

3107 sampling interval, replicate (minimum 3) one mL aliquots of well mixed digester sludge shall be 

3108 placed into microcentrifuge tubes and centrifuged at 10,000 x g for 15 min. The activity 

3109 associated with the supernatant shall be measured by LSC. Solids shall be analyzed using 

3110 combustion followed by LSC to determine to total amount of radioactivity associated with the 

3111 sludge solids. 

3112 Digester sludge shall be extracted following methods evaluated and verified prior to the 

3113 start of the study. These methods shall be able to detect and quantify parent and degradates at 

3114 least as well as those reported in the literature for PBDE analysis. The extraction method shall 

3115 be robust, for example sequential extraction by solvent washing, soxhlet extraction and 

3116 supercritical fluid extraction, but shall not substantially change the test substance or degradation 

3117 products, or the structure of the matrix itself. Solvent extracts and extracted solids shall be 

3118 analyzed to determine total radioactivity. Untreated controls shall be extracted in the same 

3119 manner as the test substance-treated systems, but will not be analyzed for radioactivity. 
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3120 (M) Characterization of extracted radioactivity. Digester sludge extracts from the treated 

3121 systems shall be analyzed for radiolabeled test substance and degradation products using high 

3122 performance liquid chromatography with radiochemical detection. Methods of analysis shall be 

3123 verified prior to the start of the study. 

3124 

3125 (N) Quantification of test substance and degradation products. Digester sludge extracts 

3126 from the untreated control, abiotic control and treated systems shall be analyzed for 

3127 quantification of BDE-209 (decaBDE) and trace level lower brominated diphenyl ethers 

3128 including but not limited to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE3129 201(octaBDE), as well as brominated dibenzofurans. 

3130 Methods for analysis shall be evaluated and verified prior to the start of the study and 

3131 shall reference available best practice techniques for the type of analyte. This analysis shall be 

3132 conducted using gas chromatography/electron capture negative chemical ionization mass 

3133 spectrometry (GC/ECNI-MS). Expected limits of detection (LOD) and quantitation (LOQ) for 

3134 reasonably anticipated products shall be determined and reported to EPA prior to starting the 

3135 test. 

3136 All debromination products shall be measured in each sample, including background and 

3137 time zero samples, and both biotic systems and abiotic (inhibited) controls. 

3138 

3139 (O) Treatment of results. Total mass balance of radioactivity shall be calculated at each 

3140 sampling interval. Results shall be reported as a percentage of added radioactivity. Regression 

3141 analysis of the percentage of test substance and major metabolites as a function of time shall be 

3142 performed and the time for 50% degradation (DT50) and the time for 90% degradation (DT90) of 

3143 the test substance and major metabolites shall be calculated, when appropriate. The ratio of 

3144 BDE-197 (octaBDE) to BDE-201 (octaBDE) shall be determined, if present. 

3145 (vii) Records to be maintained. Records to be maintained shall include, but are not 

3146 limited to, the following: 

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

3148 (B) Identification and characterization of the test substance as provided by Sponsor. 

3149 (C) Experiment initiation and termination dates. 

3150 (D) Stock solution concentration calculations and solution preparation. 

3151 (E) Inoculum source and pretreatment data. 

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

3153 (G) Temperature data recorded during test period. 

3154 (H) Copy of final report. 

3155 (viii) Final report. A final report of the results of the study shall be prepared by the 

3156 testing facility. The report shall include, but is not limited to the following, when applicable: 
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3157 (A) Name and address of facility performing the study. 

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

3159 (C) Objectives and procedures stated in the approved protocol, including any changes in 

3160 the original protocol. 

3161 (D) Identification and characterization of the test substance as provided by Sponsor. 

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

3163 the analysis. 

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

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

3166 (H) A description of the test system. 

3167 (I) A description of the preparation of the test solutions, the testing concentrations, and 

3168 the duration of the test. 

3169 

3170 (J) A description of sampling and analytical methods, including level of detection, level 

3171 of quantification, and references. 

3172 

3173 (K) A description of the test results including measured values for individual PBDE 

3174 congeners and polybrominated dioxin/furan (PBDF) homolog group. 

3175 

3176 (L) A description of all circumstances that may affect the quality or integrity of the data. 

3177 (M) The name of the study director, the names of other scientists or professionals, and the 

3178 names of all supervisory personnel involved in the study. 

3179 

3180 (N) The signed and dated reports of each of the individual scientists or other 

3181 professionals involved in the study, if applicable. 

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

3183 (P) A statement prepared by the Quality Assurance Unit listing the types of inspections, 

3184 the dates that the study inspections were made and the findings reported to the Study Director 

3185 and Management. 

3186 

3187 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks, 

3188 and data sheets etc. 

3189 

3190 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 

3191 final report after it has been accepted, such changes shall be made in the form of an amendment 

3192 issued by the Study Director. The amendment shall clearly identify the part of the study that is 

3193 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 

3194 Study Director and Laboratory QA officer. 
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3195 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 

3196 written amendments signed by the Study Director and approved by the Sponsor's Representative 

3197 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 

3198 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 

3199 form of written deviations signed by the Study Director and filed with the raw data. All changes 

3200 to the protocol shall be indicated in the final report. Changes to the test standard require prior 

3201 approval from EPA using procedures in 40 CFR 790.55. 

3202 (xi) Good laboratory practices. This study shall be conducted in accordance with Good 

3203 Laboratory Practice Standards for EPA and shall be consistent with OECD Principles of Good 

3204 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 

3205 the facility's quality assurance unit for compliance with Good Laboratory Practices, Standard 

3206 Operating Procedures, and the specified protocol. A statement of compliance with Good 

3207 Laboratory Practices shall be prepared for all portions of the study conducted by the testing 

3208 facility. The Sponsor is responsible for compliance with Good Laboratory Practices for 

3209 procedures that may be performed by other laboratories (e.g., residue analyses). Raw data for all 

3210 work performed at the testing facility and a copy of the final report shall be filed by project 

3211 number in archives located on the facility's site or at an alternative location to be specified in the 

3212 final report. 

3213 (xii) Literature cited: 

3214 (A) Gerecke AC, Hartmann PC, Heeb NV, Kohler H-PE, Giger W, Schmid P, Zennegg 

3215 M, Kohler M. Anaerobic degradation of decabromodiphenyl ether. Environmental Science & 

3216 Technology 39:1078-1083. 2005 

3217 

3218 (B) Gerecke AC, Giger W, Hartmann PC, Heeb NV, Kohler H-PE, Schmid P, Zennegg 

3219 M, Kohler M. Anaerobic degradation of brominated flame retardants in sewage sludge. 

3220 Chemosphere 64:311-317. 2006. 

3221 

3222 (C) U.S. Environmental Protection Agency. Series 835-Fate, Transport and 

3223 Transformation Test Guidelines. OCSPP Number 835.3280: Simulation test to assess primary 

3224 and ultimate biodegradability of chemicals discharged to wastewater: Mineralization and 

3225 transformation in digester sludge. 2008. 

3226 

3227 (4) photolytic degradation of decabromodiphenyl ether in the indoor environment in 

3228 accordance with the following guideline: 

3229 (i) Title: Photolytic Degradation Testing of Decabromodiphenyl Ether (CAS No. 1163-

3230 19-5) in the Indoor Environment. 

3231 

3232 (ii) Source. US EPA, based on a method in an article entitled “Photodegradation of 

3233 decabromodiphenyl ether in house dust by natural sunlight” by Stapleton and Dodder (2008) 

3234 reported in Environmental Toxicology and Chemistry 27:306–312. 

3235 

3236 (iii) Introduction. Recent studies have found elevated levels of polybrominated 

3237 diphenylethers (PBDEs) in indoor air and house dust, suggesting the presence of indoor sources. 

3238 It has also been observed that photolytic degradation of BDE-209 (decabromodiphenyl ether) can 
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Page 81 of 91 

3239 take place in house dust when exposed to sunlight, forming debrominated products. It is not well 

3240 understood, however, how PBDEs are transferred from the sources to indoor media (e.g., house 

3241 dust) and whether photolytic degradation can occur under indoor lighting conditions. Most 

3242 Americans spend over 85% of their time indoors. Elderly and young children tend to stay indoors 

3243 even longer. Therefore, understanding indoor exposure is a key to exposure assessment and risk 

3244 reduction. This guideline describes test methods to characterize potential sources of these 

3245 emerging contaminants in the indoor environment. 

3246 

3247 (iv) PBDE off-gassing and photolytic degradation.

3248 

3249 (A) Objectives. The objectives of this first part of the investigation are to determine (1) if 

3250 PBDEs can migrate out of plastics/fabrics by volatilization; and 

3251 

3252 (2) determine if photolytic degradation can take place on the surfaces of plastics and 

3253 fabrics and quantify these processes. 

3254 

3255 (B) Experimental Design. Accelerated aging tests shall be conducted in an 

3256 environmental chamber. PBDE off-gassing will be determined by taking integrated air samples 

3257 and potential photolytic degradation by taking wipe samples on the surface of test specimens. 

3258 The chamber system must meet the following criteria: 

3259 

3260 (1) It has uniform UV-A light irradiation sources; 

3261 

 (2) The light intensity is no less than 5 Watts per square meter (W/m2 3262 ) incident to the test 

3263 specimen; 

3264 

3265 (3) The chamber has a constant air flow to allow air sampling; and 

3266 

 (4) The moisture content in the air flow is no less than 10 g/m3 3267 (i.e., 50% relative 

3268 humidity at 23 °C). 

3269 

3270 (5) The light source shall be operated according to ASTM G 151-09, Standard Practice 

3271 for Exposing Nonmetallic Materials in Accelerated Test Devices that Use Laboratory Light 

3272 Sources. 

3273 

3274 (6) Window-filtered sunlight shall be simulated according to ASTM D 4459-06, 

3275 Standard Practice for Xenon-Arc Exposure of Plastics Intended for Indoor Applications. ASTM 

3276 D 4459-06 is intended to simulate the effects produced by exposure to solar irradiation through 

3277 glass. A chamber system conforming to D4459-06 can provide spectral irradiance of 

approximately 0.3 W/m2 3278 /nm at 340 nm (i.e., peak emission) when operated in the continuous 

3279 light-on mode without water spray. This light source satisfies the light intensity requirement of 5 

W/m2 3280 as specified above. 

3281 

3282 (C) Materials and methods.

3283 

3284 (1) Test specimens. The test specimens shall include BDE-209-containing high impact 

3285 polystyrene (HIPS) coupons and commercial fabric swatches. HIPS coupons shall be prepared 
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3286 using typical commercial extrusion and injection molding conditions for the manufacture of 

3287 HIPS television cabinet backs. High purity (99% or greater) BDE-209 shall be used in making 

3288 the coupons. The high purity will assist in detection of any lower brominated diphenyl ethers 

3289 formed as degradants. The coupons shall be manufactured using high impact polystyrene resin, 

3290 12 wt% BDE-209, antimony oxide (4% by weight), and the typical additives of television cabinet 

3291 backs (UV inhibitors, antioxidants, colorants, etc.). A total of 36 coupons shall be prepared for 

tests listed in Table 1. Each coupon shall have an area of at least 100 cm2 3292 (one-side). 

3293 Fabric swatches shall be obtained from a commercial source, depending on availability, or 

3294 manufactured using 99+% BDE-209 as the flame retardant. A total of 36 swatches shall be 

prepared for tests listed in Table 1. Each swatch shall have an area of at least 100 cm2 3295 (one3296 side). 

3297 

3298 (2) Test matrix.

3299 

3300 A total of six tests listed in Table 1 shall be conducted. 

3301 

3302 Table 1. Test matrix for PBDE off-gassing and photolytic degradation 

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 

3306 (3) Test procedure.

3307 

3308 (i) Prepare 12 identical coupons (or swatches) for an aging test 

3309 

3310 (ii) Put aside 3 coupons (or swatches) for taking wipe samples. These wipe samples 

3311 represent no-exposure conditions. To take a wipe sample of fabric, use the California roller 

3312 method per Ross, et al. (1991) in paragraph (i)(4)(xi)(F). 

3313 

3314 (iii) Clean the chamber by wiping the interior surfaces with ethanol-soaked paper towel 

3315 

 (iv) Take two wipe samples for chamber walls (100 cm2 3316 area each) 

3317 

3318 (v) Place three passive air samplers (PUF disks) on supporting cradle about half chamber 

3319 height and away from inlet air 

3320 

3321 (vi) Place the remaining 9 coupons (or swatches) on chamber floor or rack, depending on 

3322 the type of chamber used 

3323 

3324 (vii) Close chamber door and, for light-on tests, turn on the UV light, and start the test 
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3325 

3326 (viii) At 300 elapsed hours, turn off the UV light and then open the chamber door 

3327 

3328 (ix) Remove three coupons (or swatches) from the chamber for taking wipe samples 

3329 

3330 (x) Remove one PUF disk for determination of time-integrated air concentrations of 

3331 BDE-209, lower PBDE congeners, and polybrominated dibenzofurans (PBDFs) 

3332 

3333 (xi) Close chamber door and turn on the UV light 

3334 

3335 (xii) At 600 elapsed hours, turn off the UV light and then open the chamber door 

3336 

3337 (xiii) Remove three coupons (or swatches) from the chamber for taking wipe samples 

3338 

3339 (xiv) Remove one PUF disk for determination of time-integrated air concentrations of 

3340 BDE-209, lower PBDE congeners, and PBDFs 

3341 

3342 (xv) Close chamber door and turn on the UV light 

3343 

3344 (xvi) At 900 elapsed hours, turn off the UV light and then open the chamber door 

3345 

3346 (xvii) Remove the last three coupons (or swatches) from the chamber for taking wipe 

3347 samples 

3348 

3349 (xviii) Remove one PUF disk for determination of time-integrated air concentrations of 

3350 BDE-209, lower PBDE congeners, and PBDFs 

3351 

 (xix) Take two wipe samples for chamber walls (100 cm2 3352 area each) 

3353 

3354 (4) Sampling and analytical methods.

3355 

3356 (i) Surface sampling for HIPS coupons. ASTM D-6661, Standard Practice for Field 

3357 Collection of Organic Compounds from Surfaces Using Wipe Sampling, or an equivalent 

3358 method, shall be used for surface sampling on HIPS coupons. The wipe samples shall be 

3359 extracted (Stapleton et al. (2008) in paragraph (i)(4)(xi)(F) of this section) and then analyzed for 

3360 BDE-209, lower PBDE congeners, and PBDFs. 

3361 

3362 (ii) Surface sampling for fabric swatches. A modified ASTM D-6661 method, as 

3363 described below, shall be used for surface sampling on fabric swatches. Modified procedure: 

Use 10×10 cm2 3364 heavy filter paper instead of cotton gauze pad; Place the fabric swatch on pre3365 cleaned flat surface; Place the solvent-wetted filter paper on the fabric swatch; Place a 10×10 

cm

2 3366 stainless steel (or aluminum) plate on the paper filter; Add additional weights on the plate 

3367 such that the total weight is 2 lbs; Wait for 5 minutes; Remove plate and weights; Extract the 

3368 paper filter. 

3369 

3370 (iii) Air sampling. Time-integrated air samples shall be collected by using passive air 

3371 samplers (PUF disks; see Harrad, et al, 2006 (in paragraph(i)(4)(xi)(D) of this section) and 
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3372 references therein). 

3373 

3374 (iv) Analytical method. High sensitivity is a key factor in selecting the analytical method. 

3375 A method based on chromatography/mass spectrometry in electron capture negative ionization 

3376 mode (GC/MS-ECNI) shall be used. The analytes shall include BDEs and PBDFs as listed in 

3377 Bezares-Cruz et al. 2004 in paragraph (i)(4)(xi)(B) of this section; Stapleton and Dodder 2008 in 

3378 paragraph (i)(4)(xi)(G) of this section; and Geller et al. 2006 in paragraph (i)(4)(xi)(C) of this 

3379 section. 

3380 

3381 (v) Accelerated aging tests for HIPS coupons and fabric swatches with house dust. 

3382 

3383 (A) Objectives. The objectives of this, second part of the investigation are to determine 

3384 (1) if PBDEs or PBDF can migrate from plastics/fabrics to settled house dust by direct 

3385 partitioning; and (2) determine if the particle-bound PBDEs are subject to photolytic degradation 

3386 and quantify these processes. 

3387 

3388 (B) Experimental design. HIPS coupons and used TV cabinets shall be subjected to 

3389 accelerated aging in a test chamber in the presence of standard house dust, National Institute of 

3390 Standards Technology, Standard Reference Material 2583 (NIST SRM 2583), free of BDE-209. 

3391 This investigation shall be performed as described in (iv) with the exception of the addition of 

3392 pre-cleaned house dust to the surface of the HIPS coupons and fabric swatches. Accelerated 

3393 aging under simulated sunlight and fluorescent lighting, exposure durations, and sample 

3394 collections shall be identical to those described in (iv), with the addition of collection and 

3395 analysis of the added house dust. This experiment requires that the coupons are sufficiently large 

(500 cm2 3396 or larger) that there is enough house dust for sampling while the dust layer is not too 

3397 thick. 

3398 The house dust can be deposited on test specimens by using a separate dust deposition 

3399 chamber or spiked manually on test specimens (Ashley et al. 2007 in paragraph (i)(4)(xi)(A) of 

3400 this section). The test samples and dust shall then be exposed to accelerated aging for 300, 600, 

3401 and 900 hours, the dust collected by vacuum, and analyzed for content of BDE-209, lower 

3402 BDEs, and PBDFs. 

3403 

3404 (C) Materials and methods.

3405 

3406 (1) Test specimens. HIPS coupons and used TV cabinets shall be used in this 

3407 investigation. The procedure for preparing HIPS coupons described in (iv)(C)(1) shall be 

followed except that the size of the coupon shall be at least 500 cm2 3408 , such that an adequate 

3409 amount of house dust can be spiked on the surface without forming a thick layer of dust. The 

target dust load is between 0.5 and 1 mg/cm2 3410 coupon. 

3411 Two used TV sets shall be vacuumed and the dust analyzed for PBDEs and PBDFs as 

3412 previously described. Samples of the backcover shall be analyzed by Fourier transform infrared 

3413 spectroscopy (FT-IR) to identify the plastic and the flame retardant. Ground samples shall be 

3414 prepared for determination of PBDE and PBDF content. 

3415 The requirements for the test chamber are the same as described in (iv)(B) unless indicated 

3416 otherwise. 

3417 

3418 (2) Test matrix. A total of five tests listed in Table 2 shall be conducted. 
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3419 

3420 Table 2. Test matrix for PBDE migration from source to house dust and photolytic degradation 

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 

3423 (3) Test procedure for HIPS coupons.

3424 

3425 (i) Prepare HIPS coupons 

3426 

3427 (ii) Determine PBDE content in test specimens by preparing and analyzing ground 

3428 samples 

3429 

3430 (iii) Evenly spike approximately 0.25 to 0.5 g NIST standard house dust SRM 2583 on 

3431 each of the six HIPS coupons. This can be done either manually (Ashley et al. 2007 in paragraph 

3432 (i)(4)(xi)(A) of this section) or in a particle deposition chamber. The targeted dust load is 

between 0.5 and 1 mg/cm2 3433 coupon 

3434 

3435 (iv) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 

3436 towel 

3437 

 (v) Take two wipe samples from chamber walls (100 cm2 3438 area each); the PBDE and 

3439 PBDF content shall be below the method detection limit 

3440 

3441 (vi) Open the chamber door, place six coupons on chamber floor (or rack), and close the 

3442 door 

3443 

3444 (vii) Set the chamber temperature at 55 °C and air change rate between 0.3 to 0.5 air 

3445 changes per hour, or the lowest air change flow the chamber system allows 

3446 

3447 (viii) Close chamber door and start the test. 

3448 

3449 (ix) At 300 elapsed hours, remove 2 coupons for dust sampling, restart chamber 

3450 

3451 (x) Repeat the above step at 600 and 900 elapsed hours. 

3452 

3453 (4) Test procedure for used TV cabinets.

3454 

3455 (i) Open the TV set and collect settled dust from the interior surfaces (see Takigami et al. 

3456 (2008) in paragraph (i)(4)(xi)(I)). 
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3457 

3458 (ii) Determine the PBDE and PBDF content in the settled dust 

3459 

3460 (iii) Clean the backcover by soft cloth and air jet; do not clean it with solvents 

3461 

3462 (iv) Determine PBDE and PBDF content in test specimen by preparing and analyzing 

3463 ground samples 

3464 

3465 (v) Divide the backcover evenly into two pieces (designated a and b in Table 2), one for 

3466 test with light and the other without light 

3467 

3468 (vi) For each half, cut flat areas into rectangular panels for testing; the total area of the 

flat panels shall be no less than 1000 cm2 3469 

3470 

3471 (vii) Evenly spike NIST standard house dust SRM 2583 on the interior side of the 

backcover panels for a targeted dust load between 0.5 to 1 mg/cm2 3472 

3473 

3474 (viii) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 

3475 towel 

3476 

 (ix) Take two wipe samples from chamber walls (100 cm2 3477 area each); the PBDE and 

3478 PBDF content shall be below the method detection limit 

3479 

3480 (x) Open the chamber door, place the half backcover with NIST house dust on chamber 

3481 floor (or rack) 

3482 

3483 (xi) Set the chamber temperature at 55 °C and air change rate between 0.3 to 0.5 air 

3484 changes per hour, or the lowest air change flow the chamber system allows 

3485 

3486 (xii) Close chamber door and start test 

3487 

3488 (xiii) At 600 elapsed hours, remove the backcover panels from chamber, collect and 

3489 extract dust samples 

3490 

3491 (5) Sampling and analytical methods. Dust samples shall be collected by micro3492 vacuuming (Ashley et al. 2007 in paragraph (i)(4)(xi)(A) of this section or ASTM 7114). 

3493 The method described by Stapleton and Dodder (2008) in paragraph (i)(4)(xi)(F) of this section 

3494 shall be used to determine the PBDE content in dust samples. Wipe and air sampling methods 

3495 are described in (iv)(C)(4). 

3496 

3497 (vi) Records to be maintained. Records to be submitted to EPA shall include, but are not 

3498 limited to, the following: 

3499 

3500 (A) The original signed protocol and any amendments. 

3501 

3502 (B) Identification and characterization of the test substance as provided by Sponsor. 

3503 
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3504 (C) Experiment initiation and termination dates. 

3505 

3506 (D) Stock solution concentration calculations and solution preparation, if applicable. 

3507 

3508 (E) Results of LSC and HPLC and/or other analysis (e.g. GC or GC/ECNI-MS). 

3509 

3510 (F) Data on temperature, air flow and inlet air moisture content. 

3511 

3512 (G) Copy of final report. 

3513 

3514 (vii) Final report. A final report of the results of the study shall be prepared and 

3515 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 

3516 

3517 (A) Name and address of facility performing the study. 

3518 

3519 (B) Dates on which the study was initiated and completed. 

3520 

3521 (C) Objectives and procedures stated in the approved protocol, including any changes in 

3522 the original protocol. 

3523 

3524 (D) Identification and characterization of the test substance as provided by Sponsor. 

3525 

3526 (E) A summary and analysis of the data and a statement of the conclusions drawn from 

3527 the analysis. 

3528 

3529 (F) A description of the transformations and calculations performed on the data. 

3530 

3531 (G) A description of the methods used and reference to any standard method employed. 

3532 

3533 (H) A description of the test system and test chamber(s), including chamber type, 

3534 dimensions and light source; and spectral irradiance inside the chamber if applicable. 

3535 

3536 (I) A description of the preparation of the test solutions, the testing concentrations, and 

3537 the duration of the test. 

3538 

3539 (J) A description of sampling and analytical methods, including level of detection, level 

3540 of quantification, and references. 

3541 

3542 (K) A description of test specimens and test matrix. 

3543 

3544 (L) A description of the test results including measured values for individual PBDE 

3545 congeners and PBDF homolog group for each matrix, exposure condition, and exposure 

3546 duration. 

3547 

3548 (M) A description of all circumstances that may affect the quality or integrity of the data. 

3549 

3550 (N) The name of the study director, the names of other scientists or professionals, and the 
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Page 88 of 91 

3551 names of all supervisory personnel involved in the study. 

3552 

3553 (O) The signed and dated reports of each of the individual scientists or other 

3554 professionals involved in the study, if applicable. 

3555 

3556 (P) The location where the raw data and final report are to be stored. 

3557 

3558 (Q) A statement prepared by the Quality Assurance Unit listing the types of inspections, 

3559 the dates that the study inspections were made and the findings reported to the Study Director 

3560 and Management. 

3561 

3562 (R) A copy of all raw data including but not limited to chromatograms, lab notebooks and 

3563 data sheets etc. 

3564 

3565 (viii) Changes to the final report. If it is necessary to make corrections or additions to the 

3566 final report after it has been accepted, such changes shall be made in the form of an amendment 

3567 issued by the Study Director. The amendment shall clearly identify the part of the study that is 

3568 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 

3569 Study Director and Laboratory QA officer. 

3570 

3571 (ix) Changes to the protocol . Planned changes to the protocol shall be in the form of 

3572 written amendments signed by the Study Director and approved by the Sponsor’s Representative 

3573 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 

3574 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 

3575 form of written deviations signed by the Study Director and filed with the raw data. All changes 

3576 to the protocol shall be indicated in the final report. Changes to the test standard require prior 

3577 approval from EPA using procedures in 40 CFR 790.55. 

3578 

3579 (x) Good laboratory practices. This study shall be conducted in accordance with Good 

3580 Laboratory Practice Standards for EPA and shall be consistent with OECD Principles of Good 

3581 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 

3582 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 

3583 Operating Procedures, and the specified protocol. A statement of compliance with Good 

3584 Laboratory Practices shall be prepared for all portions of the study conducted by the testing 

3585 facility. The Sponsor is responsible for compliance with Good Laboratory Practices for 

3586 procedures that may be performed by other laboratories (e.g., residue analyses). Raw data for all 

3587 work performed at the testing facility and a copy of the final report shall be filed by project 

3588 number in archives located on the facility’s site or at an alternative location to be specified in the 

3589 final report. 

3590 

3591 (xi) Literature cited.

3592 

3593 (A) Ashley K, Applegate GT, Wise TJ, Fernback JE, Goldcamp MJ. Evaluation of a 

3594 standardized micro-vacuum sampling method for collection of surface dust. Journal of 

3595 Occupational and Environmental Hygiene 4:215–223. 2007. 

3596 

3597 (B) Bezares-Cruz J, Jafvert CT, Hua I.. Solar photodecomposition of decabromodiphenyl 
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Page 89 of 91 

3598 ether: products and quantum yield. Environmental Science & Technology 38:4149-4156. 2004 

3599 

3600 (C) Geller AM, Krüger HU, Palm WU, Zetsch C. Identification of polybrominated 

3601 dibenzofurans from photolysis of decabromodiphenyl ether by UV spectroscopy. Abstract from 

3602 DIOXIN 2006, Oslo, Norway, August 21-24, 2006. 

3603 

3604 (D) Harrad S, Hazrati S, Ibarra C. Concentrations of polychlorinated biphenyls in indoor 

3605 air and polybrominated diphenyl ethers in indoor air and dust in Birmingham, United Kingdom: 

3606 implications for human exposure. Environmental Science & Technology 40:4633-4638. 2006. 

3607 

3608 (E) Ross, J.; Fong, H.; Thongsinthusak,T.: Margetich, S.; Krieger, R. Measuring 

3609 potential dermal transfer of surface pesticide residue generated from indoor fogger use: using the 

3610 CDFA roller method interim report II. Chemosphere 22:975-984. 1991. 

3611 

3612 (F) Stapleton HM, Kelly SM, Allen JG, McClean MD, Webster TF. Measurement of 

3613 polybrominated diphenyl ethers on hand wipes: estimating exposure from hand-to-mouth 

3614 contact. Environmental Science & Technology 42:3329–3334. 2008. 

3615 

3616 (G) Stapleton HM, Dodder NG. 2008. Photodegradation of decabromodiphenyl ether in 

3617 house dust by natural sunlight. Environmental Toxicology and Chemistry 27:306–312. 

3618 

3619 (H) Strandberg B, Dodder NG, Basu I, Hites RA. 2001. Concentrations and spatial 

3620 variations of polybrominated diphenyl ethers and other organohalogen compounds in Great 

3621 Lakes air. Environmental Science & TechnolnologyTechnology 35: 1078-(missing page). 

3622 

3623 (I) Takigami H, Suzuki G, Hirai Y, Sakai S. Transfer of brominated flame retardants 

3624 from components into dust inside television cabinets. Chemosphere 73:161–169. 2008. 

3625 (j) Reporting requirements. For c-pentaBDE and c-octaBDE, or c-decaBDE a final 

3626 report for each specific test for each subject mixture must be received by EPA by the number of 

3627 months designated for that test in this paragraph after December 31, 2012, unless an extension is 

3628 granted in writing pursuant to 40 CFR 790.55. For c-decaBDE, a final report for each specific 

3629 test must be received by EPA by the number of months designated for that test in this paragraph 

3630 after December 31, 2013, unless an extension is granted in writing pursuant to 40 CFR 790.55. 

3631 A robust summary of the final report for each specific test shall be submitted electronically in 

3632 addition to and at the same time as the final report. The term “robust summary” is used to 

3633 describe the technical information necessary to adequately describe an experiment or study and 

3634 includes the objectives, methods, results, and conclusions of the full study report which can be 

3635 either an experiment or in some cases an estimation or prediction method. Guidance for the 

3636 compilation of robust summaries is described in a document entitled “Draft Guidance on 

3637 Developing Robust Summaries” which is available on-line at: 

3638 http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm. 

3639 (1) The final report on toxicity to freshwater invertebrates of sediment-associated 

3640 contaminants shall be received by EPA by (12 months after the relevant effective date in 

3641 paragraph (k) of this section). 
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3642 (2) The final report on Laboratory soil toxicity and bioaccumulation tests with the 

3643 lumbricid earthworm Eisenia fetidaand the enchytraeid potworm Enchytraeus albidu shall be 

3644 received by EPA by (12 months after the relevant effective date in paragraph (k) of this section). 

3645 (3) The final report on toxicity to polychaetous annilids of sediment-associated 

3646 contaminants shall be received by EPA by (12 months after the relevant effective date in 

3647 paragraph (k) of this section). 

3648 (4) The final report on toxicity to nematode Caenorhabditis elegans of sediment3649 associated contaminants shall be received by EPA by (12 months after the relevant effective date 

3650 in paragraph (k) of this section). 

3651 (5) The final report on toxicity to estuarine and marine invertebrates of sediment3652 associated contaminants shall be received by EPA by (12 months after the relevant effective date 

3653 in paragraph (k) of this section). 

3654 (6) The final report on prenatal developmental toxicity in rabbits shall be received by 

3655 EPA by (12 months after the relevant effective date in paragraph (k) of this section.). 

3656 (7) The final report on two-generation reproductive toxicity with a satellite group for 

3657 body burden shall be received by EPA by (29 months after the relevant effective date in 

3658 paragraph (k) of this section). 

3659 (8) The final report on immunotoxicity shall be received by EPA by (12 months after the 

3660 relevant effective date in paragraph (k) of this section). 

3661 (9) The final report on the neurotoxicity screening battery, acute and subchronic, shall be 

3662 received by EPA by (21 months after the relevant effective date in paragraph (k) of this section). 

3663 (10) The final report on developmental neurotoxicity shall be received by EPA by (21 

3664 months after the relevant effective date in paragraph (k) of this section). 

3665 (11) The final report for the chronic toxicity/carcinogenicity test shall be received by 

3666 EPA by (60 months after the relevant effective date in paragraph (k) of this section). 

3667 (12) The final report for anaerobic aquatic metabolism shall be received by EPA by (60 

3668 months after the relevant effective date in paragraph (k) of this section). 

3669 (13) The final report for biodegradation in anaerobic digester sludge shall be received by 

3670 EPA by (24 months after the relevant effective date in paragraph (k) of this section). 

3671 (14) The final report for photolytic degradation of c-decaBDE in the indoor environment 

3672 shall be received by EPA by (24 months after the relevant effective date in paragraph (k) of this 

3673 section). 

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

3675 (1) December 31, 2012 for manufacturers (including importers) and processors of c3676 pentaBDE and c-octaBDE except as impurities, including c-pentaBDE and c-octaBDE in 
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3677 articles, for any use, and for manufacturers (including importers) and processors of c-decaBDE

3678 except as impurities, including c-decaBDE in articles, for any use except military and 

3679 transportation uses.

3680 (2) December 31, 2013 for manufacturers (including importers) and processors of c3681 pentaBDE, c-octaBDE, and c-decaBDE except as impurities,for any use including c-decaBDE in 

3682 articles, for all uses including military and transportation uses. . 

3683 

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

3685